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a publication of the brit ish pain society

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The NICE Back Pain Issue The controversy discussed

Versatis 5% medicated plaster. Refer to the Summary of Product Characteristics (SPC) for full details on side effects, warnings and contra-indications before prescribing.Presentation: Versatis is a medicated plaster (10cm x 14cm) containing 700 mg (5% w/w) of lidocaine in an aqueous adhesive base. Indication: Symptomatic relief of neuropathicpain associated with previous herpes zoster infection (post-herpetic neuralgia, PHN).Dosage and method of administration: Adults and elderly patients: Use up to threeplasters for up to 12 hours, followed by at least a 12 hour plaster-free interval. Coverpainful area once daily. Apply the plaster to intact, dry, non-irritated skin (after healing of the shingles). Remove hairs in affected area with scissors (do not shave). Remove theplaster from sachet and its surface liner before applying immediately to the skin. Plastersmay be cut to size. Re-evaluate treatment after 2 to 4 weeks. Patients under 18 years: Notrecommended. Contra-indications: Hypersensitivity to active substance, any excipients, orlocal anaesthetics of amide type (e.g. bupivacaine, etidocaine, mepivacaine and prilocaine). Do not apply to inflamed or injured skin (e.g. active herpes zoster lesions, atopic dermatitisor wounds). Warnings and precautions: Should not apply to mucous membranes or the eyes. Plasters contain propylene glycol which may cause skin irritation, methylparahydroxybenzoate and propyl parahydroxybenzoate which may cause allergic reactions.Use with caution in patients with severe cardiac impairment, severe renal impairment or

severe hepatic impairment. In animals, metabolites of lidocaine have been shown to begenotoxic, carcinogenic and mutagenic, with unknown clinical significance. Interactions:No clinically relevant interactions have been observed in clinical studies. Absorption oflidocaine from the skin is low. Use with caution in patients receiving Class I antiarrhythmicdrugs (e.g. tocainide, mexiletine) or other local anaesthetics. Pregnancy and lactation:Do not use during pregnancy or breast-feeding. Undesirable effects: Very common (≥10%): administration site reactions (e.g. erythema, rash, pruritus, burning). Uncommon (>0.1%-≤1%): skin injury, skin lesion. Very rare (<0.01%) but potentiallyserious: anaphylaxis, hypersensitivity. Adverse reactions were predominantly of mild and moderate intensity. Systemic adverse reactions are unlikely. See SPC for full details.Overdose: Unlikely. If suspected, remove plasters, provide supportive treatment (see SPC).Legal classification: POM. Marketing Authorisation number, pack sizes and basic NHS cost: PL 21727/0016, 30 plasters (£72.40). Marketing Authorisation Holder: Grünenthal Ltd, Regus Lakeside House, 1 Furzeground Way, Stockley Park East, Uxbridge, Middlesex, UB11 1BD, UK. Date of text: October 2008. V0320

WORKS WHERE IT HURTS

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Adverse events should be reported. Reporting forms and information can be found at: www.yellowcard.gov.uk.Adverse events should also be reported to Grünenthal Ltd

(tel: 0870 351 8960)

20451_Versatis Ad_Pain Soc_AW:Layout 1 30/1/09 15:34 Page 1

PA I N N E W S AUT U M N 200 9 3

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contentsPA I N N E W S AUT U M N 200 9

regulars4 Editorial6 President’s Message8 From the Honorary Secretary48 Letters to the Editor52 New Members

news10 The British Pain Society meets with Chief

Medical Officer10 New Benchmarks for Pain12 Care Commission looks at Pain and

Palliative Care in Scottish Nursing Homes12 Audit of Pain Services coming your way

soon12 NHS Evidence13 BPS submission to NHS Evidence

Accreditation Consultation Document13-14 British Pain Society Response to Improving

Access to Psychological Therapies (IAPT) 16 The Pain Medicine Subsection of the Royal

Society of Medicine

The Back Pain Issue Official BPS documentation 18 British Pain Society statement on the NICE

Guidelines for the early management of persistent non-specific low back pain

18 Call for an EGM18 Rationale for Extraordinary General

Meeting (EGM) of the British Pain Society20 Open letter to the membership from

Professor Paul Watson, President of the BPS

21 Statement of Chair of EGM21 British Pain Society response to NICE. The

lion has roared: the mouse responds.

The Back Pain Issue The Controversy 22 The NICE Guideline on the Early

Management of Persistent Non-Specific Low Back Pain

25 Back pain, NICE, and evidence28 The application of evidence to clinical

practice29 Evidence-Based Guidelines for

Interventional Pain Medicine according to Clinical Diagnosis- “The Dutch & Belgian Guidelines”

31 A good life33 A NICE Guideline on Back Pain? 36 Manual therapy for back pain? A critique of

the recent clinical guidelines by NICE37 Intervention versus Pain Management? A

Patient Perspective38 Guidelines, Needles and Evidence40 The EGM and the real debate

professional perspectives42 Compassion

changing practice44 Problem-Based Learning (PBL) in Pain

Management46 Pain relieving nerve blocks, to repeat or

not to repeat, that is the question?

pain shortcuts50 High-volume infiltration analgesia in knee

arthroplasty52 Psychosocial predictors for chronic post

surgical pain53 Smoking status predicts non completion of

a pain program53 Treatment of fibromyalgia with

antidepressants is effective

PAIN NEWS is published quarterly. Circulation 1800. For advertising enquiries contact Ms Rikke Warming at [email protected]

The editor welcomes contributions including letters, short clinical reports and news of interest to members including notice of meetings.next submission deadline : 30th October 2009

Material should be sent to: Dr Mike BaslerPAIN NEWS Editor55 Crawford RoadHoustonJohnstone RenfrewshireScotland PA67DA

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pain management programmes might be delivered and the skill mix required for effective delivery (4). It remains to be seen if the proposed CPP programmes will prove effective, and indeed, cost effective. They will require considerable investment in terms of time, training of staff, and resources. We recommend clarification of the exact nature of these programmes.

We cannot agree with the exclusion of all injections for back pain. The BPS provided evidence to support the clinical effectiveness of such procedures. The Guideline Development Group (GDG) did not consider evidence presented from cohort studies and clinical case series in its deliberations on these, or any other, treatments. We think this was misguided. Although NICE has recommended further research into these procedures, we are most concerned that a significant number of patients will be denied this choice of treatment in the interim.

The recommendation for early consideration of spinal surgery causes us great concern. No alternative is provided for those who do not wish to have an operation or who are unsuitable for surgery. It is anticipated that surgery will only be appropriate for a very small number who fulfil specific indications. Surgery is an irreversible step with an acknowledged failure rate. We feel strongly that the opinion of a Pain Management Specialist should be offered to all patients before

consideration of surgery. The treatment of back pain is complex and has to be individualised; one size does not fit all. Application of these guidelines to all those with persistent low back pain will result in a major change in clinical practice, which in the opinion of the Council of the BPS, will not represent good or appropriate patient care.

The Council of the British Pain Society recommends withdrawal of these guidelines.

1. Sir Michael Rawlins. Statistics can help, but doctors must also use their judgement. 2008; Independent News and Media.

2. Recommendations for the appropriate use of opioids for persistent non-cancer pain. British Pain Society, 2005, revision in press, expected September 2009

http://www.britishpainsociety.org/pub_professional.htm#opioids

3. Jensen MK. 10-year follow-up of chronic non malignant pain patients: opioids, health related quality of life and health care utilisation. Eur J Pain 2006;10(5):423-33

4. Recommended guidelines for pain management programmes for adults. The British Pain Society 2007 http://www.britishpainsociety.org/pub_professional.htm#pmplts

This is a consensus statement from the Council of the British Pain Society. June 10th 2009

The NICE Back Pain debate

British Pain Society statement on the NICE Guidelines for the early management of persistent non-specific low back pain

In view of the extraordinary nature of the last few months’ events it is important that a dispassionate view of the issues is presented to the membership. This section of Pain News is a collection of articles that summarise some of the key issues. It is hoped that with greater understanding of where and why we came to this position, the BPS will be able to move forward and continue as the pre eminent multidisciplinary society representing the interests of all aspects of pain management. It will therefore continue to go from strength to strength for the benefit of patients and practitioners.

Initially key documents will be presented to give an understanding of the process that occurred. After this the commentary on events, by several authors will be presented.

The British Pain Society, which represents the views of over 1,500 healthcare professionals from a variety of disciplines involved in the active management of chronic pain, has serious reservations about the NICE low back pain guidelines published May 2009.We acknowledge the high cost of low back pain, both in terms of suffering, loss of individuals to the workforce and the financial burden of treatment. We also recognise the complex nature of low back pain as a biopsychosocial disorder, and do not believe that it can be adequately assessed by using evidence from randomised controlled trials within a limited scope. Professor Sir Michael Rawlins (October 2008) advises that decision makers should incorporate judgements in reaching their conclusions (1). We do not believe that judgement has been applied fairly or appropriately in these guidelines. The guidelines specifically target those suffering pain between 6 weeks and 12 months. They are not applicable to all other types of low back or radicular leg pain. We are concerned that this is not made absolutely clear and that

BACK PAIN - OFFICIAL BPS DOCUMENTATION

commissioners and purchasers of services will apply the guidance to all back pain patients. We applaud the recommendation for people with low back pain to exercise and remain physically active, and to undergo an exercise programme. However, the inclusion of acupuncture and manual therapy as first line treatments has received a great deal more publicity and will have to be carefully controlled if the suggested modest costs of these treatments are to be realised. We welcome the recommendation that patients who may require strong opioid medication should be referred to a pain specialist (2). Long term use of opioids is not to be encouraged (3).

We also welcome the prominence given to the early provision of combined physical and psychological (CPP) programmes (similar to Pain Management Programmes) for patients who are distressed by their pain. The guidelines recommend that CPP programmes should be intensive; 100 hours over a maximum of 8 weeks. The BPS has published guidance on how



considering the known harms of acupuncture [8].

What might be more relevant is previous research indicating that targeting level of care to severity [9] is the best approach.

What we are left with, though, is a conclusion that acupuncture is no better than a toothpick.

And surgery?Lumbar discectomy is a common procedure for patients with persistent back and leg pain, particularly if it is unresponsive to non-invasive conventional therapies. Surgery tends to be of two types, a more aggressive approach involving removal of herniated disc fragments and curettage of the remaining disc, and a less invasive technique involving removal of fragments alone with little invasion of the disc space.

Issues with surgery involve shorter and longer term pain persisting, and injury to the disc and endplate of the vertebrae, with accelerated degenerative changes, disc space

collapse, and potentially more or worse back and leg pain.

A systematic review of case series [10] reported outcomes after limited and aggressive discectomy for primary lumbar disc herniation reported incidence of persistent pain in the shorter (6 months to two years) and longer term (more than two years), or recurrent disc herniation. Persistent pain affected 14% of patients (1 in 7) between six months and two years (Table 2). In the longer term, over two years, the incidence of persistent pain was much lower with limited discectomy (12%; 1 in 8) than after aggressive discectomy (28%; 1 in 4). The incidence of recurrent disc herniation was much lower with both techniques, at 7% after limited discectomy and 3.5% after aggressive discectomy, averaging 1 patient in 20.

Perhaps the most useful result is that it provides evidence of the success and failure rate with lumbar discectomy for leg or back pain. Most people, it would appear, have pain reduced to a point of

not being clinically relevant, which is good. Some (between 1 in 8 and 1 in 4) will have persistent pain despite the surgery, and 1 in 20 will have recurrent herniation, potentially very bad news because it could lead to further problems.

It is possibly not entirely fair to make too many decisions about the type of surgery that is best, because as always with case series there is a host of reasons why results may be different, typically because of differences in case mix and initial pathology and severity. What we have is some numbers to put to patients considering surgery so that they can make an informed decision. The numbers we have put considerable weight on trying

non-invasive, or less invasive, interventions before resorting to surgery.

Lessons?Effective pain management is about more than the efficacy and harms of particular interventions. It should be about integrating effective interventions into an overall package of care, which might need individualising for particular patients with particular problems, concerns, or aspirations. It is, above all, about wisdom and common sense.

These are areas where evidence cannot easily go, but where so much of the real world exists. It’s what professionals do every day, and it the role of those who are

Figure 1 Effects of acupuncture in a randomised trial in low back pain with 638 participants. Percentage at 52 weeks with ≥3/24 point reduction in Roland Morris Disability Questionnaire, and ≥2/10 point reduction in Bothersomeness index

Figure 2 An example pain ladder that might be amended for use in back pain drug therapy

Table 2 Outcomes after limited or aggressive discectomy for back or leg Pain

Outcome Number of patients

Range (%)

Overall incidence

(%)

Limited discectomy

Persistent pain (6 months to 2 years)

1434 7-26 15

Persistent pain (more than 2 years)

3263 7-16 12

Recurrent discherniation 5832 2-18 7

Agressive discectomy


4242 6-43 14


1571 19-36 28

Recurrent discherniation 6114 0-10 3.5


of Bandolier, the on-line journal of EBM, also raises concerns in this issue. The council of the BPS voted for its withdrawal as did the Faculty of Pain Medicine of the Royal College of Anaesthetists..

The costings report states that at present there are 1,000 places a year available on CPPs. They estimate that this will need to go up to 3,500 places a year (the practicalities of this are unclear).This is only 1 per cent of patients of those treated.. And yet surely ALL of those patients with disability or significant psychological distress should go on a proper PMP or CPP. That is more likely to be 35,000 (10 per cent of the total). The total number is possibly nearer to 100,000, based on the number of patients developing chronic back pain every year.

In its economic analysis NICE assumes that 95% of all interventions will stop. This was apparently formulated by NICE with “an Orthopaedic Surgeon” on the assumption that everyone would get better after the guidelines had been put in place and thus would not need treatment in Pain Clinics at any stage. In particular, there would be no place for injections AFTER 1 year, as they would all be better. This is wildly speculative and unlikely. This includes interventions for spondylosis and intravertebral disc prolapse, which were specifically excluded at the beginning of the guidelines (page 4) as specific causes of low back pain. So the savings of £33,000,000 on injections per year are not credible. Even if the interventions that some of us value, and which are not discussed in the report (e.g. epidural steroids for sciatica) are excluded, stopping facet joint radiofrequency (saving only £1.5 million) and half of the rest (saving £16,000,000) doesn’t pay for the other treatments. Sadly, local health care commissioners are urged to implement these costings, meaning vast amounts of Pain

Clinic funding for useful, validated treatments, might be stopped.

Again the estimation is that £11,800,000 million will be saved on MR scans. The point of an MR scan is to diagnose a specific treatable problem and therefore these will have to be done in order to implement the guidelines at the beginning, and at the end, when considered for surgery. So once again we have very odd looking and unrealistic costings.

The guideline states that the NHS cost of treatment for low back pain is a thousand million pounds (£1,000,000,000) per year. It is interesting to reflect that injection therapy only accounts for 3.5 per cent of this. Where does the rest of the money go?

To me one really upsetting thing about the guideline is that it proclaims patient choice, and then denies it. It seems millions will get no treatment, and some will be denied treatment that really might work. Perhaps patients should be asked if they would prefer 9 manipulation sessions, followed by 10 acupuncture sessions, OR one single injection from a pain specialist (similar costings), not both, and they could decide what they wanted, rather than have the decision forced on them..

It is important to consider that this is unlike any other guideline, anywhere else in the world. This is now Government policy, to be implemented (see NICE website, slideshow notes - “implementation of this guidance is the responsibility of local commissioners and/or providers) The costings, both national, and for communities of 100,000, allow

funding of manipulation and acupuncture at the expense of MR investigations and most injections.

See www.nice.org.uk/nicemedia/pdf/CG88CostReport.pdf.

The obvious result of the guideline, if accepted by purchasers, is that very few, if any, patients with back pain will be sent to pain clinics. What does the pain clinic offer that is in the guideline? No PMP, blocks or TENS is funded, perhaps just some assessment for opioid use. So if this hefty slice of funding is removed from pain clinics, how will they survive? What will happen to the staff working in them? In this respect, the guideline threatens the existence of pain clinics. It concerns me greatly that Service Commissioners (PCTs) are encouraged by the costings to remove funding from established Pain Clinics for all patients with LBP at ANY time (not just up to 12 months). The reassurances that have been offered in this respect so far are wholly inadequate. Removal of funding for Pain Clinics which have been slowly and carefully built up to serve local communities and into which we have put our great efforts and careers is nothing short of vandalism.

There are many factors involved in the production and maintenance of LBP, which as we all recognise, is the ultimate bio-psycho-social disorder. How sad then, that the NICE guideline does not cover the proper assessment of the patient, but moves straight on to treatment, with the assumption that all LBP is non-specific (although it also says it can come from the

discs and joints, muscles and ligaments). Although the guideline exhorts the treater to review the diagnosis, it precludes hospital assessment in multidisciplinary Pain Clinics by experienced Clinicians and Psychologists. Assessment and management is left in the community, in the hands of GP’s, Physiotherapists, Acupuncturists and Chiropractors, rather than hospital teams. Some will be well-versed in assessment, many will not. Every patient I see with LBP has already seen a physiotherapist, and had exercise guidance. The majority have had some form of manipulation, and nearly half, acupuncture. The excellent physiotherapists I work with are glad I am available, just as I welcome their earlier interventions, which I know help many. All of us know that none of us have all the answers. The guideline is based on evidence that shows the treatments offered will produce a small to no effect at the end of 12 months. At the end of their treatment, patients are simply cast adrift. Very little chronicity will be prevented, and they will then have nowhere to turn.

NICE suggests that the guideline is evidence-based, many believe it is flawed. The GDG demonstrated a strong professional selection bias and that has resulted in an unscientific, almost predictable guideline. There are many calls for NICE to withdraw the guideline and to reconsider the wider consequences. I would urge that the guideline is suspended before real and irreparable damage is done to the country’s health, our services, our future patients and NICE itself.


and Articles of Association (2)). This explicitly acknowledges that Members (who then become eligible for election as officers, such as President) are engaged in activities and interests. In practice this makes it inevitable that office-holders will take on a variety of professional roles in the course of their everyday working lives. Historically, BPS presidents have generally had multiple roles that embrace clinical, academic/teaching, and research aspects of the pain field.

When this resolution was passed it effectively signalled that officers of the BPS (and therefore it’s members) should abstain from participating in many professional activities including those such as expert panels, scientific committees, guideline development groups, think-tanks, other advisory roles, etc, etc. Such a constraint could be considered highly detrimental to advancing the pain field. Furthermore, it would favour election of officers who had no other professional roles, or any wish to participate in such. This would be inconsistent with the objectives of the BPS, and potentially establish an unfortunate precedent for other IASP chapters to emulate.

Hence, the argument that BPS officer-holders should not engage in the provision of clinical and scientific advice to the best of their abilities is unsupportable.

3. Was the Resolution supported on scientific or epistemological grounds?

The process by which clinical guidance is developed can often be complex, and resource-intensive. It is frequently a thankless task for those involved. There now exist reasonably sophisticated guideline development approaches, based on international collaborations such as the Guidelines International Network (www.g-i-n.net), of which NICE is a member. Epistemology recognises that derivation of absolute scientific

truths is rare, or arguably improbable. This means clinical guidance and descriptions of ‘best clinical practice’ inevitably evolve and progress as scientific knowledge becomes available. The idea of a guideline with ‘all the answers’ is scientifically naïve. Guidance summarises the best available evidence.

It has long been recognised that replication of results is a fundamental tenet of the scientific method. For clinical guidance, it is always important to review these documents within the context of other clinical guidance. There are multiple LBP guidelines available from around the world. These contain many similarities, and some differences. A noteworthy recent addition was the publication in May 2009 of a clinical practice guideline by the American Pain Society and the American Academy of Pain Medicine (4-6). This LBP guideline is notable for emphasizing “the use of non-invasive treatments over interventional procedures, as well as shared decision-making between provider and patient”.

This highly contemporaneous guideline is notable for three reasons. First, that it is based on a comprehensive evidence review (7). Second, that it is published, and therefore fully endorsed, on behalf of the APS (an IASP chapter, just like the BPS). Thirdly, that the conclusions and recommendations are congruent with the recent NICE guidance.

In summary, the resolution cannot be supported on the grounds of BPS rules, or for professional or scientific reasons. Of great importance is the need to maintain a clear focus on debating issues, instead of individual participation. Professor Watson is clearly an individual who has contributed significantly to the BPS. To force his resignation from the presidency over this issue has detracted significantly from the purpose and standing of the BPS, and subsequently from IASP. More importantly it delivered the noble

purposes of our Society into the hands of those who wish to lobby for their particular cause without engaging in a well-reasoned debate on issues of significant import.

4. Will the NICE guidance be modified or withdrawn after the Resolution was passed?

It is possible to raise any number of arguments about the utility of all available pain management techniques. This debate is healthy, and must continue. However, it should not become one devoted to tackling a fictitious ‘straw man’, whereby groups posit themselves as ‘interventionists’ against ‘non-interventionists’. It is timely to recall the wisdom of the statement attributed to Issy Pilowsky when describing the pain management field: “We are condemned to live in a house of many paradigms”. Several decades ago we came together as an interdisciplinary group, dedicated to understanding pain as a complex problem, so

that we can help our patients. It has been a long and hard-fought battle for recognition.

In my humble opinion, the resolution damaged only the BPS, its members, and the patients we serve. Clearly, it will not alter the current NICE guidance. This means those who proposed it will have gained nothing toward their objective, other than casting themselves as a group with something of a vindictive agenda. Sadly, the Society would is the loser, and then its members, and their patients. For this reason I urged the resolution to be withdrawn. Let’s return to the real debate: what is effective to help our low back pain patients experience less pain, distress, and disability?

“I disapprove of what you say, but I will defend to the death your right to say it”

Voltaire, 1694-1778

The opinions expressed in PAIN NEWS do not necessarily reflect those of the British Pain Society Council.

BPS CouncilProf. Sir Michael BondInterim PresidentDr Joan B HesterImmediate Past PresidentDr William CampbellHonorary SecretaryDr Pat SchofieldHonorary Secretary ElectDr Peter EvansHonorary TreasurerDr John GoddardHonorary Treasurer Elect

Elected members of CouncilDr Nick AllcockDr Eloise CarrDr Dave CounsellDr Sam EldabeDr Edward LinDr Mick SerpellDr Thanthullu VasuDr Stephen Ward

SecretariatMs Jenny NicholasSecretariat ManagerMr Ken ObbardEvents Co-ordinatorMs Rikke WarmingAdministrative & Development Co-ordinator

COVER STORYCo-opted members of CouncilProfessor Sam AhmedzaiRepresentative of the Association for Palliative MedicineDr Mike BaslerHonorary Editor, British Pain Society NewsletterMr Neil BerryRepresentative: PsychologyMs Heather CameronRepresentative: Physiotherapy Dr Beverly CollettRepresentative of the International Association for the Study of Pain (IASP)Ms Felicia CoxHonorary Co-editor, Reviews in PainProfessor Chris EcclestonChair, Scientific Programme Committee Professor Maria FitzgeraldRepresentative: Science Dr Roger KnaggsRepresentative: PharmacyDr Roger LaishleyRepresentative: Faculty of Pain Medicine, RCoAMs Celia MansonRepresentative: Royal College of NursingDr Michael PlattHonorary Co-editor, Reviews in PainMrs Nia TaylorChair, British Pain Society Patient Liaison CommitteeMs Suzy WilliamsRepresentative: Occupational Therapy


Mike Basler

“It was the best of times, it was the worst of times, it was the age of wisdom, it was the age of foolishness, it was the epoch of belief, it was the epoch of incredulity…”

Opening line of A Tale of Two Cities by Charles Dickens

A few months ago Sir Liam Donaldson showed how keen he was to support pain services, and the British Pain Society (BPS) by addressing our Annual Scientific Meeting at Sandown Park. In a short space of time thereafter, the society had to call an extraordinary general meeting leading to the resignation of the president of the society. After this the BPS was denounced on the BMJ as being “non evidenced based” by the president of NICE Sir Michael Rawlins.

How did we get here?

I have to place my cards on the table here (or conflict of interests) and say that I was a critic of the guidelines but also voted for the retention of the president. Let me also say that this editorial is my personal view, not councils, and I am a co opted, not elected,

member of council. This editorial may just confirm my ignorance and feel free to bin this or more importantly reply, to correct any obvious stupidity.

The NICE guidelines on back pain (in the first 12months) were always going to cause controversy. Anyone who has been a member of the BPS for any significant length of time will know that the evidence base for any intervention is poor and that back pain is hugely complex. The fact that there are a multitude of published (randomised or not) controlled trials of treatments for low back pain means that it was unlikely any one stakeholder would have the answers and that NICE should have tempered its conclusions. This did not occur.

As well as this, the fact that the BPS has been actively involved with NICE as a stakeholder for several years and has contributed to many guidelines, meant that a difficult balance would have to be achieved. Professor Watson’s position on the guideline group was always going to be one of contention due to the lack of evidence and the inflexibility of the NICE process which has been apparent for a long time (See Jon Raphael and Simon Dolan’s

From the Editor article in the spring 09 edition). Bandoliers little book of pain is exactly that – a little book. NICE essentially only examines grade 1 evidence and then when it actually needs to address a much larger real world issue, it lets a representative expert take a grade 4 hit. Grade 2 and 3 evidence (the old fusty stuff that used to appear in journals and was the subject of many an argument and occasionally put in the systematic review blender) is consigned to the “full of bias” black hole. That is not necessarily wrong; it is just that you leave yourself wide open to criticism if you give more weight to expert consensus. The Grade 2/3 evidence and the underpowered trials of our forefathers were less likely to come from drug or equipment companies and more likely to have real world patients. The word systematic review does not necessarily equate with good science.

In essence Prof Watson has been judged for staying on the NICE Guideline Development Group and supporting the guidelines. He may have also been dammed for not representing BPS concerns if he had left. I have no doubt he may hold beliefs that I do not agree with but the council, under his leadership, and other stakeholders had written a “robust” and well argued case for modification of the guidelines which was submitted to NICE. This was rejected by the GDG not Prof Watson.

After the guideline release the Faculty of Pain Medicine published an open letter on its website asking for the withdrawal of the guideline. Representations were being made, letters were being written and much thought was being given to an appropriate response. In my personal opinion Prof Watson and council did their best to take a reasonable approach to managing them all.

A letter outlining concerns was produced and the BPS called for the guidelines to be withdrawn and reassessed. Unfortunately following this a resolution was put forward which, due to the vagaries of charity law, would have to be debated. We now know the consequences.

Key to this debate is the idea of the effectiveness of any intervention. Most of the evidence examined was based on trials, carried out mainly in single centres, with variable cohorts (many not UK based) and treatments that may not be representative. Few, if any of these trials were ever repeated. We need evidence not only of efficacy but also of effectiveness. The efficacy of an intervention is the degree to which the desired health outcomes are achieved in the best possible circumstances. The effectiveness of an intervention is the degree to which the desired health outcomes are achieved in clinical practice (1). There is a history in anesthesia practice that a powerful effect observed in a study with a “small” sample size ( in relation to its population cohort) carried out in a single center in which efficacy has been demonstrated (2) does not necessarily translate into similar effects in a larger multicenter trial examining the effectiveness of an intervention(3).

How many of the longstanding back pain debates are related to these based on interventions which have only been subject to a few RCT’s? How many debates, however interesting, have been contested over poor evidence that only followed cohorts


for a very short time? Henry Kissinger once remarked –“The reason university politics are so intemperate is the fact that the stakes are so small”. In this case the evidence was small but the implications could be big. There was also considerable controversy over whether the interventions promoted actually had any evidence of clinical effectiveness. Unlike the usual concerns, of a clinically effective treatment which NICE deems as being not cost effective, we had the opposite situation. Treatments were being given NICE approval where there was still considerable debate over the clinical effectiveness of the therapy but, due to the high prevalence of the problem, the NICE economic computer said yes. Probe into the evidence considered and many of the trials “were at a high risk of bias” but recommendations occurred on the basis of both group consensus and submission by stakeholders. If fully implemented a dramatic sea change on the management of back pain, with a whole host of other knock on effects, may have occurred on the basis of very poor evidence and some academic economic modelling. Cash strapped PCTs, and trusts with long waiting could have been listening. Anyone trying to improve their secondary care services may have come up against this guideline.

More importantly, NICE has done nothing to counter the widespread misinformation of the guidelines in the media, even in its own publication. Consider its website which says – “This guideline is about the care and treatment that people who have persistent non-specific low back pain can expect from the NHS in England and Wales to help them manage their pain.” This is not the case. The guideline has specific limitations and to most individuals “patients with persistent low back pain” is a much wider cohort. This certainly did not help Professor Watson counter some of the anger and vitriol put forward. The media representation (that

this was the first NICE green light for complementary therapy) was disingenuous and happily pushed by some vested interests. The practicality of the guidance was also at issue. How was the 100 hours of combined physical/psychological therapy in 8 weeks to be achieved? This evidence was based on 2 RCTs (11 were considered) and the treatment was not a pain management programme. The systematic review quoted, by Guzman (4), has also been the subject of controversy and debate (5). As stated many of the cohorts examined were not from the UK. What about the social context of this biopsychosocial model? Who was to do and what was to be the “manual therapy” and “acupuncture” provided? In governance terms what standards were to be put into place to prevent the abuse of both NHS funds and a vulnerable group of patients? Given the recent furore, in relation to chiropractic claims of treatments for asthma and infantile colic (6) this was a very real concern.

Much of the fury in relation to the guidelines related to the deemed “specific targeting of facet joint injections”. The guidelines made decisions based on consensus and so there is a concern that the lack of input from someone who could defend (or not) the evidence was, in my opinion, a mistake. The BPS council put forward good candidates and was ignored by NICE (not Professor Watson). That is not saying the evidence for invasive treatments is not subject to as much controversy as any other. Anything short of a good RCT would not get anywhere with NICE and the criticising the evidence of efficacy for facet joint injections is reasonable. I, like many others, can find a facet joint or relevant nerve easily enough. From my time in Oz I also know that Nick Bogduk would take a considerable period of time with saline and local anaesthetic to determine whether the joint was involved. It looked to me then,

and there has been no new evidence to change my mind, that there are only a small proportion of people in the back pain cohort who will actually get benefit from an RF needle, but they do exist. You can only cry wolf once and I would suggest that now the issue has been highlighted, and to move the debate forward, a well designed trial may need to be done. We still have a very long way to go in the understanding and treatment of back pain on all fronts, invasive or otherwise.

Professor Watson, after some personal reflection, might have been the right person to bend the ear of the Medical Research Council and possibly even chair a few difficult meetings, knock a few heads together, and start on the road to get some important questions examined. Our intensive care colleagues talk of “care bundles”. Could we not have researched “pain bundles”? It was not to be. We are in the fortunate position of having someone of the stature and wisdom of Prof Sir Michael Bond to stand in at the present moment in time. Whatever the society needs it is not the shrill voice of any zealot. The strength of the society has always been its multidisciplinary, tolerant and inquisitive nature. We need a President who is an individual of stature to stand up against a host of vested interests for good clinical evidence and practice.

EBM is like money- a good servant but a bad master. If Sir Michael Rawlins looks through this newsletter (not journal) and see carefully considered contributions of many to this debate, I would hope that he may view the BPS in a different light.

A Tale of Two Cities is the most printed original English literature book. It is the study of several protagonists dealing with disappointment and chaos of a revolution who ultimately find resolution through sacrifice, leading to a new dawn. I won’t tempt fate rather I will leave the last word to Dr Joan Hester who

sent an email in relation to all of this which ended with the following.

“It has always been a feature of pain management; battling against the odds.

Perhaps nothing changes really.”

Wise words.

Mike Basler [email protected]

REFERENCES

1. Gray JAM: Evidence Based Healthcare, 2nd edition. Edinburgh, Churchill Livingstone, 2001, pp 169-242

2. Yeager MP, Glass DD, Neff RK, Brinck-Johnsen T: Epidural anesthesia and analgesia in high risk surgical patients. Anesthesiology 1987; 66:729-36

3. Rigg JRA, Jamrozik K, Myles PS, Silbert BS, Peyton PJ, Parsons RW, Collins KS: Epidural anaesthesia and analgesia and outcome of major surgery: A randomised trial. Lancet 2002; 359:1276-82

4. Guzmán J, Esmail R, Karjalainen K, Malmivaara A et al. Multidisciplinary rehabilitation for chronic low back pain: systematic review. BMJ. 2001; 322 (7301):1511-151.

5. Price C, Williams A. Rehabilitation for chronic low back pain (rapid response); BMJ Nov 2001; 323: 1251.

6. Ernst E. Chiropractic for paediatric conditions: substantial evidence? BMJ 2009;339:2766.


T h e B r i T i s h P a i n s o c i e T y The British Chapter of the International Association for the Study of Pain

Third FloorChurchill House35 Red Lion SquareLondon WC1R 4SG

T +44 (0)20 7269 7840 F +44 (0)20 7831 0859

E [email protected] W www.britishpainsociety.org

An alliance of professionals advancing the understanding and management of pain for the benefit of patients

A company registered in England and Wales and limited by guarantee. - Registered No. 5021381 - Registered charity No. 1103260

A registered charity in Scotland – Registered No. SC039583

4th August 2009

To all members of the British Pain Society

I think you will be aware that after an EGM last week Paul Watson resigned as President of the Society. I have been asked by the Council to act as the Interim President and I have accepted on the condition that the position will last only as long as is needed to ensure that the business of the Society is managed through this period of crisis and a substantive President is appointed.

Paul’s resignation was a shock to many and occurred as a result of a vote which censured him for being the Clinical Advisor to the NICE Guidelines Development Group, which recently produced a highly contentious guideline on the treatment of low back pain whilst at the same time he took on the role of President of the Society. Paul’s position was judged strongly by some to be a conflict of interest. This is not the occasion to discuss pros and cons of this view but it is regrettable that the problem could not have been solved in another way. There is no doubt that many in the Society have a high regard for Paul’s professional expertise, his personal integrity and the great contribution he has made to the work of the Society and it has to be said that comments in the public arena which vilify Paul are both unprofessional and totally unacceptable.

This is a difficult and turbulent time for the Society with emotions running high amongst some members. It should be borne in mind however, that the Society was critical of the NICE report. It said publicly that it should be withdrawn and that further evidence should be gathered to enable a better evidence-based set of guidelines to be developed. That and other issues arising from the publication of the report and from Paul’s resignation are being addressed by the Council and the day to day business will go forward as usual.

At this time of high emotion, we should remember that for good pain management we need the skills of all professional groups dealing with patients in pain. For many years now, we have been a multi-professional Society which flourishes through its ASMs, publications, liaison with government, with patients and other means and this must remain our position.

I sincerely hope that all members will continue to give their support to the Society and not withdraw from membership. This is a difficult and unpleasant period in the long life of the Society but it will pass and the need for our joint contributions will be as strong as ever for many years to come.

Michael BondInterim President

As many of you will have seen, in the interests of transparency, the Society has made available additionalinformation concerning the EGM, and official responses, on its website for Members. In due course, theminutes from the EGM will also be posted here. To view this information, please go to:http://www.britishpainsociety.org/secure/members_articles_submenu.htm. You will need your username(surname) and password (membership number) to view these pages.

INTRODUCING NEW ABSTRAL

CHANGING THE FACEOF BREAKTHROUGH CANCER PAIN

Abstral®� 100 micrograms, 200 micrograms, 300 micrograms, 400 micrograms, 600 micrograms and 800 micrograms Sublingual Tablets (fentanyl)

Abbreviated Prescribing Information Please refer to Summary of Product Characteristicsbefore prescribing. Presentation Sublingual tablets containing 100µg, 200µg, 300µg, 400µg,600µg and 800µg of fentanyl. Indication Management of breakthrough pain in adult patientsusing opioid therapy for chronic cancer pain. Dosage and Administration Only for use inpatients who are considered tolerant to their opioid therapy for persistent cancer pain (i.e. using60 mg oral morphine per day or 25 micrograms transdermal fentanyl per hour or equivalent).Administer directly under the tongue and allow to dissolve without chewing, sucking orswallowing. Adults: Initially 100µg, titrating upwards as necessary. Patients must be monitoredclosely by a health professional during the titration process. Once an appropriate dose hasbeen established patients should be maintained on this dose and should limit consumption toa maximum of four doses per day. Elderly and patients with renal and hepatic impairment:Special care needed in titrating elderly patients and patients with kidney or liver dysfunction;observe for signs of fentanyl toxicity Children and adolescents: Must not be used in patientsless than 18 years of age. Contraindications Hypersensitivity to any of the ingredients; opioid-naïve patients; severe respiratory depression or severe obstructive lung conditions. Warningsand Precautions Instruct patients and carers to keep tablets out the sight and reach ofchildren. Ensure patients and carers follow instructions for use and know what action to takein case of overdose. Before starting Abstral, ensure long-acting opioid treatment for persistentpain is stable. Dependence may develop upon repeated administration of opioids. Risk ofclinically significant respiratory depression. Particular caution needed during dose titration inpatients with COPD or other conditions predisposing to respiratory depression. Administerwith extreme caution in patients who may be particularly susceptible to the intracranial effectsof hypercapnia. Opioids may mask the clinical course in patients with head injuries. Use withcaution in patients with bradyarrhythmias, hypovolaemia, hypotension, mouth wounds ormucositis. Monitor carefully use in elderly, cachectic and debilitated patients. Possiblesymptoms of withdrawal on cessation are anxiety, tremor, sweating, paleness, nausea andvomiting. Interactions Fentanyl is metabolised by CYP3A4. Use with caution if givenconcomitantly with CYP3A4 inhibitors such as macrolide antibiotics, azole antifungal agents,protease inhibitors or grapefruit juice. Concomitant use of other CNS depressants, such asother morphine derivatives, general anaesthetics, skeletal muscle relaxants, sedative

antidepressants, sedative H1 antihistamines, barbiturates, anxiolytics, hypnotics,antipsychotics, clonidine and related substances may produce increased CNS depressanteffects. Respiratory depression, hypotension and sedation may occur. Concomitant use ofalcohol or partial opioid agonists/antagonists (e.g. buprenorphine, pentazocine) is notrecommended. Not recommended for use in patients who have received MAO inhibitors within14 days. Pregnancy Safety in pregnancy not established. Use only when necessary. Long-term treatment may cause withdrawal symptoms in newborn infant. Do not use during labourand delivery since fentanyl crosses the placenta and may cause respiratory depression infoetus or infant. Lactation Fentanyl is excreted into breast milk and should only be used if thebenefits clearly outweigh the potential risks for both mother and child. Driving, etc Fentanylmay impair mental or physical ability. Advise patients not to drive or operate machinery if theybecome dizzy, drowsy or experience blurred or double vision. Undesirable Effects Typicalopioid side-effects are to be expected. The most serious adverse reactions are respiratorydepression, hypotension and shock. The most commonly reported adverse reactions includenausea, vomiting, constipation, headache, somnolence/fatigue and dizziness. See SPC fordetails of these and other undesirable effects. Overdose: Immediate management includesremoval of any remaining tablets from the mouth, physical and verbal stimulation and anassessment of the level of consciousness. A patent airway should be established andmaintained, and assisted ventilation initiated if appropriate. Adequate body temperature andparenteral fluid intake should be maintained. Consider the use of opioid antagonists. PackSize and Basic NHS Price: Abstral 100-400µg 10 tablets: £49.99 Abstral 100-800µg 30tablets: £149.70. Marketing Authorisation Numbers: PL 16508/0030-35. Legal category CDPOM. Further information is available from the Marketing Authorisation Holder ProStrakanLtd, Galashiels, TD1 1QH, UK Date of PI Preparation September 2008.

M017/0190Date of preparation: July 2009

Adverse events should be reported. Reporting forms and information can be found at www.yellowcard.gov.uk.

Adverse events should also be reported to ProStrakan Ltd on 01896 664000.

Effective relief when it matters

TM

Abstral PAIN 210x285-Pain News:Layout 1 29/07/2009 15:36 Page 1


Dr WilliaM CaMpBell

Extraordinary General Meeting On Wednesday 1st July 2009 a letter supported by 25 signatures was received at The British Pain Society’s office in Churchill House, London as follows:

“We, like many others across all disciplines in the British Pain Society (BPS) have been greatly concerned by the publication of the NICE Guidelines on Low Back Pain.

We consider these to be flawed and commend the Council of the BPS for their condemnation of the said Guidelines.

The fact that a member of the Guidelines Development Group (GDG), Professor Paul Watson, continues to serve as President of the BPS sends mixed and confusing signals to NICE, to Parliament, to Hospitals and FPCs, to the Press and to the Public at large.

We would thus urge Professor Watson to stand down as President.

We call for an Extraordinary General Meeting of the BPS to debate the Guidelines, our response and should Professor Watson refuse to resign with immediate effect, to vote on the following motion.

In view of his involvement with and the continued endorsement of, the NICE Guidelines on Low Back Pain, the President of the BPS, Professor Paul Watson, should resign.”

As laid down by our Memorandum & Articles, following a request for an Extraordinary General Meeting by 24 or more members, we must convene such a meeting within 28 days, but no sooner than 14 clear days after receipt of the request

for such a meeting. Proxy voting by members in good standing was permitted by those members unable to attend in person, again as per our Memorandum & Articles. All members were contacted by first class post on the 3rd July, with details of the meeting, together with proxy voting papers, as recommended by our professional advisors in Charity and Company law – Independent Examiners. A statement by Professor Paul Watson followed in a separate mailing as it was unavailable until several days later.

The Extraordinary General Meeting was held on the morning of Tuesday 21st July 2009 at the Association of Anaesthetists of Great Britain & Ireland, London as this date suited the necessary time frame and Professor Paul Watson. I was unable to attend as Honorary Secretary, therefore Dr John Goddard agreed to Chair the meeting. 46 members of The Society attended the meeting in person with 332 present by proxy.

A presentation was made by Dr Philip Alderson, Associate Director, Centre for Clinical Practice, NICE with regard to NICE processes. This was followed by presentations by Dr Chris Wells and Professor Paul Watson and discussion from the floor. A suggestion was made to adjourn the meeting because it was considered that not all members of the Society had had the opportunity to hear the presentations and be fully informed. The Chair proposed that a timely independent secret ballot should be held. The majority view of members present was that most members who had voted by post were fully appraised of the issues involved and that a vote upon the Resolution should be taken. The Chair acceded to this view. There were186 votes in support of the Resolution and

From the Honorary Secretary

179 opposing the Resolution. The President, therefore, indicated his intention to tender his resignation forthwith and this was received in writing one week later. For further details please see the British Pain Society website.

A teleconference was held by Council on 24th July. As per the Memorandum and Articles Council may appoint a member of The Society when a Council vacancy arises. None of the current Council wished to take on the post of Interim President. It was suggested that as a past President of The Society and a recently co-opted member of Council (having been President of the International Association for the Study of Pain) Professor Sir Michael Bond would be an ideal Interim President. I therefore contacted him on behalf of Council to determine if he would consider taking on the position, during this difficult and sad time in The Society’s history. Professor Sir Michael Bond agreed to accept the post of Interim President until such times as a President would be duly elected by The Society’s normal voting mechanism. Details of the key aspects of the above were posted on BPS website.

I believe it is important that the members are aware of this summary of the above events. I am grateful to Council and the

Secretariat for their major input during this difficult time.

MembershipThe total membership has increased since my last report. Then the total membership stood at 1499, whereas it is now 1535, with a further 16 new members ratified by Council on 24th August. Of the 1535 members, there are now 729 anaesthetists, 301 nurses, 108 psychologists and 83 physiotherapists – an increase in membership within each specialty.

British Pain Society Study DaysThe last Study Day – “Back Pain” was held on the 8th June. This was a very successful and oversubscribed meeting led by Professor Paul Watson. The next two Study Days are “Neuropathic Pain” to be held on Wednesday 2nd December 2009 and “Opioids for persistent non-cancer pain” to be held on Monday 25th January 2010. The Study Day design permits maximum interaction between speakers and delegates through the workshop design, as well as networking between different specialties. There is something within these for everyone, so do attend one to see what you are missing. They are very well rated by past attendees and as a member you benefit from a discounted registration fee. For further details contact [email protected].

• A very common problem at pain clinics, as well as in the community.It is often diffi cult to achieve more than a moderate reduction in pain intensity.

• Expert speakers will discuss the mechanisms and problems in managing this group of conditions.

• Issues around detection in primary care through to off -license prescribing will be

covered on the day.• This study day brings a wide range of disciplines together to discuss

management options available now and for the future.

The British Pain Society Learning in Pain seriesNeuropathic PainWednesday 2nd December 2009, London

We are an approved provider of Continuing Professional Development (CPD) and this Study Day is worth 5 CPD points.

Third Floor, Churchill House35 Red Lion SquareLondon WC1R 4SG

[email protected]

By undergroundHolborn is a 3 minute walk(Piccadilly & Central Lines)

Tottenham Court Road is a 20 minute walk (Cen-tral and Northern Lines); (Bus: Route number 98, pay before boarding, 10 minutes)

Goodge Street is a 20 minute walk(Northern Line)

National Rails StationsEuston is a 25 minute walkTube: Take the Northern or the Victoria Line to King’s Cross change to the Piccadilly Line Bus: Route numbers 59, 68, 98 and 168, pay before boarding, 10-15 minutes

King’s Cross is a 30 minute walkTube: Piccadilly Line

Waterloo is a 25-30 minute walk Bus: Route numbers 521, 171, 59, 1, 68, 243 and 168, pay before boarding, 10 minutes

Charing Cross is a 20 minute walkTube: Take the Northern Line to Tottenham Court Road change to the Central LineBus: Route numbers 9, 87, 139 and 176, pay before boarding, 10 minutes

PaddingtonTube: Take the Bakerloo Line to Oxford Circus change to the Central Line

TaxiEuston, King’s Cross, Waterloo and Charing Cross are a few minutes journey and Paddington Station is 20-30 minutes journey.

ParkingWe are situated within a controlled parking area in the London congestion zone. Parking meters are available in the surrounding streets. There is a NCP car park in Bloomsbury Square (Holborn) and in Southampton Row (Russell Square).

Venue The British Pain Society - Churchill House - 35 Red Lion Square - London WC1R 4SG

Tel: 020 7269 7840 - Email: [email protected] Information

study_day_15.indd 1-2

09/09/2009 13:08:39


ABBREVIATED PRESCRIBING INFORMATIONPrialt®6(ziconotide)

Please refer to the SPC before prescribing.Presentation: 1 ml and 5 ml vials containing 100 μg and 500 μg ziconotide as ziconotide acetate. Indication: Treatment of severe, chronic pain in patients who require intrathecal (IT) analgesia. Dose and administration: : Must only be administered by physicians experienced in IT administration as continuous infusion via intrathecal (IT) catheter, using external or internally implanted mechanical infusion pump. When low doses are required, it must be diluted before use with preservative free 0.9% sodium chloride solution for injection. See SPC for instructions for use and handling. Adults and elderly: Initiate at 2.4 μg/day. Titrate on individual patient basis in increments of [ 2.4 μg/day, up to maximum dose of 21.6 μg/day. Minimal interval between dose increases is 24 hours; recommended interval, for safety reasons, is 48 hours or more. Patients with renal or hepatic impairment: Caution (see SPC).Children and adolescents under 18 years: Not recommended.Contra-Indications: Hypersensitivity to ziconotide or any excipient. Contraindicated in combination with IT chemotherapy. Pregnancy: Do not use during pregnancy unless clearly necessary. Studies in animals have shown reproductive toxicity and potential risk in humans is unknown. Lactation: Do not use during lactation unless clearly necessary as it is unknown whether ziconotide is excreted in breast milk. Warnings and Precautions: Caution during long-term treatment due to limited clinical data. IT administration of any medicine carries risk of potential serious infections such as meningitis, especially with external systems. Patients and physicians must be vigilant for typical signs and symptoms of meningitis. IT catheter tip placement should be carefully considered because optimal placement has not been established. Caution when administered with concomitant systemic chemotherapy. Monitoring of creatine kinase is recommended and in event of progressive elevation or clinically significant elevation in association with myopathy or rhabdomyolysis, discontinuation of ziconotide should be considered. Potential for severe allergic reactions cannot be excluded. Reduce dose or discontinue ziconotide if signs or symptoms of cognitive impairment or neuropsychiatric adverse reactions develop, after considering other contributing causes. Cognitive effects are typically reversible within 1 - 4 weeks after discontinuation, but may persist in some cases. If patients experience depressed levels of consciousness, discontinue ziconotide and consider withdrawing any concomitant CNS

depressant medicines. Re-introduction of ziconotide is not recommended. Ziconotide may cause or worsen depression with the risk of suicide in susceptible patients. Drug Interactions: No specific interaction studies, but metabolic-based interactions or plasma protein displacement type interactions are unlikely. Increased incidence of somnolence with systemic baclofen, clonidine, bupivacaine or propofol. No data regarding concomitant use of partial opioid agonists eg buprenorphine. Based on very limited data, no effect on plasma exposure when given with ACE inhibitors e.g. benazepril, lisinopril and moexipril and HIV protease inhibitors e.g. ritonavir, saquinavir and indinavir. Adding IT ziconotide to IT morphine is possible, but requires special attention due to high rate of neuropsychiatric adverse events. Adding IT morphine to IT ziconotide is better tolerated. Ziconotide does not interact with opiate receptors. Side effects: Adverse reactions reported with ziconotide in IT trials (short and long-term exposure) are: Very common effects (>1/10): confusional state, dizziness, nystagmus, memory impairment, headache, blurred vision, nausea, vomiting, abnormal gait, somnolence and asthenia. Common effects (>1/100, <1/10): decreased appetite, anorexia, anxiety, auditory hallucination, insomnia, agitation, disorientation, hallucination, visual hallucination, depression, paranoia, irritability, aggravated depression, nervousness, affect lability, mental status changes, aggravated anxiety, aggravated confusion, dysarthria, amnesia, dysgeusia, tremor, impaired balance, ataxia, aphasia, burning sensation, sedation, paraesthesia, hypoaesthesia, disturbance in attention, speech disorder, areflexia, abnormal coordination, postural dizziness, cognitive disorder, hyperaesthesia, hyporeflexia, ageusia, depressed level of consciousness, dysaesthesia, parosmia, mental impairment, diplopia, visual disturbance, photophobia, vertigo, tinnitus, orthostatic hypotension, hypotension, dyspnoea, diarrhoea, dry mouth, constipation, nausea aggravated, upper abdominal pain, pruritus, increased sweating, pain in limb, myalgia, muscle spasms, muscle cramp, muscle weakness, arthralgia, peripheral swelling, urinary retention, urinary hesitation, dysuria, urinary incontinence, fatigue, pyrexia, lethargy, oedema peripheral, rigors, fall, chest pain, feeling cold, pain, feeling jittery, exacerbated pain, blood creatine phosphokinase increased and weight decreased. Uncommon (>1/1000, <1/100): sepsis, meningitis, delirium, psychotic disorder, suicidal ideation, suicide attempt, thought blocking, abnormal dreams, incoherence, loss of consciousness, coma, stupor, convulsions, cerebrovascular accident, encephalopathy, atrial fibrillation, respiratory distress, dyspepsia, rash, rhabdomyolysis, myositis, back pain, muscle

twitching, neck pain, acute renal failure, difficulty in walking, electrocardiogram abnormal, aspartate aminotransferase increased, blood creatine phosphokinase MM increased, body temperature increased.Shelf-life: 3 years. Chemical and physical in use stability has been demonstrated for 60 days at 37°C.Special precautions for storage: 2°C - 8°C. Do not freeze. Protect from light. For storage conditions of the diluted medicinal product, see SPC.Legal Category: POM Basic UK NHS cost: Ziconotide 1ml vial: £271.83, Ziconotide 5ml vial: £1,359.14Irish Price to Wholesaler: Ziconotide 1ml vial: €339.29, Ziconotide 5ml vial: €1,696.43Marketing authorisation numbers: Ziconotide 1ml vial: EU/1/04/302/001, Ziconotide 5ml vial: EU/1/04/302/003 Marketing authorisation holder: Eisai Ltd.Further Information from: Eisai Ltd, Mosquito Way, Hatfield, Hertfordshire, AL10 9SNDate of preparation: March 2009

Adverse events should be reported. Reporting forms andInformation can be found at www.yellowcard.gov.uk.

Adverse events should also be reported to Eisai Ltd. on0845 676 1400/0208 600 1400 or [email protected]

Eisai code: PRIALT-UK2108a. Date of preparation: May 2009

Prialt whole page, 4 colour advert for Palliative Medicine, 210 x 280mm with 3mm bleed all round


NEWS

Following on from the very positive report that the Chief Medical Officer published this year, Professor Paul Watson has convened an Action Group which has met to push the pain agenda forward. Professor Watson also had a very positive meeting with Sir Liam Donaldson in July of this year.

Initially four main topics were discussed

The CMO recommended - For patients in hospital, a pain score should become part of the vital signs that are monitored routinely. The assessment of the quality of pain management should be undertaken by the CQC.

The BPS made representations that the Essence of Care Benchmark guidelines be published and disseminated. This is occurring. It also asked that Pain assessment be put on SHA quality assurance agenda to ensure pain is measured in hospitals. Pain assessments should be carried out on admission, a care plan produced and reassessed. The effectiveness of the care plan produced should be appropriate to the needs of the patients considering their social and personal circumstances and should be monitored.

The CMO recommended - Consideration should be given to the inclusion of monitoring of prescriptions of strong opioids in the Quality and Outcomes Framework for primary care

The BPS are looking to work with the Chronic Pain Policy Coalition to try to introduce a new QoF for pain assessment. It was also hoped there would be support from the RCGP and other professional organisations. It was suggested that strong opioids would be a

good measure, as it should only be used as a pain medication. This would be a way of identifying opioid use and encouraging the assessment of pain, monitoring the effectiveness of therapy and the need for referral into pain services. This was recommended to the CMO.

The CMO recommended – All chronic pain services should supply comprehensive information to a National Pain Database

Pain audit work was already underway.

It was noted that there was considerable problems getting the information from Strategic Health Authorities (SHAs). If SHAs were asked, through their PCTs to comply with the National Pain Database, then the information would be available. The CMO was asked to insist SHAs and PCTs provide information on their pain services including the location, staff involved and service provided.

The CMO recommended – Training in chronic pain should be improved in the curricula of all healthcare professionals

The Pain Education SIG already has the preliminary results from their Undergraduate Pain Education survey. This is the most comprehensive survey of its nature done in the UK. This is due to be published is soon and needs to be promoted extensively. The CMO’s was asked for his endorsement of a campaign to improve pain education in the England and Wales as well as appropriate contacts.

The CMO recommended – A model pain service or pathway of care with clear standards should be developed by experts

The 18 week care pathway has already been developed but this generic pathway is designed mainly to meet the needs of the 18 week wait, rather than looking at the quality of the care received. Some preliminary work on an Integrated Care Pathway (ICP) has already been done by the pharmaceutical industry in collaboration with some individuals. This was to be examined to see if it was a good model. This particular ICP focused on five broad areas, with

The NHS Plan (2000) reinforced the importance of ‘getting the basics right’ and of improving the patient experience. The Essence of Care, launched in February 2001, provides a tool to help practitioners take a patient-focused and structured approach to sharing and comparing practice. In June 2009 new benchmarks for pain were published for PCTs trusts and commissioners as part of the essence of care toolkits. The benchmarks look at improving and standardising best practice in 8 areas of the management of pain. (See table 1) This is the document the Chief Medical Officer agreed to implement into the Care Quality Commission which is the

interventions at primary care level, and then onto more specialised care. The ICP should map onto the ‘Map of Medicines’ which SHA’s will be using. It was recommended to the CMO that some form of ICP be agreed covering a selection of conditions initially.

Further work is being undertaken on behalf of BPS members by the council and it is hoped that more progress on these areas will occur soon.

independent regulator of health and social care in England. The CQC aims is to make sure better more consistent care is provided for everyone, so compliance would be a requirement of all Trusts. We therefore now have a new formal (and rather wordy) benchmark by which services and care can be measured. It is in the consultation process at present and the closing date is 12th October according to the website (or 2nd October according to the questionnaire!)

It is available at: http://www.dh.gov.uk/en/Consultations/Liveconsultations/DH_103064

The British Pain Society meets with Chief Medical Officer

NEWS

A consultation on new benchmarks for Pain

Table 11. Access People experiencing pain, or who are likely to experience pain,

and carers receive timely and appropriate management of pain

2. Patient and carer participation

People (where able), carers and staff are active partners in the decisions involving pain management

3. Assessment People have an ongoing, comprehensive assessment of their pain

4. Care planning, intervention, evaluation, review and prevention

People’s individualised care concerning pain is planned, implemented, continuously evaluated and revised in partnership with people, staff and carers

5. Knowledge and Skills

People, carers and staff have the knowledge and skills to understand how best to manage pain

6. Self management

People are enabled to manage their pain when they wish to, and as appropriate

7. Partnership working

People, carers and appropriate agencies work collaboratively to enable people to meet their pain management needs

8. Service evaluation and audit

People, carers and staff have the knowledge and skills to understand how best to manage pain

Targinact® tablets contain an opioid analgesicTarginact® 5 mg/2.5 mg, 10 mg/5 mg, 20 mg/10 mg and 40 mg/20 mg prolonged release tabletsPRESCRIBING INFORMATION UNITED KINGDOM

Presentation Film-coated, oblong, prolonged release tablets containing oxycodone hydrochloride and naloxone hydrochloride, marked OXN on one side and the oxycodone strength on the other. Colours: Blue - 5 mg (oxycodone hydrochloride)/2.5 mg (naloxone hydrochloride), white - 10 mg (oxycodone hydrochloride)/5 mg (naloxone hydrochloride), pink - 20 mg (oxycodone hydrochloride)/10 mg (naloxone hydrochloride) and yellow - 40 mg (oxycodone hydrochloride)/20 mg (naloxone hydrochloride). Indications Severe pain, which can be adequately managed only with opioid analgesics. The opioid antagonist naloxone is added to counteract opioid-induced constipation by blocking the action of oxycodone at opioid receptors locally in the gut. Dosage and administration Adults over 18 years: Usual starting dose for opioid naïve patients is Targinact 10 mg/5 mg, taken orally at 12-hourly intervals. Targinact 5 mg/2.5 mg is intended for dose titration when initiating opioid therapy and individual dose adjustment. The dosage is dependent on the severity of the pain and the patient’s previous history of analgesic requirements. Patients already receiving opioids may be started on higher doses of Targinact depending on their previous opioid experience. The maximum daily dose of Targinact is 80 mg oxycodone hydrochloride and 40 mg naloxone hydrochloride. Targinact tablets are not intended for the treatment of breakthrough pain. For the treatment of breakthrough pain, a single dose of “rescue medication” should amount to one sixth of the equivalent daily dose of oxycodone hydrochloride. Please refer to the SmPC for further details on dose titration. Targinact tablets must be swallowed whole. They must not be broken, chewed or crushed which leads to a rapid release and absorption of a potentially fatal dose of oxycodone. Children under 18 years: Not recommended. Contra-indications Hypersensitivity to the active substances or excipients, any situation where opioids are contra-indicated, severe respiratory depression with hypoxia and/or hypercapnia; severe chronic obstructive pulmonary disease, cor pulmonale, severe bronchial asthma, non-opioid induced paralytic ileus, moderate to severe hepatic impairment. Precautions and warnings Respiratory depression, elderly or infirm, opioid-induced paralytic ileus, severely impaired pulmonary function, hypothyroidism, adrenocortical insufficiency, toxic psychosis, cholelithiasis, prostate hypertrophy, alcoholism, delirium tremens, pancreatitis, hypotension, hypertension, galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption, pre-existing cardiovascular diseases, head injury (due to risk of raised intracranial pressure), epileptic disorder or predisposition to convulsions, patients taking MAO inhibitors, renal impairment, mild hepatic impairment, pre-operative use or within the first 12 - 24 hours post-operatively. Not suitable for the treatment of withdrawal symptoms. Interactions Substances having a CNS-depressant effect (e.g. alcohol, other opioids, sedatives, hypnotics, anti-depressants, sleeping aids, phenothiazines, neuroleptics, anti-histamines and anti-emetics) may enhance the CNS-depressant effect of Targinact (e.g. respiratory depression). Interaction with coumarin anti-coagulants may increase or decrease INR. Pregnancy and lactation Not recommended. Side-effects Common adverse drug reactions are decreased/ loss of appetite, anxiety, restlessness, headache, sedation, tremor, vertigo, decrease in blood pressure, rhinorrhoea, yawning, abdominal pain, diarrhoea, dry mouth, constipation, flatulence, vomiting, nausea, dyspepsia, increased hepatic enzymes, hiccups, altered mood, decreased activity, psychomotor hyperactivity, agitation, dysuria, pruritus, skin reactions, hyperhidrosis, muscle spasms, muscle twitching, myalgia, dizziness, drug withdrawal syndrome, feeling hot and cold, chills, asthenic conditions. Some side-effects which are uncommon but could be serious are hypersensitivity, confusion, depression, hallucinations, disturbance in attention, somnolence, speech disorder, convulsions, syncope, visual disturbances, palpitations, angina pectoris, tachycardia, increase in blood pressure, dyspnoea, respiratory depression, biliary colic, erectile dysfunction, urinary retention, peripheral oedema, abdominal distension and chest pain. Please refer to the SmPC for further details of other uncommon side-effects and oxycodone class-effects.Tolerance and dependence (addiction) may occur. It may be advisable to taper the dose when stopping treatment to prevent withdrawal symptoms. Legal category CD (Sch2) POM Package quantities and price Blisters of 28 tablets: 5 mg/2.5 mg - £ 17.56. Blisters of 56 tablets: 10 mg/5 mg - £35.11, 20 mg/10 mg - £70.22, 40 mg/20 mg - £140.44 Marketing Authorisation numbers PL 16950/0157-158, PL16950/0161-162 Marketing Authorisation holder Napp Pharmaceuticals Limited, Cambridge Science Park, Milton Road, Cambridge, CB4 0GW, UK. Tel: 01223 424444. Member of the Napp Pharmaceutical Group. Further information is available from Napp Pharmaceuticals Limited. Date of preparation July 2009.® The Napp device (logo) is a Registered Trade Mark. ® Targinact is a Registered Trade Mark.© 2009 Napp Pharmaceuticals Limited.

For medical information enquiries, please contact [email protected].

References: 1. Targinact® Summary of Product Characteristics (10 mg/5 mg and

20 mg/10 mg).2. Targinact® Summary of Product Characteristics (5 mg/2.5 mg and

40 mg/20 mg).3. MIMS July 2009.4. Simpson K, Leyendecker P, Hopp M et al. Curr Med Res Opin

2008;24(12):3503-12.5. Löwenstein O, Leyendecker P, Hopp M et al. Expert Opin Pharmacother

2009;10:531-43.

Date of preparation: August 2009 Code: UK/TA-09139

For more information, visit www.targetingpain.co.uk

Adverse events should be reported. Reporting forms and information can be found at www.yellowcard.gov.uk. Adverse

events should also be reported to Napp Pharmaceuticals Limited on 01223 424444.

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Care Commission looks at Pain in Scottish Nursing HomesDr Pat Schofield Honorary Secretary Elect of the British Pain Society reports that the tireless work of the Pain in the Elderly SIG may be about to bear substantial fruit. On the back of the recently published Alzheimer Scotland Beyond Barriers Project, which set put to examine current palliative care practice for dementia sufferers in care homes, it is now clear that Pain Assessment is firmly on the Agenda of the Care Commission, Scotland. This organisation set up in April 2002 under the Regulation of Care (Scotland) Act 2001 oversees all adult, child and independent healthcare services in Scotland. Its task is to ensure that care service providers meet the Scottish governments National Care Standards and work to improve the quality of care. It is now clear that senior figures in the commission are keen to ensure that Pain Assessment is taken seriously and

The British Pain Society, in partnership with Dr Foster has been successful in securing funding from the Healthcare Quality Improvement Partnership (HQIP) for a three year National Audit of Pain Services in England. A large vote of thanks goes to Dr Stephen Ward, Dr Cathy Price and all involved in the bid submission.

The audit will establish the provision of specialist chronic pain services in both secondary and primary care and set up a national data set where case mix, patient outcomes and patient experience data will be recorded. This will allow the benchmarking of services, continuous quality

the organisation is taking steps to getting pain assessment guidelines into all of the 950 care homes in Scotland. It is starting a process of collaboration with experts and also working with Dr Schofield’s team to make this happen. With a budget of £30 million and over 300 Care Commission officers who inspect services there is hope that a real difference can be made to many elderly patients.

The Alzheimer Scotland report of the Beyond Barriers project which was a two year project looking at the palliative care needs of patients, relatives and carers can be downloaded from http://www.alzscot.org/pages/beyond-barriers-palliative-care-report.htm

assurance, comparisons of case mix and provide information for future service development and improvement.

Similar audits in other parts of the UK, including Scotland have led to progress in the commissioning of pain services. In Scotland the GRIPS report followed the audit and ultimately led to the appointment of a “Pain Tsar”.

The audit will be conducted in three stages:

Year 1 : Establishing the provision of pain services in England. Geographical location, facilities, staffing.

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Audit of Pain Services coming your way soon

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Year 2: Case mix

Year 3: Outcomes and patient experience.

NHS Evidence is an internet based service for everyone who works in health and social care to help them make informed decisions about treatments and resources.

The web portal provides free access to best practice, clinical and non-clinical information. NHS Evidence has also developed an accreditation process to help users recognise the most trusted sources of guidance, which includes clinical guidelines, clinical summaries and best practice statements. In future, the accreditation scheme may be extended to other types of information.

NHS Evidence supports a range of activities designed to encourage a change in practice. Significant new evidence is highlighted on a monthly basis in an electronic bulletin, Eyes on Evidence - to which subscription is free via the portal, and annually through annual evidence updates in key topic areas.

This work is supported by 34 specialist collections which make up NHS Evidence Health Information Resources. The purpose of the collections is to filter the huge quantity of published research, identify relevant sources of information and review new publications.

The principle aim of the NHS Evidence service is to provide easy access to a comprehensive evidence base for everyone in health and social care who takes decisions about treatments or the use of resources – including clinicians, public health professionals, commissioners and service managers – thus improving health and patient care.

The year 1 data collection and site recruitment begins in September so look out for it and be sure to fill it in.

It will build on NICE’s significant international reputation for developing high quality evidence-based guidance. It provides access to a range of information types, including primary research literature, practical implementation tools, guidelines and policy documents.

To achieve the aim stated above, NHS Evidence will:

Provide comprehensive access to information in health and social care via a web-based portal.

Commission the development of evidence-based information from external agencies, in line with user needs and priorities.

Provide a central purchasing function to enable health professionals in the NHS to access journals and other relevant resources.

Provide a formal accreditation scheme for defined categories of information such as clinical guidelines.

Identify evidence reflecting best practice in particular topic areas to inform a range of user groups.

Engage with users and stakeholders to support the use of evidence in decision-making, and to provide feedback to develop the service.

The development of the portal is based on user feedback and will improve in line with changing user needs. Email [email protected] or call 0845 003 77 44.

NHS EvidenceNEWS


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Under the careful watch of Dr Nick Allcock and with the help of Dr John Goddard the BPS have responded to the NHS Evidence consultation process. NHS Evidence, which lives under the NICE umbrella, is a new organisation tasked with accrediting organisations which produce guidance. It uses the AGREE tool to accredit organisations. In the longer term, it is likely that BPS publications may be subject to the NHS evidence process. The NHS evidence consultation document on draft accreditation can be found at http://www.library.nhs.uk/accreditation

As a recognised stakeholder with NICE the BPS consults widely to ensure that it responds to any NICE submission relevant to Pain. This onerous task was marshalled efficiently by Dr Goddard and has now been put under the trusty stewardship of Dr Allcock. The response to NHS Evidence is reprinted below.

The British Pain Society Response to Draft Accreditation Decision Consultation Documents:

• ScottishIntercollegiateGuidelines Network (SIGN)

• NationalInstituteforHealthand Clinical Excellence Centre for Clinical Practice (NICE CCP)

• NationalInstituteforHealthand Clinical Excellence Centre for Health Technology Evaluation (NICE CHTE): Multiple Technology Appraisal (MTA) and Single Technology Appraisal (STA)

The British Pain Society has a membership of over 1,550 and is

involved in all aspects of pain and its management through the work of the Council, Committees and Working Parties. As part of its work The British Pain Society aims to produce contemporary guidance, supported by available evidence, on clinical and other pain matters.

The British Pain Society has welcomed the introduction of a system to accredit guidance. The process reflected in these reports appears rigorous and gives a clear indication of the strengths and the weaknesses of the process adopted by the organisations reviewed. While accepting the recommendations of the Advisory Committee in respect of the above mentioned institutions, we would like to comment on some issues relating to these judgements.

We note that not all of the criteria are met by the organisations reviewed. Where this is the case actions are identified to address these issues. The reports indicate that the review period for these is at the next review point in three years. This raises a couple of issues. Firstly, the clarity of the decision to approve an organisation when not all the criteria are met. For reasons of transparency should a justification be offered for approval despite ongoing uncertainty in relation to certain criteria? Although not suggesting that organisations should have to meet all the criteria to be approved, the threshold for the approval of an organisation not meeting all the criteria seems unclear. Clarification would be helpful for organisation such as the BPS who may apply for accreditation in the future. Secondly, where uncertainties in the process are identified and actions proposed, 3 years seems

a long period to review the implementation of amendments.

We note that the NICE CCP does not meet the standard for clarifying the method used to arrive at recommendations. The BPS has raised concerns over the recently published guideline, Early Management of Persistent Non-Specific Low Back Pain (CG88 May 2009). Although NICE CCP does meet the standard for involving stakeholders from relevant professional groups, in this case no expert on non surgical interventions was present on the GDG which has led to some concerns in relation to the bias of the GDG. This particularly relates to the inclusion of recommendations based on consensus agreement within the group where robust empirical evidence is lacking. In areas where there is limited systematic evidence and consensus agreement is used to formulate

Dr Neil Berry

The NHS’s Improving Access to Psychological Therapies (IAPT) programme is designed to support Primary Care Trusts in implementing NICE guidelines for people suffering from depression and anxiety disorders in England. The aim is to recruit and train around 40 therapists per 250,000 of the UK population to deliver cognitive behavioural therapies.

The programme recognises that patients with chronic pain are one of many target populations that may benefit from the new services. A number of Special Interest Groups have been established by IAPT and the one that is particularly relevant to pain services is concerned with

recommendations, we believe that the low back pain guidelines illustrate a lack of consistency in the translation of evidence into recommendations. NICE suggest that the differentiation between recommendations is based on the wording of the recommendation and the NICE guidelines manual (2009) page 102 states ‘The GRADE system (see section 6.2.1.1) allocates labels or symbols to represent the strength of a recommendation. NICE has chosen not to do this, but instead to reflect the concept of strength in the wording of the recommendation (see section 9.3.3).’ We would suggest that this has, in the case of the low back pain guidelines, led to inconsistencies in the translation of the strength of the evidence into recommendations.

We hope that these comments are constructive and supportive of the process.

long-term conditions and medically unexplained symptoms. This SIG produced two “positive practice guides” in November 2008 and, earlier this year, Professor Chris Main drew council’s attention in particular to the medically unexplained symptoms guide. The council shared the concerns raised by Professor Main and their response is published here.

The Chair of the SIG, Dr John Hague, met with Sir Michael Bond and Neil Berry, the council’s psychology representative, on the 11th August. The Society has been invited to nominate a representative to join the SIG and Neil is the Society’s nominee. The BPS response to the document is printed overleaf..

BPS submission to NHS Evidence Accreditation Consultation Document

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British Pain Society Response to Improving Access to Psychological Therapies (IAPT)

PA I N N E W S Au tumn 200 914

T h e B r i T i s h P a i n s o c i e T y The British Chapter of the International Association for the Study of Pain

Third FloorChurchill House35 Red Lion SquareLondon WC1R 4SG

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An alliance of professionals advancing the understanding and management of pain for the benefit of patients

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A registered charity in Scotland – Registered No. SC039583

British Pain Society Response to the Department of Health Improving Access to PsychologicalTherapies (IAPT) Documents:

Long-term conditions positive practice guide*

Medically unexplained symptoms positive practice guide*

(*These documents were both published on 12th November, 2008 and reflect the deliberations of The IAPT Long-term Conditions and Medically Unexplained Symptoms Special Interest Group chaired by Dr John Hague, GP and independent consultant to The Sainsbury Centre for Mental Health.)

1. The British Pain Society recognises that many patients who suffer pain also suffer with depression and anxiety. We welcome the fact that, through IAPT, steps are being taken to improve the psychological care that these patients receive.

2. The British Pain Society supports IAPT in seeking to improve the access of patients to effective psychological therapies but regrets the fact that these documents were produced without consulting The Society.

3. Pain Services have played a major role in developing and applying biopsychosocial models and in providing interdisciplinary services for patients suffering pain, whether medically explained or medically unexplained. In physical health matters, Pain Services have led the way in making CBT based programmes an integral part of our services. Among our patients are a considerable number who may come under the medically unexplained physical symptoms umbrella including patients with chronic pelvic pain, tension headache, chronic low back pain, atypical chest pain and fibromyalgia

4. The British Pain Society broadly supports the Long-term conditions positive practice guide (LTC). However, we have a number of concerns in relation to the Medically unexplained symptoms positive practice guide (MUPS):-

i. Firstly, we believe that construing pain as medically unexplained is rarely helpful to patients with chronic pain. We recognise that not all pain can be fully explained in terms of identifiable peripheral physiology and pathology but there is mounting evidence that much of the answer lies in complex central mechanisms. We are concerned that IAPT therapists working uniprofessionally and apart from specialist pain services will be ill-equipped to work effectively with chronic pain patients. Their efforts may actually prove to be counter-therapeutic.

ii. The Society questions whether the MUPS guide adds anything of value to the LTC guide. Paragraph 4 of the MUPS document recognises: ...these mental health disorders [depression / anxiety] are detectable and treatable, irrespective of the explanation for the physical symptoms [our emphasis] . Pain Services, as the LTC guide recognises, have demonstrated that it is possible to provide effective multidisciplinary, CBT-based, pain management programmes to patients with medically unexplained pain alongside patients whose pain is better understood.

iii. It is undoubtedly the case that all medical services, whether their patients are presenting with pain, respiratory, dermatological, gastro-intestinal, cardiovascular, neurological or other conditions, deal with patients who are anxious and depressed. Some of these patients have physical symptoms that are medically unexplained but many do not. The Society suggests that the goal of IAPT services should be to help existing physical health services, in primary and secondary care, to improve the psychological care that all anxious and depressed patients receive.

iv. Patients with medically unexplained physical symptoms are not all affected by mental health issues. The decision to refer a patient for psychological therapy should be based on the identification of mental health problems of such severity that they interfere with the individual s capacity to adapt both psychologically and physically to challenging symptoms. It should not be based on the simple fact that the physical symptoms are medically unexplained.

v. Multidisciplinary pain services have demonstrated that the depression and anxiety of patients can be successfully managed without the need to persuade patients that their distress is a cause of their physical symptoms. Most patients are able and willing to recognise that anxiety and depression can exacerbate physical symptoms and / or impair their ability to manage physical symptoms.

vi. While showing some recognition of the complexity of the relationships between depression / anxiety and physical symptoms, the MUPS guide promotes the view that mental health problems are likely to be the key to understanding and managing medically unexplained medical symptoms (paragraph 13). It may be appropriate to consider somatisation when a major psychiatric condition is present. However, the concept of somatisation can be too easily invoked when patients are simply displaying the sort of heightened somatic concern that is a frequent and understandable response to chronic pain and other distressing symptoms. As the document recognises, it is an inference that can cause distress to patients and, in the pain field, it often reflects the clinician s lack of knowledge of painful conditions and the complex biological mechanisms contributing to them.

vii. The MUPS document, in contrast to the LTC document, gives insufficient weight to the importance of multidisciplinary, biopsychosocial care for patients with medically unexplained physical symptoms. Psychological therapies are likely to be better received and more effective when offered alongside appropriate medical and physical therapies.

viii. The MUPS document understates the importance of specialist assessments and specialist services for patients presenting with medically unexplained physical symptoms and places an overreliance on primary care medical judgements.

ix. The Society is well aware that unnecessary medical and surgical investigations and treatments are detrimental to the public purse and to patients. However, it is also concerned that, in seeking to move away from models and services which have paid too little attention to psychological issues, IAPT may push the pendulum of change to a point where patients are viewed and treated within a framework that pays too little attention to biological and physical factors.

5. The British Pain Society particularly welcomes paragraph 8 of the LTC document and will be pleased to be involved in future developments:

“Mental health commissioners are encouraged to work closely with commissioners who have responsibilities for relevant physical health services. More integrated commissioning will ensure that better links are made between IAPT services, and physical health services, to ensure continuity of care and effective referral pathways for people with co-morbid physical and mental health problems.”

PA I N N E W S Au tumn 200 916

Dr aNDreW BaraNoWski Vice-President of the Pain Medicine subsection, the royal society of Medicine london

In 1994, I was invited by a number of colleagues to organise a national conference and as a result of many enquiries was fortunate to discover the Royal Society of Medicine and the Anaesthetic Section of the RSM. The meeting was entitled Psycho-physical Measurement in Health and Disease. Since then these open meetings have become a vital part of the Anaesthetic Section’s annual programme. The Section of Anaesthesia is one of 55 sections within an educational society that has a significant history for anaesthetists – it preceded and enabled the development of both the Association of Anaesthetists for Great Britain and Ireland and the Royal College of Anaesthetists (and as a consequence the Faculty for Pain Medicine); this was celebrated last year when the Association of Anaesthetist of Great Britain and Ireland gave a medal to the Section of Anaesthesia at their 100 year anniversary.

The origins of the Royal Society of Medicine date back to the 18th century when throughout Europe medical societies began to be founded with the objective of bringing together physicians and surgeons in order to further scientific, professional and social communication. The first general medical society of note in England was the Medical Society of London, founded in 1773. Twenty-six members of that society broke away and following a meeting at the Freemasons’ Tavern, Great Queen Street on 22 May 1805 resolved to form themselves into a new medical society, The Medical and Chirurgical Society of

London, which eventually became the RSM. Even today, many of us continue to meet in the RSM bar to discuss science and medicine! The RSM is currently one of the largest providers of accredited education in the UK. Much of that education occurs at its head quarters in central London but it holds regional meetings and also accredits meetings aboard. Since the first meeting I have organised or co-organised some 25 meetings at the RSM, 6 of these abroad. The quality and substantial interest they have generated have led to the formation of a Pain Medicine Subsection within the Anaesthetic Section. My appointment as Vice-president in 2008 and the recruitment of a multidisciplinary Council has been a major part in supporting what is considered a major event by the RSM. Sub-sections once established eventually become full sections, but in their tender years they rely upon the financial and academic support of a more established Sections and the Anaesthetic Section has kindly pump-primed our coffers!

What is the relevance to British Pain Society members? In the first instance, though there are many agencies organising meetings related to pain, those of the RSM have always been delivering innovative multidisciplinary and multispecialist programmes with titles such as: “Pain in sports medicine”, “Pain management for primary care”, “Pain associated with diabetes”, “Upper limb pain”, “Head and neck pain”, “Pain medicine - multidisciplinary evidence based education and patient care”, “Psychiatry and the pain patient”, “Pain from torture, organised violence and war”. Within the RSM other Sections

also have an interest in pain, for instance, Psychiatry, Orthopaedics, Catastrophes and Conflicts, and Clinical Neurosciences Sections. We therefore have access to resources envied by others and in future we will run many joint meetings, such as an up and coming joint meeting with the Orthopaedic Section on “Pain and the orthopaedic patient”. Secondly, we need help to maximise the use of our resources and we would like to invite you to join us on the pain medicine steering group to help organise a meeting. Regardless of your primary clinical discipline and even if you are not a member of the RSM you are welcome to provide us with suggestions for meetings and we will try to accommodate them.

Thirdly but really most importantly, regardless of your primary clinical discipline or whether you are a member of the RSM, you are able to attend our meetings. In addition, should you wish, we can bring our meetings to you, via our network of Regional RSM Deans.

Finally, it is our intention to set up two essay prizes, one for medical students and another for Advanced Pain Trainees at the beginning of next year. For information on these and our up and coming meetings please bookmark the Pain Medicine Subsection web site http://www.rsm.ac.uk/academ/smtpain.php

Our up and coming meetings include:

• Ouchthathurts:Acutepaininchildren. 6th November 2009. Have you ever considered as to how you might use hypnosis in children or run paravertebral blocks in them? Also, “Will my babies hate me when they are older?” Fear and facts about the long term effects of neonatal pain. And, how much do you know about risk management and paediatric pain?

• Fromlabtopatient-Thefacial pain journey. 12th March 2010. In this meeting we will be looking at: The art of questioning and listening – how to take a meaningful history and how art may help with this. We will explore how nerve injuries occur in the face and can be managed including those due to head and neck cancer. Patients will present their perspective of their journey through a facial pain unit; support groups and medical sociologists will tell us how facial pain impacts on society.

Our Pain Medicine Subsection thanks The British Pain Society for all their support as we work towards establishing the RSM Pain Medicine Subsection. Furthermore, we are in agreement that collaboration to maintain the high profile and affordability of Pain Medicine education is essential. We will continue to work together to use our resources in the best way possible.

The Pain Medicine Subsection of the Royal Society of Medicine

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pain management programmes might be delivered and the skill mix required for effective delivery (4). It remains to be seen if the proposed CPP programmes will prove effective, and indeed, cost effective. They will require considerable investment in terms of time, training of staff, and resources. We recommend clarification of the exact nature of these programmes.

We cannot agree with the exclusion of all injections for back pain. The BPS provided evidence to support the clinical effectiveness of such procedures. The Guideline Development Group (GDG) did not consider evidence presented from cohort studies and clinical case series in its deliberations on these, or any other, treatments. We think this was misguided. Although NICE has recommended further research into these procedures, we are most concerned that a significant number of patients will be denied this choice of treatment in the interim.

The recommendation for early consideration of spinal surgery causes us great concern. No alternative is provided for those who do not wish to have an operation or who are unsuitable for surgery. It is anticipated that surgery will only be appropriate for a very small number who fulfil specific indications. Surgery is an irreversible step with an acknowledged failure rate. We feel strongly that the opinion of a Pain Management Specialist should be offered to all patients before

consideration of surgery. The treatment of back pain is complex and has to be individualised; one size does not fit all. Application of these guidelines to all those with persistent low back pain will result in a major change in clinical practice, which in the opinion of the Council of the BPS, will not represent good or appropriate patient care.

The Council of the British Pain Society recommends withdrawal of these guidelines.

1. Sir Michael Rawlins. Statistics can help, but doctors must also use their judgement. 2008; Independent News and Media.

2. Recommendations for the appropriate use of opioids for persistent non-cancer pain. British Pain Society, 2005, revision in press, expected September 2009

http://www.britishpainsociety.org/pub_professional.htm#opioids

3. Jensen MK. 10-year follow-up of chronic non malignant pain patients: opioids, health related quality of life and health care utilisation. Eur J Pain 2006;10(5):423-33

4. Recommended guidelines for pain management programmes for adults. The British Pain Society 2007 http://www.britishpainsociety.org/pub_professional.htm#pmplts

This is a consensus statement from the Council of the British Pain Society. June 10th 2009

The NICE Back Pain debate

British Pain Society statement on the NICE Guidelines for the early management of persistent non-specific low back pain

In view of the extraordinary nature of the last few months’ events it is important that a dispassionate view of the issues is presented to the membership. This section of Pain News is a collection of articles that summarise some of the key issues. It is hoped that with greater understanding of where and why we came to this position, the BPS will be able to move forward and continue as the pre eminent multidisciplinary society representing the interests of all aspects of pain management.

Initially key documents will be presented to give an understanding of the process that occurred. After this the commentary on events, by several authors will be presented.

The British Pain Society, which represents the views of over 1,500 healthcare professionals from a variety of disciplines involved in the active management of chronic pain, has serious reservations about the NICE low back pain guidelines published May 2009.We acknowledge the high cost of low back pain, both in terms of suffering, loss of individuals to the workforce and the financial burden of treatment. We also recognise the complex nature of low back pain as a biopsychosocial disorder, and do not believe that it can be adequately assessed by using evidence from randomised controlled trials within a limited scope. Professor Sir Michael Rawlins (October 2008) advises that decision makers should incorporate judgements in reaching their conclusions (1). We do not believe that judgement has been applied fairly or appropriately in these guidelines. The guidelines specifically target those suffering pain between 6 weeks and 12 months. They are not applicable to all other types of low back or radicular leg pain. We are concerned that this is not made absolutely clear and that


commissioners and purchasers of services will apply the guidance to all back pain patients. We applaud the recommendation for people with low back pain to exercise and remain physically active, and to undergo an exercise programme. However, the inclusion of acupuncture and manual therapy as first line treatments has received a great deal more publicity and will have to be carefully controlled if the suggested modest costs of these treatments are to be realised. We welcome the recommendation that patients who may require strong opioid medication should be referred to a pain specialist (2). Long term use of opioids is not to be encouraged (3).

We also welcome the prominence given to the early provision of combined physical and psychological (CPP) programmes (similar to Pain Management Programmes) for patients who are distressed by their pain. The guidelines recommend that CPP programmes should be intensive; 100 hours over a maximum of 8 weeks. The BPS has published guidance on how



The following individuals requested a call for an EGM, on the following grounds:

“We, like many others across all disciplines in the British Pain Society (BPS) have been greatly concerned by the publication of the NICE Guidelines on Low Back Pain.

We consider these to be flawed and commend the council of the BPS for their condemnation of the said Guidelines.

The fact that a member of the Guidelines Development Group (GDG), Professor Paul Watson, continues to serve as President of the BPS sends mixed and confusing signals to NICE, to Parliament, to Hospitals and FPCs, to the Press and to the Public at large.

We would thus urge Professor Watson to stand down as President.

Dr. J.C.D.Wells

The EGM might consider several issues:-

1) Whether the NICE guidelines on Low Back Pain (LBP) are good for patients? The BPS council have, however, already recommended their withdrawal. The evidence base of the guidelines appears flawed, with over 1/3 of the recommendations being based purely on consensus opinion

We call for an Extraordinary General Meeting of the BPS to debate the Guidelines, our response and should Professor Watson refuse to resign with immediate effect, to vote on the following motion.

“In view of his involvement with and the continued endorsement of, the NICE guidelines on Low Back Pain, the President of the BPS, Professor Paul Watson, should resign”.”

Signed by: Dr J.C.D. Wells; Dr S Gupta; Dr J Richardson; Dr K Kyriakides; Dr S Balasubramanian; Dr R Munglani; Dr C.A. Gauci; Dr M.H. Ather; Dr V Gadiyar; Dr A Karmarker; Dr D Phukan; Dr D.M. Tewani; Dr M Fernandez; Dr R Khiroya; Dr A Hammond; Dr G.H. Kadiwal; Dr A.R. Cooper; Dr S White; Dr P McGowan; Dr A.G. Erdmann; Dr G. Baranidharan; Dr R Walker; Dr S Krishnamoorthy; Dr M Lal Sharma.

of the Guidelines Development Group (GDG), whom some might consider not representative and reflecting specific vested interests. The statement that the guidelines improve patient choice is then followed by the exclusion of several treatment options, on the grounds of inadequate evidence, or personal opinion. No provision is made for proper assessment of patients on physical or psychological grounds (less than 4000 MRI scans for 4 million



Call for an EGM

Rationale for Extraordinary General Meeting (EGM) of the British Pain Society (BPS)

patients), and there is no proper consideration of the bio-psycho-social model of back pain.

2) Whether the guidelines help Pain Clinics and pain services? Half of the BPS members are anaesthetists, 25% nurses, mainly working in Pain Clinics. Little in the guideline suggests they can help LBP patients, apart from looking at some on long-term opioids (commenced by GPs). Acupuncture is preferred to TENS, Combined Physical and Psychological (CPP) interventions to Pain Management Programmes (PMP), and manipulations to interventional procedures. Although the guidelines exclude consideration of sciatica and other physical causes of BP, the funding plan is to take £36 million from hospital pain services, 95% of ALL injections now given being stopped to provide for acupuncture and manipulation. This includes epidural steroids injections for sciatica.

www.nice.org.uk/nicemedia/pdf/CG88CostReport.pdf , 3.5.3 onwards

3) Does the BPS wish to do anything about the guidelines?

The recent realisation of the importance of pain in the CMO’s report represents a real chance for Pain Clinics. This NICE document, however, sidelines them, by recommending that the most common pain problem, LBP, is not appropriately managed in Pain Clinics, and funding should be taken from them to provide for other therapies. If the BPS wishes to maintain the importance of its position, it needs to continue to challenge the guidelines. It also needs to put the case to purchasers of the importance of buying Pain Clinic services. It needs to present a case to politicians. To these people, the President of the BPS is the Chief Executive Officer, and the spokesperson. He or she represents the policy of the organisation. Purchasers and politicians will say “Your President

is not only in favour of the guidelines but has been a major influence in their development, and continues to promote them”

(BMJ 4th June 2009; 338:b 1805, Savigny, Watson, Underhill).

4) The position of Professor Paul Watson as President?

PW is a man of great talent who has done much for the society, and hopefully will continue to do so. There is absolutely no problem with him having his views, and continuing in the Society, in any position EXCEPT that of President. He would be very useful in NICE liaison.

He served as Clinical Advisor (Clinical advisor:- A clinician with an academic understanding of the research in the area and its practical implications to the service, who advised the development team on searches and the interpretation of the literature )to the GDG, and chaired sessions when the Chair, Underwood, was away.

However, how can he serve as the spokesperson of the BPS when his position on the vitally important issue of LBP Guidelines is at odds with the rest of the BPS council. The same would apply to any member of the GDG. PW offered to resign from NICE, but it would have been more appropriate for him to offer to resign as President of a Society that he no longer appears to represent. NICE are delighted to have him , and on their website he is now identified as President of the BPS.

http://www.nice.org.uk/nicemedia /pdf/LowBackPainConsultation AppendixF.pdf

PW argues that the guidelines reach a conclusion opposed by only some members of the Society, but the BPS Council voted overwhelmingly for their withdrawal. How can he stay?


Copies of the following letter were mailed to all members of the Society

An open letter to the membership from Professor Paul Watson, President of the BPS

As you will now know a group or members have called for an EGM to discuss the NICE guidelines and to call for my resignation. I think there is a need for some clarification of my position before the meeting takes place and before the membership vote.

I was asked to be the Clinical Advisor to NICE more than two years before I became President and I accepted because I support the use of best evidence into clinical practice. It is important to state here that I was not engaged to represent the views of the British Pain Society in anyway but to act as an independent advisor to the Guideline Development Group (GDG).

It perhaps is useful to outline the way in which NICE works. The role of the Clinical Advisor is to help the Guideline Development Group (GDG) identify the evidence for treatments within the remit of the scope of the treatments or condition to be examined. The scope of the guideline is handed down by NICE with little room to change it, the original scope was suggested to NICE by the Pain Society. The GDG can choose to accept whatever level of evidence they deem is appropriate; it is then the role of the Clinical Advisor to collect and provide this evidence to assist in the development of the guidelines. The interpretation of the evidence and how that is incorporated into the guidelines

and the final evidence statements is the role of the GDG.

There are many treatments used in the management of low back pain few of which have been subjected to good research scrutiny. This makes the task of reviewing the literature difficult. Anyone who has done a comprehensive literature search on back pain will understand the huge volume of literature from small studies on back pain using a variety of treatment techniques some well established and commonly used and others which can appear very unusual to us. Many are based on cohort studies comparing treatments often without control groups, this makes the task of comprehensively reviewing the evidence difficult. The GDG took the decision to only look at studies which were randomised controlled trial with sufficient numbers to be confident in the results.

It has been suggested that NICE ignored the evidence presented by the BPS and other interested parties many of whom are involved in the support of the motion to remove the President. This was not the case and the NICE website carries a full disclosure of the responses to the communication with all stakeholders. No evidence was rejected which met the criteria developed by the GDG. The evidence on interventional therapies presented was case series and cohort studies which the GDG had decided not to accept for any treatment. Some people feel aggrieved about this. I wish you to consider that many treatments which members of the BPS would not recognise as bona fide also have a body of evidence which consists mainly

intellectual and academic freedom of the membership of the British Pain Society.

I have been asked why I did not resign when I became President Elect. I put it to NICE that I should resign at that time but they were of the opinion that my conduct to that point had been totally impartial and furthermore they felt the BPS is not a single issue pressure group but is an organisation with a wide variety of professionals so they did not see my position would present a conflict of interest; I therefore agreed to stay.

It has also been suggested that I should have resigned when it became apparent that the guidelines would not support some of the therapies used regularly by some members of the BPS. I believe this would have been disingenuous. To agree to be part of a process when it suits you but to remove yourself when it does not is the antithesis of the impartiality which is required in such a role. In addition, once one becomes part of such a process one signs up to the outcome and to the joint responsibility for the outcome. NICE requires that all the GDG members sign up to the collective responsibility for the guideline which is the case with all such guidance and I acted honourably to my duty to NICE in doing so.

I will of course accept the decision of the Society. I hope that those who have called this EGM will act honourably and do likewise and remain with the Society and work with the membership and Council should the decision not go in their favour.

Prof Paul J. Watson 6/7/2009

of data from cohorts and case series. These are published in peer reviewed journals. The providers of many therapies can point to cohort studies, some very large indeed, in support of their claim to justify funding. Unfortunately when we rely on cohort studies alone the level of evidence is often only equal to those treatments we would not wish to offer in our clinics.

I draw the membership’s attention to the recent American Pain Society (APS) document published soon after NICE on the management of low back pain which drew similar conclusions to NICE about the contentious issues which have prompted this, the use of injection therapies and other interventional techniques. NICE has a duty to come up with guidance on what should or should not be offered by the NHS based on evidence of efficacy and cost effectiveness it cannot make statements such as “unable to recommend treatment A” as the APS did , it must state “do not offer treatment A.”

It has been suggested to me that NICE should only have considered “established” hospital practices. I would find it hard to justify to a patient. If treatments have, on the face of it, equal levels of evidence, even if we find one of them difficult to accept from our own professional stand point, I believe we must consider them equally and, if necessary, offer them equally. Using only RCT evidence in some ways helps to avoid this problem by setting a higher bar of evidence.

I believe the motion as worded will make it difficult for anyone to take a significant role in the development of guidelines on treatment in the future if there is a threat that, should the guidance not reach the conclusions favoured by some members of the BPS, that person might be hounded out of office. I don’t believe this is helpful for the Society or for the development of treatment guidance. It also threatens the

Open letter to the membership from Professor Paul Watson, President of the BPS



Dr JohN GoDDarD

As Chair of the Extraordinary General Meeting held on 21st July 2009, I wish to report that 46 members of the British Pain Society attended. Dr Philip Alderson, Associate Director, Centre for Clinical Practice, NICE, gave a presentation with regard to NICE processes. Dr Joan Hester responded to questions on the Society’s involvement in the low back pain guideline. Dr Chris Wells proposed the Resolution that the President should resign due to his personal involvement with the guideline and a continuing conflict of interest with his role as President. Professor Paul Watson responded stating his position as clinical advisor to the guideline development group and the fact that at no time did he represent the British Pain Society on the group. He also detailed the progress that he had made since his Presidency started, including dialogue with the Chief Medical Officer with regard to pain management services and the broader interests

The Council of The British Pain Society would like to clarify its position, in response to the letter from Sir Michael Rawlins and Professor Peter Littlejohns and their outrage at the democratic proceedings of The British Pain Society.

Council of The British Pain Society deeply regrets the resignation of the President, Professor Paul

of the British Pain Society. The position of the British Pain Society in the national and international arena was considered. Comment from the floor occurred after all presentations.

A suggestion was made to adjourn the meeting because it was felt that not all members of the Society had had the opportunity to hear the presentations today and be fully informed. The Chair proposed that a timely independent secret ballot should be held. The majority view of members present was that most members who had voted by post were fully appraised of the issues involved and that a vote upon the Resolution should be taken. The Chair acceded to this view.

186 votes supported the Resolution and 179 opposed the Resolution. The President, therefore, intends to tender his resignation forthwith. Council will need to decide how to proceed in the wider interests of the Society.

Watson. We continue to hold Paul Watson in high regard and believe he has acted honourably. He has contributed immensely to the Society over many years and retains the respect not only of Council, but of the vast majority of the membership.

We are a multidisciplinary organisation committed to the promotion of best practice

We believe that the British Pain Society does respect the academic freedom of its members and officers. We wish to reassure Rawlins and Littlejohns that we do embrace the principles of evidence based medicine, but also recognise its limitations and that it must be applied with judgement (Rawlins, Harveian Oration 2008). We believe that this guideline, in the latter part of the pathway, is not in the best interests of many patients and would welcome the opportunity to engage in a constructive debate with NICE with regard to the guideline, and more importantly, its implementation and future revision.

As a Society, we need to reflect on recent events and examine our procedures. We also need to retain our multidisciplinary membership and move forward, continuing to champion the importance of pain management in the interests of patients. We maintain a strong commitment to high quality interdisciplinary pain management, based on the application of evidence, with judgement, for individual patients.

Council of the British Pain Society is pleased to announce the appointment of Sir Michael Bond, past President, as the Interim President of the Society.

Signed by Executive Officers on behalf of the Council of the British Pain Society.

in the management of those experiencing pain. We are also a limited company, bound by company law and our Memorandum and Articles. It needs to be recognised that the Officers of the Society acted in accordance with the Memorandum and Articles in holding an Extraordinary General Meeting in response to a request by twenty four members. We are disappointed that an alternative way of dealing with this issue was not possible and that the resolution suggesting a conflict of interest and calling for Professor Watson to resign was carried by just seven votes; the total votes cast representing only a quarter of the Society’s membership. We would emphasise that Professor Watson’s professional integrity was never questioned at the meeting.

We share some of the sentiment expressed by Rawlins and Littlejohns. The meeting, the resolution and the outcome now represent an uncomfortable chapter in the Society’s history.

These events reflect the sincere concerns of some within the Society’s membership; they were of the view that the NICE low back pain guideline represented a serious conflict of interest for their President. While only a minority of the Society’s membership adopted this stance, there should be no doubt that that this group are not alone in their concerns about the guideline.

Although the guideline contains many important elements we would wish to wholeheartedly endorse, we have concerns with some aspects of the NICE process that has resulted in this guideline. We are particularly concerned that access to a pain specialist does not form part of the care pathway. We are also concerned with regard to the omission of an expert in non-surgical interventions from the guideline development group and the costing report, which includes injections performed outside the specified window of the guideline.



Statement of Chair of EGM

British Pain Society response to NICEThe lion has roared: the mouse responds


prof Charles GreeNouGh MD frCs Professor of sPinal studies, uniVersity of durhaM

The author is an orthopaedic spinal surgeon and has performed fusions for non-specific low back pain. He was a member of the GDG for the NICE guideline on the early management of persistent non-specific low back pain.

The views expressed are those of the author and not necessarily of the GDG or NICE.

Guideline - IntroductionIn May of 2009 the National Institute for Health and Clinical Excellence produced a guideline on the early management of persistent non-specific low back pain. Since publication there has been a very large amount of comment, some measured and reflective and some less so. The majority of comment has focussed on two or three recommendations and in many cases the overall thrust of the document as a treatment pathway for patients has been overlooked.

Guideline – Does what it says on the TinThe guideline addresses the treatment of non-specific low back pain with duration of symptoms between six weeks and twelve months. The guideline does not address the issue of diagnosis; either in the individual patient or in the design of clinical triage and management systems. The guideline starts from the perspective of the management of a patient with established non-specific low back pain. If, for example, after clinical evaluation there is a suspicion of nerve root entrapment then it is clear that such a patient does not come under the remit of the guideline and should

be investigated appropriately for suspected neurological entrapment. The same will apply of course to any other suspected specific pathology.

The guideline explicitly indicates that the diagnosis should be kept under formal review as the patient passes along the clinical pathway. If at any stage clinical suspicion arises that there might be a specific cause for the low back pain, then the patient no longer comes under the remit of the guidelines and should be investigated appropriately.

Guideline – The Process The intention when developing the guideline was to examine the evidence for treatments that are commonly recommended for patients with non-specific low back pain of between six weeks and twelve months duration. A Guideline Development Group (GDG) was convened with members having expertise in many different areas of low back pain management. It is very important to note, however, that no member of the GDG was there as representative of any society or speciality.

We are all aware of the enormous body of published research in the management of non-specific low back pain. We are also all aware of the comprehensive and detailed work that has been done on the grading of evidence, the structure of systematic reviews and metanalyses. It was determined that the GDG would consider only evidence from randomised controlled trials and that this standard of evidence would be applied to all treatments, except in cases where randomised controlled trial evidence was not available.

Hundred of hours were put in by the research staff, as described in the report, to locate relevant studies, systematic reviews, metanalyses etc. All included studies underwent data extraction and were scrutinized by the members of the GDG. Members of the GDG were also able to bring forward studies for consideration.

The GDG then undertook hours of painstaking deliberations to try to be certain that every recommendation was based to the fullest possible extent on best evidence as described above. Every member of the GDG of course had their own professional background but this was excluded as far as possible. For example, I left the room when the recommendations concerning referral for surgery were formulated.

Guideline – The PathwayThe clinical pathway for management of patients with non-specific low back pain is one of the most important parts of the guideline. This pathway provides structure and a hierarchy of treatment and is fundamental to the understanding of the guidelines.

Patients enter the pathway at six weeks duration of symptoms. The diagnosis must be kept under review at each stage.

All patients should be offered advice to continue to be physically active pursuing normal activities and self management should be promoted. Drug treatments are offered for pain relief and to allow patients to keep active.

At this stage one of three treatments (group exercise programme, manual therapy or acupuncture) may be offered. In the absence of a satisfactory improvement another of these three options may be considered.

Following on from this, in patients with continuing high disability and/or significant psychological distress, referral for a combined physical and psychological treatment programme may be

considered. This should include a cognitive behavioural approach and physical exercises and this is a high intensity programme. Programmes of this type are very uncommon in the United Kingdom, although commonly available on the Continent and in North America where results have been very satisfactory with substantial improvements on many measures such as the Quality Adjusted Life Year (QALY).

The structure of the successful programmes may be seen in the references provided with the Guideline. Some are structured as 3 week full time programmes and others somewhat less intensive but completed within an eight week period. All have a cognitive behavioural approach but with a heavy emphasis on exercise and training; many also include occupational tasks.

The final stage of the pathway is a consideration for referral for an opinion on spinal fusion. This is recommended only for patients with continuing severe pain and disability who have completed the recommended combined physical and psychological treatment programme and who have had any psychological distress appropriately managed. It is recommended that due consideration should be given to possible risks of surgery and that referral should be made to a specialist spinal surgical service.

Guideline – Some Specific Issues A. ImagingConflicting results in terms of pain, disability and health status score when x-ray was compared with no x-ray were reported in two randomised controlled trials (RCT). Both, however, showed increased satisfaction in the x-ray group. There is evidence of harm with x-ray usage. No trials of MRI against no MRI have been undertaken but early MRI has been compared with late MRI and MRI has also been compared with x-ray. MRI was associated with improvement in patient reassurance against x-ray but no other differences were

The NICE Guideline on the Early Management of Persistent Non-Specific Low Back Pain

BACK PAIN - THE CONTROVERSY


found. Early MRI demonstrated some improvement in some subscales of the SF 36 as well as improved reassurance. However, reassurance was not a primary outcome measure selected by the GDG for the evaluation of research studies. Careful history and physical examination may provide equal benefit and reassurance.

It remains the case that there is no strong relationship between any MRI finding and low back pain which can guide a more specific treatment.

Other difficulties may arise following MRI scanning in non specific low back pain. It is well recognised that asymptomatic disc prolapse, for example, is common with radiological evidence of neurological entrapment. Referred leg pain is also common, 39 percent of 643 patients with mechanical back pain in my own clinic (Coxon et al 2009) demonstrated pain radiating below the knee on body map drawings. A combination of referred pain and an asymptomatic disc prolapse on the same side is an obvious potential source of unnecessary and unsuccessful intervention.

The British Pain Society, in a response to NHS Institute for Innovation for Improvement, also noted difficulties with communication and interpretation of MRI scans to patients that resulted in people being made unnecessarily anxious and frightened. The Pain Society also believes that poorly managed increased access to MRI scans might lead to an increased demand on secondary services (Price and Hester).

In the context of referral for spinal fusion MRI scan may identify patients who are unsuitable for surgery because of multiple level degenerative disease.

B. Strong Opiods The evidence of the short term use of opioids is clear.

Prolonged use of strong opioids is associated with harms and for this reason the guideline requires due consideration to the risk of dependence and side effects and suggests referral for specialist assessment in patients requiring longer term opioid prescription. The short term trials generally used a period of 12 weeks and it might be suggested that use for more than 12 weeks should prompt consideration of referral.

C. Recommended TherapiesEvidence for improved outcome from exercise programmes was noted in a number of RCT’s. In some studies, treatment with an exercise programme combined with manual therapy was superior. Manual therapy itself demonstrated improvement in some but not all randomised controlled trials. Economic assessment of a large well conducted UK based trial found that manipulation alone had a 50 percent probability of being the most cost effective option with combined treatment of manipulation and exercise therapy being most cost effective in 40 percent (calculated at £20,000 per QALY).

Interestingly the evidence regarding acupuncture indicated that acupuncture and sham acupuncture (needling in other than classical acupuncture points) were equally effective. However, both acupuncture and sham acupuncture were consistently superior to controls. This may cast doubt on meaning of the classical points but demonstrates the acupuncture as a process is effective. An economic analysis indicated that acupuncture was cost effective with a 90 percent certainty using £20,000 per QALY as the threshold of acceptability.

D. Effect Sizes In each of the three recommended first line treatments (group therapy, manual therapy, and acupuncture) effect sizes were small, up to .041 QALY. These, however, were the only therapies for which there was satisfactory high quality evidence of any improvement at all. Health

significant exercise component and many also included goal setting and problem solving. Some included occupational training. The effect size of these programmes was more significant, up to 0.99 QALY.

G. Referral for Surgical ConsiderationFour relevant RCT’s relating to fusion surgery were found. In one study surgery was randomised against routine care and in two randomisation was against a combined physical and psychological programme. The fourth study was restricted to a specific diagnosis of a spondylolisthesis. Meta-analysis demonstrated benefit of surgery of 4.87 points on the Oswestry Disability Index (ODI). Surgery carries risks of serious and of less serious complications and it was recommended that referral for surgery should only be considered in patients who had completed a combined physical and psychological treatment programme and in addition had had management of any significant psychological distress. Referral should be undertaken to a specialist spinal surgical service.

Regarding surgery, the American Pain Society (Chou et al 2009) found fair evidence of a moderate improvement compared to standard treatment although no difference compared to intensive rehabilitation. Their recommendation for fusion was B - “The panel recommends that clinicians consider offering the intervention to eligible patients”.

Guideline – Non Specific Low Back PainNon-specific low back pain is a condition for which there are a wide variety of different treatments undertaken by a large number of different professional and non-professional groups. In general it might be considered that if a single condition has a large number of treatments then none of these treatments can be particularly effective, or it would have dominated the field in the same way that total

economic analysis demonstrated sufficient improvement over a large population to justify the recommendations.

E. Therapeutic Injections Facet joint injections and epidural injections are a frequently used modality for the management of non-specific low back pain. In the year 2007/2008 HES Data indicates that some 65,000 such injections were carried out in the NHS alone. This figure excludes injections undertaken for a radiculopathy or any other specific cause.

This area of the guideline has attracted the most comment, some of which has been less than cool and dispassionate. The simple fact is that there is no randomised controlled evidence to support either of these treatments. Epidural injections for non-specific low back pain have not been subjected to randomised controlled trial. The only RCT conducted on facet joint injections demonstrated no difference between injection with steroid and injection with saline.

A multi-disciplinary group representing the American Pain Society have also carefully reviewed a number of interventions for non-specific low back pain. Their remit was for pain of any duration and not limited to less than 12 months. As far as steroid facet joint injections were concerned, they found fair evidence that facet joint injections were of no benefit. They graded the intervention as D - “The panel recommends against offering the intervention. The panel found at least fair evidence that the intervention is ineffective or that harms outweigh benefits.” (Chou et al 2009).

F. Combined Physical and Psychological Treatment ProgrammeEvidence for the effectiveness of these programmes was of good quality. The best evidence for effectiveness was in programmes of more than 100 hours of exposure of a period of up to eight weeks. All successful programmes included a CBT approach with a very


hip replacement dominated osteotomies, capsulectomies, forage etc previously performed for hip arthritis.

In non-specific low back pain even those treatments that can have effectiveness demonstrated in randomised controlled trials often have small effect sizes. Ineffective treatments are not cost free and more importantly have a deleterious effect on the patient by focussing on usually passive therapies and delaying effective positive management.

Very many treatments are supported by published case series and cohort studies. Some of these treatments would not be considered within conventional care in the U.K. Some treatments such is IDET reported extremely satisfactory results in cohort studies but were subsequently demonstrated to be ineffective in RCTs.

There is no place for accepting a lower standard of evidence for one treatment than another.

Guideline – Future Research The NICE Guideline has identified six high priority areas for future research. Two of these are for widely used treatments for which current evidence is inadequate (facet joint injections and transcutaneous electrical nerve stimulation). Many other treatments lack a substantial evidence base.

NICE Guideline is regularly reviewed and will develop as further evidence becomes available.

Guideline – The Way ForwardThe NICE Guideline is the culmination of many hours of literature review and prolonged and detailed analysis and discussion. It has been the subject of consultation and all stake holder comments have been documented and answered. Comments and the responses are available on the NICE Web Site.

It is of considerable interest that independently to the GDG a panel

representing the American Pain Society was undertaking exactly the same review of treatments in low back pain but in their case without the 12 month cut off. The conclusions of this American panel are almost identical to those of the GDG and in particular correspond exactly in the consideration of facet injections, combined physical and psychological programmes and fusion surgery, the areas of the greatest controversy in the U.K. This effectively eliminates the possibility of any unintentional bias in the development of the NICE Guideline.

The recommendation of the combined physical and psychological programme is the most exciting new feature in the guideline. These programmes are very uncommon in the United Kingdom but have robust evidence of effectiveness and an effect size better than most other treatments. The implementation of these programmes in the U.K. will provide huge benefits to the population suffering from non-specific low back pain. The development of these programmes will also provide an effective treatment with significantly fewer risks and complications than the spinal fusion which may be reserved for those who fail to benefit from this programme.

Delay in management decisions, and delay by non contributory investigations or ineffective therapies will reduce the prognosis in this patient group. A properly constructed clinical pathway, such as illustrated in the guideline, will ensure timely delivery of the effective treatments and will streamline early management for many patients to their ultimate benefit.

There has been much discussion of evidence based medicine in recent years. It is now time to support it.

REFERENCES

Referred pain Referred Pain CAN Radiate Below the Knee. R. A

AUTHOR

Prof Charles Greenough MD MChir FRCS Consultant Spinal Surgeon, Professor of Spinal Studies, University of Durham, Clinical Director Golden Jubilee Regional Spinal Cord Injury centre, The James Cook University Hospital Marton Road, Middlesbrough TS4 3BW UK

Tel 44 1642 854311 Fax 44 1642 282649 [email protected]

Coxon, R Shipley, M Murray et al. Accepted for podium presentation, Spine Society of Europe, Warsaw, October 2009.

The British Pain Society Responds to the NHS Institute for Innovation and Improvement – C Price, J Hester; British Pain Society web site.

Interventional Therapies, Surgery, and Inter-Disciplinary Rehabilitation for Low Back Pain. An Evidence-Based Clinical Practice Guideline from the American Pain Society, Chou R, Loeser JD, Owens DK et al, SPINE 34:1066-1077, 2009.

Edinburgh2011 ASM21-24 June 2011

DiAry notEthe Annual Scientific Meeting 2011 is in collaboration with the Canadian Pain Society and will take place in Edinburgh, tuesday 21 June –Friday 24 June 2011


Dr aNDreW Moore editor bandolier balliol college oxford

I have to admit to a sinking feeling when asked me to consider how evidence had been used in the NICE guidance on treating back pain. When it comes to NICE, my general view is that I am going to be dead in 20 years or so, and really don’t want to fill the remaining time with stuff like this.

Let me be clear at the outset where I stand on NICE. I think it is a good idea, and went before a House of Commons Select Committee to argue for a large increase in its funding, so that it could be:

1. National (it isn’t now, using only selected folk to examine evidence),

2. an Institute (an organisation for promoting use of evidence in medicine, finding the questions to ask as much as the answers, of which there will be precious few),

3. clearly related to clinical medicine (as opposed to academia, where brownie points for pointy headed academics is the norm, and clinical practice all but ignored),

4. and Excellent (which NICE just isn’t in its present incarnation).

The problem for me is that NICE has, perhaps necessarily given its remit by the Government, descended into formulaic ways of doing things. It should be asking some serious questions, not trying to tell everyone what to do, as if one size really did fit all. Anyway,

it is what it is, and anything critical I say about it refers to structures and organisation, and particularly to remit, rather than individuals.

The way NICE does things can work in evidence rich areas, and it has to be acknowledged that NICE can do great work. The 2008 osteoarthritis guidelines are a case in point, possibly overlooked outside general practice. These guidelines swept away decades of blind ignorance to put topical NSAIDs early in the care pathway, because all the evidence is that they are effective and safe, relegating rubefacients (appropriately) to the outer limits. Overnight, topical NSAIDs went from being a marker of bad prescribing to a marker of good prescribing. The evidence hadn’t changed; it’s just that someone looked at it. Patients will be better treated and safer as a result. Part of the NICE osteoarthritis guidance, on coxibs and NSAIDs, is incorporated into the back pain guidance.

Pain evidence It’s not enough to know about evidence in a general sense. It is critical to know specifically about pain evidence and the nature of pain trials. For example, responses in pain trials are often, indeed usually, reported as average changes on continuous measures like 100 mm VAS scales. For this to be meaningful it supposes that the underlying distribution is normal, so that most respondents will be close to the average to a greater or lesser extent. In fact, responses in pain trials, acute and chronic, are often U-shaped rather than bell shaped, and the average is completely unrepresentative – almost no-one gets the average result.

Instead we need to go to responder analyses [1]. These tell us that what looks like a relatively small change in the average included people with very great pain relief and those who get worse. A 10 mm change over placebo might not look very good, but try saying that 60% get a moderate or substantial benefit in terms of pain relief [1] – the same answers from the same trials.

It is only possible to get meaningful results from pain trials using responder analyses – as we are now enjoined to do [2].

Back pain desertThe evidence around back pain is a desert. A recent systematic review [3] used a search strategy recommended by the Cochrane Back Review Group for placebo controlled randomised trials of interventions for acute or chronic low back pain. Placebo could include sham interventions, or minimal interventions. Trials with specific causes of back pain, or with surgery, within the previous 12 months, were excluded. Pain outcomes had to be continuous, but any duration of therapy was allowed.

The authors found 76 trials for 34 different interventions (Table 1). Few interventions were reported in three trials or more, with more than 500 patients, and for longer than a few weeks. Only for analgesics, herbal medicines, muscle relaxants, and NSAIDs were there more than 500 patients. For the rest of the interventions, only three had as many as 250 patients, with seven over 200 and 23 below 200 patients.

For the four interventions with adequate data:

• Analgesicsproducedsignificantly less pain than placebo in three trials of chronic back pain over 10 weeks.

• Herbalmedicines(typenotstated) produced significantly less pain than placebo in four trials of chronic back pain, but only over three weeks.

• Musclerelaxantsproducedsignificantly less pain than placebo in nine trials, all but one of acute back pain over one week.

• NSAIDsproducedsignificantlyless pain than placebo in seven trials of acute and chronic back pain over an average of six weeks. There is evidence that as many as 60% of people with back pain will have a moderate or substantial response with coxib or NSAID. See table 1.

For no other intervention was there sufficient evidence to tell whether they worked or did not work. The simple fact is that for most interventions there is just not enough data on which to make an informed opinion. And this systematic review is probably putting more of a gloss on the data than is justified, because it used a non-standard quality scoring scale with 11 items, almost certainly insensitive and letting through trials likely to be biased in one important way or another. This is all we have in the way of randomised trials.

What we can say is that muscle relaxants are probably useful in acute low back pain, and analgesics and NSAIDs in chronic and acute low back pain. For herbal medicines we have to reserve judgement because the trials were too short to be valid for chronic low back pain, because we don’t know what the herbal medicines were, and because herbal medicines are too often adulterated, particularly with NSAIDs.

What about acupuncture – toothpick medicine?Acupuncture for back pain has been suggested as being appropriate by NICE and by some systematic reviews [4]. Yet systematic reviews of acupuncture have been shown to be of exceptionally poor quality, and frequently misleading because


Back pain, NICE, and evidence


they include clinical trials of poor reporting quality (leading to bias), inadequate validity (especially with regard to outcomes), and of low size [5]. While 16 of 35 systematic reviews of acupuncture claimed that it worked, application of quality, validity, and size guidelines showed that all 16 made claims that could not be substantiated by the evidence, and that “true” acupuncture was no different to

“sham” acupuncture. Yet another examination of acupuncture for pain suggested that any benefits could not be distinguished from bias [6].

Acupuncture is claimed to be better than waiting list controls, or usual care, and reviews and a recent clinical trial of high quality [7] support this. Participants (638)

were randomised to one of four treatments:

1. Individualised acupuncture prescribed by diagnostician at the beginning of each visit.

2. Standardised acupuncture based on a system considered effective by experts.

3. Simulated acupuncture, involving use of a toothpick that did not puncture the skin.

4. Usual care chosen by patients and their physicians.

The main results were these:

• Therewasnodifferencebetween individualised acupuncture, standardised acupuncture, or sham acupuncture.

• RMDQscoresfellfrom11to6 for acupuncture of any sort by 52 weeks, compared with 7.9 for usual care. Any form of acupuncture was better than usual care.

• Bothersomenessscoresfellfrom 5 to 3.5-4 for all four groups, with no difference between them.

• Useofmedications(about65%at baseline) fell to 47% with acupuncture, but remained at 59% with usual care.

• TherewasnodifferenceinSF-36 mental and physical component scores.

• Cuttingdownonusualactivitiesfor more than seven days in the last month at 52 weeks was more common with usual care (18%) than with acupuncture.

• Moreparticipantswithusualcare missed work or school for more than a day (16%) than with acupuncture (5%-10%).

• Therewasnodifferenceintotal costs of back-related health services between groups ($160-$221), though costs of acupuncture were not included.

• Adverseeventsoccurredin12/315 with real acupuncture, compared with 0/162 for simulated acupuncture, with one serious adverse event for real acupuncture.

• Onepatientintheusualcaregroup went on to have back surgery.

This large, well conducted trial merely confirmed what was already known, that acupuncture using needles was the same as sham acupuncture – in this case a toothpick that did not puncture the skin.

It also confirmed that doing something was better than doing nothing more than usual. Whether this is a simple context effect, a beneficial effect from being involved in a clinical trial, or something extra remains a moot point, but the magnitude of benefits is rather small (Figure 1), and suggests that context effects could be the main generator of benefits.

There is nothing new in these results, but the detail is interesting. For instance, there were statistical differences in the proportion of patients with RMDQ reduction of 3/24 points or more at 52 weeks for any type of acupuncture over control, but half of those with usual care obtained this level of benefit (not quite equivalent to a moderate improvement).

The additional effect of acupuncture was not great, with no difference in bothersomeness at all. And while there were minor differences in time off work and use of analgesics, there was no significant cost benefit for acupuncture over usual care, though the costs of acupuncture treatment were not included, suggesting that acupuncture could be more costly with minimal additional benefit, especially when

Table 1 Evidence from randomised trials in acute and chronic low back Pain

Intervention Number of Mean duration (weeks)Trials Patients

Acupuncture 4 149 3

Analgesics 3 748 10

Anticonvulsants 1 96 10

Antidepressants 4 217 7

ATP 1 161 4

Back school 1 26 10

Behaviour therapies 2 34 6

Colchicine 1 15 12

Electroacupuncture 1 25 2

Exercise 3 204 4

Facet injections 3 257 3

Heat wrap therapy 2 255 1

Herbal medicines 4 705 3

Immunoglobulins 1 41 2

Infra red 1 38 7

Isis 1 116 52

Laser 2 76 4

Magnets 1 36 3

Massage 1 51 4

Muscle ralaxants 9 820 1

Nerve blocks 1 17 2

Neuroreflexology 1 70 0

NDMA antagonists 1 43 8

NSAIDs 7 1349 6

Physiotherapy 1 120 4

Proiotherapy 3 263 13

PTIT 3 139 19

Radiotherapy 1 32 6

RF denervation 4 223 7

Shortwave 1 65 4

SMT 6 247 2

TENS 4 178 2

Traction 1 150 5

Vitamin B12 1 60 2


considering the known harms of acupuncture [8].

What might be more relevant is previous research indicating that targeting level of care to severity [9] is the best approach.

What we are left with, though, is a conclusion that acupuncture is no better than a toothpick.

And surgery?Lumbar discectomy is a common procedure for patients with persistent back and leg pain, particularly if it is unresponsive to non-invasive conventional therapies. Surgery tends to be of two types, a more aggressive approach involving removal of herniated disc fragments and curettage of the remaining disc, and a less invasive technique involving removal of fragments alone with little invasion of the disc space.

Issues with surgery involve shorter and longer term pain persisting, and injury to the disc and endplate of the vertebrae, with accelerated degenerative changes, disc space

collapse, and potentially more or worse back and leg pain.

A systematic review of case series [10] reported outcomes after limited and aggressive discectomy for primary lumbar disc herniation reported incidence of persistent pain in the shorter (6 months to two years) and longer term (more than two years), or recurrent disc herniation. Persistent pain affected 14% of patients (1 in 7) between six months and two years (Table 2). In the longer term, over two years, the incidence of persistent pain was much lower with limited discectomy (12%; 1 in 8) than after aggressive discectomy (28%; 1 in 4). The incidence of recurrent disc herniation was much lower with both techniques, at 7% after limited discectomy and 3.5% after aggressive discectomy, averaging 1 patient in 20.

Perhaps the most useful result is that it provides evidence of the success and failure rate with lumbar discectomy for leg or back pain. Most people, it would appear, have pain reduced to a point of

not being clinically relevant, which is good. Some (between 1 in 8 and 1 in 4) will have persistent pain despite the surgery, and 1 in 20 will have recurrent herniation, potentially very bad news because it could lead to further problems.

It is possibly not entirely fair to make too many decisions about the type of surgery that is best, because as always with case series there is a host of reasons why results may be different, typically because of differences in case mix and initial pathology and severity. What we have is some numbers to put to patients considering surgery so that they can make an informed decision. The numbers we have put considerable weight on trying

non-invasive, or less invasive, interventions before resorting to surgery.

Lessons?Effective pain management is about more than the efficacy and harms of particular interventions. It should be about integrating effective interventions into an overall package of care, which might need individualising for particular patients with particular problems, concerns, or aspirations. It is, above all, about wisdom and common sense.

These are areas where evidence cannot easily go, but where so much of the real world exists. It’s what professionals do every day, and it the role of those who are

Figure 1 Effects of acupuncture in a randomised trial in low back pain with 638 participants. Percentage at 52 weeks with ≥3/24 point reduction in Roland Morris Disability Questionnaire, and ≥2/10 point reduction in Bothersomeness index

Figure 2 An example pain ladder that might be amended for use in back pain drug therapy

Table 2 Outcomes after limited or aggressive discectomy for back or leg Pain

Outcome Number of patients

Range (%)

Overall incidence

(%)

Limited discectomy


1434 7-26 15


3263 7-16 12

Recurrent discherniation 5832 2-18 7

Agressive discectomy


4242 6-43 14


1571 19-36 28

Recurrent discherniation 6114 0-10 3.5


BACK PAIN - THE CONTROVERSY interested in evidence to help: it’s all about tools rather than rules.

For example, pain is increasingly dealt using simple care pathways in which drugs may be used together, as appropriate, rather than instead of one another [11] (Figure 2). Simple ladders like this, based on the WHO ladder for cancer pain, offer a sensible approach even to back pain, giving patients a degree of control. Evidence may support the choice of rung, but it is the practitioners who decide what rungs are appropriate, and in what order. This example comes from another arm of the NHS (Do Once And Share).

The fact is that back pain is difficult, and evidence about particular interventions limited. Evidence on suitable care pathways for primary care is almost non-existent. If there is a lesson, it is that NICE works best when the work is done for them, in the form of reviews of evidence in the literature, ideally from disinterested but informed task forces, to begin to fill the evidence lacunae. The BPS should consider a crash programme of task forces to fill the gaps.

REFERENCES:

1. RA Moore et al. Responder analysis for pain relief and numbers needed to treat in a meta-analysis of etoricoxib osteoarthritis trials: bridging a gap between clinical trials and clinical practice. Annals of the Rheumatic Diseases, 2009, Apr 12. [Epub ahead of print].

2. RH Dworkin et al. Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations. J Pain 2008;9:105-121.

3. LA Machado et al. Analgesic effects of treatments for non-specific low back pain: a meta-analysis of placebo-controlled randomized trials. Rheumatology 2009 48: 520-527.

4. J Yuan et al. Effectiveness of acupuncture for low back pain. A systematic review. Spine 2008 33: E887-E900.

5. CJ Derry et al. Systematic review of systematic reviews of acupuncture published 1996-2005. Clinical Medicine 2006 6:381-386.

6. SV Madsen et al. Acupuncture treatment for pain: systematic review of randomised clinical trials with acupuncture, placebo acupuncture, and no acupuncture groups. BMJ 2009 338:a3115.

7. DC Cherkin et al. A randomized trial comparing acupuncture, simulated acupuncture, and usual care for chronic low back pain. Archives of Internal Medicine 2009 169: 858-866.

8. E Ernst, A White. Life-threatening adverse reactions after acupuncture? A systematic review. Pain 1997 71: 123-6.

9. EM Haland Haldorsen et al. Is there a right treatment for a particular patient group? Comparison of ordinary treatment, light multidisciplinary treatment, and extensive multidisciplinary treatment for long-term sick-listed employees with musculoskeletal pain. Pain 2002 95: 49-63.

10. MJ McGirt et al. Recurrent disc herniation and long-term back pain after primary lumbar discectomy: review of outcomes reported for limited versus aggressive disc removal. Neurosurgery 2009 64: 338-345.

11. McQuay HJ. Pain ladders, systematic reviews, and trials. In Systematic Reviews in Pain Research: Methodology Refined. Eds McQuay HJ, Kalso E, Moore RA. IASP Press: Seattle, 2008: pp 373-380.

Dr DaviD aNDreW Walsh frcP, Phd

back Pain unit, king’s Mill hosPital, MeMber of the nice back Pain gdg

The recent National Institute for Health and Clinical Excellence (NICE) guidelines on the early management of persistent non-specific low back pain have raised interesting questions within the British Pain Society about the application of evidence based guidelines to clinical practice.

The notion of medicine as a science requires that our treatments are biologically plausible, as well as that they achieve the desired clinical outcomes. The double-blind, randomised, placebo-controlled trial is ideally suited to test mechanistic hypotheses about treatments. However, clinical practice is more concerned with providing effective treatments than with addressing discrete mechanisms. Whether patients do better with a treatment than without it is more important than whether that benefit is greater than with matching placebo.

It is important that the client’s and therapist’s understanding of a problem are consistent with its treatment. A purely empirical approach to medical evidence sits uncomfortably with this model, and it is unclear that empirical evidence of efficacy from RCTs should be the sole criterion by which NHS resources are allocated. However, it is preferable to allocate our limited health care resources to treatments with evidence of efficacy, but uncertain mechanism of action, rather than to treatments without that evidence, however persuasive is their scientific rationale.

Randomised controlled trials are the most appropriate methodology

for investigating interventions that address discrete and stable outcomes. If fewer people die following a new treatment designed to save lives compared with controls, then I should choose the new treatment. Treatments for chronic pain typically result in a spectrum of reversible outcomes. The conclusion from RCT evidence that one treatment is more effective than another does not mean that it will be effective for all patients. Indeed the apparently `inferior’ treatment may be more effective for some patients. Here we are most interested in individual and actual, rather than predicted, responses. Our patients may have the opportunity of trying both treatments and deciding which best helps their pain, a luxury that cannot be afforded where the outcome is death. The RCT data may help us to advise which treatment should be tried first, but individual response would determine which treatment should be continued.

We have little evidence by which we can know whether patients who have been failed by one treatment are likely to respond to another. With the ever increasing number of evidence based treatments for low back pain, each likely to produce an incomplete response; the NHS may not be able to afford to sustain a patient pathway through which all treatments are offered in sequence. In this context, it would be difficult to deny our patients treatments for which there is good evidence of cost effectiveness, and instead offer treatments that are equally or more costly and with less sound evidence.

For me, practicing evidence based medicine means that we should continue doing what we have always done unless there is either

The application of evidence to clinical practice


good evidence that something else is better, or better evidence that something else is good. Only rarely are there head to head studies by which we can be sure that one treatment is better than another. Increasingly, however, there is now good evidence that some treatments for low back pain can be helpful, whereas for other treatments the evidence is

less robust. NICE guidelines play an important role in highlighting where this is the case.

The views expressed are those of the author and not necessarily of the GDG or NICE. Dr Walsh again produced a thorough declaration of any conflict of interests and this can be obtained on request.

time. The LeClaire paper (vide infra) proves the point. You cannot treat intervention in isolation.

These guidelines have been officially accepted by the Dutch and (Flemish) Belgian societies of anaesthesiologists, which has given them a legal status in the Benelux countries.

They were also presented to the Dutch health insurance authority, which remarked that authors were the first group of specialists who had come forward with a formally constructed standard of care. The authority intimated that these guidelines were perfectly acceptable as a standard of care in pain therapy in Benelux countries. The Belgian Medical Specialist Association encouraged other specialities to follow the authors’ initiative.

System adopted to appraise the literatureThe authors of the guidelines use a modification of the system described by Guyatt et al (Grading strength of recommendations and quality of evidence in clinical guidelines: report from an American College of Chest Physicians task force-Chest, 2006’ 129: 174-181).

Pain Practice has more details on the systems applied and the full reference is supplied at the end of this article.

This system can be summarised by Table 1.

Section of the Flemish society of Anaesthesiologists) and the Dutch pijn NVA (pain section of the Dutch society of Anaesthesiologists).A group of pain specialists with research experience and specialist knowledge was set up to study the available evidence on 26 important pain syndromes. The preliminary text was subjected to a plenary meeting of both societies and was finalised in February 2009.

Conditions coveredTrigeminal Neuralgia; Cluster Headaches; Atypical Facial Pain; Cervical Radicular Pain; Cervical Facet Pain; Cervicogenic headache; Whiplash Associated Disorders; Occipital Neuralgia; Shoulder Pain; Thoracic Radicular Pain; Thoracic Facet Pain; Lumbar Radicular pain; Lumbar Facet Pain; Sacroiliac Joint Pain; Coccygodynia; Discogenic Pain; Neuropathic Pain; CRPS-1 & 2; Herpes Zoster; Diabetic Neuropathy; Carpal Tunnel Syndrome; Meralgia Paraesthetica.

The guidelines are, of course, monodisciplinary in nature, i.e. they are a review of interventional techniques applicable to each particular diagnosis, but the book gives a vital overview of the state of the art of interventional pain medicine as it specifically deals with diagnosis and takes a critical look at the evidence for the various techniques in current use.

It is important to realise that interventional techniques will only work if patient selection is correct, as otherwise they are a waste of

BackgroundThe original pain intervention guidelines were initiated in 1994 by the Dutch Society of Anaesthesiologists in conjunction with the CBO (the Dutch equivalent of NICE).

It was under this umbrella that the pain centre of the University of Maastricht recently took the initiative to renew these guidelines.

The initial steps to renewal of these guidelines took place in Antwerp on December 2007 during a combined meeting of the Belgian VAVP (Pain

Dr. Charles a. GauCi World institute of Pain

I have just received a copy of this very impressive volume, which comprises the guidelines applicable in the Dutch Speaking Benelux countries. The 440-page volume, written in Dutch, a veritable magnum opus, which covers the many interventional procedures commonly carried out in pain clinics.

In my opinion the word “impressive” does not even begin to do this book justice!

The team of authors was led by highly respected academics with impeccable research credentials, Professor M. van Kleef MD PhD FIPP of Maastricht and Dr. J. van Zundert MD PhD FIPP of Genk, Belgium, both working out of the University of Maastricht.

These individuals have published extensively in peer-reviewed journals and their publications include several original research papers.


Evidence-Based Guidelines for Interventional Pain Medicine according to Clinical Diagnosis- “The Dutch & Belgian Guidelines”

Table 1

Scoring of evidence Grade of evidence

1- benefit of the effectiveness of the treatment is greater than the risk and burden of the complication of the treatment. This code only given when no major complications have been described for the related technique. 2- The benefit of the effect closely balances with the risk and burden of the possible complications

A: highest level of evidence (various RCTs of good quality) B: RCTs with methodological limitations or large observational studies. C: Observational studies or case series 0: technique only described in case reports or for which no information is published in peer-reviewed journals at time of writing.

Additional interpretation of evidence

(+): positive outcome studies

(-): negative outcome studies

(✢): positive & negative outcome studies


The Evidence Scores and Implications for recommendation are summarised in Table 2.

The recommended techniques are described in detail and a practice algorithm was proposed.

Specific Areas of InterestLumbar Facet Joint PainWhen one looks at the, critical analysis adopted by the authors of the Dutch guidelines and at the high objective standards reached in their work then the fact that a the NICE Guideline development group did not have a single individual with extensive knowledge of interventional pain procedures is thrown into sharp focus. If we are both applying evidence hierarchies why the large difference between the Benelux and UK guidelines in relation to interventional back pain procedures? Let us take one example, which is of particular current interest to us. The Dutch guidelines give RF facet denervation a score of 1B+ i.e. a positive recommendation. This positive recommendation was made on the basis of the following RCTs;

Gallagher J et al ; Pain Clinic 1994; 7 (1): 193-8

Van Kleef M et al: Spine 1999; 24, 1937-42

Tekin I et al Clin. J Pain 2007; 23 (6); 524-9

Nath S et al Spine 2008: 33 (12); 1291-7; discussion 8

Another RCT, namely that of Van Wijk et al Clin J Pain 2005: 21,(4): 335-44, was partly positive, however the outcome measure here was not the VAS but a sum score, which represents a methodological failure, however, the global perceived effect was also in favour of RF.

The authors ruled out the paper by LeClaire et al ( Spine 2001; 26 (13) : 1411-6: discussion; 7) as it failed to provide any reliable evidence that the patients who were subjected to RF facet denervation had been correctly diagnosed as having been suffering from lumbar facet joint pain. This paper is the subject of controversy. For many this study did not properly select patients. All patients who underwent a test

blocks were evaluated after one week by the family doctor. 92% of all patients seen were included in this study.

Acording to Schwartzer et al [Spine 1994: 19 (7): 801-6] and Cohen SP et al; [Anesthesiology. 2007 Mar; 106(3): 591-614], the prevalence of properly diagnosed facet pain is about 15% in the population; there was obviously a large element of inappropriate entries in the LeClaire trial. This important factor completely nullified the negative conclusion reached and made this paper completely worthless for scoring purposes. This paper was the subject of deliberation by the NICE GDG. It was seen as a negative paper against Radiofrequency ablation (ignoring all the positive evidence in its favour).

As seen above, interventional techniques will only work if patient selection is correct, as otherwise they are a waste of time. Carrying out any form of intervention therapy, especially RF, without rigorous patient selection is a bit like playing Hamlet but without the Prince of Denmark-utterly useless!

As I reiterate in my opinion you cannot treat intervention in isolation. I would encourage NICE to work with experts in the interventional pain field, instead of dismissing our interest.

The guideline gives therapeutic intra-articular lumbar facet joint injections a score of

2B +/-.This was on the basis that “multiple RCTs with methodological weakness yielding contradictory results better or worse than the control treatment; benefits closely balanced with risk and burdens or uncertainty in the estimates of benefit, risk and burdens”.

It is recommended that facet joint injections be “considered”.

This conclusion fits in with the clinical observations of many practising pain clinicians i.e. that lumbar facet joint injections are not normally an end in themselves; they are best performed as a short-term diagnostic stepping stone, allowing one to consider whether the patient needs RF denervation.

Table 2 Summary of Evidence Scores & Implications for recommendations (*)

Score Description Implication

1A Effectiveness demonstrated in various RCTs of good quality. The benefits clearly outweigh risks & burdens

Positive recommendation

1B+ One RCT or more RCTs with methodological weaknesses demonstrate effectiveness. The benefits clearly outweigh risks & burdens.


2B- One or more RCTs with methodological weaknesses demonstrate effectiveness. Benefits closely balanced with risks and burdens


2B ✢ Multiple RCTs with methodological weaknesses yield contradictory results better or worse than the control treatment. Benefits closely balanced with risks and burdens or uncertainty in the estimates of benefits, risks and burdens.

Considered, preferably study-related

2C- Effectiveness only demonstrated in observational studies. Given that there is no conclusive evidence of the effect, benefits closely balanced with risks & burdens.

Considered, preferably study-related

0 There is no literature or there are case reports available, but these are insufficient to suggest effectiveness and/or safety. These treatments should only be applied in relation to studies.

Only study-related

2C- Observational studies indicate no or too short-lived effectiveness. Given that there is no positive clinical effect, risk and burdens outweigh the benefits.

Negative recommendation

2B- One or more RCTs with methodological weaknesses or large observatorial studies that do not indicate any superiority to the control treatment. Given that there is no positive clinical effect, risk and burdens outweigh the benefits.


2A RCT of good quality which does not exhibit any clinical effect. Given that there is no positive clinical effect, risk and burdens outweigh the benefits.


(*) van Kleef M et al; Pain Practice vol. 9 Issue 4, 2009, 248


BACK PAIN - THE CONTROVERSYToo many of us in the pain field, based on our long clinical the dismissal of facet joint RF in comparison to the approval of spinal fusion seemed highly problematic. Add to that conclusions concerning acupuncture (no RCTs here, of course), and we are indeed faced with an example of dare pondus idonea fumo!

So if you’re lucky enough to get back pain in one of the Benelux countries, there is every possibility that it would be treated by RF.

On the other hand if you’re unlucky enough to get it in the UK, you are likely to start with acupuncture and end up with a spinal fusion, at least if NICE have their way!

So much for a common European policy! An increased rate of spinal fusions will inevitably lead to a large increase in failed back surgery patients with an ensuing large drain on resources. It is highly ironic that pain clinics would then be faced with more complicated pain patients at a time when the number of pain clinics would have dwindled due to a reduction in resources, which could be the direct result of these NICE guidelines being introduced

Can we point this out to our patients when we inform them that we cannot treat them as we would wish because of these guidelines? Will they have the right to seek treatment in the Benelux countries under European Law? To be fair to our surgical colleagues,

many I have spoken to are also horrified by the NICE guidelines and tell me that they intend to ignore them.

I suggest that NICE have a look at the Dutch guidelines and assess why such a large discrepancy exists. They may wish to then reflect on NICE guidelines and possibly admit to the fact that it would have been worthwhile to have a clinician with an interest in interventional pain medicine on the original GDG. These NICE guidelines have got to be reviewed as a matter of urgency.

Surely ASIPP - The American Society of Interventional Pain Physicians- whose guidelines also recommended RF and our Benelux colleagues can’t all be wrong or can they?

The British Pain Society, the Faculty of Pain Medicine of the Royal College of Anaesthetists and The World Institute of Pain has asked NICE to withdraw these guidelines for re-evaluation. In the interest of our patients, this is precisely what they should do and quickly.

The reference for this is: van Kleef M et al; Evidence-Based Guidelines for Interventional Pain Medicine according to Clinical Diagnosis: Pain Practice:, Volume 9, Issue 4, 2009; 247-251.

Should anyone be interested in the score of a particular interventional technique, please email me at [email protected].

Dr Charles pither the real health institute, london

Life is difficult (i).

Scott Peck’s memorable opening line has lost none of its relevance in the early twenty-first century. Pain doctors know this. We daily are travailed by the woes of a population who suffer from ailments that do not seem to have solutions. Am I alone in sometimes wishing I were back in the operating theatre as an SHO in anaesthesia. A varicose vein stripped, a carpal tunnel decompressed, a cataract removed; simple technical solutions to tiresome medical conditions.

But it is seldom like that in the pain clinic. Just now and again the solvable problem seen soon enough to achieve the kind of cure that we were drawn to medicine to achieve. Mostly it’s a struggle.

But what a noble struggle! Recently I was at a major pain meeting in the US. The opening address was a predictable Hollywood style affectation of laudation and self-congratulation. We could have been in Baptist Chapel in Missouri. The audience, comprising pain doctors from all over the world, loved it. Here we were being told of the inestimable value of the noble endeavour of aiding the pained. Pain relief was a human right; pain was a disease, how terrible that people should have to endure needless suffering, which we, the audience, had the power to resolve. Here was a rallying cry for the right to an anodyne world.

How appalling that there should still be barriers to accessing techniques that could diminish the terrible pains that beset mankind. Better drugs, longer needles, more volts. You know the kind of thing.

But what of Scott Peck? What about that kind of pain? Ah that’s different. That’s emotional pain innit. Not the sort that can be fixed by us guys. Mmmm.

Did you see Smiths article in the BMJ (ii) about the lack of randomised controlled trials of the effectiveness of parachutes? Of course there are none. His point was that some things are self evident, and don’t need to be proven with randomised controlled studies. Like the benefits of repairing a harelip, or treating pneumonia, or draining an abscess, or removing unsightly and painful varicose veins. I’ll join that crusade any day. To deliver that kind of medicine is indeed a privilege, it’s what inspired us to apply to medical school as teenagers.

But what about doing the 6th spinal operation or converting the 32 year old opioid dependent back pain sufferer to an intrathecal system to improve analgesia?

Remember Sheila Cassidy, that outspoken torture survivor who startled the hospice world by voicing that there comes a time when medical treatment needs give way to another type of care, when we have to cease taking on the burden and be honest about our impotence. Sometimes the doctor has to acknowledge the limitations of their offerings and become comforter and companion on a journey rather than hero-innovator (iii). And the skills needed to play that role are indeed uncommon, crucial and worthy. In one of his perceptive Illness Narratives Kleinman describes just such a situation. The terminal cancer sufferer surrounded by friends and a trusted family doctor, eschews further treatment and slips from life surrounded by loved onesiv. A good death - dying with dignity, without doctors interfering and

A good life


trying too hard. Honesty and openness for sure. No bullshit.

But what about a good life? (And I am not talking of self-sufficiency in Surbiton!) Don’t we have the same rights – to freedom from spin? Getting down to the real issues and as well as this, protection from doctors trying too hard?

This touches on a crucial question: What should we do when we have people with problems we cannot solve but who are still needy and perhaps desperate? Medicine has always been driven by problems not solutions. From the earliest Shaman, through ancient medical systems be they Chinese, Ayurvedic or Hippocratic, the interactions starts with a perturbation to the persons well being, and ends with the a prescription of some sort. Given pain is the commonest symptom reported to doctors it is not surprising that there has to be a place where the most desperate find refuge; it’s called a pain clinic. And here we see the anxious somatiser defeated by intolerable symptoms in the absence of convincing pathology, we see the aggrieved litigant with a point to make. We recognise the yoke of social isolation, and the shackles of poor education, we see illness conviction compounded by erroneous damage laden diagnoses. We see the erosive effects of the stresses of modern life, and the absence of resolution in a community that isn’t. We see the pain of life encapsulated in the pains of the body, and daily we see the damage done by raising false hopes where there is in reality no solution. Of course it is the back or the neck that hurts, but that’s not the cause of the pain. We see life’s difficulties in every clinic, and our difficulty is how to help.

What evidence based medicine has surely told us is that out best efforts don’t achieve very much. If we are being honest – really honest – not the spin that we provide for the PCT, or the Trusts review of the service, or an article

for the local paper. Really honest, when only ourselves are listening, we just haven’t got that wonder drug in the cupboard, or the equivalent of a harelip repair or a hip replacement.

Does this devalue our endeavours?

No, not for a minute. We know we help, and our patients know we help. Mention that you are a pain specialist at a dinner party and the guaranteed response is one of respect and admiration. Without doubt a field of medicine that cannot be reduced to an algorithm, and where the majority of problems are insoluble is indeed a noble pursuit.

But the crucial issue is how best to respond to the person who we cannot help medically? And in this I guess we divide into two camps. There are the crowd with whom I rubbed shoulders in New England, for whom specialist training confers a technical armamentarium that allows them to never stop doing things in the face of ongoing pain. There is a diagnosis there somewhere and we can find it if we probe deep enough. This is the ‘can do’ mentality. The rationale for treatment is the persistence of the symptom. It is better to do something than nothing. One has to try, and trying means doing things; increase the morphine some more, do another block, explore a different route, perform another operation.

And then there are those who see it differently, who are struck by the

is how they can be happy when they have nothing?

I was talking to a Danish colleague the other day about a meeting we are organising next year in Odense. I was telling him about the turmoil that had befallen the BPS. ‘I can’t understand what all the fuss is about’ he said, ‘It wouldn’t happen in Denmark, spinal injections are very rarely performed here in the first place’ (v).

But then what do the Danish know about pain – after all they are happiest and most stable society in Europe.

REFERENCES

i Peck S, The Road Less Travelled 1978 Arrow

ii Smith GC, Pell JP Parachute use to prevent death and major trauma related to gravitational challenge: systematic review of randomised controlled trials BMJ 2003;327:1459-1461

iii NJ Georgiades, L Phillimore The myth of the hero-innovator and alternative strategies for organizational change 1975 - Elsevier Publishing Company

iv Kleinman A The Illness Narratives 1988 Basic books

v Jan Hartvigsen personal email

breadth of the patients’ difficulties, who ask questions that reveal the empty life in which the seed of an aching back has grown into a life-devouring Triffid, and who know that the problems presented aren’t going to be sorted by a few more milligrams of this or another injection of that. They see the inadequacies of the coping of the individual as a product of a society that places unrealistic expectations on medical treatments, while offering nothing by way of an alternative belief or support system. They see that while it is undoubtedly more difficult to say no, saying yes is often a much greater folly in the longer term. And of course saying no doesn’t mean doing nothing, it just means doing different things, perhaps those things that the nineteenth century physician did, or Sheila Cassidy was alluding to. Perhaps its something called care. As the Bob Franke song goes: ‘its hard love, but its love just the same’. And the extraordinary thing is that it can make a difference. Not in the ‘immunising against measles’ sort of way, but in a way that can improve peoples difficult lives. In a Scott Peck sort of way. And of course the point is that it isn’t a different pain at all. It’s all pain, just pain.

There are places in the world where people seem to be happy. Our children go off on their gap years and return to speak with awe and wonder that people in far off places can seem to be genuinely happy. And of course the point that provokes the awe and wonder


Dr Chris Wells liVerPool

The Intractable Pain Society (IPS) of Great Britain and Ireland was started in 1971 by a group of consultant anaesthetists, interested in using their skills in regional blocks to provide pain relief for those suffering from chronic unrelieved pain, especially from cancer. They were often asked to see patients with low back pain; few other specialists were interested in this group of patients, and orthopaedic surgeons were abandoning the idea of disc surgery as worse than useless for this group.

At the start of the 1980s, only consultant anaesthetists were permitted to be members and the British and Irish Chapter of IASP, organised by David Bowsher, mainly consisted of scientists. At that time Chris Main, Annabelle Broome (a psychologist) and I set up the Pain Interest Group (PIG), an equivalent of a “psychology of pain” Special Interest Group. Psychologists, nurses and physiotherapists were not allowed to be members of the IPS at that time. Happily, common sense prevailed - anaesthetists opened their doors and all three groups eventually merged and became the Pain Society, reflecting the fact that the IPS was the first international society formed (3 years before IASP). Acute post-operative pain was also included in its remit, leading to the removal of the word “intractable” from its title.

Multidisciplinary pain management flourished, and the society grew, becoming the British Pain Society (BPS) for the sake of international clarity. However, half of the members are still anaesthetists, and they still run nearly all of the pain clinics in the UK. Sadly there is the prospect that this

will change if the guideline is instituted, hence the feeling of desperation.

As it developed the BPS took on several roles. At times it took on the role of a trade union, helping out through the years with nursing issues about training, terms and conditions for psychologists and even intervening to support one neurosurgical member. Indeed, it helps all of those members who continue to practice. Pain Clinics are largely administered by anaesthetists with an interest - or sole practice - in pain medicine. Many work closely with neurosurgeons and the new breed of spinal surgeons who manage back pain. Most of these are delighted to work with their anaesthetic colleagues, and indeed the majority of referrals I receive for back pain come from these disciplines. I now work only in private practice and, like many pain clinicians; the most common problem I see is low back pain.

The Guideline Development Group (GDG) was set up by NICE through the National Collaborating Centre for Primary Care and the Royal College of General Practitioners. I believe if the guideline was entitled “Analgesic management of Low Back Pain patients before specialist advice” it would be fine. The extrapolation of the guideline into hospital and Pain Clinic medicine, with the notable absence of these disciplines on the GDG, is a key point at which the guideline courts controversy. Consider the formulation of a guideline on chest pain, without cardiologists and with only one surgeon. NICE have confirmed that they should have consulted with an expert on interventional pain medicine, that they asked the BPS and RCoA for nominations to fill this role on the GDG, and received the details of

treatments costed could also be considered as the same as those for mild to moderate non-specific nociceptive pain.

The guideline points out that one-third of the UK adult population suffer from low back pain (LBP) every year, that is, 20 million people. Its economic analysis refers to only 350,000. I am uncertain as to what happens to the other 19,650,000 people. Presumably the GDG hopes they will all get better with no treatment, although it is suggested that 4 million of these patients (20%) will attend their GP with back pain.

It goes on to discuss the role of information and education, which is hardly new. Recommendations about physical activity and exercise have been given by physiotherapists and pain specialists - and indeed by most GPs – since, and even before, the CSAG Report was published in 1994, 15 years ago. In fact none of the treatments suggested are new, and I find it difficult to see why NICE states “New guidelines to help millions....” when all of these techniques are widely used, and none prevent chronicity, save only for 3,500 patients having a combined psychology and physiotherapy approach (CPP). Specific treatment includes physical activity and exercise in a structured group programme, (which is fine), manual therapy, including spinal manipulation, of 9 sessions over 12 weeks, and acupuncture, 10 sessions over 12 weeks. Why 9 sessions? Surely if it is fixable, 1 or 2 will help. If it only helps for a short time, why stop at 9? And just how does it help in any case?

Reviews of acupuncture and manual therapy, including manipulation, have shown that there is evidence that they produce initial pain relief, but very scant evidence that there is any long-term relief. Chinese acupuncturists think we are quite strange in advocating a single acupuncture treatment every

two nominees. One had experience in interventional pain procedures and the other did not.Sadly we know that GDG therefore went ahead without anyone with practical experience in interventional pain management. For a guideline applicable to so many individuals how could this have been allowed to happen? Even if this was some unfortunate error, you may have hoped the GDG to have noticed this discrepancy, and called for someone in pain medicine to review the evidence and give advice. When it came to acupuncture they clearly felt they required further expert advice and were able to so. However the GDG did not think it appropriate to enlist a pain physician and neither did NICE; even after reading the submission from the BPS.

The guideline states that it covers non-specific low back pain between 6 weeks and 12 months. It excludes malignancy, infection, fracture, ankylosing spondylitis and other inflammatory disorders. It also specifically mentions that it does not cover radicular pain from nerve root compression or cauda equina syndrome. Given that it prohibits the use of MRI scans and X-rays, the GDG fails to explain how these conditions can be diagnosed. Indeed, one of their great failings is that the guideline does not address, in any way, the assessment of low back pain, prior to labelling it “non-specific”. It does, however, point out that several structures, the joints, discs and connective tissue, may contribute to symptoms. It also accepts that psychological issues are important, although this is not mentioned in the introduction. In the treatment recommendations, and especially in relation to the economic modelling, psychosocial issues are largely ignored. Biopsychosocial issues, perhaps the most important aspect, are skimmed over. As these are of paramount importance in management, and in particular in the development of chronicity, this is a failing. Generally the

A NICE Guideline on Back Pain?



week; if you were in China, you would have 3 treatments a day. They recognise that acupuncture has a short-term benefit and needs to be repeated regularly. They would think 10 treatments over 12 weeks to be akin to giving someone with cancer a morphine tablet once every week for 10 weeks and expecting useful analgesia. However, certainly it is a reasonable form of analgesia for some, although there is absolutely no evidence to suggest that it reduces distress or disability, or prevents chronicity. Indeed all of the trials reviewed by the NICE committee indicated this. Again, why stop at 10 sessions?

All of the independent evidence on manual therapy indicates the same thing. There is some initial benefit. There is very little benefit at 1 year. There are significant side-effects. Thus the 3 main non-drug treatments offered would produce some mild to moderate analgesia which indeed is no bad thing. It is unclear, however, where all of the therapists will be found who are available to produce at least 7 times the present amount of treatment via these therapies (see NICE costings) and there is every indication that there will still be many thousands of back pain sufferers at the end of the treatment.

The guideline points out that another of these treatment options (CPP) should be used if the chosen treatment does not result in satisfactory improvement; that combined physical and psychological treatment programmes should be considered for ALL of those who have received one less intensive treatment and have a high degrees of disability or significant psychological distress. At first glance, this looks like a sensible idea to provide conventional Pain Management Programmes (PMPs). However, further clarification with the GDG committee, and a look at the costings, shows that this is a physiotherapy-based rehabilitation programme, with a little bit of “psychology”, perhaps

given by the physios themselves and certainly with no medical involvement. The cost is £4000, compared for example with a cost of almost £12,000 for the Walton PMP. So, in essence the costings agenda is for PMPs to be replaced by the cheaper CPP.

NICE estimate that this will require an increase of facilities so that 3,500 patients can be treated with CPP instead of the present figure of 1000 throughout the country. This is the type of programme which Professor Watson showed to be effective in getting back pain sufferers back to work in the early stages of LBP. This does not represent many treatments for the 4 million sufferers attending their GPs. We can estimate at least 2 million of these will have significant long-term disability and psychological distress, with 100,000 a year going on to chronicity beyond one year.

The committee finally suggests referral for consideration for surgery. This is only for “people who have completed an optimal package of care”, including drugs, acupuncture, manipulation and the physiotherapy pain management. Is the suggestion here that the patients will have surgery for their musculo-ligamentous pain? Is it admission that some have other problems which have not been properly diagnosed? If that’s the case, the guideline reverses even basic medical reasoning. It proposes we treat them until it fails, then identify the cause!

The guideline goes on to repeat some useful information, for instance, pointing out that interventional physiotherapy such as laser, interferential and ultrasound does not show any benefits. In particular, they warn against lumbar supports and traction, but this is not new information. It was addressed in the CSAG report many years earlier. However, under section 1.5.4, the guideline blandly indicates that transcutaneous electrical nerve stimulation (TENS) should not be used.

There is as good evidence for TENS as for acupuncture. That is, it is rather weak evidence. However, TENS has 2 benefits - first of all, it is less expensive than acupuncture and secondly it is patient-administered and encourages self-reliance. Furthermore, the active mechanism by which we understand TENS works; a-beta fibre stimulation and spinal inhibition of pain is also the same mechanism by which spinal cord stimulation is thought to be effective. Spinal cord stimulation has been recommended by NICE for failed back surgery syndrome and complex regional pain syndromes, and TENS was originally developed as a means of assessing patients for these conditions.

The guideline recommends weak opioids even though it is accepted that there is absolutely no evidence to suggest that these work. In fact, the relevant section states that “no data were available to support use of mild (I assume weak) opioids therefore the recommendation was made by consensus of the GDG”. But how then can treatment e.g. interventions, which were beyond the knowledge of the GDG, be excluded?

Whilst accepting that some patients should have an option for spinal fusion, for which there is some weak evidence, the GDG feels that they should not have radiofrequency facet joint denervation. This does not seem reasonable. The committee members only looked at 3 papers on this particular technique. Two out of the 3 revealed improvement in pain. Under section 4.5, they discussed invasive procedures. These were usually undertaken “after the condition has lasted a long time (more than 12 months)”. Pain Clinics are so poorly resourced that patients often cannot be seen before 12 months. Obviously, if a patient has a specific problem with the facet joints, which is causing pain, and simple treatments are offered but fail, the procedure could be

carried out before 12 months, and before spinal fusion. The guideline goes on to accept that there is evidence that pain arising from the facet joints can be a cause of low back pain, although the GDG says that the role of specific therapeutic interventions remains unclear. After issuing the draft report, the committee was sent several RCTs showing the effectiveness of these treatments, but chose not to review them. They did ask that there should be development of specific criteria for patient selection, and a comparison with non-invasive therapies which is appropriate in the longer term.

To many the GDG seemed unrepresentative and, given 13 of 39 recommendations were based on “the personal opinion of the committee”, there were bound to be concerns that the document was biased and lacked an evidence base. It comprised 3 advocates of manipulation, several advocates of exercise, psychological management and one of surgery. Nobody was co-opted on to explain about drugs, TENS or interventional procedures. An expert was called for acupuncture. The advice is to use exercise, manipulation, acupuncture, CPPs and surgery. If there was another GDG with 3 interventionists and other pain physicians, the results would surely have been different. There is weak evidence for many things (Cohen, BMJ, 2008:337:a2718) and any GDG would then have to rely on consensus. The strong evidence exists for NSAIDs and analgesics (Machado et al, Rheumatology 2009 48:520-527).

Since the guideline has been published it has been criticised by many differing disciplines Those include Edvard Ernst, Professor of alternative studies , who feels that neither acupuncture nor manipulation have been shown to be particularly helpful in low back pain. Andrew Moore, Editor of Bandolier, the on-line journal of EBM, also raises concerns in this issue. The council of the BPS voted for its withdrawal as did the


Faculty of Pain Medicine of the Royal College of Anaesthetists..

The costings report states that at present there are 1,000 places a year available on CPPs. They estimate that this will need to go up to 3,500 places a year (the practicalities of this are unclear).This is only 1 per cent of patients of those treated. And yet surely ALL of those patients with disability or significant psychological distress should go on a proper PMP or CPP. That is more likely to be 35,000 (10 per cent of the total). The total number is possibly nearer to 100,000, based on the number of patients developing chronic back pain every year.

In its economic analysis NICE assumes that 95% of all interventions will stop. This was apparently formulated by NICE with “an Orthopaedic Surgeon” on the assumption that everyone would get better after the guidelines had been put in place and thus would not need treatment in Pain Clinics at any stage. In particular, there would be no place for injections AFTER 1 year, as they would all be better. This is wildly speculative and unlikely. This includes interventions for spondylosis and intravertebral disc prolapse, which were specifically excluded at the beginning of the guidelines (page 4) as specific causes of low back pain. So the savings of £33,000,000 on injections per year are not credible. Even if the interventions that some of us value, and which are not discussed in the report (e.g. epidural steroids for sciatica) are excluded, stopping facet joint radiofrequency (saving only £1.5 million) and half of the rest (saving £16,000,000) doesn’t pay for the other treatments. Sadly, local health care commissioners are urged to implement these costings, meaning vast amounts of Pain Clinic funding for useful, validated treatments, might be stopped.

Again the estimation is that £11,800,000 million will be saved

on MRI scans. The point of an MRI scan is to diagnose a specific treatable problem and therefore these will have to be done in order to implement the guidelines at the beginning, and at the end, when considered for surgery. So once again we have very odd looking and unrealistic costings.

The guideline states that the NHS cost of treatment for low back pain is a thousand million pounds (£1,000,000,000) per year. It is interesting to reflect that injection therapy only accounts for 3.5 per cent of this. Where does the rest of the money go?

To me one really upsetting thing about the guideline is that it proclaims patient choice, and then denies it. It seems millions will get no treatment, and some will be denied treatment that really might work. Perhaps patients should be asked if they would prefer 9 manipulation sessions, followed by 10 acupuncture sessions, OR one single injection from a pain specialist (similar costings), not both, and they could decide what they wanted, rather than have the decision forced on them..

It is important to consider that this is unlike any other guideline, anywhere else in the world. This is now Government policy, to be implemented (see NICE website, slideshow notes - “implementation of this guidance is the responsibility of local commissioners and/or providers”). The costings, both national, and for communities of 100,000, allow funding of manipulation and acupuncture at the expense of MRI investigations and most injections.

See www.nice.org.uk/nicemedia/pdf/CG88CostReport.pdf.

The obvious result of the guideline, if accepted by purchasers, is that very few, if any, patients with back pain will be sent to pain clinics. What does the pain clinic offer that is in the guideline? No PMP, blocks or TENS is funded, perhaps just some assessment for opioid use. So if this hefty slice of funding is removed from pain clinics, how will they survive? What will happen to the staff working in them? In this respect, the guideline threatens the existence of pain clinics. It concerns me greatly that Service Commissioners (PCTs) are encouraged by the costings to remove funding from established Pain Clinics for all patients with LBP at ANY time (not just up to 12 months). The reassurances that have been offered in this respect so far are wholly inadequate. Removal of funding for Pain Clinics which have been slowly and carefully built up to serve local communities and into which we have put our great efforts and careers is nothing short of vandalism.

There are many factors involved in the production and maintenance of LBP, which as we all recognise, is the ultimate bio-psycho-social disorder. How sad then, that the NICE guideline does not cover the proper assessment of the patient, but moves straight on to treatment, with the assumption that all LBP is non-specific (although it also says it can come from the discs and joints, muscles and ligaments). Although the guideline exhorts the treater to review the diagnosis, it precludes hospital

assessment in multidisciplinary Pain Clinics by experienced Clinicians and Psychologists. Assessment and management is left in the community, in the hands of GP’s, Physiotherapists, Acupuncturists and Chiropractors, rather than hospital teams. Some will be well-versed in assessment, many will not. Every patient I see with LBP has already seen a physiotherapist, and had exercise guidance. The majority have had some form of manipulation, and nearly half, acupuncture. The excellent physiotherapists I work with are glad I am available, just as I welcome their earlier interventions, which I know help many. All of us know that none of us have all the answers. The guideline is based on evidence that shows the treatments offered will produce a small to no effect at the end of 12 months. At the end of their treatment, patients are simply cast adrift. Very little chronicity will be prevented, and they will then have nowhere to turn.

NICE suggests that the guideline is evidence-based, many believe it is flawed. The GDG demonstrated a strong professional selection bias and that has resulted in an unscientific, almost predictable guideline. There are many calls for NICE to withdraw the guideline and to reconsider the wider consequences. I would urge that the guideline is suspended before real and irreparable damage is done to the country’s health, our services, our future patients and NICE itself.


professor e erNst Peninsula Medical school, co-author of: trick or treatMent? singh s, ernst e. alternatiVe Medicine ontrial. banthaM Press, london. 2008

Recent NICE guidelines recommended “manual therapy” for back pain.1 In this brief article, I will summarize the reasons why this decision might not be wise.

The Guidelines are simplisticThe guidelines use the term “manual therapy” and fail to adequately differentiate between spinal manipulation and mobilisation or between treatment by chiropractors, osteopaths and physiotherapists. The umbrella term “manual therapy” for spinal manipulation/mobilisation is, in my view, not helpful. There are dozens of different manual therapy techniques. Of course, it would be unreasonable to evaluate each of them separately for its effects on back pain – an experienced therapist chooses and mixes the techniques (s)he feels are appropriate depending on the patient’s signs and symptoms. But it is by no means unreasonable to assess different categories of techniques according to their potential risks.

The Guidelines under-estimate riskAnd what might these risks be? There is a mountain of evidence to show that about 50%(1) of all patients will suffer from mild to moderate adverse effects, usually local or referred pain or worsening of presenting symptoms,(2) after receiving spinal manipulation. These usually last one or two days and are mostly mild to moderate. Chiropractors therefore tend to trivialise these adverse effects. Yet they are often severe enough to temporarily affect the patient’s quality of life.(2) Therefore I am not convinced that they are negligible.

In addition to these frequent adverse effects, chiropractic spinal manipulation has been associated with very serious complications. These occur mostly after certain types of neck manipulation and frequently relate to vascular accidents caused by arterial dissection. Yet other types of injuries are also on record (Table 1). (3-9) Several hundred such cases have been published but the exact incidence is anybody’s guess – gross under-reporting renders any attempt to calculate precise figures futile.(10)

Neither the frequent mild to moderate adverse effects nor the serious complications are problems of “manual therapy” per se but of certain types of upper spinal manipulation, namely of “high-velocity, low amplitude thrusts”, (HVLATs), particularly those with a rotational element.(11) As it happens, this type of approach is the hallmark of the chiropractic profession.(12) Physiotherapists and osteopaths use it too but less frequently. Therefore it also is chiropractors who are mostly associated with the serious complications mentioned above. It follows that pretending that “manual therapy” is just one uniform type of treatment and that no differences exist between the three professions using “manual therapy” is simplistic and misguided – so much so that, in my view, it must lead to wrong conclusions.

So why do the NICE guidelines ignore all this? Surely the panel was aware of these subtleties and risks! Yes, the guidelines discuss them, albeit very briefly. And they argue that this is relevant for other conditions but not for back pain. Patients suffering from back pain will receive “manual therapy” of the lower and not the upper spine, it is assumed. But this is clearly not true. Chiropractors see the spine as an entity, and they will “adjust” what they call “subluxations” with spinal manipulation where they diagnose them unrelated to the site of the pain. Thus patients with back pain will often receive HVLATs on the upper spine. There are several well-documented cases where patients with symptoms unrelated

to the upper spine received upper spinal manipulation from a chiropractor and experienced severe complications afterwards.

The conclusion of all of this is that the NICE guidelines misjudge the risks of spinal manipulation, particularly when performed by chiropractors. One reason for this might be the presence on the NICE panel of the chair of the General Chiropractic Council - an individual who incidentally is not known for his research efforts on the subject in question.

Guidelines over-estimate benefitThe Cochrane review of Spinal manipulative therapies for back pain(13) concludes that there is “no evidence that spinal manipulation is superior to other standard treatments for acute or chronic low back pain” This, it seems to me, is far less positive than the conclusions in the NICE guidelines. Why?

The answer seems to lie in the inclusion criteria. The Cochrane review included 39 RCTs, while the NICE guidelines were based on just 7. (1) By defining the inclusion criteria much more narrowly, the NICE guidelines clearly had to rely on far less data. The study that turned out to be overwhelmingly decisive for the NICE guidelines was the UK BEAM trial.(14) The lead author of this study was also the chair of the NICE panel. The UK BEAM trial had been heavily criticised when it was first published.(15-17) Moreover, it also did not demonstrate an impressively large effect. In fact, the original article contains the following sentence: “The spinal manipulation package improves back pain by a small to moderate margin at three months and by a smaller but still statistically significant margin at one year”.1 This, however, did not seem to deter the NICE panel from issuing a positive recommendation based predominantly on this study. In my view, the Cochrane review and its conclusions are a much better

Manual therapy for back pain? A critique of the recent clinical guidelines by NICE



reflection of the totality of the evidence currently available to us.

ConclusionNICE’s positive recommendation of “manual therapy” for back pain” is seriously misguided. As I am by no means the only expert to criticise it, one might hope or even expect that NICE consider the facts and revise their guidelines according.

REFERENCE LIST

1 National Institute for Clinical Excellence. Low back pain: Early management of persistent non-specific low back pain. www.nice.org.uk ed. London: National Institute for Clinical Excellence; 2009.

2 Ernst E. Prospective investigations into the safety of spinal manipulation. J Pain Sympt Managem 2001; 21:238-242.

3 Lipper MH, Goldstein JH, Do HM. Brown-Séquard syndrome of the cervical spinal cord after chiropractic manipulation. Am J Neuroradiol 1998; 19:1349-1352.

4 Schmitz A, Lutterfbey G, von Engelhardt L, von Falkenhausen M, Stoffel M. Pathological cervical fracture after spinal manipulation in a pregnant patient. J Man Phys Ther 2005; 28(8):633-636.

5 Chen HC, Hsu PW, Lin CY, Tzaan WC. Symptomatic hematoma of cervical ligamentation flavum: case report. Spine 2005; 30(16):E489-E491.

6 Tomé F, Barriga A, Espejo L. Multiple disc herniation after chiropractic manipulation. Rev Med Univ Navarra 2004; 48:39-41.

7 Tseng SH, Lin SM, Wang CH. Cervical epidural hematoma after spinal manipulation therapy. J Trauma Injury

Infection Critical Care 2002; 52:582-586.

8 Tolge C, Iyer V, McConnell J. Phrenic nerve paby accompanying chiropractic manipulation of the neck. South Med J 1993; 86:688-690.

9 Padua L, Padua R, LoMonaco M, Tonali PA. Radiculomedullary complications of cervical spinal manipulation. Spinal Chord 1996; 34:488-492.

10 Stevinson C, Honan W, Cooke B, Ernst E. Neurological complications of cervical spine manipulation. J Roy Soc Med 2001; 94:107-110.

11 Sherman MR, Smialek JE, Zane WE. Pathogenesis of vertebraal artery occlusion following cervical spine manipulation. Arch Pathol Lab Med 1987; 111:851-853.

12 Gouveia LO, Castanho P, Ferreira JJ. Safety of chiropractic interventions: A systematic review. Spine 2009; 34:E405-E413.

13 Assendelft WJJ, Morton SC, Yu Emily I, Suttorp MJ, Shekelle PG. Spinal manipulative therapy for low-backpain. The Cochrance Database of Systematic Reviews 2004; Issue 1. Art No.: CD000447.pub2. DOI: 10.1002/14651858.CD000447.pub2.

14 UK BEAM Trial Team. United Kingdom back pain exercise and manipulation (UK

BEAM) randomised trial: cost effectiveness of physical treatments for back pain in primary care. BMJ 2004; 329:1381.

15 Tillett R. United Kingdom back pain exercise and manipulation (UK BEAM) trial. What happened to participants who were not included in the analysis? BMJ 2005; 330:674.

16 Tveito TH, Eriksen HR. United Kingdom back pain exercise and manipulation (UK BEAM) trial. Is manipulation the most cost effective addition to “best care”? BMJ 2005; 330:674.

17 Ernst E. United Kingdom back pain exercise and manipulation (UK BEAM) trial. Touch may have had non-specific effect, among other things. BMJ 2005; 330:673-674.

Table 1 Serious complications other than arterial dissection associated with upper spinal manipulation.

First Author (ref) Type of Injury

Lipper (3) Cord hemisection (Brown-Séquard Syndrome)

Tseng (7) Cervical epidural haematoma

Tolge (8) Phrenic nerve palsy

Padua (9) Myelopathy and radiculopathy

Schmitz (4) Cervical fracture

Chen (5) Haematoma of cervical ligamentum flavum

Tomé (6) Multiple cervical disc herniations

the British Pain SocietyCalendar of Events 2009/10

Throughout the year, the British Pain Society organise a series of Study Days, Seminars and Conferences, with topics reflecting its multidisciplinary membership.

Details of the 2009/10 events are as follows:

Events for Pain Professionals

All British Pain Society meetings are open to members and non-members. For more information please visit www.britishpainsociety.org or contact the Secretariat on 020 7269 7840 / [email protected].

•PLCAnnualVoluntarySeminar‘Livingwelldespitepain-practicalwaysofcopingwithmusculoskeletalpain’London, 26th October 2009

•NeuropathicPainStudyDayLondon, 2nd December 2009

•PainEducationSpecialInterestGroupSeminarLondon, 17th December 2009

•OpioidsStudyDayLondon, 25th January 2010

•AnnualScientificMeetingManchester, 13th - 16th April 2010



Ms Mary ray Patient liaison coMMittee and coMMunications coMMittee of the british Pain society, MeMber of the clinical ethics coMMittee of her local hosPital trust

“Give me the strength to change the things I can change; the humility to accept those things I can’t; and the wisdom to know the difference.” I’m not at all religious but it’s a great prayer. It sums up the challenge of learning to live with pain. It also has resonance for the debate over intervention versus pain management in the last three editions of Pain News. As a patient, I’ve found the articles and letters absorbing reading.

I like David Walsh’s (1) sensitive discussion of the complex and difficult issues patients and clinicians face when considering treatment options. As he says, the decision as to when, or whether, to take the route of acceptance or seek another test or treatment, “…. is often a personal one, specific to the individual, within the limits of available resources.” But how can people choose acceptance and self-management if they are not offered as tangible options from the outset? I agree with Frances Cole’s (2) balanced approach: identifying self care information resources as crucial in helping patients , ‘…care for themselves and make effective decisions about their condition and health.’

As Sarah Barker points out (3), any dichotomy between a medical and a biopsychosocial approach raises issues about evidence based practice, and the timing of treatment options. I agree with her (and many patients), that Pain Management Programmes shouldn’t be an end of the road treatment, as is so often the case,

but should be integrated with medical treatment options. I’m intrigued by her description of pain management to help prepare patients for a medical intervention.

Things are changing in some pain clinics, and some GP practices, with pain management being offered much earlier in the pain journey, instead of at the end. But it’s still the case that access to pain management is often only through a pain consultant. It can be time consuming and expensive if every patient has to see the most senior member of the team before any service is offered. So resources can be part of the key, alongside the fact that it isn’t easy to change the way things have usually been done.

Why ‘gate keep’ pain management as a ‘last option’ only once all other medical routes have been tried and persistent pain remains? It can be frustrating: for patients who might have been open to self-help all along if they’d had the chance; for patients whose resistance may be compounded if they feel let down by the medical route and that self-help is ‘second best’; and for staff who may find it harder to present pain management as a positive way of coping with persistent pain as a result.

If we really believe in patients being helped to self manage why not provide pain management from the outset? Given that the medium is the message, isn’t there a contradiction in aiming to maximise patient independence and self management, but organising and delivering services with a traditional medical model? And it can be counter-productive: it may perpetuate patients’ expectations of a cure; waiting times may be longer; senior

professionals’ time may not be used in the most effective way; and patients may be passive recipients of services rather than active partners.

Ways of coping with pain can be offered in lay language by nurses and therapists as an option in the first line of service. That is beginning to happen - whether in the hospital setting, outreach clinics or primary care. That way of offering pain services could be more cost effective, reduce waiting times, and keep a consistent link between the aims, the services offered, and the delivery of those services. It could enable staff expertise and time to be used more effectively – with consultants and psychologists freed to train staff and see those patients with more intractable or complex problems. It could minimise patients developing unhelpful habits such as inappropriate posture or dependence on pain killers. And it could help patients to be more open minded and realistic when weighing up questions about medication or possible medical interventions.

It’s true that there’s no such thing as a typical patient - from those who are highly motivated to self manage and want to keep medical treatment to a minimum, to those for whom searching for a cure is paramount. Clinicians have the difficult task of trying to understand not only each patient’s expectations, circumstances and approach to their pain, but their own professional interests and reactions to each patient (4).

The personalised approach to pain management which Neil Berry describes (5) is an interesting way to work with those differences. Might it be even more effective if patients didn’t need the recommendation of the consultant to reach that ‘a la carte’ menu that he described? What about referrals from GPs, therapists, specialist nurses, or even self-referral, at the start of the patient journey? Early pain management might result in fewer interventions, a lower

drugs cost, and fewer attendant problems of depression, loss of work, and disruption to family and social life.

Of course diagnosis and treatments are a crucial part of pain services. But might patients who already have a better understanding of pain, and ways to manage it, be better equipped to make informed decisions about whether to undergo an intervention or try particular medications?

When it comes to informed consent, we are none of us very good at weighing up the risks and benefits of medical interventions. Patients’ understanding of risk is affected by the way it’s presented (6), and doctors themselves often misinterpret risk statistics, with single event probabilities being particularly confusing (7).

Should odds be presented numerically, such as 1 in a 100, or as a percentage? As data becomes more specific which risks and benefits should be quoted: national, departmental, or individual consultant outcomes? How do you deal with the complexity of interpreting changes over time in line with medical progress and evidence based research? And what about new drugs and treatments where percentages are skewed by small numbers?

Informed consent is undoubtedly crucial and patients need to know when risks are high or not yet reliably predictable. George Daly, of the Boston Children’s Hospital, has said (8), “Medical innovation is an interesting combination of intrepid investigators and brave patients who are willing to take risks and test new therapies before we fully understand them.” Medical progress probably wouldn’t be best served by clinicians and patients refusing to undertake new techniques. But are patients who are willing to take greater or less predictable risks being brave, or are they experiencing a more complex

Intervention versus Pain Management ? A Patient Perspective


mix of desperation and fear as well as bravery? And is that really informed consent?

It isn’t just that no two patients are alike – each one of us can be inconsistent. On bad days, when a patient feels more desperate, their tolerance of risk may be higher and the possible benefits of an intervention may seem to outweigh the risks. Yet on good days the same person may be less tolerant and decide that exactly those same risks are not worth taking. You can be the most rational person in the world – but when an intervention might improve your quality of life, emotions inevitably come into play. Hope and fear are prisms through which we see possible outcomes. And those same emotions can cloud our listening and make it harder to take in what we are told.

When it comes to evidence based medicine it may not be easy to devise a research model to test the effectiveness of providing pain management as an option at the start of the patient journey. But isn’t it worth trying to formulate questions around some of the possible advantages? For example: Patients could have a better chance of choosing acceptance and self management as a preferred option, rather than undergoing more interventionist treatments. (They can’t do that if they don’t even know about pain management.)

It could offer ways of coping better whilst patients wait for an appointment with a pain consultant.

When patients do then see a pain specialist it could be on the basis of a more balanced partnership. Discussion about medication, or interventionist techniques, could then be set in context - as part of an overall programme in which the patient can already be on the road of acceptance and pain management.

Patients who want to consider interventionist options might have a better chance to weigh up risks and benefits with a more open mind and more realistic expectations of outcomes.

There might be savings through lower drugs costs, fewer cure-seeking appointments, and fewer interventions.

Less intensive pain management programmes may be effective - as the main focus could be on preventing negative consequences of persistent pain rather than rehabilitation as in ‘end-of-the-line’ programmes.

Patients might spend less time and money on trying a range of alternative therapies when conventional medical treatment has not eased them of pain.

Yes, we are all different, and the option of early pain management won’t be right for everyone. But it may work better, for more people, than the present common, ‘end of the road’ referral system. Early pain management wouldn’t stop the emotional roller-coaster when an intervention may seem like a chance to be pain free. Hope may spring, regardless. Acceptance or mindfulness are never all or nothing: easier on good days, harder on bad ones. But if you’re already armed with understanding, ways of coping, and some degree of acceptance, you at least have the chance of being more objective and less vulnerable when considering a more intrusive treatment. Whilst genuinely informed consent may remain an ideal, it’s surely worth doing all we can to enable patients to make the right choice for them?

As a patient, I am wary of stepping into this kind of debate. On the one hand, you could say that my inevitable realms of ignorance should make me the last person to speak up. On the other hand, as Sarah Barker (2) says – “The fact that many patients say they wished they’d attended a pain

management programme years ago needs to be heeded.”

REFERENCES

1. Walsh, D.A., (2009) Are treatments for pain over-rated? Pain News Summer 28

2. Cole, F., (2009) Helping Patients Help Themselves More Often Pain News Summer 28

3. Barker, S. (2009) Letter to Editor Pain News Summer 28

4. Notcutt, W. (2009) Nice ’n Nasty, Interestin’ and Mundane – Fairness in the Clinic Pain News Summer 28

5. Berry, N. (2009) Table d’hote or a la carte Pain News Summer 28

6. Bandolier (2004) ‘Understanding risk’ www.medicine.ox.ac.uk/bandolier/band128/b128-6.html accessed 8.7.09

7. Gigerenzer, G., and Edwards, A. (2003) ‘Simple tools for understanding risks; from innumeracy to insight’, British Medical Journal, 327, 741-744

8. Daly, G., Boston Children’s Hospital. Quoted on BBC Radio 4 ‘Frontiers’ on 29th June 2009. Programme on Stem Cell Research.

9. Ray, M., and Hester, J., (2009) ‘A Patient’s Journey with Persistent Pain’, BMJ 2009;339:b2786. Available free, see http://www.bmj.com/cgi/content/full/339/jul24_1/b2786

Guidelines, Needles and Evidence


Dr stepheN WarD bPs council MeMber

As a previous editor of Pain News and dedicated interventionist I was not surprised when asked to write a short piece about ‘interventions’ and how seething mad we needle jockeys are at the temerity of NICE in daring to suggest that ‘interventions’ have no place in the management of what is now, rather limply, called ‘CG88 - Early management of persistent non-specific low back pain’. Rather

than seething about the tyrannical recommendation that we should ‘NOT inject therapeutic substances into the back’ and ‘DO NOT refer for radiofrequency denervation’ (I’ve scribbled ‘on pain of death’ on my copy) interventionists are seething about the document as a whole. From the curious title to the overt bias of the Guideline Development Group (GDG) to the way in which the evidence was reviewed and interpreted. This view is shared by the British Pain Society and the Faculty of


Pain Medicine – we are not out on a limb here. I think NICE made several mistakes with this guideline and interventions can only be discussed in this context.

First, the target population isn’t clear. Never a good start for a guideline. The original brief was to create quite a simple guide for general practitioners faced with a patient transgressing from the acute to the chronic stage. The scope and the title has changed no less than three times. Rather than create a simple and useful action plan for our primary care colleagues, the guideline group have somehow attempted to cross the divide and encompass complex secondary care pain management and even orthopaedic surgery. In taking on this leviathan they have failed.

Second, it is essential that when creating a guideline, any group who would be adversely affected by the guideline should be consulted with and involved in guideline development. Pain medicine physicians are one such group – the majority of us do injections for back pain (even though we may not call ourselves interventionalists) and we will be adversely affected. For those who erroneously believe that the ‘no injection’ rule applies only to the first 12 months, you will be surprised to learn that in the NICE guideline costings document, available on the NICE website, 95% of injection and denervation procedures are to stop in order to pay for spinal manipulation and acupuncture.

Third, there was no pain physician on the GDG. There was no pain physician consulted at any stage. Not a single GDG member has performed a fluoroscopic facet joint injection or a medial branch block or has ever been on the business end of a radiofrequency needle. There are lots of us around and we would have been useful (some would say essential) contributors. It is inconceivable that at some point in the guideline development process the GDG

did not at least consider the impact the guideline might have on pain physicians.

NICE may counter by pointing out that they have a ‘stakeholder’ comment process. I would urge you to look at the stakeholder comments table and the responses by NICE (http://tinyurl.com/llo9jl). They should have made life easy and simply written ‘computer says no’ in every box.

Third, NICE chose to consider evidence from randomised controlled trials and no other. Michael Rawlins, the NICE chairman, is no fan of the reliance on RCTs for guideline development. In his Harveian Oration he says

‘It is scientific judgement – conditioned by the totality of the evidence – that lies at the heart of making decisions about the benefits and harms of therapeutic interventions’.

We know that RCT evidence for the treatment of chronic back pain is poor. In CG88 we read that ‘much of the evidence reviewed were small studies with insufficient power.’ So the evidence is poor. What do you do? Naturally, you consider lesser evidence (non-randomised trials, cohort studies, pragmatic trials that sort of thing) until you reach the very last and hopelessly inadequate level : ‘the consensus’. NICE though chose to overtly ignore all the evidence that may lie in between and the majority of this guideline has been achieved by ‘consensus’. The NICE GDG had no choice – remember this was a leviathan and simply too broad and complex to do it justice.

What we get with a consensus is just that – the consensus of a group comprising an overwhelming number of manual therapists and physiotherapists. A guideline that precisely mirrors the composition of the Guideline Development Group. Low back pain guidelines recently published by the American Society of Interventional Pain Physicians have reached

starkly different conclusions – unequivocal recommendations for most interventional procedures. Quelle surprise!

If the Guideline Development Group had been truly honest they would have simply pronounced that ‘more research is needed’. Instead we have a guideline that is deeply flawed and tainted by personal bias, inadequate methodology and just a whiff of government directive. There are too many facet joint injections being done – let’s get rid of them by saying that acupuncture and manipulation is better.

Fourth, where there was at least some RCT evidence available, the GDG accepted a statistically significant finding as evidence of clinical significance. Treatments like spinal manipulation (SMT) and acupuncture have been trumpeted in the press and by NICE as ‘effective’ yet yield improvements in disability scores that are usually in single figures and as such clinically meaningless.

In a recent meta-analysis, Machado nicely demonstrates how poorly ANY treatment for low back pain performs if you consider improvement in pain scores (LA Machado et al. Analgesic effects of treatments for non-specific low back pain: a meta-analysis of placebo-controlled randomized trials. Rheumatology 2009 48: 520-527.). I urge all to read his paper (which has been reviewed by Bandolier). In effect it show that only 5 out of 34 interventions that had acceptable trial data have analgesic efficacy of greater than 20mm on an 100mm VAS scale. When confidence intervals are included the there is only one trial of electroacupunture that can show more than a 20mm VAS improvement and this only had 25 patients. In short the jury is out on virtually everything.

All of us should take stock of this. It is simply disingenuous of NICE to suggest that one treatment is any better than another and disingenuous of us to think that

our preferred treatment has any advantage over injection treatment or anything else. Your Dad is not bigger than my Dad. The simple fact is that in isolation and in the fabricated world of the RCT, all of our treatments are woeful (single small trials don’t count by the way so let’s not have the electroacupuncturists writing in).

In the real world of course we all work in pain clinics offering multidisciplinary treatment. Behavioural therapy, physiotherapy, acupuncture, analgesics, TENS and even a facet joint injection here and there – all thrown in at roughly the same time. Does combined therapy like this achieve ‘analgesic efficacy’? Are the therapies cumulative? Synergistic? Probably.

The great sadness is we may never know. The NICE guideline is clear in its ambition – single and sequential therapies. Do not move to treatment B unless treatment A has failed.

Machado is telling us something very important here –this approach is doomed.

In conclusion, I haven’t really written about interventions at all. I am comfortable knowing that for selected patients and at the right time injections and denervations are incredibly helpful.

I’m going to ignore the NICE guideline and keep doing what I’m doing until they turn the lights off – I shall sleep at night comforted by the plain and unassailable truth that there is only one treatment with level 1A evidence for low back pain and that is that spinal fusion surgery is no better than a 3 week course of physiotherapy. Don’t let the guidelines convince you otherwise.

• Averycommonproblematpainclinics,aswellasinthecommunity.Itisoftendifficulttoachievemorethanamoderatereductioninpainintensity.

• Expertspeakerswilldiscussthemechanismsandproblemsinmanagingthisgroupofconditions.

• Issuesarounddetectioninprimarycarethroughtooff-licenseprescribingwillbecoveredontheday.

• Thisstudydaybringsawiderangeofdisciplinestogethertodiscussmanagementoptionsavailablenowandforthefuture.

TheBritishPainSociety Learning in Pain series

Neuropathic PainWednesday2ndDecember2009,London

WeareanapprovedproviderofContinuingProfessionalDevelopment(CPD)andthismeetingisworth5CPDpoints.

Delegatefees:BPSMember£120,NonBPSMember£220,TraineenonMembers£150Forenquiriesorabookingform,[email protected]


Dr NiCk keNDall clinical director Pain ManageMent serVice christchurch, neW Zealand. forMer chair of the neW Zealand acute loW back Pain guideline Project

This article is adapted from a letter written in response to the resolution placed before BPS members that “in view of his involvement with and the continued endorsement of, the NICE Guidelines on Low Back Pain, the President of the BPS, Professor Paul Watson, should resign”. It was my contention that this resolution does nothing to further debate on the substance of the subject matter; and, that it was damaging to our Society and its future. Ideally, I would have liked to seen it withdrawn, and for the debate to be re-focused on the truly substantive issue: what is effective to help our low back pain patients experience less pain, distress, and disability?

The introduction of any clinical practice guideline tends to be predominantly met with two types of responses: a ‘so-what’ shrug, or controversy. I am well familiar with both, having chaired a national low back pain (LBP) guideline expert panel in New Zealand for about 7 years, and dealt with the conflicting interests and anger of professional associations.

Perhaps the strongest rationale for guideline development is when there is inconsistency in regular clinical practice. Naturally, this is likely to engender controversy and debate. In the LBP field there has clearly been both inconsistency in clinical practice, and controversy whenever guidelines have been published.

Common responses to LBP guidance have included frank disbelief about the evidence, through to concerns over service funding. We should not skirt the issue that some clinicians persist with their clinical approaches because it gives them income(1). As President of the International Association for the Study of Pain (IASP), John Loeser urged us to ‘focus on outcomes rather than incomes’. Many clinicians refuse to accept that not everything done in the name of therapy is actually helpful. This has meant that other approaches have been needed to encourage the clinical workforce to adopt the most effective techniques, and to desist from using less effective ones. This requires tackling the considerable inertia found in clinical practice. As the guideline development process has matured, the policy-makers and those responsible for funding decisions, have found them steadily more useful as an aid to funding decisions. This has become institutionalised as the National Institute for Health and Clinical Excellence (NICE) within the NHS.

The counter-productive response to attack one or more individuals involved in LBP guideline development has fortunately been less common over the years. Certainly, it is difficult to discern a purpose in such a tactic, especially one that could be productive to any party. There is an important matter of principle at stake here. Every BPS member and office-holder should be allowed the intellectual freedom, and the professional respect, to argue for their point of view without fear of attracting personal vitriol. The notion that any debate can be advanced by selectively removing

an individual from it is one that never deserves support. It reminds me of the need to defend the right to an opinion: “I disapprove of what you say, but I will defend to the death your right to say it” (Voltaire, 1694-1778). I therefore welcomed the opportunity to address a number of questions before the resolution was decided by the BPS membership. As you know my letter ultimately did not change the outcome of the EGM but I think the points made were valid and still need careful consideration.

1. Could the Resolution have been supported on the grounds that Professor Watson contravened the purposes or rules of the British Pain Society?

The study of pain, and the management of pain, is undoubtedly important yet complex. For this reason the International Association for the Study of Pain was founded in 1973. “The purposes [of IASP] are exclusively educational, scientific, and charitable in nature” (Article 2, IASP Bylaws; (2)). IASP Membership has always been multidisciplinary in nature, and is open to “Scientists, physicians, health professionals and others interested in the mission of the Association” (Article 3A, IASP Bylaws; (2)). The British Pain Society is a chapter of IASP (functioning under Article 7, IASP Bylaws; (2)). The BPS “is the largest multidisciplinary professional organisation in the field of pain within the UK” (see What is the British Pain Society? www.britishpainsociety.org).

All BPS members are subject to a code of conduct, which has arisen historically from interactions between the Society and commercial interests: “Officers, elected council members, co-opted members of the Council and members of the Society should not purport to represent the views of the British Pain Society” with respect to pharmaceutical meetings and products or make statements about other

products or commercial services (Code of Conduct, BPS, www.britishpainsociety.org). NICE “is the independent organisation responsible for providing national guidance on the promotion of good health and the prevention and treatment of ill health” (About NICE, www.nice.org.uk). NICE is neither a pharmaceutical company, nor an organisation that endorses commercial products.

Professor Watson held the presidency of the BPS. During the development of, and in the final version of, NICE Clinical Guidance 88 (Low back pain: Early management of persistent non-specific low back pain, issued May 2009) Professor Watson is listed as a member of the Guideline Development Group, and his title is listed as “Professor Paul Watson (Clinical Advisor), Professor of Pain Management and Rehabilitation, Department of Health Sciences, University of Leicester” (Appendix A, NICE Clinical Guideline 88).

There does not appear to be a single instance where Professor Watson is referred to as president of the BPS, other than in his accurate declaration of interest (3). Nor, according to a text search of NICE documents, does there appear to be a single instance where any statement or opinion is made on behalf of the BPS.

Hence, any argument that Professor Watson has contravened either the fact, or the spirit, of the BPS regulations and/or code of conduct is untenable. This also holds true for the bylaws of the IASP.

2. Was the Resolution supported on the grounds that Officers of the British Pain Society should exempt themselves from other professional roles?

Membership of the BPS is open to “scientists, medical practitioners or other healthcare professionals (whether in training or fully qualified) interested in the objectives of the Society” (Section 6.1, BPS Memorandum

The Extraordinary General Meeting resolution had nothing to do with the real debate



and Articles of Association (2)). This explicitly acknowledges that Members (who then become eligible for election as officers, such as President) are engaged in activities and interests. In practice this makes it inevitable that office-holders will take on a variety of professional roles in the course of their everyday working lives. Historically, BPS presidents have generally had multiple roles that embrace clinical, academic/teaching, and research aspects of the pain field.

When this resolution was passed it effectively signalled that officers of the BPS (and therefore it’s members) should abstain from participating in many professional activities including those such as expert panels, scientific committees, guideline development groups, think-tanks, other advisory roles, etc, etc. Such a constraint could be considered highly detrimental to advancing the pain field. Furthermore, it would favour election of officers who had no other professional roles, or any wish to participate in such. This would be inconsistent with the objectives of the BPS, and potentially establish an unfortunate precedent for other IASP chapters to emulate.

Hence, the argument that BPS officer-holders should not engage in the provision of clinical and scientific advice to the best of their abilities is unsupportable.

3. Was the Resolution supported on scientific or epistemological grounds?

The process by which clinical guidance is developed can often be complex, and resource-intensive. It is frequently a thankless task for those involved. There now exist reasonably sophisticated guideline development approaches, based on international collaborations such as the Guidelines International Network (www.g-i-n.net), of which NICE is a member. Epistemology recognises that derivation of absolute scientific

truths is rare, or arguably improbable. This means clinical guidance and descriptions of ‘best clinical practice’ inevitably evolve and progress as scientific knowledge becomes available. The idea of a guideline with ‘all the answers’ is scientifically naïve. Guidance summarises the best available evidence.

It has long been recognised that replication of results is a fundamental tenet of the scientific method. For clinical guidance, it is always important to review these documents within the context of other clinical guidance. There are multiple LBP guidelines available from around the world. These contain many similarities, and some differences. A noteworthy recent addition was the publication in May 2009 of a clinical practice guideline by the American Pain Society and the American Academy of Pain Medicine (4-6). This LBP guideline is notable for emphasizing “the use of non-invasive treatments over interventional procedures, as well as shared decision-making between provider and patient”.

This highly contemporaneous guideline is notable for three reasons. First, that it is based on a comprehensive evidence review (7). Second, that it is published, and therefore fully endorsed, on behalf of the APS (an IASP chapter, just like the BPS). Thirdly, that the conclusions and recommendations are congruent with the recent NICE guidance.

In summary, the resolution cannot be supported on the grounds of BPS rules, or for professional or scientific reasons. Of great importance is the need to maintain a clear focus on debating issues, instead of individual participation. Professor Watson is clearly an individual who has contributed significantly to the BPS. To have forced his resignation from the presidency over this issue has detracted significantly from the purpose and standing of the BPS, and subsequently from IASP. More importantly it delivered the noble

purposes of our Society into the hands of those who wish to lobby for their particular cause without engaging in a well-reasoned debate on issues of significant import.

4. Will the NICE guidance be modified or withdrawn after the Resolution was passed?

It is possible to raise any number of arguments about the utility of all available pain management techniques. This debate is healthy, and must continue. However, it should not become one devoted to tackling a fictitious ‘straw man’, whereby groups posit themselves as ‘interventionists’ against ‘non-interventionists’. It is timely to recall the wisdom of the statement attributed to Issy Pilowsky when describing the pain management field: “We are condemned to live in a house of many paradigms”. Several decades ago we came together as an interdisciplinary group, dedicated to understanding pain as a complex problem, so that we can help our patients. It has been a long and hard-fought battle for recognition.

In my humble opinion, the resolution damaged only the BPS, its members, and the patients we serve. Clearly, it will not alter the current NICE guidance. This means those who proposed it will have gained nothing toward their objective, other than casting themselves as a group with something of a vindictive agenda. Sadly, the Society is the loser, and then its members, and their patients. For this reason I urged the resolution to be withdrawn. Let’s return to the real debate: what is effective to help our low back pain patients experience less pain, distress, and disability?

REFERENCES

1. Sanders SH. Nerve Block Therapy for Low Back Pain: Show Me the Money and the Science. APS Bulletin. 2002 July/August 2002;12(4).

2. International Association for the Study of Pain (IASP). Amended and Re-stated Bylaws of the International Association for the Study of Pain http://www.iasp-pain.org/AM/Template.cfm?Section=IASP_Bylaws1&Template=/CM/ContentDisplay.cfm&ContentID=1277. Seattle, WA: IASP; 2007. p. 18.

3. National Institute for Health and Clinical Excellence (NICE). Appendix F – GDG Declarations of Interest. Low Back pain Full Guideline- final version May 2009 www.nice.org.uk/nicemedia/pdf/CG88FullGuidelineAppendixF.pdf. London, UK: NICE; 2009. p. 1-11.

4. Chou R, Atlas SJ, Stanos SP, Rosenquist RW. Nonsurgical interventional therapies for low back pain: a review of the evidence for an american pain society clinical practice guideline. Spine. 2009 May 1;34(10):1078-93.

5. Chou R, Baisden J, Carragee EJ, Resnick DK, Shaffer WO, Loeser JD. Surgery for low back pain: a review of the evidence for an American Pain Society Clinical Practice Guideline. Spine. 2009 May 1;34(10):1094-109.

6. Chou R, Loeser JD, Owens DK, Rosenquist RW, Atlas SJ, Baisden J, et al. Interventional therapies, surgery, and interdisciplinary rehabilitation for low back pain: an evidence-based clinical practice guideline from the American Pain Society. Spine. 2009 May 1;34(10):1066-77.

7. American Pain Society in conjunction with American Academy of Pain Medicine. Guideline for the Evaluation and Management of Low Back Pain: Evidence Review http://www.ampainsoc.org/pub/pdf/LBPEvidRev.pdf. Glenview, IL: American Pain Society; 2009.


PROFESSIONAL PERSPECTIVES

Dr pip ChaGGer surrey

It is worth noticing that only reassurance has been identified as a key intervention and communication strategy in the Department of Health’s ‘18 Week Commissioning Pathway – Chronic Pathway 2008. In essence, reassurance is one of a number of people skills that can be used by health professionals to assure or restore a pain sufferer’s confidence when the pain sufferer has an actual or perceived feared or uncertain outcome. A patient’s perceived self-confidence has been established to be a very important mediating variable in the distress, healthcare seeking behaviour, depression and anxiety experienced by many pain sufferers. However, a recent review of the evidence suggests that the effects of reassurance specifically in the field of pain is ‘inconsistent, sometimes small, sometimes transient, and sometimes paradoxical’ and can have adverse and positive effects on the behaviour a pain sufferer (1). What might be the missing link in the pathway?

Compassion, which is another communication strategy and is repeated every day by pain clinicians, might prove to be a major ingredient that optimises the link between clinical interventions and reassurance in the pathway. This is because the compassionate tone of a reassuring message given to a pain sufferer might mediate how reassured a patient feels and

influence the number of treatment choices they make within the pathway. Why is compassion so important?

Advocating on behalf of pain sufferers has always required compassion. Compassion has played a major part in motivating and maintaining a pain clinicians’ commitment to work in the field of chronic pain. Compassion has also been a central tenet in developing ethical health care and research systems in pain care. In our NHS service, several obstacles have been identified that affect a clinician’s capacity to provide compassionate care to patients and their families (e.g., values instilled in clinical training, being too busy, a lack of scientific evidence, a lack of experience of talking therapies, a clinician’s fear of talking about distress and dying, stress, depression and burnout, ward climates and building design, and work pressures on waiting time initiatives and financial productivity) in both physical and mental health care settings. Another important obstacle might be that for some clinicians when something is not clearly defined and cannot readily be weighed or measured, it is almost as though that thing is not worth taking seriously or they struggle to assimilate a concept. This despite the fact that all clinicians and pain sufferers in their private lives can certainly all recognize that compassion does indeed exist and is certainly as real and as important as anger or anxiety (just read Shakespeare’s

‘Antony and Cleopatra’). In part due to the ever increasing evidence base on the importance of using compassion in psychological interventions for emotional disorders measuring and rating compassionate care has been included into the government’s agenda aimed at improving the quality of patients’ experience in the NHS (2, 3). Furthermore, the importance of compassion in our interactions with pain sufferers has clearly been recognised by in this year’s NHS Constitution, which defines the skill of giving compassion, as: ‘we respond with humanity and kindness to each person’s pain, distress, anxiety of need. We search for the things we can do, however, small, to give comfort, and relieve suffering. We find time for those we serve and work alongside. We do not wait to be asked, because we care’ (4). More recently, ‘The King’s Fund’ published a paper called ‘The Point of Care. Enabling compassionate care in acute hospital settings’, which provided a number of western perspectives of compassion, places a greater emphasis on defining compassion in healthcare (5). For example, Lowenstein refers to compassion as something that includes ‘empathy, respect, a recognition of the uniqueness of another individual, and the willingness to enter into a relationship in which not only the knowledge but the intuitions, strengths, and emotions of both the patient and the physician can be fully engaged (2008; see table 1 with other definitions of compassion).

A major criticism of the literature on compassion is that there is very little guidance on how to use compassion to improve the effectiveness of clinician-patient interactions and a field manual has not been developed. Mindfulness technology has been shown to be consistently effective in pain management programmes; therefore might Buddhism has some useful tips about practising compassion?

In Buddhism, compassion, although not clearly defined, is the wish that others be free from suffering and gives an individual a sense of urgency to help others. From a Buddhist perspective there are many elements to compassion, such as acknowledging suffering, trying to understand what the patient might be experiencing, respect and acceptance and the emotional tone of a compassionate message. The near enemy to compassion is pity and distress, which keeps an individual at a distance, and does not urge one to help others. Compassion happens when an individual recognises the experiences, the points of views and the suffering of others and tries to understand them, without getting stuck or sucked in emotionally. This approach is similar to mindfulness techniques used in pain management programmes. Moreover, compassion is not directed just at one person (for example, your patient) but the aim is to be compassionate towards everyone (e.g., older people). This might help to reduce any prejudices and stereotypes influencing a clinician’s behaviour (e.g., making decisions about mental capacity). For many centuries Buddhist practitioners have been using the power of compassion to cultivate positive emotions. What strategies might be effective?

The literature suggests that learning two simple but powerful strategies concurrently from a Buddhist perspective to give compassion might be a worthwhile endeavour for all clinicians to master, while an evidence base on effective compassionate skills is established. The first strategy is referred to as ‘equalising oneself’ with the other person; and the second strategy is called ‘exchanging oneself with the other person’. To equalise oneself with another means for a pain clinician to psychologically change one’s importance to equal that of a pain sufferer. Exchanging places with a pain sufferer can only take place once a clinician can see themselves as an equal to a pain sufferer, in terms of importance, intellectual ability,

Compassion

Table 1 Some Definitions of Compassion

Author Definition

Hoffer (1969)

Compassion is the antitoxin of the soul: where there is compassion even the most poisonous impulses remain relatively harmless.

Chochinov (2007)

A deep awareness of the suffering of another coupled with the wish to relieve it.

Frank (2008)

Compassion – both giving and receiving it – entails an emotional response. It goes beyond acts of basic care and is likely to involve generosity – giving a little more than you have to – kindness, and real dialogue.


status, wealth, and desires. This process seems easy to follow but is difficult to master. However, psychologically based clinical supervision might be a place where pain clinicians try these two strategies out and experience the power of compassion. The power of compassion is to increase the awareness and responsiveness of clinicians towards the different needs of all patients (see Maslow’s ‘Hierarchy of Needs’). Equalising oneself with a pain sufferer and then viewing the world from their perspective creates an opening for that pain sufferer to say what they need to say without feeling judged or wrong and to express their most private concerns or fears. This approach may help all clinicians to read patients better and stay calm rather than experiencing anxiety, anger and stress when interacting with patients. A more compassionate approach, using these two strategies, may also give pain clinicians an understanding about where pain sufferers are coming from and trying to get to, affording a more comprehensive overview about how patients function in the world they perceive (e.g., Myers-Briggs Type Indicators). This may help all clinicians to see that their roles are primarily aimed at helping pain sufferer’s to improve their functioning in the world, though their roles and skills in the pathway may differ. Taking a moment to recognise the importance of the pain sufferer can help create a stronger therapeutic alliance with patients. It brings the clinician’s awareness into the present moment as opposed to the mind’s usual tendency to race forwards and backwards allowing the clinician to listen deeply to hear the pain sufferer’s problems.

There may be many forms of compassion and compassion might have some specific reactions from pain sufferers when compared with other chronic medical conditions. Reassurance and compassion are two different communication strategies but on occasions may work well together. For example, compassion might be the emotional part of reassurance.

Those pain clinicians that can provide both reassurance and compassion are likely to practice more function directed care rather than focusing on the procedural aspects of treatments available in the pathway. Compassionate communication will help clinician’s to go beyond merely Socratic dialogue to gain a deeper listening and understanding of their patient’s problems. Why not just try equalising and exchanging? After a while you may find that compassion benefits not only pain sufferers in terms of improving communication but also your relationships with other pain team members. However, compassion is a two-way relationship and if you have limited compassion for yourself then it is likely that you may struggle to develop compassion for others.

REFERENCES:

1. Linton S.J., McCracken, L.M. & Vlaeyen J.W.S. (2008). Reassurance: Help or hinder in the treatment of pain. Pain, 134, p5-8.

2. Gilbert, P. (2009). The compassionate mind: a new approach to life’s challenges. Constable & Robinson: London.

3. Darzi, A.W.D. (2008) High Quality Care for All: NHS Next Strategy Review Final Report. Department of Health: London.

4. Department of Health (2009). The NHS constitution: the NHS belongs to us all. Department of Health: London.

5. Firth-Cozens, J. & Cornwell, J. (2009). The point of care. Enabling compassionate care in acute hospital settings’. The Kings Fund: London.

6. Nightingale, F. (1860). Notes on nursing. D Appleton & Company: New York.

Updated Spinal Cord Stimulation Publications

TheBritishPainSociety’srevisededitionsof‘Spinal cord stimulation for the management of pain: recommendations for best clinical practice’and‘Stimulating the spinal cord to help with pain - information for patients’ arenowavailable.

Todownloadyourfreecopypleasegotothepublicationssectiononourwebsite:www.britishpainsociety/pub_home.Hardcopiescanbeorderedfromthesecretariat(chargeapplies).

Third Floor Churchill House 35 Red Lion Square London WC1R 4SGTel: +44 (0)20 7269 7840 Fax: +44 (0)20 7831 0859

[email protected] www.britishpainsociety.org

Spinal cord stimulation for the management of pain: recommendations for best clinical practice

A consensus document prepared on behalf of the British Pain Society in consultation with the Society of British Neurological Surgeons

April 2009To be reviewed April 2012

The British Pain Society's

scs_jan2009.indd 1 06/08/2009 16:46:01

Stimulating the spinal cord to help with pain - information for patients

Prepared by the British Pain Society and the Society of British Neurological Surgeons

April 2009To be reviewed April 2012

The British Pain Society

scs_patient_jan2009.indd 1 06/08/2009 16:34:35


CHANGING PRACTICE

Problem-Based Learning (PBL) in Pain ManagementDr paul WilkiNsoN neWcastle Dr aNN taylor

cardiff

One aim of the Pain Education Special Interest Group (SIG) is to provide professional development in educational strategies to educators. At the 2009 BPS meeting in Sandown, the focus was on Problem-based learning (PBL) and here we provide a brief synopsis for those who were unable to attend and hopefully a further resource for those who did. Problem based learning is essentially a small group teaching method that combines the acquisition of knowledge with the development of generic skills and is grounded in adult learning.

Snapshot of PBL use amongst attendantsOf the 60 or so attendants, a brief hand-count indicated that there was approximately equal split between those unfamiliar with PBL, those who used this occasionally and those who used the technique commonly. There is an inevitable skew in attendants towards those with an interest in education but

PBL is clearly seen as a useful strategy by many.

DefinitionPBL can be defined as an instructional strategy in which learners identify issues raised by specific problems to help understanding about underlying concepts and principles

There is much confusion with problem-solving and problem based learning. One invariable feature of PBL is the initial presentation of a problem to trigger the development of learning outcomes. It is perhaps best referred to as problem-first learning.

There tends to be a number of steps that participants follow to address the problem:

• Analysisofascenario

• Generatingideasabouthowto solve the problem

• Listingwhatisalreadyknownwithin the group

• Identifyingwhatknowledgeisneeded

• Planofactionfortheinvestigation

• Developingaimsandobjectives

• Gatheringofinformation

• Presentationoffindings

Though McMaster University University, Hamilton, Ontario pioneered the use of PBL in medical courses early 1970’s, Celestin Freinet was known to have introduced a form of PBL into a primary school in France (1920)!

How does it work? This was illustrated to those unfamiliar with PBL by giving a problem (see below) to each group and simply asking what each group viewed that they needed, or would like to learn about the problem, to help them understand it further.

This problem led to an interesting array of learning outcomes centered around silicone-chip disorders, its clinical features, pain symptoms as well as the need for veterinary opinion on the poor lady’s cat!

Having determined the learning outcomes, a traditional PBL format would then involve dividing these amongst learners who would go away and research these usually individually. In the final phase or reporting phase, the group will reform and individuals will present their work back to the group which will inevitably be analyzed further during this synthesis. Those attending the meeting will know that the individual research phase is often known impolitely as the FOFO phase, those who did not may be left wondering what this might mean!

Structured problem developmentThere are formal ways to help groups unpick problems but the common aim is to determine learning outcomes - that is what

the group would like to know to help them understand the problem or the issues raised. The Maastricht system has a series of steps. This system involves identifying key words (e.g. here pain, silicone-chip etc) within the problem. These can be underlined and the next step ensures all terms are understood. A brain-storming phase encourages free, unstructured thinking which is then followed by further processing steps to help comprehensive analysis of the problem. The final steps of research outside the group and reporting phase common to PBL have already been covered.

PBL in pain practiceCentral to the workshop was a further problem used to try to trigger a wider analysis of PBL. This scenario involved a new professor who was a PBL enthusiast who wanted to transform traditional curricula to PBL making various claims about its value. While undoubtedly heavily influenced by that problem, a number of questions arose about PBL and its value. These are now listed. In the spirit of PBL, the authors of this article do not now prescribe the answers nor profess to know them! Instead, readers are invited to explore some of these issues themselves in further detail. A reference list is provided however!

ConclusionsPBL is clearly used in current pain teaching but we were not able to identify any literature about its application in this field. PBL raises many issues and most would agree that, at the very least, has the potential to makes life interesting both for students and those involved in education!

USEFUL WEB SITES

The Higher Education Academy: Social sciences

http://www.c-sap.bham.ac.uk/resources/project_reports/ShowOverview.asp?id=4

A clinical problem

Mrs J. K. comes to the pain clinic. She says

she has silicone-chip disorder and has pain

everywhere. She wants a new medicine Incredo-

relief (available in the USA). She seems very

distressed and arrives in a wheelchair. She has

noticed increased freckling of her skin and the

veins in her arms are more prominent. Her cat

has become ill too.


http://www.ukcle.ac.uk/resources/pbl/resources.html

http://www.materials.ac.uk/guides/pbl.asp

PBL Directory – who is doing what in PBL

http://interact.bton.ac.uk/pbl/index.php

Project on the effectiveness of PBL including draft systematic review

http://www.hebes.mdx.ac.uk/teaching/Research/PEPBL/

Teaching and learning using PBL with useful resources

http://www.learningandteaching.info/teaching/pbl.htm

USEFUL REFERENCES

Wood DF. (2003). Clinical review, ABC of learning and teaching in medicine, Problem based learning http://www.bmj.com/cgi/content/full/326/7384/328

Yuan H. Williams BA. Fan L. A systematic review of selected evidence on developing nursing students’ critical thinking through problem-based learning.Nurse Education Today. 28(6):657-63, 2008 Aug.

Cohen-Schotanus J. Muijtjens AM. Schonrock-Adema J. Geertsma J. van der Vleuten CP. Effects of conventional and problem-based learning on clinical and general competencies and career development. Medical Education. 42(3):256-65, 2008 Mar.

Williams SM. Beattie HJ. Problem based learning in the clinical setting--a systematic review. Nurse Education Today. 28(2):146-54, 2008 Feb.

Koh GC. Khoo HE. Wong ML. Koh D. The effects of problem-based learning during medical school on physician competency: a systematic review. CMAJ Canadian

Medical Association Journal. 178(1):34-41, 2008 Jan 1.

Carrero E. Gomar C. Penzo W. Rull M. Comparison between lecture-based approach and case/problem-based learning discussion for teaching pre-anaesthetic assessment. European Journal of Anaesthesiology. 24(12):1008-15, 2007 Dec.

Tan CH. Amin Z. Khoo HE. Gwee M. Davis M. Koh DR. Student perceptions of the benefits of problem-based learning. Medical Teacher. 29(2-3):284, 2007 Mar.

Azer SA. Twelve tips for creating trigger images for problem-based learning cases. Medical Teacher. 29(2-3):93-7, 2007 Mar.

van Wyk J. McLean M. Maximizing the value of feedback for individual facilitator and faculty development in a problem-based learning curriculum. Medical Teacher. 29(1):e26-31, 2007 Feb.

USEFUL TEXTS

French T, Wardle T. (2006). The Problem Based Learning Workbook: Medicine and Surgery (Key Clinical Scenarios) England: Radcliffe Publishing LTD

Savin-Baden M, Wilkie K. (2006). Problem Based Learning Online. Oxford: Open University Press.

Savin-Baden M. (2003). Facilitating Problem Based Learning. Oxford: Open University Press.

Savin-Baden M, Howell Major C. (2004). Foundations of Problem Based Learning. Oxford: Open University Press.

Stewart A, van Ruiten H, Wales D. (2005). Core Clinical Cases: Bk 2, Problem Based Learning. England: PasTest.

Questions and controversies

1. Is it not better to have a little knowledge first?

2. How should students be prepared for PBL?

3. How are issues of group dynamics managed e.g. the quiet/dominant student?

4. Is it best to use content experts or process experts (expert facilitators)?

5. What are the staff training issues?

6. Can PBL problems mimic real clinical problems?

7. Is it safe? What are the risks of PBL?

8. What is the evidence of benefit (e.g. critical thinking, collaboration etc). How do we assess the evidence for its effectiveness e.g. Is there such a thing as “numbers needed to teach…”!

9. How does PBL as a sole method for curricula compare with mixed educational approaches?

10. Is it really better than traditional educational approaches?

11. How can problems adequately reflect learners’ needs?

12. What are the costs as opposed to traditional curricula?

13. How to design a suitable problem? What type of triggers can be used?

14. What are the best approaches to assessment in PBL?


CHANGING PRACTICE

Pain relieving nerve blocks, to repeat or not to repeat, that is the question?Dr Bala veeMaraJa Dr aNDreW raveNsCroft nottinghaM uniVersity hosPitals

Like it or not, injections of local anaesthetic and steroid to a variety of anatomical targets are widely used in pain management. They are often provided on a repeated basis because their effect doesn’t last and the patient has failed to find pain relief from alternative strategies, including cognitive behavioural therapy.

There is no guidance in the literature regarding how appropriate it is to repeat injections. One attends debates on ‘medicalisation’ of patients, the outdated biomedical model, or hears of miracles performed with a one-off injection and a course of physiotherapy. Unfortunately, on returning home, all good intentions of a change in practice immediately flounder, as the first patient of the day tells you that they ‘couldn’t live’ without there regular caudal epidural injection!

Ignoring how appropriate it is to repeat inject, is it actually safe? There is much written about the immediate complications of nerve blocks (albeit for anaesthesia), but not a single article concerning the long-term side effects of repeated steroid boluses. To this end we analysed a small group of twenty patients, each of whom had received epidural injections at three monthly intervals for at least five years(1). Each patient was examined and had a dexascan, synacthen and glucose tolerance tests. The results were reassuringly normal but didn’t really prove anything! We have also looked at the dose of steroid used for each injection. Traditionally we have used

80mg of methylprednisolone, why, we don’t know? A recent study conducted by us shows that the same effect can be achieved using 40mg instead, further reducing the risk(2). We intend to investigate a further reduction.

If injections are to be repeated, what would be considered a reasonable interval between injections? Studies suggest that after an injection of epidural steroid, the adrenal axis is suppressed for a period of four weeks, then returning to normal(3). Endocrinologists advise that this ‘return to normal’ period is important, meaning that even during the suppressed phase there will still be some adrenal response to stress. This is not the case if the adrenal axis is continually suppressed. So perhaps 3 months should be a minimum interlude to allow several weeks of normal adrenal function?

Assuming that there are either no long term side effects, or the side effects are so subtle as to be outweighed by the benefit of injections; the next question is what level of benefit would we expect the patient to achieve before being offered a repeat injection?

We realized that we did not assess ‘level of benefit’ or efficacy of nerve block using anything other than a few informal questions such as “did it work?” We certainly didn’t collect or record data on efficacy that we could reproduce if asked to justify our practice. We wondered if anybody else did and decided to survey the members of the Pain Society Interventional SIG.

Unfortunately we only received 41 responses to 100 emails sent, but

the results are as follows: Of the responders, 38% said that they did repeat injections multiple times, whereas 51% said that they were prepared to perform a series of 2 or 3. 26% of respondents stated they tried to limit injections to 6 monthly.

When asked how they measured efficacy of block before deciding to repeat, the majority relied upon the patients account with only 23% having a formal scoring system. This was usually the brief pain inventory. Not surprisingly, the parameters that were felt most important when assessing block efficacy were percentage pain relief (92%), duration of effect (80%), improved function (70%), reduction in analgesic medications (53%) and improved sleep (46%).

We have recently introduced a scoring system to assess the efficacy of our nerve blocks (Appendix 1). It aims to assess pain relief and improved function after injection. The score consists of a few simple questions requiring yes or no answers. The total score is 14 and we have for the time being set 8 or more as a score that would offer further nerve block.

The system has now been used to assess outcome in sixty patients. After a patient has received an injection a clear plan of action (guided by the score achieved) is written in the notes by the doctor. The patient is then reviewed by our nurse specialist at 2 months. This is easily performed over the telephone. The score achieved determines the next step according to the plan with patients scoring eight or more booked for repeat injection.

We feel that use of the scoring system has several advantages. It reduces unnecessary outpatient appointments. The fact that the questions require yes or no answers and are asked by an impartial third party adds a greater degree of objectivity. The process also encourages the collection of simple outcome data on an area of our practice that is presently

under increasing scrutiny by commissioners.

In the future, the addition of more demographic and clinical data to the outcome scores database may enable analysis of factors that predict response to certain nerve blocks?

REFERENCES

1. Eastwood J, Ravenscroft A. Chronic back pain: do repeated epidural steroid injections cause side effects? Pain Society Annual Scientific Meeting, Bournemouth 2002).

2. R . McCahon , A . Ravenscroft , V . Hodgkinson , J . Hardman. Effect of epidural steroid dose on low back disability scores. Regional Anesthesia and Pain Medicine , Volume 32, Issue 5, 52.

3. Burn J M B, Langdon L. (1974) Duration of action of epidural methylprednisolone. Am J Phys Med: 53; 29-34. Problem Based Learning. England: PasTest.

Appendix 1

Parameter Measured Score

Duration of effect 0-4 weeks 1

Duration of effect 4-8 weeks 2

Duration of effect > 8 weeks 3

Percentage pain reduction < 30%

1

Percentage pain reduction 30 - 60%

2

Percentage pain reduction > 60%

3

Improved Sleep Yes 1

Improved Sleep No 0

Improved Mobility Yes 1

Improved Mobility No 0

Reduced Medications A Lot 3

Reduced Medications A Bit 2

Reduced Medications No 1

Improved Quality of Life A Lot 2

Improved Quality of Life A Bit 1

Improved Quality of Life No 0

Do You Work No 0

Do You Work Yes 2

Total (Maximum 14)

TheaimofthePainEducationSIGseminaristoprovideanexcitingandstimulatingopportunitytomeetwithlike-mindedcolleagueswhowanttoimprovepainmanagementthrougheducation.Thedaywillprovideopportunitiesforinteractivelearning,thesharingofideasandbestpractice.Weintendtomakeitfunandfocused.

• Developingcriticalthinking

• Effectiveuseofwebsites

• Creativeuseoftheinternetforeducation

• Activenetworking

• ProblemBasedLearning

TheBritishPainSociety

Pain Education SIG one day seminar Thursday17thDecember2009,ChurchillHouse,London

Thismeeting,organisedbythePainEducationSpecialInterestGroup,isopentoall.Placesarelimited,soearlyapplicationisadvisable.WeareanapprovedproviderofContinuingProfessionalDevelopment(CPD)andthismeetingisworth5CPDpoints.

Delegatefees:BPSMember£90,NonBPSMember£110Forenquiriesorabookingform,[email protected]


PAIN SHORTCUTSPAIN SHORTCUTS

Dr ryaN Moffat glasgoW

acta anaesthesiol scand 2008; 52: 1331-1335

Total Knee Arthroplasty (TKA) is a common procedure and can be associated with severe post-operative pain. There are various techniques for post-operative analgesia used in common clinical practice. However, some of these such as neuraxial and peripheral nerve blockade (PNB) may be associated with morbidity. The authors performed a randomized control trial comparing high-volume local anaesthetic infiltration (LAI) to placebo in bilateral TKA. They hypothesized that LAI has an analgesic effect in the early post-operative period (48 hours) following TKA. Ethical approval was obtained via the local ethics committee. 12 consecutive patients scheduled for bilateral TKA received periarticular infiltration with 170mls 2% ropivacaine and epinephrine (10ug/ml) in 1 knee and 170mls of 0.9% saline in the opposite knee. A catheter was left in-situ, at 8 and 24 hours a further injection of 20mls and 50mls of the appropriate solution was performed. Randomization was achieved using computer generated random sequence and opaque sealed envelopes. Randomization was not revealed until completion of the study. The solutions used were prepared by one investigator not involved with patient data collection.The procedure was performed under spinal anaesthesia using 15mg plain bupivacaine in all patients. All patients received multi-modal analgesia including PCA morphine. The primary end point was to compare post-operative pain in each knee using a Numeric Rank Score. Pain was assessed at rest,

45° flexion of the knee, and with the leg straight and 45° elevated. Pain scores were recorded at regular intervals for 48 hours. No power calculation for the study was made.

The authors report a significant reduction in pain scores from 4 to 25 hours post-operatively at rest, from 4 to 32 hours upon 45° flexion and from 4 to 26 hours on straight leg raising. The results are presented in graphical form with median, 25 and 75 percentiles recorded. A detailed description of side effects was not performed. However, the authors state that no major side effects were observed. Although the authors conclude that LIA is effective the number of patients in this study was small, it was compared to placebo and not to a recognised analgesic technique for TKA such as peripheral nerve blockade. In addition it is difficult to comment on distinct end points such as morphine consumption, discharge date, mobilization etc if both placebo and treatment are in the one patient. However, PNB is associated with potential morbidity and LIA warrants further study as an alternative analgesic technique for TKA.

Dr saaD aNis

(anaesthetic sPr), essex

euroPean journal of Pain 13:719-730

The authors of this paper performed a systematic review of the literature aimed at identifying and making a preliminary analysis of the relationship between psychosocial elements (predictors & correlates) and chronic post surgical pain (CPSP).They performed a systematic search of Pubmed, PsychInfo and Cochrane database between Jan 1996 & June 2006. They looked at original studies only, in adults, exploring prediction, risk factors, correlates & incidence of CPSP with minimum three month follow up and pain lasting at least three months.

Each study was given a numerical points value between 0-4 dependent upon characteristics of study type, no of subjects and completeness of follow up. Maximum score of 4 was scored for a prospective study, with >100 subjects & follow up rate >80%.

For each possible predictor related to CPSP, the points score was added up for those papers favouring association and for those papers not indicating association. Each predictor/ correlate was given a value of 1-3.

1- Represented a likely association between predictor & CPSP.

2- Represented no conclusion possible

3- Represented association unlikely.

To gain score of 1 or 3 required at least 3 studies to have been reviewed with double the points score of the opposing view.

149 articles were found to be potentially relevant & of these 50 considered psychosocial correlates in an adequate manner. After review Depression, Psychological Vulnerability, Stress & Duration of Disability (Time to return to work) were assessed to have likely association with CPSP.

Various other factors were found in which the evidence was unclear these included anxiety, pre- op health & well being, self control, self- perception of recovery & higher pain relief expectations.

Factors which were found to have an unlikely association included female gender, full- time employment, low education & race.Significant limitations of the study included variability of the reviewed studies. eg. some studies used standard measurements while others used surrogate end points. Also many relevant studies were excluded if they investigated pain as one aspects of a combined end-point.

A consistent definition of CPSP would be of great benefit for further research and there was an understanding that the results were quite preliminary since evidence for the individual predictors was quite weak and heterogenous.

UPCOMING MEETINGS FOR HEALTHCARE PROFESSIONALSVISIT OUR WEBSITE @ WWW.BRITISHPAINSOCIETY.ORGFOR UPDATED EVENTS

High-volume infiltration analgesia in knee arthroplasty

Psychosocial predictors for chronic post surgical pain


PAIN SHORTCUTSPAIN SHORTCUTS


anaesth analg 2009;108:308-15

The prevalence of smoking among chronic pain patients ranges from 17% to 31%. Opioids are being increasingly prescribed in the treatment of chronic pain and the interaction between smoking and chronic pain has not been extensively studied. However, a threefold increase in the prevalence of smoking has been reported among patients receiving methadone maintenance therapy for opioid addiction. The author’s hypothesized that smoking status may affect the ability of chronic pain patients to reduce or eliminate their opioid use. 1241 patients consecutively admitted to an outpatient pain rehabilitation program were interviewed to assess their smoking status, opioid use and pain severity. Smoking status was defined as never, current or former smoker. The three week rehabilitation program was based on a cognitive-behavioural model using a multidisciplinary approach the aim of which was to restore physical and emotional functioning. Part of this approach was to reduce or eliminate patient opioid use. Patients had generally received medical care for chronic pain and experienced incomplete symptomatic relief from multiple therapies. Of the 1241 patients 313 (25%) were current smokers, 294 (24%) were former smokers and 634 (51%) were never smokers. Current smokers were younger, had fewer years of education, less likely to be married and had experienced a briefer duration of pain. On admission mean opioid use was significantly greater (p= 0.032) in smokers (146mg/day) compared to former (109.3 mg/day) and patients who had never

smoked (105.9 mg/day). Pain severity scores were higher in current smokers compared to former and never smoked groups.

The primary aim of this study was to assess if smokers were less likely to be successful in tapering opioid therapy. However, they found that only higher opioid use on admission predicted unsuccessful opioid tapering, not smoking status or pain severity (p= 0.001). Interestingly they found that 24% (75 patients) of smokers compared to 10 %( 29) former and 13% (80) never smokers did not complete the rehabilitation program (p≤ 0.001). Various reasons for non-completion of the program were given including discrepant expectations of treatment, acute illness and unrelated psychosocial stressors. The proportion of smokers to non-smokers in each category was not significant (p≥0.1). It is unclear why smokers have a higher rate of noncompletion. However, the authors suggested that smoking in addition to opioid use and increased pain severity represented an important risk factor for poor treatment adherence.

There are several limitations to the study; the patients were predominantly Caucasian females and had been motivated to complete an intensive rehabilitation program and therefore the results may not be applicable to all chronic pain patients. It could be argued however that if smokers had a higher noncompletion rate in closely supervised environment this could be even higher in regard to other treatment modalities and may be an important factor in treating smokers with chronic pain in the outpatient setting.


jaMa, january 14, 2009-Vol 301, no 2

Fibromyalgia syndrome (FMS) has an estimated prevalence of 0.5% to 5.8% in North America and Europe. It is associated with high direct and indirect disease related costs. The authors performed a meta-analysis with 3 defined goals- to assess the effectiveness of antidepressants in the treatment of FMS, determine any differences in the efficacy of anti-depressant classes and to evaluate the validity of the RCT’s studied for the meta-analysis.

Multiple databases were independently screened by 2 researchers identifying 337 citations. These were then reviewed by 2 further researchers using predefined selection criteria identifying 18 studies for inclusion. Pain scores measured using the visual analogue score (VAS), fatigue, sleep, depressed mood and HRQOL’s were identified as outcomes. The authors used Cohen categories to evaluate the magnitude of effect size. Weighted mean differences (WMD’s) and standardized mean differences (SMD’s) were used as outcome measures.

In total 1427 patients were studied with tricyclic antidepressant’s (TCA’s) investigated in 7 studies, Monoamine oxidase inhibitors (MAOI’s) in 3, selective serotonin reuptake inhibitors (SSRI’s) in 6 and 4 RCT’s studied noradrenaline reuptake inhibitors (SNRI’s). Five trials studied multiple groups. Mean duration of treatment was 8 weeks (4-28 weeks). They found that there was strong evidence for antidepressant therapy in the reduction of pain (p≤0.001), fatigue (p=0.003), improvement of sleep (p≤0.001), improvements in HRQOL’s (p≤0.001) and on depressed mood (p≤0.001).

More specifically there was strong evidence for the efficacy of SSRI’s in reducing pain (p=0.4) with small effects on depressed mood. They also found strong evidence for the efficacy of amitriptyline in reducing pain (p≤0.001), fatigue (p=0.003) and sleep disturbance (p≤0.001). Based on Cohen categories the effect size for these groups was large. The effect size on depressed mood was not significant.

There was strong evidence for the efficacy of SNRI’s in reducing pain (p≤0.001) and sleep disturbances (p≤0.001). In addition there was strong evidence for the efficacy of duloxetine in improving depressed mood (p=0.001). The effect size for these groups was small. There was strong evidence for MAOI’s in reducing pain (p=0.3).

Median rates of reported adverse effects and dropout due to adverse effects did not differ between treatment and placebo groups. Although the studies had been appropriately validated there were some potential problems with the studies. Firstly, serum antidepressant levels were not measured therefore patient compliance with medication could not be ensured. Secondly, none of the trials controlled for the use of concomitant analgesic medication. In addition there was a relatively short follow-up time and therefore no comment could be made on the long-term efficacy of antidepressants.

The authors conclude that short term usage of amitriptyline and duloxetine can be considered for the treatment of pain and sleep disturbance based on the number of patients studied (duloxetine) and effect sizes (amitriptyline). This is a helpful study which helps to clarify which medications can be useful treating FMS which can frequently be difficult to manage.

Smoking status predicts non completion of a pain program

Treatment of fibromyalgia with antidepressants is effective


Dear Editor,

The South Devon Inpatient Pain Team has designed a third opioid potency converter wheel for use by our pain team and trainee anaesthetists. Our other converters were published in this newsletter in 2005(1) and 2007(2). In all three wheels, each opioid has been assigned a specific colour so that cross-referencing is simple.

This new conversion wheel allows staff to visualise equivalent potency ranges of three strong opioids which they may encounter in patients normally managed by chronic pain and palliative care teams - morphine, oxycodone and hydromorphone. The oral oxycodone dose is simply calculated as 50% of the oral morphine dose. However the conversion for hydromorphone has been taken from the British National Formulary (BNF) (3).The recommendation is to estimate the potency of 1.3mg of hydromorphone as equivalent to 10mg of oral morphine. Some of the numbers have been rounded up to preserve the visual impact of the converter without significant compromise to doses. The hydromorphone tablets have been highlighted in the colours described BNF where applicable.

Although this latest addition has a rather shocking colour combination, it has proven itself to be useful when encountering these drugs in the peri-operative setting (especially on night shifts) so has been printed out and clipped behind my ID badge for easy reference.

It is important to note that this is a simple summary of estimated drug potency. The drugs have different pharmacokinetics and conversion of strong opioids at high doses requires clinical experience, as patients can experience symptoms of withdrawal if abrupt switches

are made to different opioids even if they have a similar potency.

The Pain Team produce and issue hand held versions of the opioid potency converters for teaching purposes. They are happy for this converter to be reproduced for use by other NHS Pain Teams.

REFERENCES

1. Natusch D, Magides A (2005) Opioid potency converter, The British Pain Society Newsletter, Spring.

2. Natusch D, Magides A (2007) Opioid potency converter, The British Pain Society Newsletter, Autumn.

3. British National Formulary (2008) 55 March, pp.15-19

Dr kathariNe steNlake (anaesthetic trainee)Dr aNDrea MaGiDes Dr DouGlas NatusCh torbay hosPital

Letters to the EditorLETTERS

CorrigendumNEW PUBLICATIONS

In his review of Cancer-related Bone pain (ed. Andrew Davies), Dr Paul Keeley inexplicably pointed to the fact that the book contains no reference to vertebroplasty. The book does, of course, cover this highly relevant topic. Dr Keeley would like to apologise for his bewildering mistake and hopes no lasting offence has been caused. To err is human.

Versatis 5% medicated plaster. Refer to the Summary of Product Characteristics (SPC) for full details on side effects, warnings and contra-indications before prescribing.Presentation: Versatis is a medicated plaster (10cm x 14cm) containing 700 mg (5% w/w) of lidocaine in an aqueous adhesive base. Indication: Symptomatic relief of neuropathicpain associated with previous herpes zoster infection (post-herpetic neuralgia, PHN).Dosage and method of administration: Adults and elderly patients: Use up to threeplasters for up to 12 hours, followed by at least a 12 hour plaster-free interval. Coverpainful area once daily. Apply the plaster to intact, dry, non-irritated skin (after healing of the shingles). Remove hairs in affected area with scissors (do not shave). Remove theplaster from sachet and its surface liner before applying immediately to the skin. Plastersmay be cut to size. Re-evaluate treatment after 2 to 4 weeks. Patients under 18 years: Notrecommended. Contra-indications: Hypersensitivity to active substance, any excipients, orlocal anaesthetics of amide type (e.g. bupivacaine, etidocaine, mepivacaine and prilocaine). Do not apply to inflamed or injured skin (e.g. active herpes zoster lesions, atopic dermatitisor wounds). Warnings and precautions: Should not apply to mucous membranes or the eyes. Plasters contain propylene glycol which may cause skin irritation, methylparahydroxybenzoate and propyl parahydroxybenzoate which may cause allergic reactions.Use with caution in patients with severe cardiac impairment, severe renal impairment or

severe hepatic impairment. In animals, metabolites of lidocaine have been shown to begenotoxic, carcinogenic and mutagenic, with unknown clinical significance. Interactions:No clinically relevant interactions have been observed in clinical studies. Absorption oflidocaine from the skin is low. Use with caution in patients receiving Class I antiarrhythmicdrugs (e.g. tocainide, mexiletine) or other local anaesthetics. Pregnancy and lactation:Do not use during pregnancy or breast-feeding. Undesirable effects: Very common (≥10%): administration site reactions (e.g. erythema, rash, pruritus, burning). Uncommon (>0.1%-≤1%): skin injury, skin lesion. Very rare (<0.01%) but potentiallyserious: anaphylaxis, hypersensitivity. Adverse reactions were predominantly of mild and moderate intensity. Systemic adverse reactions are unlikely. See SPC for full details.Overdose: Unlikely. If suspected, remove plasters, provide supportive treatment (see SPC).Legal classification: POM. Marketing Authorisation number, pack sizes and basic NHS cost: PL 21727/0016, 30 plasters (£72.40). Marketing Authorisation Holder: Grünenthal Ltd, Regus Lakeside House, 1 Furzeground Way, Stockley Park East, Uxbridge, Middlesex, UB11 1BD, UK. Date of text: October 2008. V0320

WORKS WHERE IT HURTS

Versatis is licensed for the treatment of neuropathic pain associated with

post-herpetic neuralgia

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Adverse events should be reported. Reporting forms and information can be found at: www.yellowcard.gov.uk.Adverse events should also be reported to Grünenthal Ltd

(tel: 0870 351 8960)

20451_Versatis Ad_Pain Soc_AW:Layout 1 30/1/09 15:34 Page 1


New Members Ratified on 24th August 2009 by The British Pain Society Council

Name Position Institution

Bewaji, Dr Afolake Consultant Anaesthetist East Surrey Hospital

Burch, Ms Vidyamala Consultant in Mindfulness Breathwork CIC

Ghei, Dr Aditi SPR Anaesthesia and Pain Medicine Royal Gwent Hospital

Gilbert, Mrs Sharon Clinical Nurse Specialist Royal Preston Hospital

Harding, Dr Vicki Physiotherapist INPUT, St. Thomas'

Joseph, Mrs Jan Acute Pain Sister Cheltenham General

Hospital

Kuehler, Dr Bianca Haria Specialist Doctor in Pain Chelsea and Westminster

Hospital

Long, Miss Michelle Physiotherapist Guy's & St. Thomas'

Hospital

Mihaylov, Dr Iordan SPR Anaesthesia Warwick Hospital

Patel, Dr Seetal CTI Anaesthesia Barnet Hospital

Prasad, Dr Vishal SHO Anaesthesia University Hospital Aintree

Rene, Petrone Marie Pain Nurse Specialist Barnet Hospital

Sohanpal, Dr Imrat Research Fellow Pain Royal Marsden Hospital

Watson, Nicholas

Andrew

Pain Management Trainee Pain Management Solutions

Wylde, Vikki Research Associate Bristol Implant Research

Centre

Yew, Dr Jonathan Research Fellow Pain Royal Marsden Hospital

to find out more about advertising, or placing an insert in Pain news, contact rikke Warming on 020 7269 7840 or email [email protected]

For more information on PENS therapy:

Tel: +44 (0)1293 763 070 or visit www.algotec.com

THE FIRST GENERATION OF OFFICE BASED NEUROSTIMULATION THERAPIES

COST EFFECTIVEMINIMALLY INVASIVE

PERIPHERAL NERVE STIMULATION

PENS THERAPYFrequency dependant electrical current

delivered directly to a peripheral nerve, or to

the most peripheral branches of a peripheral

nerve, to inhibit pain signals.

PENS is used to identify patients who are

likely to benefit from a permanently implanted

peripheral neurostimulator, thereby reducing

the incidence of late failure. PENS also offers

patients the potential for intermediate relief

and management of chronic peripheral

neuropathic pain.

8238 Algotec Pain Society 210x285:Layout 2 24/4/09 12:45 Page 1

Keep their neuropathic pain at bayRapid pain relief within 1 week, typically by day 21–4

Sustained pain relief, for up to 2 years3

Relief from neuropathic pain-related sleep interference1,2

LYN537l March 2009

Lyrica® (pregabalin) Prescribing InformationRefer to Summary of Product Characteristics (SmPC) before prescribing.Presentation: Lyrica is supplied in hard capsules containing 25mg, 50mg, 75mg, 100mg, 150mg, 200mg, 225mg (for Generalised Anxiety Disorder only) or 300mg of pregabalin. Indications: Treatment of peripheral and central neuropathic pain in adults. Treatment of epilepsy, as adjunctive therapy in adults with partial seizures with or without secondary generalisation. Treatment of Generalised Anxiety Disorder (GAD) in adults. Dosage: Adults: 150 to 600mg per day, given in either two or three divided doses taken orally. Treatment may be initiated at a dose of 150mg per day and, based on individual patient response and tolerability, may be increased to 300mg per day after an interval of 3-7 days (for neuropathic pain) or 7 days (for epilepsy or GAD), the dose may be increased to 450mg per day after an additional 7 day interval (for GAD), and to a maximum dose of 600mg per day after a further 7-day interval. Treatment should be discontinued gradually over a minimum of one week. Renal impairment/Haemodialysis: dosage adjustment necessary; see SmPC. Hepatic impairment: No dosage adjustment required. Elderly: Dosage adjustment required if impaired renal function. Children and adolescents: Not recommended. Contra-indications: Hypersensitivity to active substance or excipients. Warnings and precautions: There have been reports of hypersensitivity reactions, including cases of angioedema. Pregabalin should be discontinued immediately if symptoms of angioedema, such as facial, perioral, or upper airway swelling occur. Patients with galactose intolerance, the Lapp lactase de� ciency or glucose-galactose malabsorption should not take Lyrica. Some diabetic patients who gain weight may require adjustment to hypoglycaemic medication. Occurrence of dizziness and somnolence could increase accidental injury (fall) in elderly patients. There have also been post marketing reports of loss of consciousness, confusion and mental impairment. Cases of renal failure have been reported and discontinuation of pregabalin did show reversibility of this adverse effect. In controlled studies, a higher proportion of patients treated with pregabalin reported blurred vision than did patients treated with placebo which resolved in a majority of cases with continued dosing. In the clinical studies where ophthalmologic testing was conducted, the incidence of visual acuity reduction and visual � eld changes was greater in pregabalin-treated patients than in placebo-treated patients; the incidence of fundoscopic changes was greater in placebo-treated patients. In the postmarketing experience, visual adverse reactions have also been reported, most of which refer to transient

vision loss, visual blurring or other changes of visual acuity. Discontinuation of pregabalin may result in resolution or improvement of these visual symptoms. Suicidal ideation and behaviour have been reported in patients treated with anti-epileptic agents.

A meta-analysis of randomised placebo controlled trials of anti-epileptic drugs has also shown a small increased risk of suicidal ideation and behaviour. The data does not exclude the possibility of an increased risk for pregabalin. Patients should be monitored for signs of suicidal ideation and behaviours and appropriate treatment should be considered. Patients (and caregivers of patients) should be advised to seek medical advice should signs of suicidal ideation or behaviour emerge. Insuf� cient data for withdrawal of concomitant antiepileptic medication, once seizure control with adjunctive Lyrica has been reached, in order to reach monotherapy with Lyrica. After discontinuation of short and long-term treatment withdrawal symptoms have been observed in some patients; insomnia, headache, nausea, diarrhoea, � u syndrome, nervousness, depression, pain, sweating and dizziness. The patient should be informed about this at the start of the treatment. Concerning discontinuation of long-term treatment there are no data of the incidence and severity of withdrawal symptoms in relation to duration of use and dosage of pregabalin. (see side effects). There have been post-marketing reports of congestive heart failure in some patients receiving pregabalin. These were mostly elderly, cardiovascular compromised patients who received treatment for a neuropathic indication. Pregabalin should be used with caution in these patients. Discontinuation of pregabalin may resolve the reaction. Ability to drive and use machines: May affect ability to drive or operate machinery. Interactions: Pregabalin appears to be additive in the impairment of cognitive and gross motor function caused by oxycodone and may potentiate the effects of ethanol and lorazepam. In the postmarketing experience, there are reports of respiratory failure and coma in patients taking pregabalin and other CNS depressant medications. Pregnancy and lactation: Lyrica should not be used during pregnancy unless bene� t outweighs risk. Effective contraception must be used in women of childbearing potential. Breast-feeding is not recommended during treatment with Lyrica. Side effects: Adverse reactions during clinical trials were usually mild to moderate. Most commonly (>1/10) reported side effects in placebo-controlled, double-blind studies were somnolence and dizziness. Commonly (>1/100, <1/10) reported side effects were appetite increased, euphoric mood, confusion, libido decreased, irritability, ataxia, disturbance in attention, coordination abnormal, memory impairment, tremor, dysarthria, paraesthesia, vision blurred, diplopia, vertigo, dry mouth, constipation, vomiting, � atulence, erectile dysfunction, fatigue, oedema peripheral, feeling drunk, oedema, gait abnormal and weight increased. See SmPC for less commonly reported side effects. After discontinuation of short and long-term treatment withdrawal symptoms have been observed in some patients; insomnia, headache, nausea, diarrhoea, � u syndrome, nervousness, depression, pain, sweating and dizziness. Concerning discontinuation of long-term treatment there are no data of the incidence and severity of withdrawal symptoms in relation to duration of use and dosage of

pregabalin. (see warnings and precautions) In the post-marketing experience, the most commonly reported adverse events observed when pregabalin was taken in overdose included somnolence, confusional state, agitation, and restlessness. Legal category: POM Date of revision: December 2008 Package quantities, marketing authorisation numbers and basic NHS price: Lyrica 25mg, EU/1/04/279/003, 56 caps: £64.40, EU/1/04/279/004, 84 caps: £96.60; Lyrica 50mg, EU/1/04/279/009, 84 caps: £96.60; Lyrica 75mg, EU/1/04/279/012, 56 caps: £64.40, Lyrica 100mg, EU/1/04/279/015, 84 caps: £96.60; Lyrica 150mg, EU/1/04/279/018, 56 caps: £64.40; Lyrica 200mg, EU/1/04/279/021, 84 caps: £96.60; Lyrica 300mg, EU/1/04/279/024, 56 caps: £64.40; Lyrica 225mg, EU/1/04/279/034, 56 caps: £64.40. Marketing Authorisation Holder: P� zer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK. Lyrica is a registered trade mark Further information is available on request from: Medical Information Department, P� zer Limited, Walton Oaks, Dorking Road, Walton-on-the-Hill, Surrey KT20 7NS

REFERENCES: 1. van Seventer R et al. Curr Med Res Opin. 2006;22:375–384. 2. Siddall PJ et al. Neurology 2006;67:1792–1800. 3. Portenoy R et al. Pregabalin for painful diabetic peripheral neuropathy and postherpetic neuralgia: onset and duration of analgesia in combined analyses of clinical studies. Poster presented at the 25th Annual Scientific meeting of the American Pain Society: San Antonio, Texas; 3–6 May 2006. 4. Freynhagen R et al. Pain 2005;115:254–263.

Adverse events should be reported. Reporting forms and information can be found at www.yellowcard.gov.uk.

Adverse events should also be reported to P� zer Medical Information on 01304 616161

LYR NEP Pain News 63523.indd 1 13/3/09 10:43:10