SPECIFIC TREATMENT OF PROBLEMS OF THE SPINE (STOPS) TRIALS

Dr Jon Ford (PhD, MPhysio, BAppSciPhysio) Dr Andrew Hahne (PhD, BPhysio) Luke Surkitt (BPhysio) Alex Chan (BPhysio) Matt Richards (BPhysio) Sarah Slater (BPhysio)

•  Patient reports –  “My backs out” –  “The doctor says it’s a muscle strain” –  “The doctor says I’ll get better but its now 6 weeks”

•  Clinical questions –  Does it matter which treatment I provide? –  How do I diagnose the problem? –  What treatment can I provide that is specific to the diagnosis? –  Is there evidence to support these clinical decisions?

Clinical scenario

Clinical practice guidelines •  Syntheses of CPGs (Dagenais et al 2010, Koes et

al 2010) •  High quality guidelines from last 10 years

(average 4 years old)

Recommendations •  Identify “flags”

What is “organic pathology” •  Typically regarded as disc herniation with

associated radiculopathy (DHR) –  Conservative trial followed by surgery if non-responsive –  MRI not indicated unless surgery being seriously

considered •  Potential counter-productive effect of attempting

to identify pathoanatomical cause of the pain (beyond serious pathology including DHR)

Specific treatment recommendations

•  Specific treatment for organic pathology other than DHR not provided

•  Treatment specific to the flag identified not clearly stated

•  Due to low level evidence on the efficacy of specific treatment –  eg Which treatment is most effective for

•  High fear avoidance beliefs? •  Disc herniation with associated radiculopathy?

Generic treatment recommendations

•  Advice/reassurance for acute LBP ± medication for short term relief

•  Chronic LBP –  Exercise –  Cognitive behavioural approach –  Multi-disciplinary intervention –  Acupuncture –  Opiates

•  Variable recommendations for manual therapy due to lack of consistent evidence

Lack of evidence •  Diagnostic injection •  Therapeutic blocks •  Pilates •  Massage therapy •  Specific treatment (eg SIJ, O’Sullivan, McKenzie,

motor control, etc)

And there’s more… •  Treatment effects are small (less than 0.5) when

compared to “minimal intervention” or “usual care” –  Borderline clinical meaningfulness

•  Non-significant treatment effects comparing one treatment to another

Classification issues (aka lumping and splitting)

•  False assumption of sample homogeneity

•  Application of generic treatment protocols

•  Dilution of the effect of specific treatment

Are these treatments appropriate for all “non-specific LBP” cases?

•  Motor control •  Manual therapy •  Pilates •  McKenzie •  Functional restoration/graded activity •  Cognitive-behavioural approach •  Neurophysiological education •  Treatment of signs and symptoms

Systema(c  reviews  

•  Based  on  the  premise  of  uniden(fied  subgroups  dilu(ng  the  treatment  effect  in  RCTs  to  date  our  group  conducted  a  number  of  systema(c  reviews  

•  Our  results  showed  that  there  are  some  individual  trials  that  show  larger  effects  when  Rx  is  applied  to  specific  subgroups  but  the  level  of  evidence  was  generally  low  or  moderate  at  best  

Classification based RCTs

Classification RCTs

The effectiveness of physiotherapy functional restoration for post-acute low back pain (Richards, Ford et al 2012) – in press

Recent advances in classification

•  Peter O’Sullivan –  Movement and control impairment subgroups –  Exercise, motor control, cognitive-behavioural Rx

•  STaRT Back –  Orebro based subgroups of low, mod and high risk –  Advise/functional restoration/cognitive behavioural Rx

•  Tom Petersen/Mark Laslett –  Pathoanatomical subgroups –  McKenzie treatment for discogenic pain

Identified issues •  Mixing populations •  Reinventing the wheel – what about manual

therapy? •  Complexity (O’Sullivan) •  Poorly described and non-reproducible treatment

protocols •  “Forcing” patients into one subgroup (O’Sullivan

and McKenzie)

The STOPS approach •  The right population - sub-acute, non-

compensable •  Well accepted/validated subgroups

–  Reducible discogenic pain –  Disc herniation with associated radiculopathy –  Z-joint dysfunction –  Non-reducible discogenic pain –  Multi-factorial persistent pain

•  A sophisticated but well described and reproducible assessment and classification system

Evidence-based and time honoured specific treatment

Subgroup   Specific  treatment  DHR  and  NRDP   Manage  inflamma(on,  motor  control,  pacing/posture,  pain  

con(ngent  graded  func(onal  restora(on,  educa(on  

RDP   Mechanical  loading  strategies,  pacing/posture,  tape  à  motor  control  

Z-­‐joint   Unilateral  manual  therapy  with  Maitland  style  clinical  reasoning  à  motor  control  

MFP   Time  con(ngent  graded  func(onal  restora(on,  cogni(ve-­‐behavioural  approach,  pain  educa(on  

Ford et al 2011a,b Ford et al 2012a,b

Design •  Specific physiotherapy treatment program for

each subgroup vs “evidence-based advice” •  300 participants randomly allocated •  Follow-ups at 5-weeks, 10-weeks, 6-months, 12-

months, 24-months

Inclusion/exclusion criteria •  Inclusion criteria

–  Aged 18-65 –  New episode of lumbar related pain between 6 weeks and 6

months

•  Exclusion criteria –  Compensable clients –  Post-surgery –  Epidural in the previous 6 weeks –  Cauda equina syndrome

Classification

Classification process •  Full assessment (60 minutes) •  Data entered into a purpose built excel

spreadsheet •  Classification subgroup automatically calculated

Z-joint subgroup •  Unilateral symptoms •  A regular compression pattern (Edwards 1992)

–  Extension in standing reproducing the participant’s clinical pain

–  Ipsilateral lateral flexion or quadrant in standing reproducing the participant’s clinical pain

•  Comparable palpatory findings •  A positive response to assessment of the

comparable palpatory finding

RDP •  Positive on at least 4 of 9 subjective features of discogenic

pain (Chan et al 2012) •  Positive response to repeated movement or sustained

positioning (MLS) defined as an: –  Increase in range of motion of the MLS during application by at

least 50% or –  Increase in AMT in any movement by at least 50% after

application or –  Increase in observed segmental intervertebral motion during

AMT after application or –  Improvement in resting pain and/or centralisation (>1min –  Reduction in an observed lateral shift postural abnormality

Treatment •  14 clinics across metropolitan Melbourne •  10 SMC treating physiotherapists •  10 sessions of specific Rx over 10 weeks •  2 sessions of advice over 10 weeks (Indahl et al 1995) •  Treatment integrity

–  240 page treatment manual –  2 day training –  Clinical notes submitted at 3 and 7 weeks –  Monthly telephone hook up

Participant info sheets •  Diagnosis    •  Program  (meframes  •  Treatment  op(ons  •  Motor  control  training  •  Direc(onal  preference  exercises  •  Func(onal  restora(on  exercises  •  Goal  seOng  •  Pacing  and  graded  ac(vity    

•  Dealing with an increase in pain

•  Inflammation •  Pain versus function •  Pain management

strategies (2) •  Posture •  Relaxation •  Sleep

Treatment protocols •  Algorithmic, sophisticated yet reproducible •  Detailed protocols published (Ford et al 2012a, b,

c, d) •  Adhering to the key principles of the original

developers (Maitland 1987, McKenzie 1981, Mayer et al 1985, Saal and Saal 1989)

Ford et al 2012

Ford et al 2012

Outcome measures •  Primary outcomes:

–  Activity limitation (Oswestry) –  Leg pain intensity (0-10 numerical rating scale) –  Back pain intensity (0-10 numerical rating scale)

•  Secondary outcomes –  Sciatica frequency and bothersomeness scales –  Global rating of change (7-point scale) –  Satisfaction with physiotherapy treatment (and results) –  Psychosocial status (Orebro) –  Quality of life (EuroQol-5D) –  Number of work days missed –  Interference with work

•  Other measures –  Co-interventions –  Medication

Analysis •  Between-group effects •  Continuous outcomes

–  Linear mixed model with baseline score as a covariate

•  Ordinal outcomes –  Mann Whitney U test

•  Dichotomous outcomes –  Relative risk, risk difference, and number needed to

treat

Results    

•  See  IFOMPT  presenta(on  •  12  month  results  will  be  published  mid  2013  •  Results  show  that  specific  physiotherapy  works!  

Contact  

E:    stopsbackpain@gmail.com  W:      www.facebook.com/STOPSbackpain  T:    @stopsbackpain  

Hahne A, Ford J. Functional restoration for a chronic lumbar disk extrusion with associated radiculopathy. Physical Therapy. 2006;86:1668-80.

Ford J, et al. Classification systems for low back pain: a review of the methodology for development and validation. Physical Therapy Reviews. 2007;12:33-42.

Heymans M, et al. Exploring the contribution of patient-reported and clinician based variables for the prediction of low back work status. Journal of Occupational Rehabilitation. 2007;17:383–97.

Wilde V, et al. Indicators of lumbar zygapophyseal joint pain: survey of an expert panel with the Delphi Technique. Physical Therapy. 2007;87:1348–61.

Ford J, et al. The test retest reliability and concurrent validity of the Subjective Complaints Questionnaire for low back pain. Manual Therapy. 2009;14 283-91.

Hahne A, et al. Outcomes and adverse events from physiotherapy functional restoration for lumbar disc herniation with associated radiculopathy. Disability and Rehabilitation. 2010;Early Online:1-11.

Hahne A, et al. Conservative management of lumbar disc herniation with associated radiculopathy: a systematic review. Spine. 2010;35:E488-E504.

Our papers

Ford J, et al. A classification and treatment protocol for low back disorders. Part 2: directional preference management for reducible discogenic pain. Physical Therapy Reviews. 2011;16:423-37. Ford J, et al. A classification and treatment protocol for low back disorders. Part 1: specific manual therapy. Physical Therapy Reviews. 2011;16:168-77. Hahne AJ, et al. Specific treatment of problems of the spine (STOPS): design of a randomised controlled trial comparing specific physiotherapy versus advice for people with subacute low back disorders. BMC Musculoskeletal Disorders. 2011;12:104. Ford J, Hahne A. Pathoanatomy and classification of low back disorders Manual Therapy. 2012;In press. Ford J, et al. A classification and treatment protocol for low back disorders. Part 3: functional restoration for intervertebral disc related disorders. Physical Therapy Reviews. 2012;17:55-75. Ford J, et al. A classification and treatment protocol for low back disorders. Part 4: functional restoration for low back disorders associated with multifactorial persistent pain. Physical Therapy Reviews. 2012;In press. Richards M, et al. The effectiveness of physiotherapy functional restoration for post-acute low back pain: a systematic review. In press. 2012. Slater SL, et al. The effectiveness of sub-group specific manual therapy for low back pain: A systematic review. Manual Therapy. 2012;17:201-12. Surkitt LD, et al. Efficacy of directional preference management for low back pain: a systematic review. Physical Therapy. 2012;92:652-65.

Other references Dagenais S, et al. Synthesis of recommendations for the assessment and management of low back pain from recent clinical practice guidelines. The Spine Journal. 2010;10:514-29. Koes BW, et al. An updated overview of clinical guidelines for the management of non-specific low back pain in primary care. Eur Spine J. 2010;19:2075-94. Petersen T, et al. The McKenzie method compared with manipulation when used adjunctive to information and advice in low back pain patients presenting with centralization or peripheralization. Spine. 2011.

Hill JC, et al. Comparison of stratified primary care management for low back pain with current best practice (STarT Back). Lancet. 2011.