Chronic low back pain, considerations aboutNatural Course, Diagnosis,Interventional Treatment and Costs

Coen Itz

Copyright Coen Itz 2016 ISBN 978 94 6159 625 3 Production / print Datawyse | Universitaire Pers Maastricht

UNIVERSITAIREPERS MAASTRICHT

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Chronic low back pain, considerations about:

Natural Course, Diagnosis, Interventional Treatment and Costs

Ter verkrijging van de graad van doctor aan de Iniversiteit Maastricht,

Op gezag van rector Magnificus: Prof. dr. Rianne M. Letschert Volgens het besluit van het College van Dekanen,

In het openbaar te verdedigen op woensdag 16 november 2016 om 12.00

door

Coenraad Johannes Itz

Promotores Prof. dr. Maarten van Kleef Prof. dr. Frank Huygen Co-promotor Dr. Bram Ramaekers Assessment Committee Prof. dr. Bert Joosten (chairman) Prof. dr. Emile Curfs Prof. dr. Manuela Joore Prof. dr. Roberto Perez Prof. dr. Rob Smeets

Het was een verre reis Zul je voorzichtig zijn? Ik weet wel dat je maar een boodschap doet hier om de hoek en dat je niet gekleed bent voor een lange reis. Je kus is licht, je blik gerust en vredig zijn je hand en voet. Maar achter deze hoek een werelddeel, achter dit ogenblik een zee van tijd. Zul je voorzichtig zijn? (vrij naar adriaan morrien)

7

CONTENTS

Chapter 1 Introduction 9

Chapter 2 Clinical course of Nonspecific Low Back Pain: A Systematic Review of Prospective Cohort Studies Set in Primary Care 17 (Itz, EJP accepted April 2013)

Chapter 3 Dutch multidisciplinary guideline for invasive treatment of pain syndromes of the lumbosacral spine 37 (Itz, Pain Practice accepted April 2015)

Chapter 4 Medical specialists care and hospital costs for low back pain in The Netherlands 73 (Itz, EJP accepted October 2016)

Chapter 5 A proposal for the organization of the referral of patients with chronic non-specific low back pain 91 (Itz, CMRO accepted July 2016)

Chapter 6 General Discussion 105

Summary 115 Nederlandse samenvatting 121

Valorisation Addendum 127

Dankbetuigingen 133 Curriculum Vitae 137

9

Chapter 1 Introduction

Introduction

11

Eighty percent of the population has at least one episode of Low Back Pain (LBP) during their life. (1) In some studies this figure even mounts to 90%, which means that the vast majority of adults have experienced at least one episode of LBP. Waddell described LBP as a twentieth century health care enigma; he referred to the size of the problem but also to the different factors influencing the experience and outcome of LBP. (2) In his book “The back pain revolution” Waddell states that humans have always had back pain, and that this low back pain is no more common or severe now than it was in earli-er times.(3) He made a plea for less medicalization of back pain and directing patients with acute and sub acute problems to the general practitioner (GP) for conservative management. The most recent NICE guidance (4) recommends advising patients to continue normal activities as much as possible.

BURDEN OF LOW BACK PAIN

Ehrlich (5) describes low back pain as “neither a disease nor a diagnostic entity of any sort. The term refers to pain of variable duration in an area of the anatomy afflicted so often that it is has become a paradigm of responses to external and internal stimuli “ In the NICE guidance the anatomic region is defined as “the back between the bottom of the rib cage and the buttock creases”.(4) Reviews of epidemiological studies on low back pain highlighted their heterogeneity in definition, age group, data collection, recall period etc. thus making the poolability very difficult. (6) LBP was reported to have a point prevalence ranging from 12% to 33%, 1-year prevalence between 22% and 65%, and lifetime prevalence ranging from 11% to 84%. (7)

Defining the prevalence of chronic low back pain (CLBP) is complicated by the hetero-geity of its definition, and national insurance and industrial sources of data include only those individuals in whom symptoms result in loss of days at work or other disability.(8)

The Global Burden of Disease study found LBP to be the number one cause of years lived with disability. (9)

THE COURSE OF LBP

The natural course of LBP is poorly documented. Spitzer et al (10) came in 1987 to the conclusion that about 8% of all patients would still have back pain one year after the first consultation. However, a more recent review of studies, conducted in patients, repre-sentative for the general patient population, showed that 62% of the patients still expe-rienced pain after 12 months. (11) Another systematic review found that in a cohort of patients with LBP at baseline, 75% and 73%, reported to not to be pain free at the 5- and 10- years of follow-up, respectively. (12) These observations contradict the common believe that the course of LBP is generally favorable. This favorable course is based on

CHAPTER 1

12

occupational studies in which ‘return to work’ or ‘recovery from disability’ is investigat-ed.(13) However, this presumed favorable course has recently been questioned. (14) A better understanding of the natural course of low back pain should facilitate defining the research question for epidemiological studies, and improve the therapeutic decisions.

CHRONIC LBP HAS NO UNIFORM LANGUAGE

Already in 1982 Nachemson et al. (15) that a commonly used classification of low-back disorders was required to improve epidemiology and treatment studies. Spitzer used the classification specific and non-specific low back pain. (16) While Bogduk differenti-ates between nociceptive, somatic referred or neuropathic pain, such as radicular pain and radiculopathy (17) Jenkins described a classifications of mechanical low back pain, low back pain with radiculopathy, serious pathological low back pain and low back pain with psychological overlay.(18) Schwarzer (19) subdivided the mechanical low back pain into: facet joint pain, discogenic pain and sacro-iliac joint pain pointing towards to po-tential causal structure.

To improve the communication between health care professionals and optimize treatment selection a globally accepted and used classification system is required.

DIAGNOSTIC AND TREATMENT OF LBP

When patients suffer “specific” LBP, meaning that an underlying pathology can be iden-tified, the treatment will address the cause and pain management is auxiliary. As al-ready indicated, “non-specific” LBP should be further can be subdivided in mechanical LBP and LBP with radiation into the leg, lumbosacral radicular pain. Efforts should be made to identify the structure responsible for mechanical low back pain.

Hancock et al. (20) systematically reviewed the literature to assess the accuracy of the tests to identify the facet joints, the intervertebral disc and the sacro-iliac joints as source of low back pain. They found that there are tests for disc and SIJ that have some diagnostic value. The tests for pain originating from the facet joint are less reliable (20)

When conservative treatment, consisting of pharmacological management and where appropriate exercise therapy, fails to provide satisfactory pain relief or medica-tion causes intolerable side effects, interventional treatment like anesthesiology treat-ment or surgery, may be considered. (21)

The possible anesthesiological treatments are: injection techniques, radiofrequency treatment and Spinal Cord Stimulation (SCS). Injection treatment relies on the principles of regional anesthesia, where local anesthetic with or without corticosteroid is injected in the vicinity of the nerve. Radiofrequency treatment aims at changing the pain con-duction through the nerve by applying a high frequency current. Spinal cord stimulation

Introduction

13

changes the pain conduction/perception through application of electrical stimulation at the spinal cord.

Spine surgical treatments aim at decompressing the causative structure. The treatment selection should be based on the best available evidence. (21) A

guideline reviewing the available evidence per diagnosis and assessing the value of the evidence in a systematic manner would help the clinician in the treatment selection

MEDICAL SPECIALIST CARE AND COSTS OF LBP

Treatment guidelines recommend a stepwise approach often involving a multidiscipli-nary team. The GP, also described, as the health care provider who is closest to the patient and his/her family, ideally should has a coordinating role. When conservative treatment fails, the GP can select from about 15 different specialists where to refer to patient, which is a difficult task. In absence of a referral algorithm it is not clear how patients with LBP should be referred to second line care and between specialties within the hospital. This information may help designing a LBP treatment pathway that opti-mizes the use of health care resources, improves treatment outcome and reduces costs. For this purpose, there is need for more information regarding the current organization and costs of LBP care. Moreover, based on these data, proposals for possible improve-ments of the organization of LBP care may be provided. Considering the issues raised above, the main objective of this thesis is: to examine the natural course, costs and organization of care for LBP patients and explore alternative disease classifications systems to enable tailored treatment. This objective is subdivided into 5 research questions:

1. What is the natural course of pain in patients with non-specific LBP of less than 3 months of duration, with a follow-up of at least 12 months, and set in primary care? Chapter 2

2. Can LBP be classified in such a way that it helps identifying the potential cause and thus directs referral and treatment? Chapter 3

3. What is the available evidence for the interventional management of the differ-ent sub-diagnoses of LBP, what is the value of this evidence and how can these findings be summarized? Chapter 3.

4. What is the medical specialist care in terms of the order of consultation of the dif-ferent medical specialisms upon referral of LBP patients to the hospital? What are the hospital costs for LBP patients in total and per specialism? Chapter 4

CHAPTER 1

14

5. What are the paradigms leading to the currently applied management scheme of LBP patients and can we identify weaknesses and failures in order to propose an alternative management plan? Chapter 5

Introduction

15

REFERENCES

1. Kent P, Kongsted A, Jensen TS, Albert HB, Schiottz-Christensen B, Manniche C. SpineData - a Danish clinical registry of people with chronic back pain. Clin Epidemiol. 2015;7:369-80.

2. Waddell G. Low back pain: a twentieth century health care enigma. Spine. 1996;21(24):2820-5. 3. Waddell G. The Back Pain Revolution. Waddell G, editor. New York: Churchill Livingstone; 1999. 438 p. 4. NICE. Low back pain and sciatica (draft for consultation): NICE; 2016 [updated exp pub date: Sept 2016. 5. Ehrlich GE. Low back pain. Bull World Health Organ. 2003;81(9):671-6. 6. Leboeuf-Yde C, Lauritsen JM. The prevalence of low back pain in the literature. A structured review of 26

Nordic studies from 1954 to 1993. Spine (Phila Pa 1976). 1995;20(19):2112-8. 7. Walker BF. The prevalence of low back pain: a systematic review of the literature from 1966 to 1998.

Journal of spinal disorders. 2000;13(3):205-17. 8. Andersson GB. Epidemiological features of chronic low-back pain. Lancet. 1999;354(9178):581-5. 9. Global Burden of Disease Study C. Global, regional, and national incidence, prevalence, and years lived

with disability for 301 acute and chronic diseases and injuries in 188 countries, 1990-2013: a systematic analysis for the Global Burden of Disease Study 2013. Lancet. 2015;386(9995):743-800.

10. Spitzer. Scientific approach to the assessment and management of activity-related spinal disorders. A monograph for clinicians. Report of the Quebec Task Force on Spinal Disorders. Spine. 1987;12(7 Suppl):S1-59.

11. Hestbaek L, Leboeuf-Yde C, Manniche C. Low back pain: what is the long-term course? A review of studies of general patient populations. Eur Spine J. 2003;12(2):149-65.

12. Kaaria S, Luukkonen R, Riihimaki H, Kirjonen J, Leino-Arjas P. Persistence of low back pain reporting among a cohort of employees in a metal corporation: a study with 5-, 10-, and 28-year follow-ups. Pain. 2006;120(1-2):131-7.

13. Croft PR, Macfarlane GJ, Papageorgiou AC, Thomas E, Silman AJ. Outcome of low back pain in general practice: a prospective study. BMJ. 1998;316(7141):1356-9.

14. Hestbaek L, Leboeuf-Yde C, Engberg M, Lauritzen T, Bruun NH, Manniche C. The course of low back pain in a general population. Results from a 5-year prospective study. J Manipulative Physiol Ther. 2003;26(4):213-9.

15. Nachemson AL, Andersson GB. Classification of low-back pain. Scand J Work Environ Health. 1982;8(2):134-6.

16. Spitzer W, Le Blanc F. Scientific approach to the assessment and management of activity-related spinal disorders. Report of the Quebec Task Force on Spinal disorders. Spine. 1987;Suppl:12-7.

17. Bogduk N. On the definitions and physiology of back pain, referred pain, and radicular pain. Pain. 2009;147(1-3):17-9.

18. Jenkins H. Classification of low back pain. Australas Chiropr Osteopathy. 2002;10(2):91-7. 19. Schwarzer AC, Aprill CN, Derby R, Fortin J, Kine G, Bogduk N. The relative contributions of the disc and

zygapophyseal joint in chronic low back pain. Spine. 1994;19(7):801-6. 20. Hancock MJ, Maher CG, Latimer J, Spindler MF, McAuley JH, Laslett M, et al. Systematic review of tests

to identify the disc, SIJ or facet joint as the source of low back pain. Eur Spine J. 2007;16(10):1539-50. 21. van Kleef M, Mekhail N, van Zundert J. Evidence-based guidelines for interventional pain medicine

according to clinical diagnoses. Pain Pract. 2009;9(4):247-51.

17

Chapter 2

Clinical course of Nonspecific Low Back Pain: A Systematic Review of Prospective Cohort

Studies Set in Primary Care

Coen J. Itz MD, Josee W. Geurts MSc, Maarten van Kleef MD PhD FIPP, Nelemans Patty MD PhD.

(Itz CJ, Geurts JW, van Kleef M, Nelemans P. Clinical course of non-specific low back pain: a systematic review of prospective cohort studies set in primary care. European journal of pain. 2013;17(1):5-15.)

Clinical course of Nonspecific Low Back Pain

19

ABSTRACT

Background and Objective Nonspecific low back pain is a relatively common and recurrent condition for which at present there is no effective cure. In current guidelines the prognosis of acute nonspe-cific back pain is assumed to be favourable but this assumption is mainly based on re-turn to function. This systematic review investigates the clinical course of pain in pa-tients with nonspecific acute low back pain who seek treatment in primary care.

Data bases and Data treatment Included were prospective studies, with follow-up of at least 12 months, that studied the prognosis of patients with low back pain for less than 3 months duration in primary care settings. Proportions of patients still reporting pain during follow-up were pooled using a random-effects model. Subgroup analyses were used to identify sources of vari-ation between the results of individual studies.

Results A total of 11 studies were eligible for evaluation. In the first 3 months recovery is ob-served in 33% of patients, but one year after onset 65% still report pain. Subgroup anal-ysis reveals that the pooled proportion of patients still reporting pain after one year was 71% at 12 months for studies which considered total absence of pain as a criterion for recovery versus 57% for studies which used a less stringent definition. The pooled pro-portion for Australian studies was 41% versus 69% for European or USA studies.

Conclusions The findings of this review indicate that the assumption that spontaneous recovery occurs in a large majority of patients is not justified. There should be more focus on intensive follow-up of patient who have not recovered within the first three months.

Chapter 2

20

INTRODUCTION

Nonspecific low back pain is a relatively common and recurrent condition with major medical and economical implications for which today there is no effective cure. (van Tulder et al., 1995; Roelofs et al., 2008; Becker et al., 2010; van Middelkoop et al., 2011) Most treatment strategies and guidelines are based on the assumption that the progno-sis of acute low back pain is favourable and that the pain resolves spontaneously in the majority of patients.(Spitzer, W.O. et al., 1987; Andersson, 1999; van Tulder, M. et al., 2006) However, the evidence for this statement is mainly based on occupational studies in which ‘return to work’ or ‘recovery from disability’ is studied.(Spitzer, W.O. et al., 1987; Croft et al., 1998; Andersson, 1999) These studies indicate that most back pain patients return to function, this in spite of their pain.(Bowey-Morris et al., 2011) There seems to be a lack of information on the course of acute non-specific low back pain when pain rather than return to work is considered as endpoint.

A previous systematic review which assessed the prognosis of acute low back pain found high rates of low back pain after one year follow-up (42 to 75%). (Hestbaek et al., 2003) However, this aforementioned review did not evaluate the clinical course by providing information on proportions of patients with early onset of low back pain and also included studies that were not performed in primary care settings.

The present review is designed to investigate the clinical course of pain in patients with nonspecific low back pain of less than 3 months duration, with a follow-up of at least 12 months, and set in primary care.

METHODS

Study selection

A literature search was performed for suitable articles published between 1990 and 2010 in English, German and Dutch, referenced on MEDLINE and PUBMED, and EM-BASE. Table 1. The search was started at 1990 because in 1987 Spitzer wrote his mono-graph: Scientific approach to the assessment and management of activity-related spinal disorders. A monograph for clinicians. Report of the Quebec Task Force on Spinal Disor-ders. (Spitzer, W.O. et al., 1987) This study had a major impact on the treatment of low back pain, and still has impact today. Therefore, we were basically interested in evi-dence provided by studies, which were published in the years following this publication.

Clinical course of Nonspecific Low Back Pain

21

Table 1. Search Strategy

Search PUBMED

Search Strategy:

Search ("Low Back Pain"[Majr] AND "Follow Up Studies"[Mesh] AND "Prognosis"[Mesh] (350)

NOT (trauma OR surgery OR children OR chronic) [Title/Abstract] (87)

Search MEDLINE

Search Strategy:

1 low back pain OR sciatica (including related terms) (10008)

2 prognosis OR onset OR inception cohort

OR follow up (including related terms) (4823)

3 1 and 2 (24)

Search EMBASE

Search Strategy:

Limit to human and years 1990-2010

Search terms used: back pain OR sciatica (title)

Follow up OR inception OR onset OR prognosis Or cohort (abstract)

Acute OR sub acute (abstract) (29)

The following key words were used: low back pain and sciatica, follow-up and prognosis, onset or inception cohort, acute or sub-acute. Two authors (CI and JG) independently screened the titles, abstracts, and keywords of all references identified by the literature search to determine if they addressed the research question. Full-text publications were retrieved for potentially relevant articles. The bibliographies of the retrieved articles were screened for additional relevant papers.

Studies were considered eligible for review if they allowed for evaluation of the clin-ical course of non-specific low back pain and met the following inclusion criteria: 1) The study was prospective in design ( prospective cohort study or controlled trial); 2) The study population consisted of adult patients with nonspecific low back pain; 3) Patients were included within 3 months after low back pain onset with follow-up data of at least one year; 4) One of the study outcomes was pain and the proportion of patients with or without pain could be extracted from the study or could be established after contacting the (corresponding) author; 5) The patients were recruited in primary care settings; 6) Data were available from patients who did not undergo an intervention or from patients who underwent an intervention which was reported not to affect the pain scores. Stud-ies were excluded if: 1) The study population included patients with trauma, surgery and/or injury; 2) The selection of patients was restricted to special work conditions or pregnant women. When multiple studies were identified with overlap in study popula-tions, only the original study was included to avoid potential duplication of datasets.

Chapter 2

22

Table 2. Three Methodological Tests containing 12 Individual Criteria for Prevalence Studies to determine the quality of the studies

1. Is the final sample representative of the target population?

A. At least one of the following must apply in the study: an entire target population, randomly selected sample, or sample stated to represent the target population.

B. At least one of the following: reasons for nonresponse described, nonresponders described, comparison of responders and nonresponders, or comparison of sample and target population.

C. Response rate and, if applicable, drop-out rate reported.

2. Quality of the data?

D. Primary data of low back ‘pain’. (it was not taken from a survey not specifically designed for that purpose)

E. Appropriate use of statistics for the design of the study, and/or analysis described and appropriate, and/or analysis provides sufficient presentation of data.

F. Same mode of data collection used for all subjects and, in longitudinal studies, at the first and second data collection.

G.

At least one of the following: questionnaire validated, tested for reproducibility, or tested (if low back pain information was collected by this method).

H. At least one of the following: Interview validated, tested for reproducibility, or adequately described and standardized(if low back pain information was collected by this method).

I. At least one of the following: Examination validated, tested for reproducibility, standardized or performed by the same person (if low back pain information was collected by this method).

3. Definition of low back pain (LBP)

J. Precise anatomic delineation of the lumbar area or reference to an easily obtainable article that contains such specification.

K. Further useful specification of the definition of LBP, or question(s) put to study subjects quoted such as the frequency, duration or intensity, and character of the pain, or reference to an easily obtainable article that contains such specification.

L. Recall periods clearly stated: e.g., 1 week, 1 month, or lifetime.

Modified Leboeuf criteria adding E: Appropriate use of statistics.(Leboeuf-Yde and Lauritsen, 1995)

DATA EXTRACTION

Two authors (CI and JG) independently extracted data from selected studies on propor-tion of pain and relevant population and study characteristics. The main study parame-ter is the proportion of patients with pain at 12 months. Other parameters of interest were proportions of patients with pain at 1, 3, and 6 months. In cases where absolute numbers of patients with pain at 12 months could not be derived from the publication and/or the definition of recovery from pain was unclear, the authors were contacted for additional information.

Study characteristics considered of interest were: sample size; country where the study was performed; year of publication; percentage of male participants; mean age;

Clinical course of Nonspecific Low Back Pain

23

definition and localisation of low back pain; mean time since onset; and definition of recovery from pain. Items concerning representativeness of the target population such as response and drop-out rates during follow-up were also recorded.

QUALITY ASSESSMENT

For assessment of the quality of the articles modified Leboeuf criteria were used.(Leboeuf-Yde and Lauritsen, 1995) Table 2. This method uses criteria related to the representativeness of the study sample, the quality of data and the definition of LBP. An additional item concerning analysis of data (item E) was added. The authors (CI and JG) independently scored these items. In cases of disagreement, discrepancies were discussed with a third author (PN) and consensus was achieved. Each study was as-signed a score, expressed as a proportion of fulfilled criteria out of the total number of relevant criteria. Information provided in the published report of the study was scored as present (+ criterion fulfilled), absent (- criterion not fulfilled) or not applicable’ (NA). Table 3. If the study design appeared to allow for the omission of a certain criterion, it was noted as methodologically acceptable( +). The main study parameter for this review was the proportion of patients with pain. Therefore, if data on pain were presented in a way that did not allow for calculation of proportions, the score ‘not applicable’ was used for item E, otherwise it was scored as present (+ criterion fulfilled). For each study, only one of the items G, H and I were scored depending on the method that was used to evaluate presence of pain (questionnaire, interview or examination).

We distinguished between studies with a quality score of > 70% versus studies with a score of ≤70 % to evaluate whether the quality of studies affects the proportion of patients with pain after one year. The cut-off point of 70% was arbitrarily chosen.

Chapter 2

24

Table 3. Assessment of quality according to the modified Leboeuf criteria

Study Representativeness Quality of the data Definition of low back pain

Total %

A B C D E F G H I J K L

(Bousema et al., 2007)

+ + + - + + - NA NA + - + 70

(Burton et al., 1999)

+ - + - + + + NA NA - - + 60

(Croft et al., 1998)

+ - - + + - NA + NA - + - 50

(Dettori et al., 1995)

- + + - + + - NA NA - - + 50

(Epping-Jordan et al., 1998)

- + + + + + + NA NA + + - 80

(Henschke et al., 2008)

+ + + + + + - NA NA + + + 90

(Klenerman et al., 1995)

+ - + - + - - NA NA - - + 40

(McGuirk et al., 2001)

+ + + + + - + NA NA - + + 80

(Schiottz-Christensen et al., 1999)

+ + + - + + - NA NA - - + 60

(Sieben et al., 2005)

+ + + + + + + NA NA + - - 80

(Werneke and Hart, 2001)

+ + + + + + + NA NA - - + 80

(Leboeuf-Yde and Lauritsen, 1995)

DATA ANALYSIS

The primary outcome of interest is the proportion of patients who still suffer from low back pain at one year after onset. Secondary outcome measures were the proportion of patients with low back pain 1, 3 and 6 months after onset.

Proportions of patients with pain at 12 months, and if available at 1, 3, 6 months, were derived from studies. For each time point, proportions were pooled using random-effects models as proposed by DerSimonian and Laird using the inverse of the standard errors of the proportion of individual studies as weights.(DerSimonian and Laird, 1986) The I2-index was used to test for heterogeneity between study results. Significance of this index indicates that differences between studies cannot be solely attributed to sampling variation and that differences in study population, design and analysis are responsible for variation between study results.(Higgins et al., 2003)

Clinical course of Nonspecific Low Back Pain

25

Subgroup analyses were used to evaluate whether presence or absence of a specific study characteristic is associated with higher or lower pooled proportions of patients with pain at 12 months. For this purpose, studies were categorized into subgroups ac-cording to the presence or absence of a specific study characteristic. The differences in pooled proportions between subgroups with corresponding 95% confidence intervals were calculated to evaluate the magnitude of effect of the study characteristic on study result and to test the effect for statistical significance.

All analyses and were performed with the statistical package STATA (Copyright 2009, StataCorp LP, Texas, USA). P-values ≤ 0.05 were considered to indicate statistical signifi-cance. Graphs were created with either STATA or R (version2.12.2: http:www.r-project.org/).

RESULTS

Study Selection

The search strategy identified 99 papers eligible for evaluation. After applying the in- and exclusion criteria 83 studies were excluded. Sixteen studies were provisionally in-cluded for this systematic review. Figure 1. Two studies in which the population was a subpopulation from an original study, which was already included for this review, were excluded for evaluation.(Wahlgren et al., 1997; Costa Lda et al., 2009) The authors of ten studies were contacted by mail and e-mail to get additional information on propor-tions of patients with pain at one year and, if available, other follow-up time-points and the exact definition used for being pain free.(Faas et al., 1993; Weber et al., 1993; Det-tori et al., 1995; Klenerman et al., 1995; Croft et al., 1998; Epping-Jordan et al., 1998; Burton et al., 1999; Werneke and Hart, 2001; Karjalainen et al., 2003; Grotle et al., 2007) This approach resulted in a total of eleven studies that were finally included for evaluation in this review. (Dettori et al., 1995; Klenerman et al., 1995; Croft et al., 1998; Epping-Jordan et al., 1998; Burton et al., 1999; Schiottz-Christensen et al., 1999; McGuirk et al., 2001; Werneke and Hart, 2001; Sieben et al., 2005; Bousema et al., 2007; Henschke et al., 2008)

Chapter 2

26

Figure 1 Flow chart of the study selection.

Characteristics of Included Studies

In table 4 the characteristics of the 11 included studies are shown. The number of par-ticipants in each study varied between 83 and 973. The percentage of male participants varied between 45% and 100%. The outcome parameter that was considered of primary interest varied largely between the evaluated studies and included pain but also physi-cal activity and function; disability; fear avoidance and sick leave. Two studies were performed in the USA, two studies in Australia and the remaining 7 studies were Euro-pean studies.

The anatomical definition of low back pain was mostly defined according to localisa-tion of the pain; in six studies no definition was stated. The definition of low back pain differs between studies, one study defined low back pain as pain in the thoracic and lumbar region, other studies formulated low back pain as localized ‘between the scapu-lae and the gluteal folds’, or ‘below thoracic vertebra 6 (T6)’, or ‘between T12 and the buttock crease’.

Different methods and pain scales were used for the evaluation of pain intensity namely: Visual Analogue Scale (VAS); Numeric Rating Scale(NRS); Graded chronic Pain Scale (GCPS); and Descriptor Differential Scale (DDS); and a few studies used a for the

Clinical course of Nonspecific Low Back Pain

27

study defined question.(Price et al., 1983; Gracely and Kwilosz, 1988; Von Korff et al., 1992; Childs et al., 2005)

Studies used different cut-off points for classifying patients as free from pain and different periods in which the patient had to be pain free (varying from 1 day to 6 months).

The mean time since onset of low back pain varied between 0 and 12 weeks. In many studies, the timing of the follow-up visits was at 1, 3, 6, and 12 months. Table 4. Methodological quality varied between 40% and 90%. Table 3.

Clinical course of low back pain

Figure 2 shows the course of acute low back pain during follow-up of one year accord-ing to the pooled proportions of patients with pain at 1, 3, 6 and 12 months. These pooled proportions at 1, 3, and 6 months after onset were 80% (95% CI: 61-100%); 67% (95% CI: 50-83%) and 57% (95% CI: 46%-68%) respectively. The pooled proportion of patients with pain one year after onset of low back pain was 65% (95% CI: 54%-75%).

The Forest plot (figure 3) shows the proportions of patients who still reported pain at one year after onset of low back pain with 95% confidence interval for the individual 11 studies. The I2 index was 96.5 % which indicates large heterogeneity of study results.

There are five studies which reported proportions with pain at both 3 and 12 months.(Croft et al., 1998; Burton et al., 1999; McGuirk et al., 2001; Sieben et al., 2005; Henschke et al., 2008) All five studies showed that after 3 months there was little addi-tional recovery, namely between three and twelve months the percentage of patients still reporting pain decreased by only 1% to 7%.

Figure 4 shows the results of subgroup analyses with respect to the effect of pre-specified study characteristics on study results. The pooled proportion of patients with pain at one year after onset was significantly lower in two Australian studies than the pooled proportion based on nine studies from Europe or the USA. The pooled propor-tion of patients with pain at one year after onset was significantly lower for studies which used a less stringent definition of recovery from pain, i.e. studies which also con-sidered patients who reported mild pain as being free from pain and studies which used a for the study developed question.(Dworkin et al., 2005; Dworkin et al., 2009)

Tabl

e 4:

Det

ails

of th

e Da

ta E

xtra

cted

from

the

Incl

uded

Stu

dies

M

ean

(SD)

if n

ot st

ated

oth

erw

ise.

M

ain

Stud

y Pa

ram

eter

Auth

or (y

ear)

co

untr

y an

d qu

ality

scor

e

Char

acte

ristic

s of t

he st

udy

& so

cial

dem

ogra

phic

s

Defin

ition

LBP

Curr

ent h

istor

y/ba

selin

e

Follo

w-u

p(FU

)

Pain

Pro

port

ion

base

line

N

desc

riptio

n of

sa

mpl

e m

ain

stud

y pa

ram

eter

ge

nder

%

mal

e

age

in y

ears

m

ean(

SD)

med

ian(

IR)

defin

ition

and

lo

caliz

atio

n

onse

t LBP

in w

eeks

[M

ean

days

] 'm

edia

n(IR

)' 1L

E-LB

P %

FU ti

me

poin

ts

(res

pons

e ra

te o

n pa

in sc

ale)

defin

ition

pai

n fr

ee a

t FU

tim

e-po

int

(pai

n sc

ale)

2-6

w

eeks

pa

in (%

)

12

wee

ks

pain

(%)

6-9

mon

ths

pain

(%)

12

mon

ths

pain

(%)

Bous

ema

(200

7)a

The

Net

herla

nds

70%

124

Patie

nts f

rom

PCP

s &

resp

onde

rs

adve

rtise

men

t

phys

ical

ac

tivity

55

47

(38-

52)

pain

loca

lized

bel

ow

scap

ulae

and

abo

ve

the

glut

eal f

olds

4-7

'3

7(32

-45)

' 20

.8

12 m

onth

s (72

%)

≥ 3w

kn L

BP c

ompl

aint

s fr

ee a

nd c

urre

nt p

ain

(VAS

)

62

/89

(70%

)

Burt

on (1

999)

b N

orth

Eas

t Uni

ted

King

dom

60

%

162

Patie

nts f

rom

PCP

s fe

ar

avoi

danc

e be

liefs

45

43 (1

1)

- 0-

12

- 2w

ks (7

7%);

12

wks

(72%

);

12 m

onth

s (78

%)

≥ 1w

k VA

S sc

ore

of

zero

(V

AS 0

-100

)

110/

126

(87%

) 93

/117

(7

9%)

98

/126

(7

8%)

Crof

t (19

98)c

Man

ches

ter a

rea

Uni

ted

King

dom

50

%

218

Patie

nts f

orm

PCP

s ou

t of a

pre

viou

s cr

oss s

ectio

nal

popu

latio

n su

rvey

disa

blin

g lo

w

back

pai

n -

- -

0-12

'2

1(14

-63)

' -

1 w

eek

(97%

);

3mon

ths (

86%

);

12m

onth

s (78

%)

0-1

VAS

(VAS

1-1

0) o

n da

y of

inte

rvie

w a

nd

free

of b

ack

rela

ted

disa

bilit

y in

the

prev

ious

wee

k (q

uest

ion)

207/

212

(98%

) 14

9/18

8 (7

9%)

12

8/17

0 (7

5%)

Dett

ori (

1995

)d Ge

rman

y 50

%

149

USA

Arm

y ac

tive

duty

per

sonn

el

livin

g in

Ger

man

y

func

tiona

l st

atus

81

28

-

0-1

[ 3

] 52

.7

6-12

mon

ths (

77%

) fr

ee o

f rec

urre

nt p

ain

at 6

to 1

2 m

onth

s af

ter o

nset

cur

rent

LB

P (6

-poi

nt sc

ale)

72

/115

(6

3%)

Eppi

ng (1

998)

e

Uni

ted

Stat

es o

f Am

eric

a 80

%

140

Mal

e pa

tient

s fro

m

the

Nav

al M

edic

al

Cent

er in

San

Die

go pa

in

inte

nsity

10

0 32

(7)

Pain

loca

lized

T6

or

belo

w

6-10

-

12 m

onth

s (56

%)

scor

e of

zero

(D

DS 0

-10)

63/7

8 (8

1%)

Hens

chke

(200

8)h

Aust

ralia

90

%

973

cons

ecut

ive

patie

nts f

rom

PCP

's in

Syd

ney

area

pain

in

tens

ity

55

43 (1

4)

pain

loca

lized

bel

ow

T12

and

abov

e th

e bu

ttoc

k cr

ease

0-2

25

6 w

eeks

(99%

);

3mon

ths (

99%

);

12m

onth

s (97

%)

pain

free

in p

ast w

eek

(SF3

6; it

em7)

57

3/95

5 (6

0%)

457/

956

(48%

)

388/

944

(41%

)

Klen

erm

an

(199

5)k

Uni

ted

King

dom

40

%

300

Patie

nts f

rom

PCP

s M

erse

ysid

e Re

gion

i.e

. met

ropo

litan

co

unty

fear

-av

oida

nce

beha

viou

r

50

- -

0-1

- 12

mon

ths (

41%

) fr

ee o

f con

stan

t or

inte

rmitt

ent p

ain

(pai

n dr

awin

g)

97

/123

(7

9%)

McG

uirk

(200

1)m

Au

stra

lia

80%

83

cont

rol p

atie

nts i

n a

com

para

tive

stud

y, p

atie

nts

from

4 G

Ps

pain

in

tens

ity

48

53 (4

2-67

) -

0-12

[1

4]

- 3m

onth

s (87

%);

6mon

ths(

72%

); 12

mon

ths (

55%

)

scor

e of

0-1

0 m

m o

n pa

in in

tens

ity

(VAS

0-1

00 m

m)

37

/72

(51%

) 22

/60

(37%

) 20

/46

(44%

)

Chapter 2

28

M

ean

(SD)

if n

ot st

ated

oth

erw

ise.

M

ain

Stud

y Pa

ram

eter

Auth

or (y

ear)

co

untr

y an

d qu

ality

scor

e

Char

acte

ristic

s of t

he st

udy

& so

cial

dem

ogra

phic

s

Defin

ition

LBP

Curr

ent h

istor

y/ba

selin

e

Follo

w-u

p(FU

)

Pain

Pro

port

ion

base

line

N

desc

riptio

n of

sa

mpl

e m

ain

stud

y pa

ram

eter

ge

nder

%

mal

e

age

in y

ears

m

ean(

SD)

med

ian(

IR)

defin

ition

and

lo

caliz

atio

n

onse

t LBP

in w

eeks

[M

ean

days

] 'm

edia

n(IR

)' 1L

E-LB

P %

FU ti

me

poin

ts

(res

pons

e ra

te o

n pa

in sc

ale)

defin

ition

pai

n fr

ee a

t FU

tim

e-po

int

(pai

n sc

ale)

2-6

w

eeks

pa

in (%

)

12

wee

ks

pain

(%)

6-9

mon

ths

pain

(%)

12

mon

ths

pain

(%)

Schi

ottz

(199

9)s

Denm

ark

60

%

524

patie

nts f

rom

130

GP

s in

Nor

th

Jutla

nd

sick

leav

e

62

38 (2

9-46

) -

0-2

[4

] 30

1

mon

th(9

6%);

6

mon

ths(

92%

);

12 m

onth

s(94

%)

com

bina

tion

of si

ck

leav

e an

d qu

estio

n ab

out f

eelin

g of

wel

l-be

ing

conc

erni

ng L

BP

(que

stio

n w

ith a

nsw

er

yes)

385/

503

(77%

)

291/

484

(61%

) 23

5/49

1 (4

8%)

Sieb

en (2

005)

t Th

e N

ethe

rland

s 80

%

222

Patie

nts f

rom

35

GPs

pain

/disa

bilit

y 56

51

% >

45

acut

e pa

in lo

caliz

ed

belo

w sc

apul

ae a

nd

abov

e th

e gl

utea

l fo

lds

0-3

25

3 m

onth

s(81

%);

6 m

onth

s(76

%);

12

mon

ths(

77%

)

No

back

pai

n pr

oble

m

Scor

e of

zero

(G

CPS

0-4)

13

1/17

5 (7

5%)

99/1

65

(60%

) 12

3/16

9 (7

2%)

Wer

neke

(200

1)w

U

nite

d St

ates

of

Amer

ica

80

%

223

Patie

nts r

efer

red

for c

onse

rvat

ive

trea

tmen

t to

phys

ioth

erap

ists i

n Vi

rgin

ia

max

imal

pai

n in

tens

ity

52

38 (1

0)

not c

ervi

cal

0-6

54.7

6

mon

ths (

84%

) 12

mon

ths(

80%

) sc

ore

of ze

ro d

urin

g pa

st w

eek

(NRS

0-1

0)

133/

191

(70%

) 10

7/17

7 (6

1%)

LBP,

low

bac

k pa

in; –

, not

spe

cifie

d; P

CP, p

rimar

y ca

re p

ract

ice;

GP,

gen

eral

pra

ctiti

oner

; FU

, fol

low

-up;

1LE

-LBP

, firs

t lif

etim

e; IR

, Int

erqu

artil

e Ra

nge;

DDS

, Des

crip

tor

Diffe

rent

ial S

cale

(Gra

cely

and

Kw

ilosz

, 198

8); G

CPS,

Gra

ded

Chro

nic

Pain

Sca

le (V

on K

orff

et a

l., 1

992)

; VAS

, Visu

al A

nalo

gue

Scal

e (P

rice

et a

l., 1

983)

; NRS

, Num

eric

Rat

ing

Scor

e (C

hild

s et

al.,

200

5); S

F36,

Qua

lity

of L

ife S

hort

For

m; S

D, s

tand

ard

devi

atio

n. a

(Bou

sem

a et

al.,

200

7); b

(Bur

ton

et a

l., 1

999)

; c (C

roft

et a

l., 1

998)

; d (D

etto

ri et

al.,

19

95);

e (E

ppin

g-Jo

rdan

et a

l., 1

998)

; h (H

ensc

hke

et a

l., 2

008)

; k (K

lene

rman

et a

l., 1

995)

; m (M

cGui

rk e

t al.,

200

1); s (S

chio

ttz-

Chris

tens

en e

t al.,

199

9); t (S

iebe

n et

al.,

200

5); w

(Wer

neke

and

Har

t, 20

01).

Clinical course of Nonspecific Low Back Pain

29

Chapter 2

30

DISCUSSION

The findings of this review indicate that the majority of patients (65%) still experience pain one year after onset of low back pain. In the first three months, recovery is ob-served in a substantial part of the patients, but thereafter only few patients recover.

The conclusion of this review is in line with a previous systematic review which ques-tioned the prognosis of acute low back pain and also found high rates of low back pain after one year varying between 42% and 75%.(Hestbaek et al., 2003) This review dif-fered from the present review by also including studies that were performed in second-ary and tertiary care settings and no restriction to recent onset of acute low back pain. Despite the differences both reviews arrive at similar results. This finding may indicate that in the present review efforts to restrict the study population to patients with early onset of back pain have not been successful. The definition of recent onset low back pain is, with a duration of less than 3 months, rather arbitrarily defined and relies heavi-ly on the memory of patients who may feel that their back pain is of recent origin whereas it could have started more than three months ago.

Figure 2 Course of low back pain. Dots show pooled proportions. Error bars show 95% confidence intervals. The figures at the bottom of the figure depict the number of studies that provided information for the specific time points.

The findings in this review are in sharp contrast with current recommendations and guidelines for the treatment of patients with nonspecific low back pain which are based on the assumption that in a large majority of patients spontaneous recovery occurs. The European guidelines for acute nonspecific low back pain cite that acute low back pain is usually self-limiting ( a recovery rate of 90% within 6 weeks) and only 2 to 7 % of people

Clinical course of Nonspecific Low Back Pain

31

develop chronic pain, although references to underpin this statement are not provid-ed.(van Tulder, M. et al., 2006) The assumption that spontaneous recovery is common resulted in management recommendations that put strong emphasis on reassurance of the patient that rapid recovery is to be expected, limitation of referral to secondary care, and continuation of daily activities.

It may be worth considering what may be the basis for this widespread belief that spontaneous recovery is common. One of the reasons may be that in many studies on back pain published during the last 20 years ‘return to work’ or ‘recovery from disability’ was considered evidence for recovery from low back pain.(Spitzer, 1987; Andersson, 1999) However, this supposition may be criticized as it is quite conceivable that patients may still suffer from pain. Another reason may be that individual studies show variation in results, although none of the reviewed studies reported a recovery rate of 80 to 90%.

Four larger studies which were included in this review reported that the proportion of patients who are still having pain one year after onset varied between 41 and 75%. Therefore, another aim of the present review was to explore reasons for the large varia-tion between studies in pain results. An important source of heterogeneity that was identified was the definition of pain recovery that was used. The subgroup of studies which considered total absence of pain as a criterion for recovery and used a validated pain questionnaire, for example the Visual Analogue Scale, showed a higher pooled proportion of patients with pain (71%) compared with the studies which used less strin-gent standards and/or were content with considering low pain scores as indicative of complete recovery (57%). The difference in the pooled proportions is 20% (Figure 4).

Another interesting finding may be that studies performed in Australia (McGuirk et al., 2001; Henschke et al., 2008) reported more favourable prognosis than the studies from Europe and the USA. The pooled proportion of patients with pain at 12 months was lower in Australian studies than in American/European studies, with a difference of 27% (Figure 4). One explanation for this finding could be that the American/European studies generally used a combination of outcome measures regarding low back pain. This is in accordance with the IMMPACT recommendations by Dworkin et al. who rec-ommended use of a combination of relevant validated outcome measures to evaluate treatment effectiveness.(Dworkin et al., 2005) In the Australian study by McGuirk only a VAS scale was used and patients who reported mild pain, with one single pain intensity score from 0 to 10 mm on a VAS scale from 0-100 mm, were considered as being free from pain. The other Australian study by Henschke et al. used only one modified ques-tion of the SF 36 questionnaire (Henschke et al., 2008) whereas the SF questionnaire was not developed for this purpose.

The results of this and other systematic reviews indicate that the current approach towards management of patients with nonspecific low back pain calls for reorientation. The paradigm that the prognosis of low back pain is mostly favourable can lead to con-servatism in pain management and could be contra productive for innovations in pain

Chapter 2

32

treatment. It may have paralyzed the need for knowledge about mechanism and causes of back pain and hampered development of further treatment options.

Figure 3 Forest plot of a random-effects meta-analysis on the proportion of patients with low back pain 1 year after onset. The size of the square box is proportional to the weight that each study contributes in the meta-analysis. The pooled estimate and 95% confidence interval (CI) are marked by a diamond.

There should be more focus on intensive follow-up and monitoring of patients who have not recovered from pain within three months. Pharmacologic treatment and min-imally invasive interventions must be considered.

Further research is needed to re-evaluate the concept of nonspecific low back pain. At present, low back pain with unknown cause is diagnosed as nonspecific. But it can not be excluded that within this heterogeneous group identification of patients with specific causes is possible. Classification into more specific subgroups could result in more homogeneous groups and help advance development of more pinpointed and specified pain treatment options.

This review has some limitations. First, results are based on published data with a large variation in study results. To account for this heterogeneity a random-effects model was used, but such a meta-analytic approach has limitations and therefore re-sults from pooling must be interpreted with caution. However, if we had refrained from pooling, the conclusion would still be that pain persists in a substantial proportion of

Clinical course of Nonspecific Low Back Pain

33

patients, as even studies with conservative estimates indicate that at least 40% of pa-tients are not free from pain after one year of follow-up.

Second, for the evaluation of the course of low back pain over time the pooled pro-portions at consecutive time points were derived from different sets of studies. There were only five studies which reported results at both 3 and 12 months.(Croft et al., 1998; Burton et al., 1999; McGuirk et al., 2001; Sieben et al., 2005; Henschke et al., 2008) The pooled proportions of patients with pain from these studies were 67% (50%-83%) and 62% (44%-81%) at 3 and 12 months respectively, and are consistent with the conclusion that one third of patients recovers within the first three months and that the majority still reports pain at 12 months.

Third, this review provides information on prevalence of pain at longer follow-up, but not on severity of pain. Information on the distribution of pain scores in patients with persisting pain were not provided in detail by the included studies, only one study pre-sented a mean VAS pain score of 26.5 mm in patients who still suffer pain at 12 months follow-up.(Bousema et al., 2007) It is recommended to address this issue in more detail in future studies on clinical course of patients with nonspecific acute low back pain.

Figure 4 Difference in pooled proportions with pain at 12 months between subgroups. Studies are categorized into subgroups according to presence versus absence of a specific study characteristic. Presented are differ-ences in pooled proportion with [95% confidence intervals (CIs)] between subgroups of studies. Positive difference indicates higher pooled proportion in studies in the first subgroup compared with the pooled proportion of the second subgroup. Negative difference indicates lower pooled proportion in the first sub-group compared with the pooled proportion of the second subgroup. LBP, low back pain.

Chapter 2

34

CONCLUSIONS

This systematic review shows that spontaneous recovery from nonspecific low back pain occurs in the first three months after onset of low back pain in about one third of patients, but the majority of patients (65%) still experience pain one year after onset of low back pain. These findings indicate that the assumption underlying current guide-lines that spontaneous recovery occurs in a large majority of patients is not justified. There should be more focus on intensive follow-up and monitoring of patients who have not recovered within the first three months. Future research should be directed at improvement of classification of nonspecific low back pain in more specific groups.

ACKNOWLEDGEMENT

The authors like to thank Sander van Kuijk from the Department of Epidemiology of the Maastricht University for his help.

AUTHOR CONTRIBUTIONS

Both Coen Itz and José Geurts independently screened the titles, abstracts, and key-words of all references identified by the literature search, extracted data from selected studies on population and study characteristics and assessed the quality of the articles. José Geurts corresponded with authors from studies considered for evaluation. Anal-yses were performed by José Geurts and Patty Nelemans. Patty Nelemans and Maarten van Kleef oversaw and contributed to the overall execution of the project. All authors discussed the results and commented on the manuscript. All authors helped to write the manuscript.

Clinical course of Nonspecific Low Back Pain

35

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37

Chapter 3

Dutch multidisciplinary guideline for invasive treatment of pain syndromes of the

lumbosacral spine

Coen J. Itz MD, Paul C. Willems MD, PhD, Dick J. Zeilstra MD, PhD, Frank J. Huygen, MD, PhD, FIPP. (Itz CJ, Willems PC, Zeilstra DJ, Huygen FJ. Dutch Multidisciplinary Guideline for Invasive Treatment of Pain Syndromes of the Lumbosacral Spine. Pain practice : the official journal of World Institute of Pain. 2015.)

Chapter 3

38

ABSTRACT

Objectives When conservative therapies such as pain medication or exercise therapy fail, invasive treatment may be indicated for patients with lumbosacral spinal pain. The Dutch Society of Anesthesiologists, in collaboration with the Dutch Orthopedic Associa-tion and the Dutch Neurosurgical Society, has taken the initiative to develop the guide-line ‘Spinal low back pain’, which describes the evidence regarding diagnostics and inva-sive treatment of the most common spinal low back pain syndromes, i.e., facet joint pain, sacroiliac joint pain, coccygodynia, pain originating from the intervertebral disc, and failed back surgery syndrome. Methods The aim of the guideline is to determine which invasive treatment intervention is preferred for each included pain syndrome when conservative treatment has failed. Diagnostic studies were evaluated using the EBRO criteria and studies on therapies were evaluated with the GRADE system. For evaluation of invasive treatment options, the guideline committee decided that the outcome measures of pain, function and quality of life were most important. Results The definition, epidemiology, pathophysiological mechanism, diagnostics and recommendations for invasive therapy for each of the spinal back pain syndromes are reported. Discussion The guideline committee concluded that categorization of low back pain into merely specific or nonspecific gives insufficient insight into the low back pain problem and does not adequately reflect which therapy is effective for the underlying disorder of a pain syndrome. Based on the guideline ‘Spinal low back pain’, facet joint pain, pain of the sacroiliac joint, and disc pain will be part of a planned nationwide cost-effectiveness study.

Multidisciplinary guideline invasive treatment pain syndromes of the lumbosacral spine

39

INTRODUCTION

Low back pain is a widespread problem with major social and economic impact. About 85-90% of the patients with low back pain suffer from what is (until now) described as ‘nonspecific’ low back pain; this is defined as low back pain not attributable to an identi-fiable, acknowledged specific pathology, such as an infection, tumor, osteoporosis or fracture (1).

Current guidelines on nonspecific low back pain generally assume that spontaneous recovery occurs in the majority of these patients. However, a systematic review (2012) has shown that spontaneous recovery from nonspecific low back pain during the first 3 months after onset occurs in only about one-third of the patients; the majority still experiences pain 1 year after onset (2). In practice, a proportion of these patients is generally referred to a pain clinic where some are diagnosed with e.g. facet joint pain, sacroiliac joint (SIJ) pain, coccygodynia, discogenic pain, and failed back surgery syn-drome (FBBS). If indicated, invasive treatment is applied.

There is no consensus among practitioners and policymakers about the place of this kind of diagnosis. In the current guidelines on nonspecific low back pain, such diagnoses are usually classified as ‘nonspecific low back pain’ and treatment is limited to reassur-ance, analgesics and activation/mobilization (3).

However, pain specialists claim that these diagnoses should not be classified as non-specific but rather as ‘specific’. It is suggested that better identification of these patients in an earlier phase and, if indicated, the use of invasive treatment would improve the prognosis of those patients. (4)

The Dutch Society of Anesthesiologists felt a strong need to bring clarity to this field. In collaboration with the Dutch Orthopedic Association and the Dutch Neurosurgical Society, they developed a multidisciplinary clinical guideline to deal with this topic. This guideline describes the evidence with regard to the diagnostics and effectiveness of the invasive treatment of five spinal low back pain syndromes, i.e. 1) facet joint pain, 2) SIJ pain, 3) coccygodynia, 4) discogenic pain and 5) FBSS. This guideline is available only in Dutch. The choice of topics and the interventions described in this guideline are based on those commonly used in daily clinical practice. The guideline aims to provide an-swers to clinically relevant problems. The main purpose of the guideline is to determine the evidence of invasive treatment when conservative treatment has failed. Because there is no consensus about the place of the five above-mentioned pain syndromes, the guideline pays special attention to the definition, epidemiology, underlying pathophysi-ology and validity of the diagnosis, as well as to the effectiveness of invasive treatment of these five spinal low back pain syndromes. (5).

The task force proposes to classify spinal low back pain syndromes into 1) ‘uncom-plicated and complicated’ degenerative pain syndromes, and 2) non-degenerative pain syndromes (Figure 1).

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40

Figure 1: Proposal for a new classification system for ‘Spinal low back pain’. The guideline discussed here focuses on the degenerative uncomplicated spinal low back pain syndromes (Figure 1).

The diagnosis and treatment of the degenerative complicated and non-degenerative spinal low back pain syndromes will be reviewed in separate guidelines, which are cur-rently being developed. The diagnosis and therapy of the lumbosacral radicular pain syndrome has been reviewed in a guideline developed earlier (6).

To our knowledge, this is the first guideline on spinal low back pain which makes use of the Grading of Recommendations Assessment, Development and Evaluation (GRADE) method. This is new method of assessment is gaining popularity in guideline develop-ment. An important difference compared with earlier assessment methods is that, in-stead of focusing on the study design, the GRADE method focuses on assessment of the strength of evidence for prior defined, relevant outcome measures. This brings the GRADE method more in line with actual clinical practice.

The aim of this article is to provide an English summary of the main findings of the Dutch guideline for invasive treatment of degenerative uncomplicated pain syndromes of the lumbosacral spine (http:/www.anesthesiologie.nl/richtlijnen: in Dutch).

Spinal low back pain

Degenerative Non-degenerative

Uncomplicated- Facet joint pain- Sacroiliac joint pain- Coccygodynia- Disc pain- Failed Back Surgery

Syndrome

Complicated- Degenerative

Lumbar scoliosis- Degenerative

Spondylolisthesis- Acquired

Canal stenosis

- Spondylolysis- Scoliosis - Tumors- Fractures- Non-degenerative

spondylolisthesis- osteoporoticvertebral

collapse- Spondylodiscitis- Sacroiliitis- Kyfosis / M.Scheuerman- Rheumatoid

arthritis/spondylitis

Multidisciplinary guideline invasive treatment pain syndromes of the lumbosacral spine

41

METHODS

Task force

A multidisciplinary task force was set up in 2009 to develop the guideline. The task force comprised representatives of specialties related to the diagnostics and clinical decision-making process of spinal low back pain syndromes amenable for invasive treatment, i.e. anesthesiology (pain medicine), orthopedics and neurosurgery. All members of the task force are acknowledged experts and key players in the clinical and scientific field of low back pain; no member of the task force had anything to disclose in relation to the development of this guideline. A focus group of 8 patients was also involved in the development of the guideline. Methodological support was provided by epidemiologists from the Quality of Healthcare center of the Dutch Association of Medical Specialists.

Primary clinical question

The primary clinical question in the guideline is: Which invasive treatment intervention is preferred if conservative treatment has failed?

Outcome measures

During the preparation phase, the relevant outcomes were inventoried and arranged according to the sequence of importance for the patient. For evaluation of the invasive treatment options, the task force decided that the outcome measures of ‘pain’, ‘func-tionality’ and ‘quality of life’ were the most important. For clinically relevant differences in pain and functionality, use was made of the values as proposed by Ostelo et al. (7) (Table 1). Table 1. Threshold values for clinically relevant differences in pain and functionality for patients with low back pain.

Questionnaire* (range) Absolute threshold Relative threshold with regard to baseline value

VAS (0-100) 15 30%

NRS (0-10) 2 30%

RDQ (0-24) 5 30%

ODI (0-100) 10 30%

QBPQ (0-100) 20 30%

VAS = Visual Analog Scale, NRS = Numerical Rating Scale, RDQ = Roland Morris Disability Questionnaire, ODI = Oswestry Disability Index, QBDQ = Quebec Back Pain Disability Questionnaire

Chapter 3

42

Systematic literature review

Specific English and Dutch search terms for each diagnosis included in this guideline were used to identify relevant studies (published between 1990 and June 2011) in Med-line (OVID) and in Embase (Embase.com). In addition, a manual research was made in the reference lists of the identified papers. Initially, the search strategy aimed to identi-fy (systematic reviews or meta-analyses of) double-blind randomized sham controlled trials (RCTs). If absent, an additional search was made for prospective controlled stud-ies, comparative studies, and prospective non-comparative studies. For the search strategies and evidence tables see the Guideline literature site of the Erasmus Medical Center (www.erasmusmc.nl/pijn/guidelineliterature).

Primary assessment of the identified literature was performed by at least two mem-bers of the task force whereas the results were discussed by the entire task force. For three pain syndromes (SIJ pain, coccygodenia and FBSS) no articles remained after ap-plying our inclusion and exclusion selection procedure (8) www.anesthesiologie.nl/ richtlijnen).

Selection criteria were: I) studies describing a patient population with complaints of low back pain persisting for more than 3 months for which conservative therapy (TENS, activation mobilization) was not effective; II) a relevant minimal follow-up of at least 3 months; III) a minimal study population of 15 patients (RCT 2 x 15 patients); IV) no prior surgery; V) patient selection based on a test treatment with at least 50% reduction in complaints; and VI) in RCTs the control group is sham or placebo.

Evaluation of therapeutic intervention studies

Intervention studies were evaluated using the GRADE method (http://www.gradework inggroup.org/).

A combination of the evaluated studies is used to determine the level of the burden of proof for each outcome measure. This evaluation determines the evidence level as represented in the classification shown in Table 2.

The GRADE method has four evidence levels: high, moderate, low and very low. The study design determines the starting level of the strength of evidence, i.e. systematic literature analyses of RCTs start high, and systematic literature analyses of observation-al studies start low. Five factors (limitations of study design, inconsistency, indirectness, imprecision, publication bias) can downgrade the strength of evidence by one or two levels; the guideline committee decided on the relative importance of each of these respective factors.

Multidisciplinary guideline invasive treatment pain syndromes of the lumbosacral spine

43

Table 2. The GRADE categorization of the quality of studies for each outcome measure.

Quality Study design Quality downgrade Quality upgrade

High (4) RCT 1. Study limitations -1 severe -2 very severe 2. Inconsistency -1 severe -2 very severe 3. Indirectness -1 severe -2 very severe 4. Imprecision -1 severe -2 very severe 5. Publication bias -1 probable -2 very probable

1. Large effect +1 large +2 very large 2. Dose-response relationship +1 evidence for relationship 3. Plausible confounding +1 would underestimate the effect +1 would overestimate the effect when

no effect was shown

Moderate (3)

Low (2) Observational comparative study (e.g. patient control study, cohort study)

Very low (1) Non-systematic clinical observation (e.g. case series or case reports)

NB: randomized controlled trials (RCTs) start ‘high’ (4), observational studies start ‘low’ (2). For RCTs: e.g. total 1-point downgrade: then from high (4) to moderate (3); for RCTs: e.g. 2-point downgrade: then from high (4) to low (2); for RCTs: in total ≥ 3-point downgrade: then from high (4) to very low (1). For observational studies: e.g. 1-point upgrade: then from low (2) to moderate (3).

In addition, three factors can upgrade the burden of proof of a systematic literature analysis of an observational study, i.e. large effect, dose-response relationship, and confounding that underestimates the actual effect or overestimates an actual non-existing effect.

For each investigated diagnosis (i.e. facet joint pain, SIJ pain, coccygodynia, dis-cogenic pain, and FBSS) the guideline gives a description of the definition, epidemiology, pathophysiology, validity of the diagnosis, and the evidence for invasive therapy when conservative treatment has failed. Based on the validity of the diagnosis and the evi-dence of the therapy, the task force describes considerations to be taken into account to answer the primary clinical question, and arrives at a recommendation for clinical practice (9). If there is no, and/or conflicting, or not enough evidence to give a clear recommendation, the task force recommends to perform the treatment in a study-related way. When no literature is available, or case reports are available but insuffi-cient to indicate the effectiveness or safety to give a clear recommendation for practice, the task force recommends that this treatment should be considered and preferably be administered in a study-related way. When there is not enough and/or conflicting evi-dence, and benefits are clearly balanced with risks and burdens, to give a clear recom-mendation for practice, the task force recommends this treatment should be used only study-related (Table 3).

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44

Table 3. Summary of evidence scores and implications for clinical practice

Score Description Implication

I Effectiveness demonstrated in various RCTs. The benefits clearly outweigh risk and burdens. One RCT or more RCTs with methodological weakness demonstrate effectiveness. The benefits clearly outweigh risk and burdens. One RCT or more RCTs with methodological weakness demonstrate effectiveness. The benefits are clearly balanced with risks and burdens.

Positive implication for practice

II Multiple RCTs with methodological weakness yield contradictory results better or worse than the control treatment. The benefits are clearly balanced with risk and burdens, or uncertainty in the estimates of benefits and risks and burdens. Effectiveness only demonstrated in observational studies. Given that there is no conclusive evidence of the effect, the benefits are closely balanced with risk and burdens.

Considered, preferably study-related

III No literature available, or case reports are insufficient to indicate the effectiveness and/or safety. These treatments should only be applied in relation to research.

Only study-related

IV Observational studies indicate no or too short-lived effectiveness. Given there is no positive clinical effect, the risks and burdens outweigh the benefits. One or more RCTs with methodological weakness, or large observational studies that do not indicate any superiority to the control treatment. Given there is no positive clinical effect, the risks and burdens outweigh the benefits. RCT of a good quality which does not exhibit any clinical effect. Given there is no positive clinical effect, the risks and burdens outweigh the benefits.

Negative implication for practice

RCT: randomized controlled trial (Van Boxem K, Cheng J, Patijn J, van Kleef M, Lataster A, Mekhail N, et al. 11. Lumbosacral radicular pain. Pain Pract. 2010;10(4):339-58.) ref. 161. This recommendation (i.e. study-related) implies that there is always: systematic regis-tration of the patient’s characteristics, diagnostic process, treatment (including details of the technique involved), evaluation of the results, and registration of any adverse effects and/or complications.

FACET JOINT PAIN

Definition Facet joint pain is defined as pain that originates from every structure that comprises the facet joints, including the fibrous capsule, synovial membrane, hyaline articular cartilage and bone (10). Epidemiology From the studies in which facet joint pain was carefully selected by means of controlled diagnostic blocks, the prevalence of facet joint pain in a group of patients with lumbar back pain referred to a pain specialist, was estimated at 10-30% (11-14).

Multidisciplinary guideline invasive treatment pain syndromes of the lumbosacral spine

45

Pathophysiology Degenerative processes in the spinal column are the main cause of facet joint pain (15, 16). Degenerative inflammation fills the facet joint with fluid caus-ing the joint to swell until it reaches the joint capsule, thereby causing pain. Degenera-tive disc disease and degenerative spondylolisthesis are predisposing factors (17). Diagnosis Unilateral or bilateral back pain is the most prevalent symptom (18). Pain originating from the upper lumbar facet joints radiates toward the flanks, hips and lat-eral upper legs. Pain from the lower lumbar facet joints radiates toward the posterior upper legs. Pain distal from the knee is rarely an indication for facet joint pathology (18). The pain can be triggered or aggravated by unilateral pressure on the facet joint or the transverse process. Extension, lateroflexion or rotation toward the ipsilateral side causes pain. There is unilateral muscular hypertonia in the area of the affected facet joint. There is a limitation of local unilateral movement or increased stiffness on the side of the facet pain. Flexion relieves the pain.

When causes such as fracture, tumor or infection etc. have been excluded and imag-ing technology is inconclusive, then arthritis, gout, arthrosis and a differential diagnosis of synovitis should also be considered in case of facet pathology (19). However, there are no signs or symptoms which are pathognomonic for the diagnosis. Using the Delphi technique, a test nerve block was seen as the most decisive step to confirm the diagno-sis (20). Diagnostic or prognostic nerve blocks can be performed by administering a small volume of local anesthetic at the medial branch of the dorsal ramus or intra-articular. The injections are performed under X-ray guidance (21-23). Cohen et al. re-ported on the value of the facet test blockade (24). The number needed to treat (NNT) without a test blockade is 3, with one test blockade 2.3 and with two test blockades the NNT is 1.28. Other studies report a NNT of 1.9 without a test blockade and 1.6 with one test blockade (12) and 1,1 with two test blockades (25).

Clearly, two test blockades result in a greater specificity and a lower NNT; however, from a pragmatic point of view, the task force advises to use one test blockade. Dreyfus et al. studied the most ideal position of the needle tip during a test blockade (26); they compared an end position of the needle at the upper edge of the processes articularis and the ligamentum mammiloaccesorius. This latter end position gives the lowest spread of local anesthetic to the segmental nerves if 0.5 ml local anesthetic is used; the task force advises use of this end position. Based on expert opinion the task force also advises to continuously evaluate the test blockade for 30 min. The use of MRI or CT is of no additional value in this process (15, 27-36) (Table 4).

Tabl

e 4.

Evi

denc

e sc

ore

for G

radi

ng q

ualit

y of

inte

rven

tion

stud

ies f

or th

e di

agno

ses F

acet

Pai

n an

d Di

scog

enic

Pai

n.

Diag

nosis

Int

erve

ntio

ns

Out

com

e M

easu

re

Num

ber o

f St

udie

s De

sign

Lim

itatio

ns

Inco

nsist

ent

Indi

rect

Im

prec

ise

n =

Inte

rven

tion

n =

Cont

rol

grou

p Fi

nal Q

ualit

y

Face

t Pai

n Co

rtic

oste

roid

In

ject

ions

pa

in

3 RC

T no

serio

us

side

effe

cts

not s

erio

us

inco

nsist

ent

not s

erio

us

indi

rect

se

rious

im

prec

ise

172/

334

162/

334

low

func

tion

3 RC

T no

serio

us

side

effe

cts

not s

erio

us

inco

nsist

ent

not s

erio

us

indi

rect

se

rious

im

prec

ise

131/

261

130/

261

mod

erat

e

Ra

dio

Freq

. Les

ions

pain

4

RCT

no se

rious

sid

e ef

fect

s no

t ser

ious

in

cons

isten

t no

t ser

ious

in

dire

ct

serio

us

impr

ecise

73

/141

68

/141

m

oder

ate

func

tion

3 RC

T no

serio

us

side

effe

cts

not s

erio

us

inco

nsist

ent

serio

us

indi

rect

se

rious

im

prec

ise

55/9

1 56

/91

low

Pu

lsed

Radi

o Fr

eq.

Lesio

ns

pain

2

RCT

no se

rious

sid

e ef

fect

s no

t ser

ious

in

cons

isten

t no

t ser

ious

in

dire

ct

serio

us

impr

ecise

33

/66

33/6

6 m

oder

ate

func

tion

2 RC

T no

serio

us

side

effe

cts

not s

erio

us

inco

nsist

ent

not s

erio

us

indi

rect

se

rious

im

prec

ise

13/2

6 13

/26

mod

erat

e

Disc

ogen

ic

Pain

Co

rtic

oste

roid

and

M

eth.

Blu

e In

ject

ions

pain

3

RCT

no se

rious

sid

e ef

fect

s se

rious

in

cons

isten

t no

t ser

ious

in

dire

ct

serio

us

impr

ecise

96

/194

98

/194

lo

w

func

tion

2 RC

T no

serio

us

side

effe

cts

serio

us

inco

nsist

ent

not s

erio

us

indi

rect

se

rious

im

prec

ise

82/1

69

87/1

69

low

ID

ET

pain

2

RCT/

com

para

tive

stud

y no

serio

us

side

effe

cts

serio

us

inco

nsist

ent

not s

erio

us

indi

rect

se

rious

im

prec

ise

88/2

07

119/

207

very

low

func

tion

2 RC

T/co

mpa

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e st

udy

no se

rious

sid

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fect

s se

rious

in

cons

isten

t no

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ious

in

dire

ct

serio

us

impr

ecise

81

/145

64

/145

ve

ry lo

w

qual

ity o

f life

2

RCT

no se

rious

sid

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fect

s se

rious

in

cons

isten

t no

t ser

ious

in

dire

ct

serio

us

impr

ecise

70

/113

43

/113

ve

ry lo

w

The

corr

espo

ndin

g re

fere

ncie

s are

: Fa

cet i

njec

tions

: Car

ette

S,e

t al,

N E

ngl J

Med

. 199

1; 3

25, (

14):

1002

-7 (4

2). M

anch

ikan

ti L.

et a

l, Pa

in P

hysic

ian

2001

; 4 (1

):101

-117

(41)

. Man

chik

anti

L et

al,

Pain

Phy

sicia

n 20

08; 1

1:12

1-13

2 (4

0). R

adio

Fre

quen

cy a

nd F

acet

pai

n: G

alla

gher

J et

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Pain

Clin

ic. 1

994;

7, (

1): 1

93-8

(37)

. Nat

h S

et a

l, Sp

ine.

200

8; 3

3, (1

2): 1

291-

7; d

iscus

sion

8 (3

8).

Van

Klee

f M, e

t al,

Spin

e. 1

999;

24,

193

7-42

(12)

. Tek

in I

et a

l, Cl

in J

Pain

. 200

7; 2

3, (6

): 52

4-9

(39)

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sed

RF a

nd F

acet

pai

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ekin

I et

al,

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(6):

524-

9

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(39)

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naes

th 2

008

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;20(

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34-7

(43)

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ogen

ic p

ain

and

inje

ctio

ns: K

hot A

, et a

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ine

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h W

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stu

dy a

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ose

char

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ign

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Invasive treatment: implications for practice

Of the several invasive pain treatments available for facet joint pain, we investigated: 1) radiofrequency (RF) lesion, 2) intra-articular corticosteroid injection, 3) pulsed radiofre-quency lesion, and 4) surgery.

In the search for the effectiveness of invasive treatment in facet joint pain we identi-fied 34 papers. After the selection procedure 9 papers fulfilled the inclusion criteria and were used to formulate the scientific conclusion. Details on the search strategy used are described in the Guideline literature site of the Erasmus Medical Center (www.erasmusmc.nl/pijn/guidelineliterature).

Radiofrequency lesion

After the selection procedure 4 RCTs fulfilled the selection criteria (12, 37-39) to formu-late a scientific conclusion:

- It is plausible that RF treatment of the ramus dorsalis in patients with facet joint pain has a favorable effect on pain for 3-12 months (12, 37-39).

- There is evidence that RF lesion of the ramus dorsalis in patients with facet pain has a beneficial effect on functionality for 3-6 months. (12, 39).

The results of these 4 studies cannot be pooled due to differences in the methods of reporting. All show a significant reduction in pain in the treatment group compared with the sham group. The methodological quality of the RCTs showed the following limita-tions: in all 4 studies the power is low, the evidence for functionality is low, and none of the studies validated the outcome ‘quality of life’.

Based on these considerations the task force developed the following positive impli-cation for practice (because effectiveness is demonstrated in various RCTs and the bene-fits clearly outweigh the risks and burdens):

• In facet joint pain, if conservative therapy has failed, radiofrequency lesion of the innervating medial branches of the rami dorsalis of the affected segmental nerves can be performed (12, 37-39).

Intra-articular corticosteroid injection

After the selection procedure, 3 (40-42) studies fulfilled the inclusion criteria to formu-late a scientific conclusion:

- It is concluded that there is conflicting evidence regarding the efficacy of intra-articular injections with corticosteroids on pain and there is no beneficial effect on functionality (40, 42).

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- The evidence that intra-articular injections are beneficial for the outcome pa-rameter pain is low.

The RCTs of Manchikanti et al. (40, 41) show no significant difference between the in-tervention and control group. Carette et al. (42) reported a significant difference in pain between the group receiving an intra-articular injection of prednisolone and a group receiving physiologic salt. However, the power of the studies is low and the evidence for the outcome parameter ‘functionality’ is moderate. Only Manchikanti et al. studied functionality (40) and found no significant difference between the studied groups. In severe facet arthrosis it is generally not possible to place a needle intra-articularly.

Based on the scientific conclusion and these additional considerations, the task force developed the following negative implication for practice (because there is no positive clinical effect or risk and the burdens outweigh the benefits).

• Patients with facet pain who have insufficient result from conservative therapy should not be treated with intra-articular corticosteroid injections.

Pulsed radiofrequency lesion

After the selection procedure, 1 paper fulfilled the inclusion criteria to formulate a sci-entific conclusion. There is an increasing use of pulsed radiofrequency lesion

(PRF) in the treatment of the dorsal root ganglia (cervical) and several peripheral nerves. Two RCTs compared RF lesion with PRF lesion (39, 43). One RCT (43) is only included in the ‘other considerations without a scientific conclusion’ to enable the task force to formulate the implications for clinical practice, the other RCT (39) is included with a ‘scientific conclusion’ and in the ‘other considerations’ in order to formulate the implications for clinical practice. Both RCTs show that patients with facet joint pain derive more benefit from RF lesion of the ramus dorsalis than from PRF lesion (39, 43).

Based on the scientific conclusion and these other considerations the task force de-veloped the following negative implication for practice (because there is no positive clinical effect, or risks and burdens outweigh the benefits)

• PRF has no place in the treatment of lumbar facet pain.

Surgery

After the selection procedure, no papers fulfilled the inclusion criteria to formulate a scientific conclusion. Also, in the remaining considerations the task force found no addi-tional evidence for surgical interventions in facet joint pain (44). Based on the lack of a scientific conclusion and these other considerations, the task force developed the following negative implication for practice (because there is no positive clinical effect, or risks and burdens outweigh the benefits).

• Surgical interventions are not indicated in the treatment of facet joint pain.

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PAIN IN THE SACROILIAC JOINT

Definition Pain in the sacroiliac joint (SIJ) is defined as a pain localized in the area of the SIJ that can be provoked/elicited by stress tests and by provocation tests of the SIJ, and that is completely relieved after infiltration of the SIJ with a local anesthetic (45). The SIJ is a diathrodial synovial joint and is primarily innervated by the sacral dorsal rami S1-3 (46, 47). Epidemiology Together with the facet joint, the SIJ is one of the most important sources of mechanical low back pain. The prevalence of SIJ pain is reported to range from 16-30% (48-50). In about 35% of the cases there is no known cause for the pain. Pathophysiology There are intra-articular and extra-articular causes of SIJ pain. When the etiology is intra-articular there may be an infection, inflammation or malignancy. When the cause is extra-articular, the pain is probably related to anatomical structures: enthesopathy, fractures, ligament injury or myogenic injury. The risk factors for this are: trauma [abrupt rotation and axial strain, status after lumbosacral arthrodesis (≥ 30%)], postural defect (51) due to e.g. a discrepancy in leg length (52), scoliosis (53), pregnancy (54), strenuous work (55), and inflammation due to rheumatologic diseases. Diagnosis Diagnostics comprise the usual procedures: medical history, physical examina-tion and a diagnostic nerve block. Apart from ruling out red flags (tumor, inflammation, infection, fracture, anatomic anomalies), diagnostic examinations and imaging (such as MRI) have little added value for SIJ pain (56). There is no correlation between findings on radiographs, CT and bone scan with a positive outcome of a block (57). MRI has no added value in imaging normal anatomy, but can reveal early spondyloar-thropathies and cartilage inflammation of the SIJ (58, 59). Most patients report SIJ pain to be localized in the area of the buttock (94%). The pain can refer to the lower lumbar region/spine (72%), groin (14%), higher lumbar region (6%) and abdomen (2%). Referred pain towards the leg appears in 28% of the patients, of which 12% state they have pain radiating to the foot (60). Standing up from a sitting position can provoke the pain (61). On physical examination a positive Fortin finger test is found, if the patient indicates with one finger that the pain is right in the middle and inferior to the posterior superior iliac crest. There are six provocation tests with, indi-vidually, low sensitivity and specificity, i.e. the approximation test, Gapping test, FABER test, Pelvic torsion test, Femoral Shear test and the Gillet’s test (62). With several posi-tive stress tests (at least 3 of 5/6 provocation tests), the specificity and sensitivity is reported to be 80% and 85-94%, respectively (61, 63-66).

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Young et al. found a positive correlation between SIJ pain and the worsening of symp-toms when getting up from sitting position, unilateral pain and three positive provoca-tion tests (61). As one of its diagnostic criteria, the International Association for the Study of Pain states that SIJ pain has to disappear on intra-articular infiltration with local anesthesia. For this purpose the use of single or double blockades, with a long or short-acting local anesthetic has been described (46, 48, 50, 60, 63-65, 67-70).

After the selection procedure, no papers fulfilled the inclusion criteria to formulate a scientific conclusion about the diagnostic value of a test block for SIJ. In the remaining considerations, a study was identified which describes a diagnostic nerve block under fluoroscopy to make the diagnosis more specific when there is a clinical suspicion of SIJ pain (56). Based on these considerations the task force developed the following positive implication for practice (because effectiveness is demonstrated in one or more RCTs and the benefits clearly outweigh risk and burdens).

• When there is a clinical suspicion of SIJ pain it can be useful to perform a diag-nostic nerve block under fluoroscopy to enable a more specific diagnosis.

Invasive treatment: implications for practice

Of the several invasive pain treatments available for SIJ pain we investigated: 1) intra-articular corticosteroid injection, 2) (cooled) radiofrequency lesion, and 3) surgery.

In the search for the effectiveness of invasive treatment in SIJ pain, 21 papers were identified. After the selection procedure, no papers fulfilled the inclusion criteria to formulate a scientific conclusion. More details on the search strategy used are de-scribed in the Guideline literature site of the Erasmus Medical Center. (www.erasmusmc.nl/pijn/guidelineliterature). The task force developed its implications for practice based on he remaining considerations only.

Intra-articular corticosteroid injection.

After the selection procedure, no papers fulfilled the inclusion criteria to formulate a scientific conclusion. In the remaining considerations, 2 RCTs were identified. Both trials showed significant pain reduction after intra-articular corticosteroid injections and both showed a low risk-benefit ratio. Based on the lack of a scientific conclusion and these other considerations, the task force developed the following implication for practice:

• Intra-articular corticosteroid injection can be applied for patients with SIJ pain who have insufficient or no effect from conservative therapy.

However, because larger studies are required to arrive at a more definite scientific con-clusion, the implication for practice is to carry out this procedure only study-related (because no literature is available, or case reports are insufficient to indicate effective-ness or safety to give a clear recommendation for practice) (71, 72).

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(Cooled) radiofrequency lesion

After the selection procedure, no papers fulfilled the inclusion criteria to formulate a scientific conclusion. In the remaining considerations, one RCT on radiofrequency treatment of SIJ pain was identified but failed to meet the inclusion criteria because the study group was too small (73). In this latter trial, significant pain reduction was shown after RF lesion.

Based on the lack of a scientific conclusion and these other considerations, the task force developed the following implication for practice:

• If an intra-articular corticosteroid injection provides insufficient effect, treatment using cooled RF lesion or RF lesion can be considered.

However, because larger and longer-term studies are required to arrive at a more defi-nite scientific conclusion, the implication for practice is to carry out those procedures only study-related (because no literature is available, or case reports are insufficient to indicate effectiveness or safety to give a clear recommendation for practice) (71-76).

Surgery

After the selection procedure, no papers fulfilled the inclusion criteria to formulate a scientific conclusion. In the remaining considerations, small studies were identified which describe succesful minimal invasive treatment for pain and function after treat-ment of a carefully selected group of patients for whom surgery was a last resort treat-ment (77). In contrast, several studies were found with disappointing results (78-81).

Based on the lack of a scientific conclusion and these other considerations, the task force developed the following negative implication for practice (because there is no positive clinical effect, or risks and burdens outweigh the benefits).

• Most surgical treatments are generally not advised for patients with SIJ pain. Surgical treatment (if applicable) should be performed only after a comprehensive non-invasive and minimally invasive treatment and careful consideration. Preference should be given to minimally invasive surgical techniques.

COCCYGODYNIA

Definition Coccygodynia is pain in the area of the os coccygis. Epidemiology The female to male ratio is 5:1 (82). An increased body mass index of > 27.4 in women and > 29.4 in men is a risk factor for coccygodynia (83).

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Pathophysiology The acute form of coccygodynia mainly appears after a trauma caused by a fall in the sitting position (83, 84); however, childbirth can also cause such a trauma (30). Similarly, repetitive micro traumata caused by maintaining an unaligned sitting position or through sports (e.g. bicycling or motorcycle sports) can also cause coccygo-dynia (85, 86). The coccygeal joints are involved in 70% of the traumatic cases. There is anterior luxation, hypermobility, coccygeal spicules, subluxation or luxation (84, 85). The sacrum and os coccygis lie more posterior in women. Also, the os coccygis is longer in women than in men, placing women at increased risk of developing coccygodynia (83, 87-89). Diagnosis Patients usually report pain in the location of the coccyx, generally provoked by sitting. Activities such as bicycling are painful because of the direct pressure placed on the coccyx (89). During physical examination, mobilization of the os coccygis can differentiate between nociceptive pain of the os coccygis with ligamentary and muscu-lar structures, and referred pain by pathology in the lower pelvic area (89). In coccygo-dynia the Valsalva maneuver is positive in diseases based on neural structures and neg-ative with primary involvement of the os coccygis itself (89). For diagnostic imaging plain lateral radiographs of the os coccygis are the first choice (50, 83, 84). In relation to obesity, determination of the BMI is mandatory (83). A test nerve block is not indicated. Differential diagnostics are: the levator ani syndrome, osteomyelitis, arthritis, intra ossal lipomata or chondromata, and vascular necrosis of the os coccygis (90, 91).

Invasive treatment: implications for practice.

In coccygodynia the following recommendations are made with regard to invasive ther-apy when conservative therapy has failed: 1) corticosteroid injection, 2) RF lesion of the ganglion Impar, 3) surgery. In the search for the effectiveness of invasive treatment in coccygodynia pain we identi-fied 18 papers. After the selection procedure, 2 papers fulfilled the inclusion criteria to formulate a scientific conclusion. More details on the search strategy used are de-scribed in the Guideline literature site of the Erasmus Medical Center. (www.erasmusmc.nl/pijn/guidelineliterature). The task force developedtheir recom-mendation mainly upon the remaining considerations:

Corticosteroid injection

After the selection procedure, only 1 of 7 papers fulfilled the inclusion criteria to formu-late a scientific conclusion (92). This paper shows that the risks of infiltration are low, the procedure is a little stressful, and the effect on pain is relatively positive.

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Based on the scientific conclusion and the other considerations, the task force de-veloped the following implication for practice:

• In patients with coccygodynia for whom conservative therapy has provided insuf-ficient results, a corticosteroid injection can be a treatment option.

This treatment should preferably be carried out study-related (because there is not enough and/or conflicting evidence and benefits clearly balanced with risk and burdens to give a clear recommendation for practice) (92).

Radiofrequency lesion of the ganglion Impar

After the selection procedure, no papers fulfilled the inclusion criteria to formulate a scientific conclusion. In the remaining considerations one prospective study was includ-ed. Reig et al. shows that a RF lesion of the ganglion Impar (93) has a positive effect on pain. However this trial is underpowered with too few patients and shows a relative risk of serious side effects. Based on the lack of a scientific conclusion and these other con-siderations the taskforce developed the following negative implication for practice (be-cause there is no positive clinical effect, or risks and burdens outweigh the benefits):

Patients with coccygodynia who do not have sufficient effect of conservative thera-py should not be treated with a RF lesion of the ganglion Impar. Surgery

After the selection procedure, no papers fulfilled the inclusion criteria to formulate a scientific conclusion. In the remaining considerations, 4 non-randomized studies showed a moderate positive effect of surgical interventions on coccygodynia in patients with a clear anatomical anomaly (94-97).

Based on the lack of a scientific conclusion and these other considerations the task force developed the following implication for practice:

• When there is an evident anatomical anomaly of the os coccygis, surgical inter-vention can be a treatment option for patients with coccygodynia for whom con-servative therapy and corticosteroid injection have provided insufficient results or have had no effect.

This treatment should only be carried out study-related (because no literature is availa-ble, or case reports are insufficient to indicate effectiveness or safety to give a clear recommendation for practice) (98).

DISCOGENIC PAIN

Definition Discogenic low back pain is defined as pain that originates from any structure that comprises the discus intervertebral disc, i.e. the nucleus pulposus, the annulus fibrosus, the vertebral end plate and the accompanying innervation.

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Epidemiology The prevalence of chronic discogenic low back pain in a population with back pain is reported to be 28-43% (99-101). Discogenic back pain seems to be related to a certain degree of disc degeneration (102). The prevalence of disc degeneration appears to cover the entire population; however, in some persons it develops at a markedly younger age and/or to a more severe degree. Genetic factors play an essential role and mechanical influence is relatively slight (103-106). The effect of smoking as an accompanying harmful factor is well established (107, 108). Pathophysiology The intervertebral disc consists of a nucleus pulposus which is sur-rounded by a fiber-like structure called the annulus fibrosus. The healthy disc is avascu-lar and for feeding dependent on diffusion through the annulus fibrosus and the verte-bral endplates. The nerves of the disc comprise two extensive nerve plexuses, the ante-rior plexus and the posterior plexus. The sinuvertebral nerve is the largest branch of the posterior plexus; this plexus is a diffuse network where somatic and autonomic branch-es converge. The anterior plexus receives branches of the rami communicantes. In a healthy disc, the surrounding innervation is limited to the external third of the annulus (109).

Fissures develop in the annulus fibrosus during disc degeneration. Disc degeneration is accompanied by an inflammatory response partially induced through the nucleus pulposus material (110-113). If the fissures reach the outer third part of the annulus, neo-neurovascular ingrowth can develop from the nerve plexus described above. Noci-ceptive stimulation then develops through a combination of this neo-neurovascular ingrowth and the inflammatory chemical changes. Degeneration of the intervertebral disc is characterized by signs of inflammation and nerve growth, and is seen as an im-portant cause of discogenic low back pain. Diagnosis A period of acute low back pain is often an expression of discogenic pain. This period can coincide with the initial development of a tear in the annulus fibrosus. The pain is often located medially and centrally. Axial strain, such as with sitting or standing, usually exacerbates the pain, while lying down alleviates the pain. Strolling is very poorly tolerated, whereas normal walking is better tolerated. Discogenic pain emanating from the level of L3/L4 usually radiates to the anterior side of the upper leg. From the level L4/L5 pain radiates towards the lateral side of the upper leg and sometimes towards the posterior side of the upper leg. Pain emanating from the level L5/S1 usually causes pain on the anterior side of the upper leg along with localized pain located medially on the back. Pain in the groin is also often reported; this may be because the L2 nerve root not only innervates the groin, but is also the most important source of afferent pathways to the lumbosacral disc (114-117). The main clinical features of discogenic pain during a physical examination are the bi-phasic rise from flexion (the corkscrew phenomenon) and pressure pain on the spinosus

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process; however, these are not specific and are therefore only indicative. In 1994, Vanharanta described pain originating from the disc provoked by a vibrating tuning fork pressed on the spinosus process of the affected segment (118). Diagnostic techniques, such as imaging of the lumbar spine (particularly with CT and MRI) can reveal anatomical defects and disc degeneration (119, 120). A limitation of these diagnostic techniques is that degenerative findings on imaging can also be ob-served in the asymptomatic population (121) and, therefore, cannot be proven to be the source of the patient’s pain syndrome. Provocative discography is a physiological test that is considered to be the most specific diagnostic for discogenic back pain, as well as for determining the degree of disc degeneration (101, 122, 123). Although con-troversial, the test is assumed to be able to identify the disc as pain source

There are indications that a diagnostic blockade of the disc can play a role in the di-agnosis of discogenic pain (124) (Table 5).

Provocative discography is recommended to substantiate the discogenic low back pain diagnosis after clinical suspicion of severe discogenic problems has been confirmed by diagnostic techniques (preferably MRI) (126-129). Table 5: ISIS/IASP Criteria for provocative discography: from Bogduk et al., 2004 (125)

1. Absolute discogenic pain:

- Stimulation of target discus reproduces concordant pain.

- The intensity of this pain has a Numeric Rating Scale (NRS) score of at least 7 on an 11-point scale.

- The pain is reproduced by a pressure of less than 15 psi above the opening pressure.

- Stimulation of the two adjacent discs is not painful.

2. Highly probable discogenic pain:

- Stimulation of target discus reproduces concordant pain.

- The intensity of this pain has a NRS score of at least 7 on an 11-point scale.

- The pain is reproduced by a pressure of less than 15 psi above the opening pressure.

- Stimulation of one of the adjacent discs is not painful.

3. Discogenic pain:

- Stimulation of target discus reproduces concordant pain.

- The intensity of this pain has a NRS score of at least 7 on an 11-point numerical scale.

- The pain is reproduced by a pressure of less than 50 psi above the opening pressure.

- Stimulation of the two adjacent discs is not painful.

4. Possible discogenic pain:

- Stimulation of target discus reproduces concordant pain.

- The intensity of this pain has a NRS score of at least 7 on an 11-point numerical scale.

- The pain is reproduced by a pressure of less than 50 psi above the opening pressure.

- Stimulation of one of the adjacent discs is not painful, and stimulation of another discus is painful at a pressure greater than 50 psi above the opening pressure, and the pain is discordant.

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Invasive treatment: implications for practice

Of the several invasive treatments available for discogenic pain, we investigated: 1) intradiscal injection of methylene blue, restorative solution and corticosteroids, 2) in-tradiscal RF lesion, ramus communicans RF lesion and intradiscal electrothermal thera-py, and 3) surgery.

In the search for the effectiveness of invasive treatment in discogenic pain we iden-tified 23 papers. After the selection procedure 10 studies fulfilled our inclusion criteria and were used to formulate the scientific conclusions. Details on the search strategy used are described in the Guideline literature site of the Erasmus Medical Center (www.erasmusmc.nl/pijn/guidelineliterature).

Intradiscal injection of methylene blue

After the selection procedure 1 of 4 papers fulfilled the inclusion criteria to formulate a scientific conclusion (130): an intradiscal injection with methylene blue seems to have a positive effect on reduced pain and restore function in patients with discogenic back pain. In a high-quality RCT Peng et al. showed an extremely positive effect after intra-discal injection with methylene blue on pain and function in patients with discogenic back pain. Risk of complications is low but, if they do occur, they are serious (e.g. discitis). The exact degeneration degree of the disc, in which a methylene blue injection is indi-cated, is not entirely clear. There is a risk of potential neurotoxicity of methylene blue.

Based on the scientific conclusion and other considerations (131-133), the task force developed the following implication for practice:

• Patients with discogenic low back pain for whom conservative therapy has pro-vided insufficient or no effect, should be treated with intradiscal injection of methylene blue only study-related (because there no literature is available, or case reports are insufficient to indicate effectiveness or safety to give a clear recommendation for practice).

Intradiscal injection of restorative solution

After the selection procedure, no papers fulfilled the inclusion criteria to formulate a scientific conclusion for intradiscal injections with a restorative solution. Some studies describe a relatively positive effect of Intradiscal restorative solutions. (134, 135).

Intradiscal injection therapy is a relatively inexpensive and low-impact surgerical procidures. The risk of complications is low. However complications can be serious (discitis). It is obvious to give no injections at grade 5 disc degeneration. Long-term effects of intradiscal punctures are unknown.

Based on the lack of a scientific conclusion and these other considerations, the task force developed the following implication for practice:

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• Patients with discogenic low back pain for whom conservative therapy has pro-vided insufficient or no effect, can be treated with intradiscal injection of restor-ative solution only study-related (because no literature is available, or case re-ports are insufficient to indicate effectiveness or safety to give a clear recom-mendation for practice).

Intradiscal injection of corticosteroids

After the selection procedure 1 of 5 papers fulfilled the inclusion criteria to formulate a scientific conclusion for intradiscal corticosteroid injections (136): patients with dis-cogenic low back pain appeared to derive no benefit from treatment with intradiscal injections with corticosteroids.

There was no difference between intradiscal corticosteroid injection and a placebo injection.

Based on the scientific conclusion and other considerations the task force developed this negative implication for practice (because there is no positive clinical effect, or risks and burdens outweigh the benefits):

• Patients with discogenic low back complaints should not be treated with an in-tradiscal injection of corticosteroids.

Intradiscal radiofrequency lesion

After the selection procedure 1 of 2 papers fulfilled the inclusion criteria to formulate a scientific conclusion (137). An intradiscal RF lesion seems to have no effect on pain reduction and function in patients with discogenic back pain. The absence of any treat-ment effect of an RF lesion of the discus is well explained by the large distance from the RF electrode to the nerve fibers for destruction.

Based on the scientific conclusion and these other considerations the task force de-veloped the following negative implication for practice (because there is no positive clinical effect, or risks and burdens outweigh the benefits):

• Patients with discogenic low back pain with insufficient effect of conservative treatment should not be treated with a RF lesion of the discus.

Ramus communicans radiofrequency lesion

After the selection procedure 1 paper fulfilled the inclusion criteria to formulate a scien-tific conclusion for treatment of intradiscal pain with a ramus communicans blockade (138). A RF lesion of the ramus communicans seems to have a positive effect on pain reduction and restore of function. The ramus communicans is a minimally invasive proce-dure with a low risk of complications. The side-effects are minimal and the costs are low.

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Based on the scientific conclusion and these other considerations the task force de-veloped the following positive implication for practice (because effectiveness is demon-strated in various RCTs and the benefits clearly outweigh the risks and burdens):

• In patients with dicogenic low back pain without a positive effect from conserva-tive treatments a RF lesion of the ramus may be considered.

Intradiscal electrothermal therapy

After the selection procedure 2 of 7 papers fulfilled the inclusion criteria to formulate a scientific conclusion for intradiscal electrothermal therapy (IDET): IDET seems to have a cautiously positive effect on pain, function, and quality of life in patients with discogenic low back pain (123, 139). In other studies of lower quality the benefit from IDET over a RF treatment of the disc or the disc surgery was demonstrated.

Based on the scientific conclusion and the other considerations the task force devel-oped the following implication for practice:

• For patients with discogenic low back pain for whom conservative therapy has provided insufficient effect or no effect IDET may be considered.

This treatment should be used only study-related (because no literature is available, case reports are insufficient to indicate effectiveness or safety to give a clear recom-mendation for practice).

Surgery

After the selection procedure no papers fulfilled the inclusion criteria to formulate a scientific conclusion for surgical interventions in discogenic pain. The assumption that movement of the affected segment worsens the pain (mechanical back pain) has led to the concept that immobilization or stabilization of a painful degenerative motion seg-ment will reduce the pain. The immobilization is realized by means of posterior, anterior or circumferential lumbar fusion.

Based on the literature, no overall judgment can be made regarding the efficacy of fusion versus a conservative policy for discogenic low back pain (140).

An etiological hypothesis would be to eliminate the source of pain (i.e., the disc) while preserving motion, by means of placing a lumbar disc prosthesis (total disc re-placement, TDR). Comparing TDR (with preserved motion) and lumbar fusion (stabilised interlumbar motion), no clear differences were found in clinical outcome and safety between TDR and lumbar fusion (141, 142).

Based on the lack of a scientific conclusion and these other considerations the task force developed the following implication for practice:

• In patients with discogenic pain for whom conservative therapy has provided in-sufficient or no effect, a lumbar fusion or TDR can be a treatment option.

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This treatment should preferably be administered study-related (because there is not enough and/or conflicting evidence, and benefits are clearly balanced with risks and burdens, to give a clear recommendation for practice) (see Table 4).

FAILED BACK SURGERY SYNDROME

Definition Failed back surgery syndrome (FBSS) is a broadly defined diagnosis usually attributed to persistent or renewed pain after previous back surgery. The ‘failed’ in the FBSS diagnosis does not refer to any potential failure of the surgeon, such as through an incorrect surgical indication, technique or level. It refers to not achieving the intended objective of the spinal surgery, i.e. pain reduction, possibly due to the absence of a surgically treatable cause. Therefore, the term post-surgical pain syndrome would be more appropriate (143). Usually there has to be some form of nerve compression caused by degenerative defects, such as spinal disc herniation, benign stenosis, liga-mentum flavum hypertrophy, or spondylolisthesis.

In this guideline, the term FBSS applies to patients who have undergone one or more lumbosacral operations, or who have found no reduction of pain, or a comparable level of pain has returned within, e.g., one year.

As a rule, the patient has no underlying problem that could successfully be treated sur-gically and which would further reduce the chance for success with repeated surgery (143). Epidemiology Reported estimates of the incidence/prevalence vary drastically, ranging from anywhere up to 40% of the number of surgical patients (144-147). Pathophysiology There are definite indications that certain pathophysiological factors play a role. The indications are categorized as such: residual or relapse HNP or recurrent disc herniation, nerve damage, spinal canal stenosis, postoperative infection, epidural fibrosis and/or adhesive arachnoiditis. Also, there is convincing evidence that certain psychological and environmental factors, such as smoking, play a role in the risk for developing FBSS (148-151). Diagnosis The patient’s medical history and physical examination, including appropriate imaging (X-ray, CT, MRI), are the main cornerstones for diagnostics. FBSS is a diagnosis of exclusion, which is different from the other diagnoses that fall under the category of uncomplicated degenerative spinal pain. Consultation with a spinal surgeon is needed to rule out surgically treatable causes.

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Invasive treatment recommendations

Of the several invasive pain treatments available for FBSS, we investigated: 1) epiduros-copy, and 2) spinal cord stimulation. In the search for the effectiveness of invasive treatment in FBSS we identified 22 pa-pers. After the selection procedure, no papers fulfilled the inclusion criteria to formu-late a scientific conclusion. More details on the search strategy are described in the Guideline literature site of the Erasmus Medical Center (www.erasmusmc.nl/pijn/ guidelineliterature). The task force developed recommendations based on the remain-ing considerations.

Epiduroscopy

After the selection procedure, no papers fulfilled the inclusion criteria to formulate a scientific conclusion. One RCT (152) of spinal endoscopic adhesiolysis in chronic refrac-tory low back and lower extremity pain, showed significant pain relief and functional recovery remaining after some months. Serious complications are described due to pressure increase in the epidural space during the epiduroscopy.

Based on the lack of a scientific conclusion and on these other considerations, the task force developed the following recommendation:

• Epiduroscopy can be a treatment option for patients with FBSS for whom con-servative therapy has provided insufficient or has no effect.

This treatment option is preferably administered study-related (because there is not enough and/or conflicting evidence, and benefits are clearly balanced with risk and burdens, to give a clear recommendation for practice).

Spinal cord stimulation

After the selection procedure no papers fulfilled the inclusion criteria to formulate a scientific conclusion. No placebo-controlled studies can be performed with the recently available stimulation paradigms. Two prospective randomized comparative trials clearly show a positive effect of spinal cord stimulation on leg pain in FBSS (145, 153).

Based on the lack of a scientific conclusion and these other considerations the task force developed the following positive recommendation for practice (because effective-ness is demonstrated in various RCTs, and the benefits clearly outweigh the risks and burdens):

• Neuromodulation is recommended for patients with FBSS who have pronounced leg pain and for whom conservative therapy has provided insufficient or no effect.

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DISCUSSION

In the development of this guidleine, the task force concluded that categorization into ‘specific and nonspecific’ low back pain provides insufficient insight into low back pain, and that this categorization fails to effectively indicate which available therapy is effec-tive for which underlying disorder of a back pain syndrome. Therefore, the task force proposed to categorize spinal low back pain into ‘degenerative and non-degenerative’ disorders. The degenerative disorders are then further subdivided into ‘uncomplicated and complicated’ disorders (Figure 1). It is acknowledged that such a categorization is a provisional solution that may need to be adjusted as new data and insights emerge. The current guideline addresses the invasive treatment of uncomplicated degenerative disorders. Later on, this guideline will be expanded to include complicated degenerative as well as non-degenerative disorders of the spine. Conservative treatments for the various disorders will also be inventoried, evaluated and embedded in future guidelines. This is not the first guideline on this topic. Among others, in 2008, a collaborative task force of the Dutch and Belgian Anesthesiology Pain societies succeeded in reviewing the diagnosis and treatment of 25 pain diagnoses. The majority of these reviews were trans-lated into English (published in Pain Practice) and later collected in a textbook entitled ‘Evidence-based interventional pain medicine according to clinical diagnoses’. Some of these diagnoses cover the diagnoses described in the underlying guideline on spinal low back pain (154-161). In the Dutch-Belgian collaboration the search, selection and evaluation procedure was based on the system described by Guyatt et al. (162). These authors use an Evidence-Based Guideline Development (EBGD) method and combine this with a risk-benefit consideration; especially in invasive pain medicine, this latter item is of considerable value. In this new underlying guideline, instead of using an EBGD method (155), the GRADE method is used. An important difference is that assessment based on an EBDG method (162) focuses on the study design: i.e. the systematic review is seen as the highest level of evidence, followed by RCTs and observational studies, and the lowest level of evidence is expert opinion. In the GRADE system, the main focus lies in assess-ment of the strength of evidence for prior defined, relevant outcome measures. This brings the GRADE method more in alignment with actual clinical practice (163). One of the characteristics of the GRADE method is that inclusion criteria for the studies have to be described in advance; however, such criteria can be disputed. For example, in the new guideline discussed here, the inclusion criterion states a minimal study population of 15 patients (RCT=2 x 15 patients). However, this criterion was an ‘educated guess’ and could be considered a limitation of this guideline. Nevertheless, if necessary, small-er studies could be (and were) included in the ‘remaining considerations’. This means

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that information and data from smaller studies were taken into account when develop-ing the recommendations and advice. A consequence of using the GRADE method is that, in many of the treatments for spinal low back pain syndromes, there is no evi-dence that a specific treatment actually helps. Application of the EBDG (or Guyatt) method would probably have led to a more positive image. On the other hand, the GRADE method not only examines the evidence regarding whether a therapy in fact helps, but also acknowledges that there has to be evidence that a specific treatment does not help.

An important limitation of the new guideline is that it describes the state of science only up to June 2011. Unfortunately, this is a limitation of most guidelines and ours is no exception to this rule. At the moment of publication, guidelines have generally already been overtaken by later reports. For example, new evidence has emerged regarding the treatment of SIJ pain, i.e. positive reports from RCTs using cooled RF treatment (164, 165). These data will change the conclusions and recommendations about the place of invasive treatment in SIJ pain. For this reason, guidelines need to be updated regularly. The GRADE method clearly shows the gaps in knowledge and provides a strategy for future research, not only regarding the themes but also concerning the way in which this research should be performed. In the Netherlands, the decision as to whether (or not) a therapy is reimbursed is regu-lated by law (Health Council of the Netherlands). During the development of this guide-line, a negative advice regarding the reimbursement of invasive treatment of spinal low back pain was issued by the Council. However, the Council based its decision mainly on systematic reviews commissioned by the Council itself (3, 4).

Based on our new guideline on spinal lumbar pain syndromes, the Council reconsid-ered the situation and has decided to support new research. A cost-effective study is in progress that aims to analyze minimally invasive treatment procedures in combination with a multidisciplinary rehabilitation program versus a multidisciplinary rehabilitation program alone (6) (http://www.mintstudie.nl).

The results of this ongoing study will serve as a guide to future developments (166).

ACKNOWLEDGEMENTS

The authors thank the other members of the guideline committee:

R.H.M.A Bartels; MD, PhD, neurosurgeon, Diekerhof; MD, orthopedic surgeon, M. van Kleef; MD, PhD, FIPP, anesthesiologist and pain specialist, M.A.M.B. Verheggen; MD, anesthesiologist, Mrs. E.E. Vegt; MD, anesthesiologist, A.W.J Vreeling; MD, orthopedic surgeon for their contribution to the realization of the guideline.

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All of us thank the department of support professional quality from the “Organiza-tion of Medical Specialists (OMS)”: T.A. van Barneveld; Ir, Mrs. J. Berdowsky; PhD, Mrs. N. van Veen; PhD, Mrs. S.B. Muller-Ploeger and Mrs. M. Wessels for their patience with de doctors. Last but not least we thank Mrs. K. Wiersema for the layout of the figure and tables in the manuscript.

The guideline was developed with a grant for quality improvement from the “Dutch Anesthesiology society (NVA)”

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Chapter 4

Medical specialists care and hospital costs for low back pain in The Netherlands

Coen J. Itz MD, Bram L. Ramaekers PhD, Maarten van Kleef MD PhD FIPP, Carmen D Dirksen PhD. (Itz CJ, Ramaekers BL, Van Kleef M, Dirksen CD, Medical specialists care and hospital costs or low back pain in The Netherlands. European Journal of Pain, accepted oktober 2016.)

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ABSTRACT

Introduction: To examine the organization of medical specialist care and hospital costs for low back pain in the Netherlands. Methods: Aggregated health insurance claims data were provided on all Diagnosis Treatment Combination (DTC) declarations for LBP patients first referred to the hospital in the 2nd half of 2008 and retrieved from Vektis, an organization that collects health insurance claims data. Data were available up to 1 January 2012. The data included patient characteristics, DTC specific information including: neurology, neurosurgery, orthopedic surgery, anesthesiology and radiology. Results: In total 80,652 LBP patients were referred to the hospital for the first time in the second half of 2008 accumulating to a total of 173,620 DTC’s with total costs of €194 million. Of these patients, 56% were female and 61% aged above 50 years at first referral to the hospital. The average number of DTC’s and costs per patient were 2.15 and €2,410 respectively (during the follow-up period of 3.0-3.5 year). Moreover, 51% of the patients needed only one DTC; less than 10% of patients needed 5 DTC’s. Following the DTC number, the share of consultations to the neurologist decreased, whereas that of the anesthesiology specialism increased. The largest portion of costs was allocated to the anesthesiology and neurosurgery specialisms. Conclusions: In The Netherlands, LBP patients consult a variety of medical specialisms, in particular, the neurology, Hospital costs for LBP patients are expected to increase given the rising incidence. Optimal diagnosis and tailored treatment plans might result in reduced costs and improved patient outcomes.

WHAT DOES THIS STUDY ADD

• LBP patients consult various specialists, with the majority first referred to the neurologist

• More than half of the LBP patients require only one DTC and less than 10% needed 5 DTC’s or more.

• The largest portion of the hospital costs for LBP patients is allocated to the anes-thesiology and neurosurgery specialisms.”

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INTRODUCTION

In the last decades (1990-2013), the number of patients diagnosed with low back pain (LBP) increased with 57%, although the age adjusted incidence rate per 100,000 re-mained almost the same. (1) In 2011, 425,300 new LBP cases were registered in the Netherlands. (2) Patients presenting with LBP are usually consulted by the general prac-titioner, the physical therapist, or are referred to the hospital for further evaluation. Next to the rising incidence, back and neck pain is listed among the top eight diseases with the highest burden to the patient and society. (3) Moreover, LBP is considered the leading cause of chronic pain. (4) Although the natural course of LBP is described to be favorable with the majority of the patients recovering within weeks, two literature re-views suggest that a much higher portion of patients still suffer from LBP one year after the first diagnosis. The first literature review found 62% of patients still having pain at 12 months, and 16% still being sick-listed at 6 months. (5) The second literature review, considering patients with non-specific low back pain of less than 3-months duration (first time episodes of LBP as well as relapse) who sought treatment in primary care, showed that spontaneous recovery occurs in the first 3 months after onset in about one-third of patients, but the majority (65%) still experienced pain after 1 year. This percentage varies between 57%-67% depending on the definition of persistent pain. (6)

In the Netherlands the global healthcare costs for back and neck pain amounted to €1.3 billion in 2011, of which the largest part was attributed to hospital costs. (7) Next to hospital costs, costs due to productivity losses are also substantial. (8-10) However, the costs related to loss of productivity and disabilities of LBP have diminished during the last decennium, whereas the healthcare costs slightly increased. (11) Although several studies have addressed the burden of LBP on hospital costs, there is little information available about the routing of these patients through the hospital following referral, and the share of activities and costs for the different medical specialisms and hospitals involved in care for LBP patients.

The aim of this study is therefore to examine the organization of care in The Nether-lands for LBP patients following first referral to a hospital, with regard to the order in which various medical specialisms are consulted and the hospital costs. To address the abovementioned study aim, the following research questions were formulated:

• What is the medical specialist care in terms of the order in which medical spe-cialisms are consulted after referral of LBP patients to the hospital?

• What are the hospital costs for LBP patients in total and per specialism?

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METHODS

Data collection

Data were retrieved from the Diagnosis Treatment Combination (DTC) registry of Vektis. This is an organization that collects health insurance claims data in the Netherlands. A DTC was defined as the total of activities and services of hospital and medical specialists resulting from the patient’s need for care from a medical specialist during a maximum of 1 year. We only selected specialties and DTC’s explicitly concerning LBP. This implies that part of the hospital care for LBP is possibly excluded. This may specifically be true for rehabilitation treatment. Indeed, up to 40% of rehabilitation treatment in The Neth-erlands concerns chronic pain, which includes LBP. (12, 13) Although not specifically calculated for the hospital setting, a review by Dagenais et al (10), showed that physical therapy, including rehabilitation treatment, on average contributed to 17% of the total direct healthcare costs. Therefore, the exclusion of rehabilitation DTC’s in this study is likely to result in an underestimation of hospital costs. Additionally, for this study, ag-gregated data were provided by Vektis on all DTC declarations from 1 January 2008 up to 1 January 2012, related to hospital care for patients diagnosed with LBP. No distinc-tion was made between specific and non-specific LBP, nor between acute and chronic LBP based on the database used in this study. DTC’s related to rehabilitation medicine were excluded in our study since these DTC’s are not specific for LBP. (14)

For the purpose of this study, the data for patients referred to the hospital for LBP for the first time between 1 July 2008 and 1 January 2009 were retrieved (all incident LBP cases). Follow-up data for this subset of patients were available up to 1 January 2012, covering a period of 3.0-3.5 years. The database included patient information such as: age, gender and number of DCT’s, as well as DTC specific information like: DTC duration in days, medical specialization, hospital type and costs. Although it was possi-ble that more than one DTC is ‘open’ at the same time, it is assumed that the DTC’s per patient represented a chain of activities.

Data analyses

Descriptive statistics (e.g. means, proportions, ranges and percentages) were used to present the patient characteristics of the study population (age, gender) as well as DTC specific information (number of DCT’s, duration in days per DTC, medical specialization, hospital type and costs). The relevant medical specialisms considered in our study were: neurology, neurosurgery, orthopaedic surgery, anaesthesiology and radiology. The follow-ing hospital types were distinguished: General Hospitals, Top Clinical Hospitals, Independ-ent Treatment Centres, University Hospitals and Categorical Hospitals. (Table 1) The rep-resentativeness of the selected subset of patients was examined by comparing patient

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characteristics of the subset of patients with the whole Vektis database containing all patients with LBP related DTC declarations between 1 January 2008 and 1 January 2012.

RESULTS

Patients

In total 80,652 unique LBP patients were referred to the hospital for the first time in the second half of 2008. During follow-up (until 1 January 2012), a total of 173,620 DTC’s were invoiced for these patients (Table 1). The number of DTC’s was equally dispersed over the age categories and sexes. Most patients were female (56%). Moreover, at first referral to the hospital 6% of the patients were aged between 20-29, 13% between 30-39; 20% between 40-49, 21% between 50-59, 18% between 60-69 and 22% was older than 70 years. The subset of patients selected for this study was similar to the whole LBP population that attended the hospital between 1 January 2008 and 1 January 2012 (Appendix 1). Table 1: Demographics

Number of patientsa % of patientsa Number of DTCs % of DTCs

All 80,652 100.0% 173,620 100.0% Age

20-29 4,853 6.0% 9,071 5.2% 30-39 10,342 12.8% 21,776 12.5% 40-49 15,932 19.8% 34,541 19.9% 50-59 17,077 21.2% 37,249 21.5% 60-69 14,877 18.4% 33,251 19.2% 70+ 17,571 21.8% 37,732 21.7% Gender

Male 35,312 43.8% 74,631 43.0% Female 45,340 56.2% 98,989 57.0% Hospital typeb

General 36,900 45.8% 76,470 44.0% Categorical 1,325 1.6% 3,351 1.9% Top clinical 33,235 41.2% 72,495 41.8% University medical center 5,928 7.4% 11,305 6.5% Independent treatment center 3,264 4.0% 9,994 5.8% Others 0 0.0% 5 0.0% a Characteristics at first referral b University hospitals: A tertiary and secondary care hospital which is part of a university. Top clinical hospitals: A tertiary and secondary care hospital which is not part of the university. General hospitals: A hospital providing all hospital care but no tertiary care . Independent Treatment Centres: A facility providing high volume care for selected diagnoses. Categorical hospitals: A hospital for only one specialism. Others: A private facility.

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DTC’s for LBP

The number of DTC’s per patient ranged from 1 to 22, with an average of 2.15 DTC’s per patient. About half of the patients (51%) needed only one DTC, with less than 10% of patients needing 5 DTC’s or more. Over 50% of the total costs could be attributed to the first two DTC’s (Figure 1).

Figure 1: Number of DTCs per patient and cumulative costs per DTC sequence number The vast majority of patients (84%) was first consulted by a neurologist or orthopaedist, covering 55% and 29% of the patients respectively (Figure 2 and Appendix 2). Following the first DTC, the proportion of patients that was consulted by the anaesthesiology specialism increased from 26% at the second DTC, up to 50% at the eighth DTC. Overall, the majority of DTC’s were invoiced by the neurology specialism (40%), followed by the orthopaedic (23%), anaesthesiology (23%), neurosurgery (14%) and radiology (0%) spe-cialisms (Table 2 and Appendix 2).

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Table 2: Number of DTCs, DTC costs and duration per specialism

Number of DTCsa

% of DTCs Average DTC duration (days)

Average DTC costs

Total DTC costs % of Cost

All 173,620 100.0% 96.1 € 1,120 € 194,409,126 100 Neurology 68,985 39.7% 63.1 € 630 € 43,431,537 22.3 Orthopedic 40,595 23.4% 97.8 € 948 € 38,464,721 19.7 Anesthesiology 39,953 23.0% 159.9 € 1,434 € 57,295,535 29.4 Neurosurgery 23,750 13.7% 82.9 € 2,306 € 54,762,429 28.1 Radiology 337 0.2% 8.4 € 1,350 € 454,904 0.5 aSee Appendix 3 for an overview of the 20 highest cost DTC’s per specialism and Appendix 4 for the highest volume DTC’s per specialism.

Figure 2: Percentage of patients per specialism per DTC sequence number (see Appendix 3 for more infor-mation) The average DTC duration was shortest for radiology (8 days) and longest for anaesthe-siology (160 days).

The vast majority of DTC’s for the neurology, neurosurgery and orthopaedic special-isms concerned the outpatient setting. For anaesthesiology and radiology most DTC’s were related to day care. Compared to the other specialisms, neurosurgery had the largest proportion of inpatient treatment DTC’s. This seemed consistent with the top 3 of most prevalent DTC’s (Appendix 4 and 5).

The total number of DTC’s was highest for the “general hospitals” (44%), followed by top clinical hospitals (42%), “university medical centres” (7%), “independent treatment centres” (6%) and “categorical hospitals” (2%). Relatively most DTC’s were opened in “top clinical hospitals” and least were opened in independent treatment centres (Table 3).

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Table 3: Hospital types in The Netherlands and the distribution of DTC’s over hospital type.

Number of hospitals per hospital type %

Number of DTC’s per hospital type %

Average number of DTC’s per hospital type

Hospital type * General Hospitals 54 48.2 76,470 44 1416 Top Clinical Hospital 28 25 72,495 42 2589 Independent Treatment Centers **

20 17.9 9,994 5.7 500

University Hospitals 8 0.7 11,305 6,5 1413 Categorical Hospitals 2 0.2 3,351 1.8 1676 Others *** 0 0 5 0 0 Total 112 100 173,620 100 1266

* Dutch Hospital Data 2012 RIVZ; dutch@hospitaldata.eu, Monitor ITC’s from NZA www.nza.nl (a qualitative and quantitative analysis). ** From the total of 315 ITC’s in the Netherlands, we selected only the 20 ITC’s with the specialisms orthopedic, neurosurgery, and anesthesiology within their practice. *** Others: These are DTC’s from not identified hospitals.

LBP costs

The average costs per LBP patient was €2,410, ranging from €608 for the subgroup of patients with 1 DTC to €47,223 for the one patient with 22 DTC’s. The average costs per DTC differed per specialism: ranging from €630 for radiology to €2,306 for neurosurgery (Table 2). The average cost per DTC increased for patients with more DTC’s (Figure 3), with the highest increase from 1 (average cost €608 per DTC) to 2 (average costs €1,030 per DTC) DTC’s. The total DTC costs across all five specialisms were €194 million; the largest portion of these costs was allocated to the anaesthesiology and neurosurgery specialisms (€57 and €55 million respectively: Table 2).

DISCUSSION

The aim of this study was to examine the sequence of consulted medical specialisms and costs for LBP patients referred to the hospital in the Netherlands. Most LBP patients were first referred to the neurology specialism. After the first DTC, increasingly more patients were consulting by the anaesthesiology specialism. Total hospital costs amounted to €194 million, of which the largest part could be allocated to the anaesthe-siology and neurosurgery specialisms. The average costs per patient was €2,410. The average cost per DTC typically increased for the subgroups of patients with more DTC’s.

Consistent with previous studies considering LBP patients, (2, 15-17) the LBP popula-tion in our study consisted of more women than men and most patients were aged above 50 years. Previously, the total healthcare costs for neck and back complains were estimated at €1.3 billion in the Netherlands (2011), which is equal to 1.5% of the total

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healthcare budget. (18) Approximately €0.5 billion of these costs are estimated to be hospital related. (19)

In the Netherlands, 80,652 LBP patients were referred to the hospital for the first time in the second half of 2008; this resulted in over 160,000 LBP patients annually who are referred to the hospital for the first time. Based on the average costs of €2,410 per patient over a period of 3.0-3.5 years the total costs for these patients are almost €390 million. This is also probably a reasonable approximation of the annual hospital costs for the prevalent LBP population in the Netherlands. Given that hospital costs for neck and back pain amount to €500 million annually (19), 80% of these costs (€390 million) can be allocated to LBP patients. (7)

The main limitation of this study is the use of health insurance claims data, which of-ten do not provide detailed information on for instance patient’s diagnosis, patient-specific clinical medical specialist care and extensive patient characteristics. Unfortu-nately, the DTC registry does not distinguish between traumatic and non-traumatic LBP (nor between specific and non-specific LBP, or acute and chronic LBP). This means that potential heterogeneity between patients and hospital consumption cannot be exam-ined. Additionally, the quality of claims data is often questioned. However, given that the DTC data directly impacts upon hospital reimbursement, the claims data used in this study are expected to be reliable.

Additionally, generalizability of our results to other European countries might be questioned. However, the Dutch the prevalence and treatments as well as for the quali-ty and organization of healthcare for LBP patients in the Netherlands are reasonably comparable with other European countries. (20, 21) This applies to a lesser extent for the financial registration of diagnosis and intervention of chronic pain and LBP; thereby also the Dutch cost data are more difficult to compare with other European countries. (22, 23) Therefore the Dutch results can be considered informative for other European countries, but a 1-on-1 comparison is not possible. (24-26) Furthermore, the costs cal-culated in this paper might be an underestimation of the true hospital costs since the follow-up is censored at 3.0-3.5 years, while a proportion of patients might still have received hospital care after this period. However, the impact of this is expected to be minimal as the vast majority of patients (84%) consumed up to 3 DTC’s and the maxi-mum duration of a DTC is one year, suggesting that the calculated hospital costs over a period of maximum 3.5 years are representative for the majority of the patients. As mentioned in the methods, we only selected specialties and DTC’s explicitly concerning LBP. This implies that part of the hospital care for LBP is possibly excluded (e.g. regabili-tation, geriatric, rheumatology and psychiatry). Nevertheless we believe our selection of medical specialisms covered the large majority of LBP patients in the Netherlands.

Moreover, costs outside the hospital were not considered. Therefore, the total soci-etal costs are probably higher. (11, 27)

About half of the LBP patients needed more than 1 DTC and about 10% of the pa-tients (7,879 patients) needed 5 DTC’s or more. Although the latter group seems rela-

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tively small, these patients are responsible for a substantial part of the hospital costs (€70 million (36%) of the total €194 million). Moreover, approximately 4 out of 5 pa-tients with chronic pain in the Netherlands indicate that their pain is inadequately treated. (28) This information suggests that there is room for improvement. Previously it has been recommended to increase the focus on monitoring of patients that have not recovered within the first 3 months after onset of LBP. (29) Other aspects regarding the organization of care for LBP patients may be optimized as well. (30) It can be speculated that one reason for having multiple DTC’s is the lack of a specific diagnosis and a tai-lored treatment plan. (31) Optimising the diagnostic and treatment medical specialist care could potentially lead to LBP patients needing less DTC’s. To achieve this, there could be a potential role for intermediate care focusing on back pain patients. Interme-diate care facilities are institutions that provide health related care and services to indi-viduals who do not require the level of care that hospital or skilled nursing facilities provide, but which are beyond the scope of the traditional primary care team. (32) The intention of such an intermediate care facility is to provide an appropriate diagnosis and a treatment plan tailored to the patient. This way, LBP care is offered at the appropriate facility, either in the hospital or elsewhere. (33) If, following the first DTC, LBP patients still present with complaints, a multydisciplinary approach might be helpful to define the right clinical medical specialist care for these LBP patients.

In the majority of cases (55%), the neurologist is the first medical specialist the pa-tient is referred to by the GP. (Appendix 3) Therefore, the prominent role of the neurol-ogist to determine the treatment options of LBP patients should be evaluated. Moreo-ver, the place of intermediate care and the multidisciplinary approach might be alterna-tive options to optimize the diagnosis and treatment for the LBP patient and hence should be examined in future studies. This should preferably be accompanied by re-search on patient-reported outcomes, to ensure that potential efficiency improvements are not implemented at the expense of, but result in pain reduction, improved daily functioning, quality of life and higher satisfaction in LBP patients.

The hospital costs for LBP patients are substantial in the Netherlands and are ex-pected to increase given the rising incidence of LBP. Alternative organization of care for LBP patients, such as intermediate care and a multidisciplinary approach in the hospital might improve diagnosis, result into tailored treatment and has the potential to reduce costs. (34) Also the possibility of a stratified approach, by use of prognostic screening with matched pathways (StarT-Back), may have important implications for the future management of back pain in hospital care. (35) Therefore, further research is required to examine the feasibility, (patient reported) outcomes and costs of intermediate care and a multidisciplinary approach in the hospital for LBP patients.

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REFERENCES

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2. Koes, van Tulder MW, Poos. Koes BW , van Tulder MW, Poos MJJC. How often do exist neck and back complaints and how many people die out of it? National Public Health Compass, RIVM. 2011: . In Dutch: (http://wwwnationaalkompasnl> Nationaal Kompas Volksgezondheid\Gezondheidstoestand\Ziekten en aandoeningen\Bewegingsstelsel en bindweefsel\Nek- en rugklachten). 2011.

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4. Vos T, Flaxman AD, Naghavi M, Lozano R, Michaud C, Ezzati M, et al. Years lived with disability (YLDs) for 1160 sequelae of 289 diseases and injuries 1990-2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet. 2012;380(9859):2163-96.

5. Hestbaek L, Leboeuf-Yde C, Manniche C. Low back pain: what is the long-term course? A review of studies of general patient populations. European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society. 2003;12(2):149-65.

6. Itz CJ, Geurts JW, van Kleef M, Nelemans P. Clinical course of non-specific low back pain: a systematic review of prospective cohort studies set in primary care. European journal of pain. 2013;17(1):5-15.

7. Poos M, Slobbe L, Noordt Mvd. Care use and costs. National Public Health Compass, RIVM. 2011. In Dutch: (http://wwwnationaalkompasnl> Nationaal Kompas Volksgezondheid\Gezondheidstoestand\ Ziekten en aandoeningen\Bewegingsstelsel en bindweefsel\Nek- en rugklachten). 2011.

8. Murray CJ, Lopez AD, Jamison DT. The global burden of disease in 1990: summary results, sensitivity analysis and future directions. Bulletin of the World Health Organization. 1994;72(3):495-509.

9. RIVM. Aspecifieke lage rugklachten: omvang en gevolgen. Centrum voor preventie en zorgonderzoek. 2005;Informatie.

10. Dagenais S, Caro J, Haldeman S. A systematic review of low back pain cost of illness studies in the United States and internationally. The spine journal : official journal of the North American Spine Society. 2008;8(1):8-20.

11. Lambeek LC, van Tulder MW, Swinkels IC, Koppes LL, Anema JR, van Mechelen W. The trend in total cost of back pain in The Netherlands in the period 2002 to 2007. Spine. 2011;36(13):1050-8.

12. Smeets R. Revalidatiegeneeskundige behandeling van patiënten met pijnklachten zich uitend in het houdings- en bewegingsapparaat. Report. 2012.

13. Beuse R, Brand H, Clutmans J, Niestijl G, Renes G, Vermeulen F, et al. Branche Report Revalidatie 2010. Report. Utrecht: Revalidatie Nederland, 2010.

14. Hassaart. Incentives in the Diagnosis Treatment Combination payment system for specialist medical care. PhD study. 2011.

15. Andersson GB. Epidemiological features of chronic low-back pain. Lancet. 1999;354(9178):581-5. 16. Benbadis SR, Herrera M, Orazi U. Does the neurologist contribute to the care of patients with chronic

back pain? Eur Neurol. 2002;48(2):61-4. 17. Lee J, Gupta S, Price C, Baranowski AP, British Pain S. Low back and radicular pain: a pathway for care

developed by the British Pain Society. British journal of anaesthesia. 2013;111(1):112-20. 18. van Tulder MW, Koes BW, Bouter LM. A cost-of-illness study of back pain in The Netherlands. Pain.

1995;62(2):233-40. 19. Meerding WJ, Bonneux L, Polder JJ, Koopmanschap MA, van der Maas PJ. Demographic and

epidemiological determinants of healthcare costs in Netherlands: cost of illness study. Bmj. 1998;317(7151):111-5.

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20. Breivik H, Collett B, Ventafridda V, Cohen R, Gallacher D. Survey of chronic pain in Europe: prevalence, impact on daily life, and treatment. European journal of pain. 2006;10(4):287-333.

21. Bjornberg A. European Heathcare Index. Health Consumer Powerhouse 2016-01-26 Number of pages: 117. This report may be freely quoted, referring to the source. © Health Consumer Powerhouse Ltd., 2016. ISBN 978-91-980687-5-7. EHCI. 2015;2015:117.

22. Busse R, Quentin W, Geissler A, M.. W. Diagnosis-Related Groups in Europe. Moving towards transparency, efficiency and quality in hospitals. Book, Open University Press McGraw-Hill Education McGraw-Hill House Shoppenhangers Road Maidenhead. Berkshire England SL6 2QL. 2011;458 pages(2011):458.

23. Leadley RM, Armstrong N, Lee YC, Allen A, Kleijnen J. Chronic diseases in the European Union: the prevalence and health cost implications of chronic pain. Journal of pain & palliative care pharmacotherapy. 2012;26(4):310-25.

24. Wenig CM, Schmidt CO, Kohlmann T, Schweikert B. Costs of back pain in Germany. European journal of pain. 2009;13(3):280-6.

25. Wieser S, Horisberger B, Schmidhauser S, Eisenring C, Brugger U, Ruckstuhl A, et al. Cost of low back pain in Switzerland in 2005. Eur J Health Econ. 2011;12(5):455-67.

26. Depont F, Hunsche E, Abouelfath A, Diatta T, Addra I, Grelaud A, et al. Medical and non-medical direct costs of chronic low back pain in patients consulting primary care physicians in France. Fundamental & clinical pharmacology. 2010;24(1):101-8.

27. Woolf AD, Pfleger B. Burden of major musculoskeletal conditions. Bulletin of the World Health Organization. 2003;81(9):646-56.

28. Bekkering GE, Bala MM, Reid K, Kellen E, Harker J, Riemsma R, et al. Epidemiology of chronic pain and its treatment in The Netherlands. The Netherlands journal of medicine. 2011;69(3):141-53.

29. Henschke N, Maher CG, Refshauge KM, Herbert RD, Cumming RG, Bleasel J, et al. Prognosis in patients with recent onset low back pain in Australian primary care: inception cohort study. Bmj. 2008;337:a171.

30. Koes BW, van Tulder MW, Ostelo R, Kim Burton A, Waddell G. Clinical guidelines for the management of low back pain in primary care: an international comparison. Spine. 2001;26(22):2504-13; discussion 13-4.

31. Itz CJ, Willems PC, Zeilstra DJ, Huygen FJ. Dutch Multidisciplinary Guideline for Invasive Treatment of Pain Syndromes of the Lumbosacral Spine. Pain practice : the official journal of World Institute of Pain. 2015.

32. Melis RJ, Olde Rikkert MG, Parker SG, van Eijken MI. What is intermediate care? Bmj. 2004;329 (7462):360-1.

33. Volinn E, Turczyn KM, Loeser JD. Patterns in low back pain hospitalizations: implications for the treatment of low back pain in an era of health care reform. The Clinical journal of pain. 1994;10(1):64-70.

34. Salomon JA, Vos T, Hogan DR, Gagnon M, Naghavi M, Mokdad A, et al. Common values in assessing health outcomes from disease and injury: disability weights measurement study for the Global Burden of Disease Study 2010. Lancet. 2012;380(9859):2129-43.

35. Hill JC, Whitehurst DG, Lewis M, Bryan S, Dunn KM, Foster NE, et al. Comparison of stratified primary care management for low back pain with current best practice (STarT Back): a randomised controlled trial. Lancet. 2011;378(9802):1560-71.

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APPENDIX

Appendix 1: Representativeness of the selected subset

Patients with the first DTC referred between 1 July 2008 and 1 January 2009

Patients referred between 1 January 2008 and 1 January 2012

Number of DTCs % of DTCs Number of DTCs % of DTCs

All 173,620 100.0% 1,211,161 100%

Age

20-29 9,071 5.2% 61,825 5,2%

30-39 21,776 12.5% 140,648 11,6%

40-49 34,541 19.9% 238,915 19,7%

50-59 37,249 21.5% 260,723 21,5%

60-69 33,251 19.2% 234,198 19,3%

70+ 37,732 21.7% 274,852 22,7%

Gender

Male 74,631 43.0% 525,546 43,4%

Female 98,989 57.0% 685,615 56,6%

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Appendix 2: Number and proportion of patients per specialism and per DTC number

DTCa Anesthesiology Neurosurgery Neurology Orthopedic Radiology Total

Total patients

% of patients

Total patients

% of patients

Total patients

% of patients

Total patients

% of patients

Total patients

% of patients

1 7,112 8.8% 5,514 6.8% 44,136 54.7% 23,706 29.4% 184 0.2% 80,652

2 10,295 26.2% 8,621 21.9% 12,697 32.3% 7,638 19.4% 77 0.2% 39,328

3 8,298 37.4% 4,364 19.7% 5,599 25.3% 3,860 17.4% 43 0.2% 22,164

4 5,666 43.0% 2,352 17.8% 2,948 22.4% 2,204 16.7% 15 0.1% 13,185

5 3,655 46.4% 1,246 15.8% 1,649 20.9% 1,321 16.8% 8 0.1% 7,879

6 2,161 47.2% 717 15.6% 884 19.3% 815 17.8% 5 0.1% 4,582

7 1,256 47.4% 411 15.5% 497 18.7% 484 18.3% 4 0.2% 2,652

8 736 50.1% 237 16.1% 252 17.2% 244 16.6% 0 0.0% 1,469

9 374 46.5% 132 16.4% 152 18.9% 145 18.0% 1 0.1% 804

10 193 44.8% 63 14.6% 79 18.3% 96 22.3% 0 0.0% 431

11 92 41.4% 47 21.2% 43 19.4% 40 18.0% 0 0.0% 222

12 46 40.4% 18 15.8% 29 25.4% 21 18.4% 0 0.0% 114

13 30 46.9% 13 20.3% 12 18.8% 9 14.1% 0 0.0% 64

14 15 50.0% 5 16.7% 3 10.0% 7 23.3% 0 0.0% 30

15 12 57.1% 3 14.3% 2 9.5% 4 19.0% 0 0.0% 21

16 4 36.4% 4 36.4% 2 18.2% 1 9.1% 0 0.0% 11

17 2 50.0% 1 25.0% 1 25.0% 0 0.0% 0 0.0% 4

18 2 66.7% 1 33.3% 0 0.0% 0 0.0% 0 0.0% 3

19 1 50.0% 1 50.0% 0 0.0% 0 0.0% 0 0.0% 2

20 1 100.0% 0 0.0% 0 0.0% 0 0.0% 0 0.0% 1

21 1 100.0% 0 0.0% 0 0.0% 0 0.0% 0 0.0% 1

22 1 100.0% 0 0.0% 0 0.0% 0 0.0% 0 0.0% 1 aDTC sequence number

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Appendix 3: Top 20 of highest cost of DTC’s per specialism (based on all patients referred between 1 January 2008 and 1 January 2012)a

Top 20 cost / DTC anesthesiology

Top 20 cost per DTC neurosurgery

Top 20 cost per DTC neurology

Top 20 cost per DTC orthopedic

Mechanic LBP, invasive day surgery (DC) *

Lumbar discectomy multi level (IP)

Radicular syndrome (L/S) (OP)

Chronic nonspecific LBP, (OP)

Discogenic LBP, invasive (DC)

Lumbar discectomy special technique (IP)

Radicular syndrome (L/S) (DC)

Chronic nonspecific LBP, (DC)

Chronic degenerative LBP (DC)

Extensive decompression (IP)

Radicular syndrome (L/S) (IP)

Chronic nonspecific LBP, (IP)

Mechanic LBP, neuromodulation (IP)

Spondylodesis special technique (IP).

Pseudo radicular syndrome (L/S) (OP)

Radicular Syndrome, (DC)

Chronic degenerative LBP neuromodulation (IP)l

Laminectomy limited or extended (IP).

Pseudo radicular syndrome (L/S) in (DC).

Radicular Syndrome, (IP)

Mechanic LBP, invasive (OP)

Hernia nucleus pulposus day surgery. (DC)

Spinal stenosis (L) (DC) Spinal stenosis, (DC)

Discogenic LBP, invasive (OP)

Hernia nucleus pulposus (IP)

Spinal stenosis (L) (IP) Spinal arthrosis, (OP)

Neurogenic LBP, invasive (OP)

Percutaneous nucleotomy min. invas. treatment (DC)

Lumbar pain (OP) Spondylosis, with joint replacement (IP)

Chronic degenerative LBP invasive (OP)

Chemonucleolysis (OP) Lumbar pain (DC) Radicular Syndrome, conservative (OP)

Chronic degenerative LBP, complex invasive (OP)

Chemonucleolysis (DC) Lumbar pain (IP) Spinal stenosis, (IP)

Mechanic LBP, accompaniment (OP)

Recurrence HNP (IP) Neurological pain without reason, (OP)

Scoliosis, (IP)

Discogenic LBP, accompaniment (OP)

Recurrence HNP special technique (IP)

Spinal stenosis (L) outpatient

Scoliosis, with joint replacement (JR) and (IP)

Neurogenic LBP, accompaniment (OP)

Degenerative deviation spine (IP).

Pseudo radicular syndrome. (L/S) (DC, IP)

Failed back surgery syndrome (IP)

Chronic degenerative LBP, accompaniment (IP)

Degenerative deviation spine conservative (IP)

Post laminectomy syndrome, multi discs (OP)

Spinal arthrosis, (DC)

Combination diagnoses neuromodulation (IP)

Combination diagnosis neuromodulation (IP)

Post laminectomy syndrome (DC)

Osteoporotic spinal compression, (IP)

Mechanic LBP, complex invasive DS, (IP)

Re spondylodesis (IP) Post laminectomy syndrome, (IP)

Osteoporotic spinal compression J(R) and (IP)

Discogenic LBP, complex invasive (IP)

Re exploration spine (IP) Peripheral nerves and roots (OP)

Spinal stenosis (OP)

Neurogenic LBP, invasive (IP)

Re expolration spine neuromodulation (IP)

Pseudo radicular pain (L/S) multi discs (IP)

Spinal arthrosis (IP)

Chronic degenerative LBP, invasive (IP)

Recurrence HNP co-treatment (IP)

Peripheral nerves and roots (DC)

Spondylosis (IP)

Combination diagnosis accompaniment (OP)

Combination diagnosis accompaniment (DC, IP)

Unknown neurological pain (DC)

FBSS, with joint replacement (JR) and (IP)

a Top 20 of most declared DTC’s for the specialism radiology consisted only of 1 DTC: single or multiple ce-menting of vertebral body and arches and intervertebral discs.

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* Abbreviations: OP = outpatient treatment, DC = Day Care treatment, IP = Inpatient treatment, DTC = Diag-nosis Treatment Combination, LBP = Low Back Patient, Combination diagnosis = mechanic, neurogenic, dis-cogenic, Sympatico form pain. L/S = Lumbo Sacral, Day clinic = clinical treatment without passing the night, JR = joint replacement, FBSS = Failed Back Surgery Syndrome, HNP = Hernia Nucleus Pulposis. Appendix 4: Top 3 of highest volume DTC’s per specialism (based on all patients referred between 1 January 2008 and 1 January 2012) a

Volume top 3 Anesthesiology

Volume top 3 Neurosurgery

Volume top 3 Neurology Volume top 3 Orthopedic

Diagnose + treatment DTC 1-3:

Diagnose + treatment DTC 1-3:

Diagnose + treatment DTC 1-3:

Diagnose + treatment DTC 1-3:

Mechanic discogenic LBP: (OP, DC) *

Single consultation LBP: conservative (OP, IP)

Radicular syndrome, HNP (L/T): single conservative (OP)

Chronic nonspecific LBP: conservative (OP)

Neurogenic LBP (+ leg pain): (OP, DC)

Lumbar discectomy ore levels: complex (IP)

Pseudo Radicular. syndrome (L/T):, conservative (OP)

Hernia Nucleus Pulposis: conservative (OP)

Chronic degenerative LBP: accompaniment, (DC)

limited laminectomy: (DC, IP)

Lumbago: conservative (OP)

Arthrosis, spondylosis, FBSS: conservative (OP)

a Top 3 of highest volume DTC’s for the specialism radiology consisted only of 1 DTC: single or multiple ce-menting of vertebral body and arches and intervertebral discs. * Abbreviations: OP = outpatient treatment, DC = Day Care treatment, IP = Inpatient treatment, DTC = Diagno-sis Treatment Combination, LBP = Low Back Patient, Combination diagnosis = mechanic, neurogenic, dis-cogenic, Sympatico form pain. L/S = Lumbo Sacral, Day clinic = clinical treatment without passing the night, JR = joint replacement, FBSS = Failed Back Surgery Syndrome, HNP = Hernia Nucleus Pulposis.

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Appendix 5: Distribution of DTC’s per specialism and their setting.

Specialism Setting Number of DTC’s per Setting % Neurology Total 68,982 100

DC* 2,491 3.6 IP 3,165 4.5 OP 63,326 91.8 PR 0 0

Neurosurgery Total 23,750 100 DC 441 1.8

IP 9,651 40.6 OP 13,581 57.1 PR 77 0.3

Orthopedic Total 40,593 100 DC 1,017 2.5

IP 3,656 9.0 OP 35,920 88.4 PR 0 0

Anesthesiology Total 39,953 100 DC 26,476 66.2

IP 1,495 3.7 OP 11,982 29.9 PR 0 0

Radiology Total 337 100 DC 337 100

* Abbreviations: OP = outpatient treatment, DC = day care treatment, IP = inpatient treatment, PR = private financial setting of the treatment, DTC = Diagnosis Treatment Combination.

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Chapter 5

A proposal for the organization of the referral of patients with

chronic non-specific low back pain

Coen J. Itz MD, Frank J. Huygen MD, PhD, FIPP; Maarten van Kleef, MD, PhD, FIPP. (Itz C, Huygen F, Kleef MV. A proposal for the organization of the referral of patients with chronicnon-specific low back pain. Current medical research and opinion. 2016:1-7.)

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INTRODUCTION

“Low back pain a twentieth century health care enigma”, this is how Waddell described the problem back in 1996 1. Today, 20 years later, the puzzle has not been solved yet. There is a large body of evidence that low back pain touches the vast majority of the population, with a lifetime prevalence of an episode of low back pain around 80%2. In the recently published Global Burden of Disease study 3 low back pain is the number 1 cause for years lost in disability over the periods 1990 and 2013.

The natural course of low back pain and its evolution towards chronicity is, however, less well documented. The epidemiological data for chronic low back pain seem to be contradictory, ranging from 8% to 65% at 12 months 4, 5. Moreover, there are indications that a large group of those patients attending a general practice remain untreated6.

In contrast to, for example chronic obstructive pulmonary disease (COPD) or diabe-tes mellitus, chronic low back pain is still not recognized as disease on its own. In ab-sence of a uniform classification and a validated diagnostic tool, treatment depends mainly on the perception of the cause and the preference of the treating physician, often leaving valuable possibilities unused. Guidelines from around the world on the management of low back pain all indicate that low back pain patients only need to be referred to a specialist in case of suspicion of a serious disease or specific pathologic changes7. This often results in referral to a neurologist, neurosurgeon or orthopedic surgeon, which is, according to Rosomoff HL and Rosomoff RS8 the right decision when there is suspicion of serious underlying disease. But they clearly indicate that low back pain may have another dimension. “Low back pain per se is in the majority not a neuro-logic problem, an orthopedic problem, or a neurosurgical problem, so that consultation with these groups, unless there are strong suspicions otherwise, has limited value”. In absence of clear recommendations, the general practitioner may take the decision of who to refer to which specialist merely by habit or perception. These practices may result in a long and costly road to finding the cause of the low back pain and providing an appropriate treatment plan.

We will discuss the paradigms leading to the currently applied management scheme of low back pain patients and try to identify weaknesses and failures in order to propose an alternative management plan.

THE NATURAL COURSE OF LOW BACK PAIN

The Quebec task force publication is frequently cited to support the claim that a minori-ty (8%) of patients who suffer an episode of low back pain will remain incapable to re-turn to function after 1 year 9. Three more recent studies, compiling the findings of the literature demonstrated the contrary. Two studies looking at the epidemiology over 12 months found 62% 10 and 65%5 of the patients still to suffer low back pain at the end of

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the evaluation period. A systematic review of prospective and longitudinal epidemiolog-ical studies found that patients who suffer low back pain at intake remain stable even over a period of 28 years11. Moreover, low back pain is too often considered as an iso-lated event, while previous experience of low back pain may point towards recurrence and will influence the patient’s experience of the problem. 12

The percentage of patients evolving from acute to chronic low back pain is clearly much higher than previously assumed.

DIRECT, INDIRECT AND UNNECESSARY COSTS

“The total costs of this epidemic are $ 560 billion to $ 635 billion” this quote from Pizzo et al. 13 in the NEJM refers to the cost of chronic pain in general. Health care authorities and insurance companies agree that the cost of chronic low back pain is very high. The total cost of a disease, including chronic low back pain, is commonly calculated as direct cost, attributed the medical care and indirect cost caused by disability and incapacity to work. The direct medical costs usually don’t exceed 10% of the indirect costs 14.

A government initiated study on how chronic low back pain patients were treated in Belgium calculated the different components of the direct medical costs, based on health insurance data, thus only reimbursed medical interventions could be considered 15. They found that 42% of the direct medical costs is attributed to medical imaging, while surgery takes 22%, rehabilitation and physical therapy accounts for 17%, pharma-cological treatment 5%, medical consultations for history taking 4%, spinal cord stimula-tion 4%, percutaneous radiofrequency treatment 0.15% and epidural corticosteroids 0.1%. The main question raised as conclusion of this study was: “Is the huge consump-tion of medical imaging and surgery justified?” In the same line of thoughts, we ques-tion the added value of the “step-wise” referral involving several specialists in the tra-jectory of the patient suffering chronic low back pain.

Differential diagnosis of chronic low back pain

Low back pain is commonly divided into specific and non-specific. For specific low back pain there is an identifiable underlying cause such as: cancer, infection, fracture, in-flammatory diseases, visceral, vascular and endocrine disturbances. These causes must be managed

Axial low back pain involves lumbar spine structures that include the intervertebral discs, facet joints, sacroiliac joints, and paraspinal musculature. Intervertebral disc pain: The intervertebral disc can be a source of pain in about 40% of patients with axial low back pain.16 These patients tend to be younger (age <45 years).

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The onset tends to be insidious in most cases; in some instances, an inciting event may be described such as lifting, bending, and twisting. This pain has a midline distribution. Facet joint pain: Axial low back pain attributed to the lumbar facet joints is estimated to affect 15% to 30% of patients 16. The onset of lumbar facet pain is generally insidious and it occurs more frequently in older adults (age >65 years). Lumbar facet pain can be worsened by prolonged standing and relieved with sitting or recumbence. This pain is uni- or bilateral. Sacroiliac joint pain occurs in 15% and 30% of individuals with axial low back pain and is associated with a specific inciting event in 40% and 50% of occurrences 16; motor vehi-cle collisions and falls are 2 of the most common causes. In the differential diagnosis of sacroiliac joint pain, buttock pain with radiation in an L5 or S1 dermatome is character-istic. This pain is uni- or bilateral. Muscle ligament pain may be an important contributing factor to other sources of low back pain or a primary cause by itself and is characterized by the presence of trigger points that are hyperirritable tense bands of skeletal muscles.16 Axial low back pain related to the paraspinal muscle or ligament strain is often precipitated by both strenu-ous and no strenuous activities such as heavy lifting, repetitive movements, spinal tor-sion, or trauma 16.

Radicular pain and spinal stenosis can be accompanied by, a form of nociceptive and/or neuropathic axial low back pain. For the focus of this article it is not discussed here further on. Figure 1 illustrates the different components of axial low back pain.

Evolution towards chronicity.

Chronicity of pain has been defined in 3 different ways. First pain that lasts longer than 3 months, second pain that is refractory to conventional treatment and third pain that is still present when the underlying cause is healed. Acute pain is often the reaction to a painful stimulus, described as nociceptive pain. Neuropathic pain is caused by a lesion or disease of the somatosensory system (www.iasp-pain.org/resources/painDefinition) it is mostly chronic and has been redefined as: “pain arising as a direct consequence of a lesion or disease affecting the somatosensory system”17. A continuous painful stimulus such as osteoarthrosis or rheumatoid arthritis leads to chronic nociceptive or inflamma-tory pain.

There are three types of risk factors for evolution towards chronicity: somatic, psy-chological and social factors.

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Figure 1: Summary of clinical and anatomical characteristics of Axial LBP separated from the radicular part of pain. (Hooten, 2015, Mayo clinics) EMB is evidence based and LBP is low back pain.

Structural abnormalities are not predictive for chronicity, with the exception of

moderate to severe Modic changes of the vertebral end plate that are weakly associat-ed with chronicity. Severe degenerative disc disease, herniated nucleus pulposus at baseline in patients without chronic pain were weakly linked to chronic low back pain 18.

A study evaluating the cross-sectional area of the multifidus, erector spinae, and psoas muscles found that a smaller cross sectional area of those muscles were indica-tive for a higher risk for chronic low back pain 19.

In an epidemiological study 20 it was shown that high body mass index and reduced physical activity were correlated with an increased risk for chronic low back pain. A meta-analysis on the influence of smoking on the prevalence of low back pain found a positive association 21. There is, however no evidence confirming the correlation be-tween high BMI and smoking with chronic low back pain.

Axial LBP

Sacroiliac joint:• Gluteal pain/off-midline

below L5• Worse with transitional

movements (rising from sitting position)

• EMB physical examination tests.

inciting event

common

Muscle/ligament• Delayed onset• Lumbosacral

region• Muscle spam• Hypomobility• Possible

myofascial component

Facet joint• Age > 65 years• Pain worse with standing• Paraspinal distribution

Radicular Pain

Spinal stenosis• Age > 65 years• Neurogenic claudication• Improved with forward

flexion• Radicular pain

buttocks/leg• Multiple dermatomes• EBM physical

examination

Intervertebral disc• Age < 45 years• Sitting intolerance• Pain worse with spine

loading• Midline distribution

• Insidious onset• Improves with

recumbency• Pain refer to thigh

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Heymans et al 22 found that improvement in pain and disability during the first 3 months may predict a lower risk for chronification.

In their systematic review on predictors of chronicity in patients with acute low back pain Chou et al. 23 found the most useful predictors for chronicity to be nonorganic signs such as maladaptive pain-coping behaviours, high baseline functional impairment, presence of psychiatric comorbidities and low general health status. A significant asso-ciation between catastrophizing and kinesiophobia has been demonstrated, even after correction for pain duration, severity and disability 24.

A study following 180 patients disabled by acute low back pain for 12 months found that there is a threefold risk for disability at 1 year in patients who were on work leave and found little stimulation in the job. Workplace related factors such as low degree of job satisfaction; repetitive weight baring and financial compensation for incapacity are also predictive for chronification 25. The summary of a systematic review on the risk factors for chronicity is given in table 1.

Table 1: Summary accuracy of risk factors for predicting chronic disabling low back pain at 1 yaer.

Risk factor for chronification Number of studies: comparison + LH Ratio - LH Ratio

Age 6 studies: >40>45>50 and older 0.93 1.1

Sex 8 studies: female versus male 1.3 0.73

Education 4 studies: no college and more 1.1 0.65

Smoking 4 studies: smoker vs nonsmoker 1.3 0.85

Weight 2 studies: high BMI vs low BMI 0.84 1.1

Sick leave 5 studies: compensation vs not comp. 1.4 0.86

Work satisfaction 3 studies: less vs more work satisfaction 1.5 0.88

Physical work demands 2 studies: high vs low physical demands 1.4 0.84

General health / activity 5 studies: low vs better activity level 1.8 0.85

Psychiatric comorbidities 4 studies: higher vs low psychiatric scale 2.2 0.85

Prior low back episodes 5 studies: more vs less prior episodes 1.1 0.81

Baseline pain 3 studies: high vs low pain intensity 1.3 0.33

Baseline function 3 studies: high vs low impairment 2.1 0.40

Fear avoidance, neg. coping 2 studies: high vs low coping level 2.1 0.39

Radiculopathy 7 studies: leg pain vs no leg pain 1.4 0.82

Nonorganic signs somatisation 3 studies: more vs less somatisation 3.0 0.71

LR = Likehood Ratio’s for LBP chronification are quantifying the clinical usefulness of potential yellow flags; findings associated with prolonged recovery. A Likehood Ratio above 1 is associated with increased risk, and below 1 is associated with decreased risk. (Chou, 2011, Future Medicine)

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Diverse classification systems and a wide choice of specialists

The general practitioner plays an important role in the early identification and referral of patients at risk for chronification. It is, however, unclear where to refer the patient. There are up to 15 possible specialists for referring a patient with low back pain such as: sports physician, neurologist, neurosurgeon, anesthesiologist/ pain specialist, orthope-dic surgeon, radiologist, rheumatologist , physical therapist, manual therapist, osteo-path, Mensendieck therapist, ergo therapist, acupuncturist, podologist, psychologist, and the general practitioner 26. There are no guidelines on how to select the specialty for referring a patient, the choice may seem an ad random process, which is certaintly not optimal 27. A consensus report based on a survey with the different stake holders in chronic pain highlighted the need for change28 . Communication between the different stake holders, and especially the health care professionals requires an unambiguous definition and classification system.

The lack of a code for chronic pain in the World Health Organization International Classification of Diseases and the poor understanding of the mechanisms underlying the transition from acute to chronic pain are indicated as reasons for inadequate referral and treatment of chronic pain 28. The need for a classification system is also supported by the fact that recommendations for treatment and referral of low back pain patients are often diagnose specific. However, general practitioners, convey concerns about those classification and referral recommendations, mainly because the diagnostic tools to establish the sub-diagnosis within the group of non-specific low back pain are not available 28, 29.

The use of a generally accepted classification system that divides degenerative and non-degenerative low back pain and where the degenerative low back pain is subdivid-ed into non-complicated and complicated low back pain, may be helpful to establish the management plan.

Identification of the type of problem allows more appropriate selection of the solution

A randomized controlled trial studied the impact on outcome and use of health care re-sources of a stratified approach of low back pain patients30. Patients with low back pain received the StarT back tool questionnaire that allowed stratification of the patients with low, medium or high risk for disability. Patients in the study group with low risk received 1 session of physical therapy, patients at medium risk received several sessions of physical therapy, and those at high risk receive the combination of psychologically assisted physical therapy respectively, the control group received standard care including physical therapy. Patients in the treatment group had greater improvement in disability and physical and emotional functioning, pain intensity, quality of life, days off work, global improvement ratings, and treatment satisfaction at 4 and 12 months compared to control group.

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The lower number of physical therapy sessions and the reduction in days off work point towards an economical gain by stratifying the patients before treatment.

The British Pain Society issued a pragmatic pathway that follows the patient’s journey as seen by the clinicians.31 They recommend the patient to be assessed with StarT back tool 2 weeks after the first presentation with low back pain and to manage the patient as in the study described above. At maximum 12 weeks the patient should again be evaluat-ed and depending on the fact whether the patient improved or not he will be managed in primary care or referred to a specialized pain center. In the pain center the patient will be evaluated by a multidisciplinary team. A multidisciplinary treatment may be installed but when the underlying cause can be identified a more targeted approach may be used. 31

One-and-a half line care

Early improvement, within the first 3 months was found to be predictive for a lower risk for chronification22. An adapted management program yields better outcome and has a lower cost 30. Breivik et al. 32 state that it is unrealistic that all patients with chronic pain should be seen by numerous different health care providers. The role of the general practitioner in the early stage of low back pain is crucial. He often has a long history with the patient and knows the familial predisposition and tendencies for dramatizing and catastrophizing. Improper labeling of complaints by the patient himself may lead to unnecessary health care costs. The importance of providing adequate information and reassurance was demonstrated in high quality studies33 . Assessing the risks factors, making a sub-diagnosis and providing the adequate information requires good knowledge and is time consuming.

Ideally the general practitioner should obtain assistance of a new trained spine spe-cialist nurse specialized in triage diagnosis and management of the low back pain pa-tients (Spine Physician Assistant: SPA). This assistant (SPA) works, under supervision of the general practitioner. The task of this SPA could be monitoring chronicity, absentee-ism and undesirable disease course.

The team of general practitioner and the SPA will re-assess the presence of red flags. When the clinical examination and the characteristics of the patients’ pain suggest radicu-lar pain, early 2nd line treatment may prevent further evolution and the need for surgery. When these are excluded or treated the patient should receive adequate information and be reassured. Besides the optimization of the pharmacological treatment, the patient should be stimulated to exercise.34-36 The patient should be evaluated for the presence of risk factors for chronification and attempts should be made to identify the sub-diagnosis.

The British Pain Society 31 established a treatment pathway for low back and radicular pain, that typically describes the one-and-a-half care. Attention is paid to the points were information is needed for the patient and/or the caregiver and when referral is indicated. As noted from the diagram in figure 2 the role of the primary care is rather extensive. The algorithm for specialist care illustrates the role for multidisciplinary consult.

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Figure 2: Decision diagram for treatment Low Back Pain.(LBP). GP = General Practitioner. LRS = Lumbosacral Radicular Syndrome. MDO = multidisciplinary consultation. (Lee, 2013, BJA)

As the patient progresses through the pathway, specialist treatment such as interven-tional pain management, use of anti-neuropathic pain medication and when indicated cognitive behavioral therapy will be installed. Finally, if there is no other way, a refer-

GP LBPHistory & Physical

Examination.

Cauda Equina Syndrome Non Specific LBP LRS Red Flags

Targeted examination diff

diagnosis

2e line; hospital 2e line: EMERGENCY

1e line

1,5 line

2e & 3e line

acute LBP0 - 6 w

subacute LBP6 - 12 w

Meaning conversation, cognitive behavioral therapy, reduce pain

medication

LRS revisited

low risk normal risk high risk

Improvement

Improvement

Pphysical therapy, pain medication

therapy, pain medication

Neurosurgery

Minimal Invasive interventions Interventions

Improvement

Improvement

cognitive behavioral therapyMDO

Improvement

Pain specialist Sub diagnosis

MDO

Counseling by GPs

MDO

Chronic LBP> 12 w

exercise advice, reassurance,

physical therapy, pain medication

Exercise therapy, / manual therapy,

psychological support, pain medication

Start Back Tool: risk management

Intensive psycological

investigation & cognitive

behavioral therapy

Neurosurgery, orthopedics

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ence to the second line for surgical intervention must be considered . Lee calls this “1.5 line expertise”31. The multidisciplinary follow-up of refractory patients aims at providing the most appropriate treatment in a timely fashion, thus reducing the patient’s suffer-ing and the health care expenses 37.

The team of SPA and GP, aided by validated tools will identify social and or psycho-logical factors that are predictive for chronification. In case of low risk the patient can be treated by means of physical therapy, when the risk is high, intensive psychological and cognitive behavioral treatment should be envisioned. 31, 38.

The pathway as described by the British Pain Society, is innovative. The idea to fas-ten he diagnostic fine-tuning, and the appropriate referral with a better clinical out-come and patient satisfaction as result is appealing. This assumption needs, however, confirmation.

DISCUSSION

Everybody agrees that low back pain is a serious health care and economic problem. As opposed to the earlier beliefs, there is evidence that up to 65% of the patients suffering low back pain will still suffer after 1 year, which even increases the size of the problem. There are indications that patients with pain of discogenic origin have an increased risk for chronification18. Other factors predictive for chronification are predominantly psy-chological, hence the importance of early identification of risk for chronification and appropriate management. This early management is mainly the role of the general practitioner, who is not always adequately trained for performing the first triage of low back pain patients. The British Pain Society proposed the “one-and a half line care” where the general practitioner aided by a spine physician assistant perform the diag-nostic process, collect information from additional test, assure first line treatment in-cluding referral for exercise and physical therapy and timely referral for 2nd and 3rd line care. The SPA is also the contact person who will inform the patient about the diagnosis and the probably course of the disease. In this model it is assumed that the patient will obtain the most appropriate management faster than in the current system, where referral to specialists is a matter of trial and error. It should be logic that less specialist visits and earlier return to work would represent an economic benefit.

This assumption needs to be confirmed, preferentially in randomized controlled trials.

AKNOWLEDGEMENT

The authors thank Nicole Van den Hecke for review and copy-editing

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clinical registry of people with chronic back pain. Clin Epidemiol. 2015;7:369-380. 3. Buchbinder R, Collaborators GBDRF, Forouzanfar MH, Alexander L, Anderson HR, Bachman VF, et al.

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4. Spitzer W, Le Blanc F. Scientific approach to the assessment and management of activity-related spinal disorders. Report of the Quebec Task Force on Spinal disorders. Spine. 1987;Suppl:12-17.

5. Itz CJ, Geurts JW, van Kleef M, Nelemans P. Clinical course of non-specific low back pain: a systematic review of prospective cohort studies set in primary care. Eur J Pain. 2013;17:5-15.

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7. Koes BW, van Tulder MW, Ostelo R, Kim Burton A, Waddell G. Clinical guidelines for the management of low back pain in primary care: an international comparison. Spine (Phila Pa 1976). 2001;26:2504-2513; discussion 2513-2504.

8. Rosomoff HL, Rosomoff RS. Low back pain. Evaluation and management in the primary care setting. Med Clin North Am. 1999;83:643-662.

9. Spitzer W, LeBlanc F, Dupuis M, Abenhaim L, Belanger A, Bloch R, et al. Scientific approach to the assessment and management of activity-related spinal disorders: a monograph for clinicians. Report of the Quebec task force on spinal disorders. Spine. 1987;12:S4-S55.

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11. Lemeunier N, Leboeuf-Yde C, Gagey O. The natural course of low back pain: a systematic critical literature review. Chiropractic & manual therapies. 2012;20:33.

12. Dunn KM, Hestbaek L, Cassidy JD. Low back pain across the life course. Best practice & research. Clinical rheumatology. 2013;27:591-600.

13. Pizzo PA, Clark NM. Alleviating suffering 101--pain relief in the United States. N Engl J Med. 2012;366:197-199.

14. van Tulder MW, Koes BW, Bouter LM. A cost-of-illness study of back pain in The Netherlands. Pain. 1995;62:233-240.

15. Nielens H, Van Zundert J, Mairiaux P, Gailly J, Van den Hecke N, Mazina D, et al. Chronische lage rugpijn. Brussels: Belgian Health Care Knowledge Centre; 2006.

16. Hooten WM, Cohen SP, Rathmell JP. Introduction to the Symposium on Pain Medicine. Mayo Clin Proc. 2015;90:4-5.

17. Treede RD, Jensen TS, Campbell JN, Cruccu G, Dostrovsky JO, Griffin JW, et al. Neuropathic pain: redefinition and a grading system for clinical and research purposes. Neurology. 2008;70:1630-1635.

18. Carragee EJ, Alamin TF, Miller JL, Carragee JM. Discographic, MRI and psychosocial determinants of low back pain disability and remission: a prospective study in subjects with benign persistent back pain. Spine J. 2005;5:24-35.

19. Lee HI, Lee ST, Kim M, Ryu JS. Sex differences in predicting chronicity of low-back pain after acute trauma using lumbar muscle area. Am J Phys Med Rehabil. 2015;94:123-130.

20. Nilsen TI, Holtermann A, Mork PJ. Physical exercise, body mass index, and risk of chronic pain in the low back and neck/shoulders: longitudinal data from the Nord-Trondelag Health Study. Am J Epidemiol. 2011;174:267-273.

21. Shiri R, Karppinen J, Leino-Arjas P, Solovieva S, Viikari-Juntura E. The association between smoking and low back pain: a meta-analysis. Am J Med. 2010;123:87 e87-35.

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22. Heymans MW, van Buuren S, Knol DL, Anema JR, van Mechelen W, de Vet HC. The prognosis of chronic low back pain is determined by changes in pain and disability in the initial period. Spine J. 2010;10:847-856.

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24. Picavet HS, Vlaeyen JW, Schouten JS. Pain catastrophizing and kinesiophobia: predictors of chronic low back pain. Am J Epidemiol. 2002;156:1028-1034.

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27. Chavannes A, Mens J, Koes B, Lubbers W, Ostelo R, Spinnewijn W, et al. NHG-Standaard Aspecifieke lagerugpijn (Eerste herziening). Huisarts Wet. 2005;48:113-123.

28. Kress HG, Aldington D, Alon E, Coaccioli S, Collett B, Coluzzi F, et al. A holistic approach to chronic pain management that involves all stakeholders: change is needed. Curr Med Res Opin. 2015;31:1743-1754.

29. Schellingerhout JM. [New practice guideline for spine related low back pain; anesthesiologists use a different classification system than general practitioners]. Ned Tijdschr Geneeskd. 2013;157:A6592.

30. Hill JC, Whitehurst DG, Lewis M, Bryan S, Dunn KM, Foster NE, et al. Comparison of stratified primary care management for low back pain with current best practice (STarT Back): a randomised controlled trial. Lancet. 2011;378:1560-1571.

31. Lee J, Gupta S, Price C, Baranowski AP, British Pain S. Low back and radicular pain: a pathway for care developed by the British Pain Society. Br J Anaesth. 2013;111:112-120.

32. Breivik H, Eisenberg E, O'Brien T, Openminds. The individual and societal burden of chronic pain in Europe: the case for strategic prioritisation and action to improve knowledge and availability of appropriate care. BMC Public Health. 2013;13:1229.

33. COST B13: European guidelines for the management of low back pain. Eur Spine J. 2006;15 Suppl 2:s125-127.

34. Hayden JA, van Tulder MW, Malmivaara A, Koes BW. Exercise therapy for treatment of non-specific low back pain. Cochrane Database Syst Rev. 2005:CD000335.

35. Maher C, Latimer J, Refshauge K. Prescription of activity for low back pain: What works? Aust J Physiother. 1999;45:121-132.

36. NICE. Low Back Pain: Early Management of Persistent Non-specific Low Back Pain. Low Back Pain: Early Management of Persistent Non-specific Low Back Pain. London2009.

37. Beneciuk JM, Robinson ME, George SZ. Subgrouping for patients with low back pain: a multidimensional approach incorporating cluster analysis and the STarT Back Screening Tool. The journal of pain : official journal of the American Pain Society. 2015;16:19-30.

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Chapter 6

General Discussion

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The overall aim of this dissertation, as introduced in Chapter 1 was:

“To examine the natural course, costs and organization of care for LBP patients and explore alternative disease classification systems to enable tailored treat-ment.” This Chapter summarizes: the main findings, recent literature and what this dissertation adds, implications for practice, implications for further research, final conclusions and future perspectives.

SUMMARY OF MAIN FINDINGS

In Chapter 2 we report a systematic review of the literature that investigated the natu-ral course of pain in patients attending primary care, with non-specific LBP of less than 3 months duration, and a follow-up of at least 12 months.

The analysis of 11 eligible studies showed a recovery in the first 3 months in 33% of the patients, but one year after onset 65% still report pain, thus rejecting the assump-tion that spontaneous recovery occurs in a large majority of patients. The included studies used different definitions of “pain free”, which results in varying percentages of pain free patients. The results of this study indicate that patients, who did not recover within the first 3 months after onset of the pain episode, should closely be followed, trying to reduce the chronification.

In Chapter 3 we report an evidence based, multidisciplinary guideline for the inva-sive treatment of LBP in patients whose pain is refractory to conservative treatment. The treatment options are reviewed by diagnoses as indicated in the proposed new classification system for LBP. There are many classification systems for chronic pain. Only a few systems have been tested for reliability, validity and applicability. Most sys-tems use only one dimension that is of importance for chronic pain such as the pain mechanism or the psychosocial component. There is no system that describes all the dimensions of chronic pain that is valid, reliable and applicable for all disciplines and all patients. We propose a new classification of LBP, based on degenerative or non-degenerative disease. The degenerative diseases are subdivided in complicated versus uncomplicated syndromes that have the objective to promote understanding of the underlying mechanisms and improve the referral pattern. (Figure 1, chapter 3) General practitioners stated in a reaction to the publication of the classification and the guide-line for interventional pain management that there is little justification for the classifica-tion degenerative and non degenerative versus specific and non-specific (1) The non-degenerative pain syndromes roughly overlap the diseases to be excluded by the well-known “red flags”. Where possible the underlying cause should be managed. Once the GP confirms the diagnosis “degenerative” disease refractory to conservative treatment the patient should be referred, preferentially to a multidisciplinary pain center.

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The guideline summarizes the available evidence for the anesthesiological treatment of degenerative uncomplicated pain syndromes of the lumbosacral spine, by sub diag-noses of the former non-specific degenerative uncomplicated LBP group. These sub diagnoses are: facet joint pain, sacro-iliac joint (SIJ) pain, coccygodynia, discogenic pain, and failed back surgery syndrome (FBSS).

Anesthesiological treatments consist of injection of local anesthetic solution some-times combined with corticosteroids, radiofrequency treatment and SCS. For most of the procedures the level of evidence is low according the GRADE method. (Table 4, Chapter 3)

The systematic review of the literature leads to the following recommendations for patients with pain refractory to conservative treatment:

• Radiofrequency lesioning of the medial branches of the rami dorsalis of the af-fected segmental nerves can be performed for facet joint pain

• Intra-articular corticosteroid injection can be applied for patients with SIJ. • If an intra-articular corticosteroid injection provides insufficient effect, treatment

using cooled RF lesion or RF lesion can be considered • In patients with coccygodynia, a corticosteroid injection can be a treatment op-

tion. • In patients with discogenic low back pain, a RF lesion of the ramus communicans

or IDET may be considered. • Epiduroscopy can be a treatment option for patients with FBSS • Spinal cord stimulation is recommended for patients with FBSS who have pro-

nounced leg pain It was commented that the interventional pain management should be compared

with conservative treatment because good clinical practice follows the principle “pri-mum non nocere”(1) The interventional pain management techniques are mostly only considered when conservative treatment fails or pharmacotherapy causes intolerable side effects. It is difficult to perform a comparative study where suffering patients are offered the same treatment as the one that already failed. On the other hand the diag-nostic process studies were evaluated using the EBRO criteria, and studies on therapies were evaluated with the Grading of Recommendations Assessment, Development and Evaluation system

In Chapter 4 we described the medical specialist care in terms of the order in which medical specialisms are consulted after referral of LBP patients to the hospital and the hospital cost for LBP patients in total and per specialism. We studied the Diagnosis Treatment Combination (DTC) and associated costs for LBP patients. Data were re-trieved from the DTC registry of Vektis (an organization that collects all health insurance data in the Netherlands) and analyzed using descriptive statistics. The data included patient characteristics and DTC specific information (e.g. specialisms). The vast majority of patients (84%) are first seen by a neurologist or orthopedist, covering 55% and 29% of the patients respectively. The proportion of patients consulting an anesthesiologist

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increased from 26% at the second DTC, up to 50% at the eighth DTC. Overall, the major-ity of all DTC’s were invoiced by the neurology specialism (40%), followed by the ortho-pedic (23%), anesthesiology (23%), neurosurgery (14%) and radiology (<1%) specialisms. The average costs per LBP patient was €2,410, ranging from €608 for the subgroup of patients with 1 DTC to €47,223 for the one patient with 22 DTC’s. It can be speculated that one reason for having multiple DTC’s is the lack of a specific diagnosis and a tai-lored treatment plan. Optimizing the diagnosis and treatment in medical specialist care could potentially lead to LBP patients needing less DTC’s. To achieve this, there could be a potential role for “intermediate care” focusing on back pain patients. This becomes especially relevant as the hospital costs for LBP patients are substantial in the Nether-lands (estimated to be 194 million annually) and are expected to increase given the rising incidence of LBP. Alternative organizations of care for LBP patients, such as a form of intermediate care and a multidisciplinary approach in the hospital might improve the diagnosis, result into tailored treatment and could have the potential to reduce costs.

In Chapter 5 we give some suggestions about a new organization model for LBP in the first and second line. In the previous chapters we described that considerably more patients will suffer LBP one year after the first diagnosis as originally believed. (CH 2). Interventional pain management may be considered for patients with LBP refractory to conservative treatment. The treatment recommendations are formulated by sub diag-noses in the uncomplicated degenerative LBP group. (CH 3) The seemingly uncoordinat-ed referral process is potentially related to high costs (CH 4). Therefore we try to formu-late the implications for the organization of LBP care.

Early improvement, within the first 3 months was found to be predictive for a lower risk for chronification. An adapted management program yields better outcome and has a lower cost. Breivik 2013 (2) stated that it is unrealistic that numerous different health care providers should see all patients with chronic pain. The role of the GP in the early stage of LBP is crucial. He often has a long history with the patient and knows the familial predisposition and tendencies for dramatizing and catastrophizing. However, assessing the risks factors, making a sub-diagnosis and providing the adequate information re-quires good knowledge and is time consuming. Ideally the GP should obtain assistance of a Spine Physician Assistant (SPA). This person could be a nurse specialized in triage diag-nosis and management of the LBP patients This SPA would work, under supervision of the GP. The task of this SPA could be monitoring chronicity, absenteeism and undesirable disease course. When LBP problems persist and the first hospital treatment was not successful, a multidisciplinary approach may help to find the tailored care.

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RECENT LITERATURE AND WHAT THIS DISSERTATION ADDS

The global aim of this thesis is to assemble information allowing to suggest a first and second line care system that improves treatment selection and outcome and reduces the health care cost of LBP.

During several decennia LBP was considered to have a favorable natural evolution in the vast majority of the patients.(3) The search for factors that are predictive for the chronification of LBP showed that over 70% of the patients continued to have pain 1 year after the first episode and 14% experienced marked disability.(4) A prospective study in the general population over a period of 5 years found that LBP should be con-sidered transient since the condition rarely seems to be self-limiting but merely pre-sents with periodic attacks and temporary remissions.(5) Our study shows that in the first 3 months recovery is observed in only 33% of patients, but one year after onset 65% still report pain. Subgroup analysis reveals that the pooled proportion of patients still reporting pain after 1 year was 71% at 12 months for studies that considered total absence of pain as a criterion for recovery versus 57% for studies that used a less strin-gent definition. The pooled proportion for Australian studies was 41% versus 69% for European or US studies. Our observations stress the importance of close follow-up of patients who still suffer LBP 3 months after the initial diagnosis.

Patients with LBP refractory to conservative treatment may be candidate for multi-disciplinary evaluation and treatment, including the appropriate use of interventional pain management techniques.

The paucity of evidence on the value of diagnostic and therapeutic interventions, and a lack of clear clinical guidelines or differences in healthcare and insurance systems may be the cause of high treatment variability internationally. (6) Our study adds a clear proposal for a new classification (Figure 1, Chapter 3) system for LBP and a Dutch multi-disciplinary guideline for invasive treatment of pain syndromes of the lumbosacral spine with different diagnoses in the degenerative uncomplicated LBP group. We described the following sub diagnoses: facet joint pain, (SIJ) pain, coccygodynia, discogenic pain, and FBSS and the evidence based interventional treatment recommendations. These are minimally invasive treatments such as targeted injection techniques, radiofrequency lesions and SCS.

The worldwide prevalence of LBP in 2010 was high in Australia, Western Europe and North America compared to the rest of the world. Musculoskeletal diseases are world-wide on the second place of all disorders after mental and behavioral syndromes. About 50% of all musculoskeletal diseases concern LBP. (7) The direct costs in 2007 for LBP per year per country roughly appear higher in the US and the Netherlands compared with Belgium, Sweden and the UK. (8) This thesis adds the yearly Dutch LBP hospital costs from 2008 to 2011 spe d to €194 million, of which the largest part could be allocated to the anesthesiology and neurosurgery specialisms.

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The British Pain Society published pathways for the management of pain, neuro-pathic pain and spinal pain, all dealing with LBP. The pathway on LBP reached across all disciplines and involved input from patients. (9) Early identification of people at high risk of chronic disability may allow more intensive management, better use of resources, and reduction in disability (10) The pathway progresses through first, second and third line drug treatment and non-pharmacological approaches. Timely referral of the patient to the specialist care is vital in the pathway. (11)

The GP is the coordinator of the patient care; we propose a Dutch version of this management and referral diagram for LBP (Figure 2, Chapter 5). The Spine Physician Assistant (SPA) could be a nurse specialized in triage diagnosis and management of the LBP patients who works under supervision of the GP. The task of this SPA is monitoring chronicity, absenteeism and undesirable disease course. For patients with refractory pain, a multidisciplinary approach aimed at providing the most appropriate treatment in the hospital is indicated.

IMPLICATIONS FOR PRACTICE

The assumption that spontaneous recovery occurs in a large majority of LBP patients is not justified. There should be more focus on intensive follow-up of patients who have not recovered within the first three months. The new classification enables to distin-guish “sub diagnoses” in the group with non-complicated degenerative LBP (former non-specific LBP group). The implication for practice is the possibility for more targeted treatment of some of these LBP patients. This could potentially lead to LBP patients needing less DTC’s. Intermediate care and a multidisciplinary approach in the hospital might improve diagnosis, resulting into tailored treatment and has the potential to improve outcomes and reduce costs. The patient should receive clear information by a professional who is aware of sub diagnoses for non-complicated degenerative LBP, the precursors to chronic symptoms development (pathology related or psychosocial) and minimal invasive interventions, exercises or psychological counseling. Ideally the GP should obtain assistance for this purpose, for instance from a SPA. As noted in this the-sis (Figure 2, Chapter 5) the role of the primary and intermediate (1.5 line) care is very important. The triage performed in this phase will help direct the patient to the appro-priate second line care. The multidisciplinary management of patients with refractory LBP is part of the second line health care process. An earlier appropriate referral should lead to a more satisfied patients receiving cost-effective treatment. In other words, as a last resort option it might be better for some patients not to act curative, but rather to provide appropriate care to avoid worse suffering.

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IMPLICATIONS FOR FURTHER RESEARCH

Reducing the percentage of patients who evolve towards chronic LBP requires a good understanding of the early signs and symptoms that are predictive for chronification. More research into the risks for chronification of LBP is required.

Secondly research supporting the sub-classification of non-complicated degenera-tive LBP, should help fine-tuning the sub-diagnosis.

An alternative organization of care for LBP patients based on a triage model may speed up the selection of the appropriate treatment and has the potential to reduce costs. Therefore, further research is required to examine the feasibility, (patient report-ed) outcomes and costs of intermediate care and a multidisciplinary approach in the hospital for LBP patients.

FINAL CONCLUSIONS AND FUTURE PERSPECTIVES

The main objective of this thesis was: to examine the natural course, costs and organi-zation of care for LBP patients and explore alternative disease classifications systems to promote tailored treatment.

The clinical course of LBP is different than previously assumed. Although a third of the patients that heal spontaneously within three months, more than half of all patients still have significant pain after one year. LBP patients who continue to have symptoms after 3 months deserve special attention trying to prevent chronification of their com-plaints.

By a better classification system for in particular the non-complicated degenerative LBP and identification of sub diagnoses within this group will improve treatment selec-tion. To avoid well intentioned clinical “get lost in the second line” and to promote ap-propriate treatment outside or inside the hospital, a change in the organization of care around the diagnosis and treatment of spine patients is recommended. We suggested a form of intermediate care between GP’s and the second line. The SPA could perform a triage based on the knowledge of the diagnosis and corresponding treatment possibili-ties and impossibilities, all under the supervision of the GP. This is possibly followed by a multidisciplinary evaluation in the hospital for LBP patients who do not have a satisfac-tory result after the initial treatment. This would most likely benefit the patient in terms of pain relief, function improvement and a better quality of life. Moreover, from a socie-tal perspective, alternative organization of LBP care might result health care cost sav-ings for LBP.

General Discussion

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REFERENCES

1. Schellingerhout JM. [New practice guideline for spine related low back pain; anesthesiologists use a different classification system than general practitioners]. Ned Tijdschr Geneeskd. 2013;157(32):A6592.

2. Breivik H, Eisenberg E, O'Brien T, Openminds. The individual and societal burden of chronic pain in Europe: the case for strategic prioritisation and action to improve knowledge and availability of appropriate care. BMC Public Health. 2013;13:1229.

3. Spitzer W, LeBlanc F, Dupuis M, Abenhaim L, Belanger A, Bloch R, et al. Scientific approach to the assessment and management of activity-related spinal disorders: a monograph for clinicians. Report of the Quebec task force on spinal disorders. Spine. 1987;12(7S):S4-S55.

4. Wahlgren DR, Atkinson JH, Epping-Jordan JE, Williams RA, Pruitt SD, Klapow JC, et al. One-year follow-up of first onset low back pain. Pain. 1997;73(2):213-21.

5. Hestbaek L, Leboeuf-Yde C, Engberg M, Lauritzen T, Bruun NH, Manniche C. The course of low back pain in a general population. Results from a 5-year prospective study. J Manipulative Physiol Ther. 2003;26(4):213-9.

6. Koes BW, van Tulder MW, Ostelo R, Kim Burton A, Waddell G. Clinical guidelines for the management of low back pain in primary care: an international comparison. Spine (Phila Pa 1976). 2001;26(22):2504-13; discussion 13-4.

7. March L, Smith EU, Hoy DG, Cross MJ, Sanchez-Riera L, Blyth F, et al. Burden of disability due to musculoskeletal (MSK) disorders. Best practice & research Clinical rheumatology. 2014;28(3):353-66.

8. Dagenais S, Caro J, Haldeman S. A systematic review of low back pain cost of illness studies in the United States and internationally. Spine J. 2008;8(1):8-20.

9. Lee J, Gupta S, Price C, Baranowski AP, British Pain S. Low back and radicular pain: a pathway for care developed by the British Pain Society. Br J Anaesth. 2013;111(1):112-20.

10. Price C, Lee J, Taylor AM, Baranowski AP, British Pain S. Initial assessment and management of pain: a pathway for care developed by the British Pain Society. Br J Anaesth. 2014;112(5):816-23.

11. Smith BH, Lee J, Price C, Baranowski AP. Neuropathic pain: a pathway for care developed by the British Pain Society. Br J Anaesth. 2013;111(1):73-9.

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Summary

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INTRODUCTION: CHAPTER 1

This thesis concerns: The clinical course of nonspecific low back pain within one year after the onset of symptoms. (Prevalence) Another classification proposal of low back pain with related diagnostics and treatment options. (intervention) The current organi-zation and the cost of the treatment of lower back pain in the second line. (Efficiency)

COURSE: CHAPTER 2.

Nonspecific low back pain is a relatively common and recurrent condition for which at present there is no effective cure. In current guidelines the prognosis of acute nonspe-cific back pain is assumed to be favorable but this assumption is mainly based on return to function. In our systematic review (2012) we investigated the clinical Course of pain in patients with nonspecific acute low back pain that seek treatment in primary care. Included were prospective studies, with follow-up of at least 12 months, that studied the prognosis of patients with low back pain for less than 3 months duration in primary care settings. Proportions of patients still reporting pain during follow-up were pooled using a random-effects model. Subgroup analyses were used to identify sources of vari-ation between the results of individual studies. A total of 11 studies were eligible for evaluation. In the first 3 months recovery is observed in 33% of patients, but one year after onset 65% still report pain. Subgroup analysis reveals that the pooled proportion of patients still reporting pain after one year was 71% at 12 months for studies, that considered total absence of pain as a criterion for recovery versus 57% for studies, that used a less stringent definition. The pooled proportion of patients still reporting pain for Australian studies was 41% versus 69% for European or USA studies.

The findings of this review indicate that the assumption that spontaneous recovery occurs in a large majority of patients is not justified. There should be more focus on intensive follow-up of patients who have not recovered within the first three months.

THE NEW MULTIDISCIPLINARY DUTCH LBP GUIDELINE: CHAPTER 3

Low back pain is a widespread problem with major social and economic impact. About 85% to 90% of the patients with low back pain suffer from what is (until now) described as “nonspecific” low back pain; this is defined as low back pain not attributable to an identifiable, acknowledged specific pathology, such as an infection, tumor, osteoporo-sis, or fracture. Current guidelines on nonspecific low back pain generally assume that spontaneous recovery occurs in the majority of these patients. However in our system-atic review about the Course of LBP (2012)(chapter 2) we found that spontaneous re-covery from nonspecific low back pain during the first 3 months after onset occurs in

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only about one-third of the patients; the majority still experiences pain 1 year after onset. Currently patients with low back pain that is “labeled” nonspecific are managed by reassurance, analgesics, and activation/mobilization. However, pain specialists claim that these diagnoses should not be classified as nonspecific but rather as “specific.” It is suggested that better identification of these patients in an earlier phase and, if indicat-ed, the use of invasive treatment would improve the prognosis of those patients: A proposal for a new LBP

Classification was made. The Dutch Society of Anesthesiologists, in collaboration with the Dutch Orthopedic Association and the Dutch Neurosurgical Society, developed a multidisciplinary clinical guideline on the classification, pathophysiology, diagnosis and interventional treatment of nonspecific low back pain, subdivided into 5 spinal low back pain syndromes, (1) facet joint pain, (2) SIJ pain, (3) coccygodynia, (4) discogenic pain, and (5) FBSS. The choice of topics and the interventions described in this guideline were based on those commonly used in daily clinical practice.. The main purpose of the guideline was to determine the evidence of invasive treatment when conservative treatment has failed. The task force proposed to classify spinal low back pain syndromes into (1) “uncomplicated and complicated” degenerative pain syndromes and (2) no degenerative pain syndromes. The guideline discussed here focuses on the degenera-tive uncomplicated spinal low back pain syndromes. Diagnostic studies were evaluated using the EBRO criteria, and studies on therapies were evaluated with the Grading of Recommendations Assessment, Development and Evaluation system. For the evaluation of invasive treatment options, the guideline committee decided that the outcome measures of pain, function, and quality of life were most important. Results: The defini-tion, epidemiology, pathophysiological mechanism, diagnostics, and recommendations for invasive therapy for each of the spinal back pain syndromes are reported. The guide-line committee concluded that the categorization of low back pain into merely specific or nonspecific gives insufficient insight into the low back pain problem and does not adequately reflect which therapy is effective for the underlying disorder of a pain syn-drome. Based on the guideline “Spinal low back pain,” facet joint pain, pain of the sacro-iliac joint, and disk pain is part of a planned nationwide cost-effectiveness study.

COST ASPECTS: CHAPTER 4

We examined the organization of care, with regard to the patient’s pathway of consult-ed medical specialisms and costs for low back pain in the Netherlands with assistance of Vektis, this is an organization that collects health insurance claims data in the Nether-lands. Aggregated health insurance claims data were provided on all Diagnosis Treat-ment Combination (DTC) declarations for LBP patients first referred to the hospital in the 2nd half of 2008. Data were available up to 1 January 2012. The data included pa-tient characteristics and DTC specific information including the specialisms: neurology,

Summary

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neurosurgery, orthopedic surgery, anesthesiology and radiology. In total 80,652 LBP patients were referred to the hospital for the first time in the second half of 2008 ac-cumulating to a total of 173,620 DTC’s with total costs of €194 million. These patients were followed for 3.0 - 3.5 year. The average costs per LBP patient during this period was €2,410. 56% are female and 61% aged above 50 years at first referral to the hospi-tal. The average number of DTC’s per patient was 2.15. Fifty one percent of the patients needed only one DTC; less than 10% of patients needed 5 DTC’s. The neurologist was consulted first by the majority of the patients, when the patient progresses through the system (second and following DTC’s) the share of consultations to the neurologist de-creased, whereas that of anesthesiology specialism increased. The largest portion of costs was allocated to the anesthesiology and neurosurgery specialisms. In The Netherlands, LBP patients consult a variety of medical specialisms, with the majority of patients first referred to the neurologist. Hospital costs for LBP patients are substantial and are expected to increase given the rising incidence of LBP. Optimal diagnosis and tailored treatment plans might result in reduced costs and improved patient outcomes.

ORGANIZATION: CHAPTER 5

Low back pain in general and specifically chronic low back pain forms a major burden for the patient and society. Recent studies demonstrated that up to 65% of patients evolve to chronic pain as opposed to the previously accepted 8%. As low back pain patients consult first their general practitioner, the latter should establish a treatment plan, including the appropriate referrals. There are, however no clear guidelines as to how to refer low back pain patients. The process of trial and error of different special-ties and treatment possibilities often results in a long and costly trajectory. A better understanding of the subtypes of chronic low back pain, the risks for chronification and fast adequate referral may result in higher patient satisfaction and cost reduction. We described another classification system based on the clinical and anatomical character-istics of axial low back pain, separated from radicular pain. It is important to recognize the risks for chronification such as degenerative and/or herniated disk, a smaller cross-sectional area of the multifidus, erector spinae, and psoas muscles and psychological and social factors, to be able to provide appropriate management. Also stratification of the patients according to the degree of disability may help in defining the correct treatment approach. A one and a half line approach, where a spine physician assistant (SPA) works under the supervision of the general practitioner to establish the sub-diagnosis, the risk factors for chronicity and to explain the proposed management plan to the patient, may be helpful for an early appropriate treatment selection for the pa-tient with chronic low back pain.

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GENERAL DISCUSSION: CHAPTER 6

The clinical course of low back pain is different than previously assumed. Although is a third of the patients heals spontaneously within three months, more than half of all patients still have significant pain after one year. Back patients who continue to have symptoms after 3 months deserve special attention in order to avoid chronification of their complaints, to avoid the well-intentioned clinical “get lost in the second line” and finally to get the most appropriate treatment outside or inside the hospital. By a better classification system for in particular the non-specific back problems and formulation of sub-diagnoses within this sector will give more targeted treatment options for those diseases. Sub-diagnoses should be recognized through advanced diagnostics and situa-tions around back pain that belong more in the psychosocial sector should be identified early to progress to a more efficient and faster treatment and less money wasting. "Last but not least", the patient experiences most benefit, less pain, function improvement and a better quality of life. This requires a change in the organization of care around the diagnosis and treatment of spine patients in general, and those with nonspecific back pain particularly. A form of one-and-a-half line care between GPs and the second line could bring a solution. The Spine Physician Assistant (SPA) could fulfill perform a triage with knowledge of the back diagnosis and corresponding treatment possibilities and impossibilities, all under the supervision of the GP. In General Practice attention is usu-ally focused on “curing” low back pain. What happens with patients who still have symptoms after three months? For these LBP patients, more attention to “care” may be a better solution. Of course, some of these new organization proposals need to be test-ed in practice. In particular, the effectiveness of the treatment of new diagnoses in the non-specific back pain sector in the longer term, the cost effectiveness of the recom-mended organizational changes in the low back pain care and finally an evaluation of pain experience, motion functioning and quality of life of the patient himself. All these things will be a part of future scientific research.

Summary

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Nederlandse samenvatting

Chronische lage rug pijn, beschouwingen over: het ziekte beloop, diagnose en behandeling

plus de kosten ervan

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INTRODUCTIE: HOOFDSTUK 1

Dit proefschrift gaat over: Het klinische beloop van aspecifieke lage rugpijn gedurende een jaar na het ontstaan van de klachten. (Prevalentie) Een ander classificatie voorstel voor lage rugpijn met sub-diagnostiek en daarbij behorende behandel opties. (Interven-tie)

De huidige organisatie en kosten van de behandeling in de tweede lijn van lage rug-pijn. (Efficiëntie).

HET ZIEKTEBELOOP: HOOFDSTUK 2

Aspecifieke lage rugpijn is een relatief veel voorkomende en vaak terugkerende aan-doening waarvoor op dit moment geen effectieve behandeling bestaat. In de huidige richtlijnen wordt aangenomen dat de prognose van acute aspecifieke lage rugpijn rede-lijk gunstig is, maar deze aanname is hoofdzakelijk gebaseerd op herstel van het functi-oneren. In ons systematisch onderzoek van de literatuur (Itz 2012 EJP) analyseerden we het klinisch beloop van pijn bij patiënten met aspecifieke acute lage rugpijn die behan-deling zochten in de eerste lijn. Geïncludeerd waren prospectieve studies, met een follow-up van ten minste 12 maanden, waarbij de prognose van patiënten met lage rugpijn bestudeerd werd welke minder dan 3 maanden klachten hadden en hulp zoch-ten bij de huisarts. De proporties van patiënten die nog steeds pijn rapporteerde tijdens de follow-up periode werden gepoold met behulp van het zogenaamde “random-effect” model. Subgroep analyses werden gebruikt om de oorzaak van variatie tussen de resultaten van individuele studies vast te stellen. In totaal kwamen 11 studies in aanmerking voor beoordeling. In de eerste 3 maanden werd voor gepoolde proporties herstel waargenomen bij 35% van de patiënten, maar een jaar na het begin van de klachten werd nog steeds pijn gerapporteerd bij de 65% overige (gepoolde proportie van) patiënten. Uit een subgroep analyse op basis van de definitie “pijn-vrij” blijkt dat de gepoolde proportie van patiënten die nog pijn rapporteerde na één jaar 71% bedroeg indien het criterium totale afwezigheid van pijn was (VAS = 0) versus 57% voor studies waarbij een minder strenge definitie van “pijn-vrij” (VAS < 2) werd gehanteerd. De ge-poolde proportie van patiënten die nog steeds pijn hebben na 1 jaar, voor Australische studies was 41% versus respectievelijk 69% voor de Europese of USA-studies. De bevin-dingen van dit onderzoek geven aan dat de veronderstelling waarbij spontaan herstel optreedt bij een grote meerderheid van de patiënten niet gerechtvaardigd is. Patiënten die drie maanden na het optreden van rugproblemen niet hersteld zijn moeten inten-sief gevolgd worden.

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DE NIEUWE MULTIDISCIPLINAIRE NEDERLANDSE RICHTLIJN LAGE RUGPIJN: HOOFDSTUK 3

Lage rugpijn is een veel voorkomend probleem met een grote maatschappelijke en economische impact Ongeveer 85% tot 90% van de alle patiënten met lage rugpijn hebben de zogenaamde "aspecifieke" lage rugpijn. Daaronder wordt verstaan, lage rugpijn die niet te wijten aan specifieke herkenbare pathologie, zoals een infectie, tu-mor, osteoporose of fracturen. In de huidige richtlijnen voor aspecifieke lage rugpijn wordt algemeen aangenomen dat spontaan herstel optreedt bij het merendeel van deze patiënten. Maar in onze systematische review over het verloop van LBP (Itz 2012 EJP) toonden we aan dat spontaan herstel van aspecifieke lage rugpijn tijdens de eerste 3 maanden na het begin van de klachten slechts bij een derde van de patiënten het geval is; de meerderheid ervaart echter nog steeds pijn na 1 jaar. Patiënten met aspeci-fieke lage rugpijn worden behandeld door ze gerust te stellen, analgetica en activa-tie/mobilisatie.. Pijn specialisten beweren, echter, dat deze diagnoses niet als aspeci-fiek, maar veeleer als specifiek moeten worden geklasseerd. Er wordt gesuggereerd dat betere herkenning van deze patiënten in een eerdere fase van de ziekte plus, indien geïndiceerd, het gebruik van meer op die sub diagnoses gerichte invasieve behandelin-gen, de prognose van deze patiënten zou kunnen verbeteren: Er werd een voorstel voor een nieuw classificatie systeem bij lage rugpijn geformuleerd. De Nederlandse Vereni-ging voor Anesthesiologie, in samenwerking met de Nederlandse Orthopedische Ver-eniging en de Nederlandse Vereniging voor Neurochirurgie, ontwikkelden een multidis-ciplinaire klinische richtlijn omtrent de classificatie, pathofysiologie, diagnose en inter-ventionele behandeling van lage rugpijn voor 5 spinale lage rugpijn syndromen, namelijk (1) facet gewrichtspijn, (2) SIJ pijn, (3) coccygody-, (4) discogenic pijn en (5) FBSS. De keuze van de onderwerpen en de in deze richtlijn beschreven interventie is gebaseerd op dat wat gewoonlijk gebruikt wordt in de dagelijkse klinische praktijk. De belangrijkste doelstelling van de richtlijn was de evidentie van de interventionele behandelingen van lage rugpijn, wanneer de conservatieve behandeling faalde, te analyseren. De volgende classificatie voor lage rugpijn werd voorgesteld: een indeling in: (1) "ongecompliceerd en gecompliceerd" degeneratieve pijn syndromen en (2) niet degeneratieve pijn syn-dromen. De richtlijn die vervolgens wordt besproken richt zich op de reeds genoemde degeneratieve ongecompliceerde spinale lage rugpijn syndromen. (Itz 2015 PP)

Diagnostische studies werden geëvalueerd met behulp van de EBRO criteria, terwijl studies m.b.t. de therapie werden beoordeeld aan de hand van de GRADE (Grading of Recommendations Assessment, Development and Evaluation system) systematiek. Voor de evaluatie van invasieve behandelingen, werd besloten dat de uitkomstmaten: pijn, functionaliteit en kwaliteit van leven het belangrijkst waren. Het resultaat per wervelko-lom gerelateerd pijn syndroom was: een definitie, de epidemiologie, het pathofysiolo-gische mechanisme, het diagnostische proces en aanbevelingen voor invasieve thera-pie. De richtlijncommissie concludeerde dat de indeling van lage rugpijn in slechts speci-

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fieke of niet-specifieke onvoldoende inzicht geeft in het probleem van lage rugpijn en dat er onvoldoende rekening gehouden wordt met welke therapie effectief is voor de onderliggende aandoening van zo’n wervelkolom gerelateerd pijnsyndroom. Voor een volledige uitwerking van de diagnostiek en therapeutische aanbevelingen per pijn syn-droom verwijs ik naar de desbetreffende paragraaf. (Itz 2015 PP) Op basis van de richt-lijn wervelkolom gerelateerde lage rugpijn zal in de toekomst een landelijke kostenef-fectiviteit studie plaatsvinden naar facet gewrichtspijn, pijn van het SI-gewricht, en discogene pijn.

DE KOSTEN: HOOFDSTUK 4

We hebben gekeken naar de organisatie van de zorg, met name het traject dat de pati-ent doorloopt langs de geraadpleegde medische specialismen en de kosten voor de behandeling lage rugpijn met de hulp van Vektis; dit is een organisatie die de declaratie gegevens voor ziektekostenverzekeraars verzamelt in Nederland. Geaggregeerde decla-ratie gegevens voor de ziektekostenverzekering werden verstrekt over alle Diagnose Behandeling Combinaties (DBC’s) voor alle lage rugpijn patiënten die voor het eerst werden verwezen naar het ziekenhuis in de 2e helft van 2008 en die daarna werden vervolgd tot 1 januari 2012. De gegevens bevatten patiëntkenmerken en DBC specifieke informatie met inbegrip van de specialisten: neurologie, neurochirurgie, orthopedische chirurgie, anesthesiologie en radiologie. In totaal werden 80.652 lage rugpijn patiënten geteld waarbij voor het eerst in de tweede helft van 2008 een DBC werd geopend. In de periode tot 1-1-2012 werden voor deze patiënten 173.620 DBC’s geopend voor een totaal aan kosten van 194.000.000 € bij door verwijzing naar en in het ziekenhuis. In die periode van 3 -3,5 jaar waren de gemiddelde kosten voor deze lage rugpijn patiënten € 2.410. Bij de eerste verwijzing naar het ziekenhuis was 56% vrouw en 61% boven de 50 jaar. Het gemiddelde aantal DBC’s per patiënt was 2.15. Eenenvijftig percent van de patiënten had slechts één DBC en minder dan 10% van de patiënten had 5 of meer DBC’s nodig. Naarmate meerdere DBC nodig waren daalde het aantal neurologische DBC’s en steeg juist het aantal anesthesiologische DBC’s per patiënt. Het grootste ge-deelte van de kosten werd veroorzaakt door de anesthesiologische en neurochirurgi-sche specialismen In Nederland worden lage rugpijn patiënten naar verschillende speci-alisten in het ziekenhuis verwezen. De meeste worden voor het eerste consult verwe-zen naar de neuroloog. Ziekenhuiskosten voor lage rugpijn patiënten zijn aanzienlijk en zullen naar verwachting nog toenemen, gezien het stijgende aantal gevallen van lage rugpijn patiënten. Optimale lage rugpijn diagnostiek en een gerichtere behandeling ervan kunnen leiden tot lagere kosten en betere patiënt tevredenheid ten aanzien van pijn, functionaliteit en kwaliteit van leven. (Itz 2016 EJP)

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DE ORGANISATIE VAN DE ZORG: HOOFDSTUK 5

Lage rugpijn in het algemeen en chronische lage rugpijn in het bijzonder vormt een grote belasting voor de patiënt en de samenleving. Recente studies hebben aangetoond dat tot 65% van alle patiënten chronische pijn ontwikkelen in tegenstelling tot de eer-der gerapporteerde slechts 8%. Als patiënten met lage rugpijn zich voor het eerst pre-senteren bij hun huisarts, moet deze een behandelplan op te stellen, met inbegrip van de juiste verwijzingen. Er zijn echter geen duidelijke richtlijnen over hoe deze patiënten met lage rugpijn door verwezen zouden moeten worden. Het proces van “maar wat proberen” door verschillende medisch specialisten binnen hun eigen behandelmoge-lijkheden resulteert vaak in een lang en kostbaar traject. Een beter begrip van de sub-diagnoses van chronische lage rugpijn, de risico's voor chroniciteit en een snelle ade-quate doorverwijzing kan leiden tot een grotere patiënt tevredenheid en kostenreduc-tie. We beschrijven hier (Itz 2016 CMRO) een classificatie voor lage rugpijn op basis van de klinische en anatomische kenmerken van axiale lage rugpijn naast die van radiculaire pijn. Het is belangrijk om het risico voor chronificatie bijtijds te herkennen zoals een degeneratieve discus en / of hernia ervan, slechte conditie van diverse rugspieren en enkele psychosociale factoren; dit alles kan leiden tot een beter pijn management. Te-vens kan een indeling naar ernst van functie beperking bij de patiënt helpen bij het bepalen van de juiste behandeling strategie. Een anderhalf lijn aanpak, waarbij een Spinal Physician Assistant (SPA = een in rugpijn gespecialiseerde verpleegkundige die werkt onder supervisie van de huisarts) en een belangrijke rol speelt en die kijkt naar de sub-diagnostiek, de risicofactoren voor chroniciteit en legt het voorgestelde beheers-plan aan de patiënt uit; kan nuttig zijn voor een vroege selectie en een passende be-handeling voor patiënten met dreigende chronische lage rugpijn.

CONCLUSIE: HOOFDSTUK 6

Het klinische beloop van lage rugpijn is anders dan eerder werd aangenomen. Terwijl een derde van de patiënten spontaan geneest binnen drie maanden, heeft meer dan de helft van de patiënten nog steeds significant pijn na één jaar. Rug patiënten die klachten blijven houden na 3 maanden verdienen bijzondere aandacht om het chronisch worden van hun klachten te voorkomen, om te vermijden dat ze verdwalen in de goedbedoelde klinische zorg van de tweede lijn, maar om er uiteindelijk voor te zorgen dat ze de meest geschikte behandeling in of buiten het ziekenhuis krijgen. Door een betere classi-ficatie voor met name de niet-specifieke lage rugklachten en formulering van sub-diagnose binnen deze sector zullen meer gerichte behandel opties zorgen voor een betere prognose van deze ziekten. Het herkennen van deze patiënten door middel van geavanceerde diagnostiek plus discus pathologie en het onderkennen van situaties rond rugpijn die meer in de psychosociale sector thuis horen betekent een stap voorwaarts

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naar een efficiëntere en snellere behandeling en leidt tot een situatie waarin minder geld verspild wordt. Uiteindelijk heeft de patiënt er het meeste voordeel van in de vorm van minder pijn, betere functionaliteit en een hoger kwaliteit van leven. Dit vereist een verandering in de organisatie van de zorg rond de diagnose en behandeling van de wervelkolom patiënten in het algemeen, en die met aspecifieke rugklachten bijzonder. Een vorm van anderhalve lijn zorg tussen huisarts en de tweede lijn in, kan een oplos-sing te bieden. De “Spine Physician Assistant” (SPA) kan deze rol vervullen door triage met de kennis van rug diagnostiek en bijbehorende behandeling mogelijkheden en onmogelijkheden; dit alles onder supervisie van de huisarts. In huisartsgeneeskunde wordt de aandacht meestal gericht op "het genezen/cure" van lage rugpijn. Maar wat gebeurt er met de patiënten die nog klachten hebben na drie maanden? Voor deze lage rugpijn patiënten, zou meer aandacht voor "zorg/care" in plaats van “cure” wellicht een betere oplossing zijn. Natuurlijk moeten sommige van deze nieuwe organisatie voorstel-len eerst in de praktijk worden getest. Met name onderzoek naar de effectiviteit op lange termijn van de behandeling van nieuwe diagnoses in de niet-specifieke sector van lage rugklachten en onderzoek naar de kosteneffectiviteit ervan en van de aanbevolen organisatorische veranderingen in de lage rugpijn zorg zijn in de nabije toekomst van belang. Waarbij uiteindelijk de patiënt zelf niet uit het oog moet worden verloren ten aanzien van: de evaluatie van pijnervaring, verbetering van de functionaliteit en verho-ging van de kwaliteit van leven. Deze punten dienen in toekomstig wetenschappelijk onderzoek worden bekeken.

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Valorisation Addendum

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RELEVANCE

In this thesis we described the prevalence of LBP and the current LBP care system. We proposed a potentially more efficient way of care for low back pain (LBP) patients that involve a better pain reduction, functional recovery and quality of life, while optimizing the use of health care resources. Low back pain ranks first in the diseases that cause most years lived with disability.(1) Eighty percent of the population will suffer at least one episode of low back pain during lifetime and patients with chronic low back pain consume the majority of the health care resources attributed to LBP.(2) For a long time it was assumed that the majority of LBP patients recover spontaneously within weeks to a few months,(3) but the natural course of LBP does not seem so favorable.(4) The divergence in these epidemiological data may be attributed to the difference in definitions of recovery. There is need for consensus on the definition and classification of chronic LBP and there is need for more precise epidemiological data.

Our review study showed that in the first 3 months recovery is observed in 33% of patients, but one year after onset 65% still report pain.(5) The importance of the find-ings of this review is that the assumption that spontaneous recovery occurs in a large majority of patients is not correct. Historically LBP has been subdivided into: specific and non-specific low back pain. For specific low back pain an underlying pathology such as: infection, tumor, fracture, etc. can be identified and treated. The terminology “non-specific” LBP suggests that no cause or causal structure can be identified and therefore no treatment can be indicat-ed. Since, the structures potentially responsible for the LBP have been identified, treat-ment has been directed towards those structures. The content of the term “non-specific” has been changed now. A new classification system including this changed non-specific content has become more accessible to different involved parties. (6)

When the classification of LBP allows indicating the causal structure, a target specific treatment may be envisioned. The anesthesiological pain management techniques mostly target a specific nerve, such as the injection therapy, radiofrequency treatment, spinal cord stimulation.

In this context we describe different diagnoses in the former non-specific LBP sec-tion based on the proposal of the new classification system summarized in an evidence-based guideline on diagnose related interventions. (i.e., facet joint pain, SIJ pain, coc-cygodynia, discogenic pain, and FBSS).(7) This guideline gives a description of the defini-tion, epidemiology, pathophysiology, validity of the diagnosis, and the evidence for (minimal) invasive therapy when conservative treatment has failed.

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In The Netherlands the cost for care of neck and back pain for 2011 was estimated to be 1.3 billion Euros. Thirty-eight percent is attributed to hospital care, 29% to first line care, 17% to elderly care and 8% to medication and other devices.(8) In absence of a referral algorithm it is not clear how patients with LBP are referred to second line care and whether the cost of care varies according to the consulted specialist in second line. This information is crucial for designing a treatment pathway that optimizes the use of health care resources and improves treatment outcome. Early appropriate management and recognition of risk factors for chronification are crucial to an optimized treatment pathway. The general practitioner is best placed to guide the patient to the right specialist in the second line care. The GP has, however, about 15 possible specialists he can refer the patient to. Clarification and guidance is urgently needed in this field. (9)

TARGET GROUPS

Clinicians

The findings of our studies are of interest for the general practitioners and specialists potentially involved in the management of (chronic) LBP patients. We found that ap-propriate, early referral, may improve treatment outcome and optimize the use of healthcare resources. The general practitioner plays an important role in the detection of risks for chronification and timely referral to the right specialist.

Our analysis of aggregated health insurance claims on the Diagnosis Treatment Combination (DTC) learned that the majority of the patients with low back pain are first referred to the neurologist and orthopedic surgeon. The average number of DTC’s per patient was 2.15. The share of consultations by the neurologist decreased as the share of anesthesiology increased.(10)

The improvement proposal is that the general practitioner should obtain assistance of a trained spine specialist nurse specialized in triage diagnosis and management of the low back pain patients (Spine Physician Assistant: SPA). This assistant (SPA) works, under supervision of the general practitioner. The task of this SPA could be monitoring chro-nicity, absenteeism and unexpected course of disease.

Researchers

We suggested that a better, uniformly accepted classification of low back pain and early appropriate referral may improve treatment outcome and reduce costs. Further re-search should be performed to confirm this assumption. Efforts should be made to

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implement the management algorithm to allow cost-benefit analysis of the proposed new structure.

Patients

We found that natural course of non-specific low back pain is not as favorable as origi-nally believed. Patients who are treated according to the treatment guideline in the new organizational system may have a better pain reduction, improvement of quality of life and early return to normal function.

ACTIVITIES

The findings of the studies in this thesis lead to conclude that spontaneous recovery of low back pain does not happen in de majority of the patients. Patients who have not recovered within the first 3 months after the diagnosis are at higher risk for chronifica-tion. Therefore, it is recommended to perform an intensive follow-up of these patients. The new classification enables us to distinguish “sub diagnoses” in the former non-specific LBP section. The implication for practice is the possibility for more targeted treatment of some of these LBP patients. This could potentially lead to LBP patients needing less DTC’s. The recommendations issued in the guideline for the management of non-specific low back pain are evidence based. An important factor for treatment success is the correct patient selection. The hospital costs for LBP patients are substantial in the Netherlands and are expected to increase given the increasing incidence of LBP. Alternative organization of care for LBP patients, such as intermediate care and a multidisciplinary approach in the hospital might improve diagnosis, result into tailored treatment and has the potential to reduce costs. The position of the general practitioner as person of confidence for the patient and his family should be exploited to improve the early detection of risk factors for chronifica-tion, the potential sub diagnosis and hence the correct referral. Therefore, the general practitioner should obtain assistance of a trained spine specialist nurse, specialized in triage diagnosis and management of low back pain patients. Patients referred to the second line should be evaluated and managed by a multidisciplinary team, allowing the initiation of interventional pain management, rehabilitation and when necessary cogni-tive behavioral treatment.

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INNOVATIONS

In this thesis we first presented a novel useful classification system with validated sub- diagnoses for non-specific low back pain. The identification of sub-diagnosis allows a more tailored treatment approach.

Secondly we established an evidence-based multidisciplinary guideline for interven-tional pain management by clinical (sub)-diagnosis.

Third we propose an innovative organization of the assessment, referral, and follow-up of patients with chronic non-specific LBP in the general practitioner’s office. A Spine Physician Assistant should perform the assessment of risk for chronicity, and gathering patient information.

IMPLEMENTATION

The information gained in this thesis will have an impact on the use of health care re-sources. A detailed diagnostic process with attention for the sub-diagnoses and risk for chronification should lead to an appropriate referral to second line, where the minimal invasive treatment options can be applied. Better understanding of the classification of low back pain will improve the referral pattern and reduce the need for multiple DTC’s, thus reducing the costs of care for low back pain.

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REFERENCES

1. Global Burden of Disease Study C. Global, regional, and national incidence, prevalence, and years lived with disability for 301 acute and chronic diseases and injuries in 188 countries, 1990-2013: a systematic analysis for the Global Burden of Disease Study 2013. Lancet. 2015;386(9995):743-800.

2. Kent P, Kongsted A, Jensen TS, Albert HB, Schiottz-Christensen B, Manniche C. SpineData - a Danish clinical registry of people with chronic back pain. Clin Epidemiol. 2015;7:369-80.

3. Spitzer WO, Skovron ML, Salmi LR, Cassidy JD, Duranceau J, Suissa S, et al. Scientific monograph of the Quebec Task Force on Whiplash-Associated Disorders: redefining "whiplash" and its management. Spine. 1995;20(8 Suppl):1S-73S.

4. Hestbaek L, Leboeuf-Yde C, Manniche C. Low back pain: what is the long-term course? A review of studies of general patient populations. Eur Spine J. 2003;12(2):149-65.

5. Itz CJ, Geurts JW, van Kleef M, Nelemans P. Clinical course of non-specific low back pain: a systematic review of prospective cohort studies set in primary care. Eur J Pain. 2013;17(1):5-15.

6. Hooten WM, Cohen SP, Rathmell JP. Introduction to the Symposium on Pain Medicine. Mayo Clin Proc. 2015;90(1):4-5.

7. Itz CJ, Willems PC, Zeilstra DJ, Huygen FJ. Dutch Multidisciplinary Guideline for Invasive Treatment of Pain Syndromes of the Lumbosacral Spine. Pain Pract. 2015.

8. Lambeek LC, van Tulder MW, Swinkels IC, Koppes LL, Anema JR, van Mechelen W. The trend in total cost of back pain in The Netherlands in the period 2002 to 2007. Spine (Phila Pa 1976). 2011;36(13):1050-8.

9. Itz C, Huygen F, Kleef MV. A proposal for the organization of the referral of patients with chronicnon-specific low back pain. Curr Med Res Opin. 2016:1-7.

10 Itz et al. Medical specialists care and hospital costs for low back pain in The Netherlands, EJP oktober

2016

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Dankbetuigingen

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Door mijn achtergrond vanuit de anesthesiologie en het zorg verzekeringswezen heb ik twee ervaringen kunnen combineren in dit proefschrift. De collega’s met wie ik samen-werkte op de afdelingen anesthesiologie in Den Bosch en Helmond plus die van de kan-toren zorgverzekeraar VGZ in Eindhoven en Arnhem ben zeer erkentelijk.

Een paar mensen wil nu zeker nog in het bijzonder bedanken. Mijn 1e promotor prof. Dr. M. Van Kleef wil ik bedanken voor de promotieplaats die hij mij heeft aangeboden en het vertrouwen dat hij het hele traject in mij heeft gehad.

Mijn 2e promotor prof. Dr. F. Huygen wil ik bedanken voor de plaats die hij mij aan-bood in de richtlijn werkgroep “wervelkolom gerelateerde pijn klachten van de lage rug” en de steun bij het schrijven van het artikel erover in Pain Practice.

Mijn copromotor dr. B. Ramaekers wil ik graag bedanken voor zijn geduld met mij bij het schrijven van ons kosten artikel, de Introduction de General Discussion van mijn proefschrift.

De beoordelingscommissie: Prof. Dr. B Joosten (voorzitter), Prof. Dr. M Joore, Prof. Dr. E Curfs, Prof. Dr. R. Perez, en Prof. Dr. R. Smeets wil ik graag bedanken voor de tijd en energie die zij hebben geïnvesteerd in het kritisch lezen van mijn proefschrift.

Ik hoop geen van jullie na mijn promotie en pensionering uit het oog te verliezen. Hij heeft het zich niet gerealiseerd maar, Bas Geerdes: vroeg destijds of ik in zijn plaats voor Zorgverzekeraars Nederland de lezing “Pijnbestrijding en uw zorgverzekeraar” wilde verzorgen ter gelegenheid van het jubileumcongres ZonMw te Nieuwegein; mijn promotie onderzoek was hier een indirect gevolg van.

Maarten van Kleef, Frits van Merode, Bert Vrijhoef: zijn van groot belang geweest voor de start en het vervolg van mijn promotie activiteiten in Maastricht.

Dirk Ruwaard, Arnold van Alphen en Fons Kessels hebben mij steeds op allerlei ma-nieren ondersteund tijdens mijn nul uren aanstelling aan de Universiteit te Maastricht. José Geurts, Patty Nelemans, Sander van Kuijk: hebben mij ingewijd in de kunst van het schrijven van een wetenschappelijke artikel: taal technisch, methodologisch en grafisch.

Bart Verhulst, Martin Duvivier en Jeroen Arts zorgden ieder op hun manier voor het mogelijk maken om te werken aan mijn proefschrift tijdens mijn aanstelling als advise-rend arts bij zorgverzekeraar VGZ Eindhoven. Ubbo Noordhof, Karin Wiersema en Hans Jansen (paranimf) waren essentieel bij de ontwikkeling van de lay-out, de tekst en de omslag en de indeling van mijn proefschrift.

Frank Huygen, Paul Willems, Dick Zelstra, Carel Diekerhof, Michiel Terheggen, Ellis Vegt, Arnold Vreeling, Teus van Barneveld, Jocelyn. Berdowsky en Sabrina Muller Ploe-ger hebben mij tijdens de deelname aan de werkgroep “Wervelkolom gerelateerde pijnklachten van de lage rug” en nog lang daarna geholpen bij het schrijven van mijn richtlijn artikelen.

Paul Sterkenburg, Niels Hoeksema en Chantal van Tilburg: stonden aan de wieg van mijn zorg data onderzoek bij Vektis Zeist en hebben mij steeds ondersteund bij de ver-

Dankbetuigingen

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dere uitwerking daarvan voor het kosten artikel. Carmen Dirksen, Bram Ramaekers en Nicole van den Hecke hebben mij in de laatste fase van het schrijven van mijn proef-schrift met engelen geduld geholpen met hun expertise op het gebied van puntjes op de i en andere specifieke eindfase activiteiten bij het afronden van mijn proefschrift. Jules (paranimf) en Marcel Boere zijn mijn Maastrichtse hoop in bange dagen, waar het aankomt op richting geven en maathouden in Maastricht.

Karli, Joris en Emile zorgden voor onvoorwaardelijke steun door dik en dun, vooral daar waar hun respectievelijke echtgenoot en vader het op latere leeftijd in zijn hoofd haalde om te gaan promoveren: ik hou van jullie allemaal. Dank je wel Coen.

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Curriculum Vitae

Curriculum Vitae

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Coen Itz was born on July 26 1948 in Heerlen. He obtained the HBS-b diploma in the Grotius College, Heerlen and the Protestant Lyceum Eindhoven.

After his graduation he joins the Holland America Line and navigates between Rot-terdam and New York during a few years. Afterwards he studied medicine at the State University Utrecht.

He specialized in anesthesiology at the Free University Amsterdam with Prof. C. Pearce. Coen worked as all round anesthesiologist for 25 years in the Willem Alexander Hospital Den Bosch and the Elkerliek Hospital in Helmond. He obtained the certificate for Advanced Trauma Life Support (ATLS), he obtained the retrograde registration as intensive care (ICU) specialist and has a License for Acupuncture.

After a career of 25 years as anesthesiologist Coen makes a switch and becomes a medical advisor for the health insurer VGZ Eindhoven, where he provides the conceptu-al support for the purchase of second line care. Coen is member of the core team of the Association of Counseling Physicians in the health insurance (Vereniging Adviserend Geneeskundigen in de Zorgverzekering (VAGZ))

As advising physician for the health insurer VGZ, Coen is involved in the introduction of a new registration system for invoicing medical specialist activities with the founda-tion DBC Onderhoud, Zorgverzekeraars Nederland en Vektis. In 2015 Coen finished his career with VGZ having reached retirement age. Meanwhile, since 2011 Coen started his PhD. Coen is married with Karli Seckl and father of two adult sons. He is an active sportsman, when he quit his busy clinical job he ran the marathon in New York, as a way of relaxa-tion. He also has several administrative functions in social organizations.

ADDITIONAL RESEARCH

1980: “The correlation between artificially induced nystagmus en faked seasickness”. Research during the medical education under guidance of Prof. J. Groen. (KNO AZU Utrecht)

PRESENTATIONS

2011: “Intraoral interventions under general anesthesia outside the equipped operation room” lecture for the College of Advising dentists (College van Adviserende Tandartsen (CAT)). This lecture had the objective to highlight the risks of general anesthesia outside the hospital, because at that time several small dental clinics were established.

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2012: “Pain Management and your Health Insurer” Lecture during the jubilee congress of ZonMW for Health Care insurers in Netherlands. This lecture was the trigger fort he elaboration of this thesis.

2016: “The Cost of Low Back Pain” lecture for the “Invited conference Dutch Spine Consortium” for the “Vrije Universiteit in Amsterdam”. This lecture highlited the results of the Cost paper: Medical specialists care for low back pain in The Netherlands: Patients' pathway of consulted medical specialisms and costs.

PUBLICATIONS

1. Itz CJ, Geurts JW, van Kleef M, Nelemans P. Clinical course of non-specific low back pain: a systematic review of prospective cohort studies set in primary care. Eur J Pain. 2013;17(1):5-15. (Maastricht)

2. Itz CJ, Willems PC, Zeilstra DJ, Huygen FJ. [Multidisciplinary practice guideline 'Invasive treatment of spine related low back pain']. Ned Tijdschr Geneeskd. 2013;157(32):A6030. (Utrecht)

3. Itz CJ, Willems PC, Zeilstra DJ, Huygen FJ. Dutch Multidisciplinary Guideline for Invasive Treatment of Pain Syndromes of the Lumbosacral Spine. Pain Pract. 2016;16(1):90-110. (Rotterdam)

4. Itz C, Huygen F, Kleef MV. A proposal for the organization of the referral of patients with chronicnon-specific low back pain. Curr Med Res Opin. 2016:1-7. Maastricht / Rotterdam)

5. Itz CJ, Ramaekers BL, van Kleef M, Dirksen CD. Medical specialists care for low back pain in The Netherlands: Patients' pathway of consulted medical specialisms and costs. European Journal of Pain accepted oktober 2016; (Maastricht)

SPECIAL RECOGNITION

The “Wesly Price” from the scientific committee of the VAGZ for the publication “Clinical course of non-specific low back pain: a systematic review of prospective cohort studies set in primary care” (Zeist, 2013)

Schattenseite der Medizin

Systematisch werden Rücken-, Herz- oder Kniepatientennutzlosen Verfahren ausgesetzt. Viele Therapieversucheberuhen auf Trugschlüssen oder finanziellen Interessen.Deutlich wird dies, wenn Ärzte zu Patienten werden:Sie lassen sich seltener behandeln als der Rest der Bevölkerung.

Jörg Blech: 29.08.2005 - DER SPIEGEL