Scrambler Therapy: An Innovative Neuromodulation Approach to Complex Regional...
E-book Dissertatie Coen Itz
1. Chronic low back pain, considerations about
Natural Course, Diagnosis,
Interventional Treatment and Costs
Coen Itz
2. Copyright Coen Itz 2016
ISBN 978 94 6159 625 3
Production / print Datawyse | Universitaire Pers Maastricht
UNIVERSITAIRE
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3. 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
4. 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
5. 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)
6.
7. 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
11. 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
12. 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
13. 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
14. 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
15. 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.
16.
17. 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.)
18.
19. 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.
20. 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.
21. 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.
22. 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;
23. 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.
24. 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)
25. 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)
26. 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
27. 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)
30. 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
31. 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
32. 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
33. 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.
34. 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.
35. Clinical course of Nonspecific Low Back Pain
35
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37. 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.)
38. 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.
39. 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).
40. Chapter 3
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
41. 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
42. 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.
43. 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).
44. Chapter 3
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).
45. 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).
48. Chapter 3
48
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).
49. Multidisciplinary guideline invasive treatment pain syndromes of the lumbosacral spine
49
- 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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50
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).
51. Multidisciplinary guideline invasive treatment pain syndromes of the lumbosacral spine
51
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).
52. Chapter 3
52
(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).
53. Multidisciplinary guideline invasive treatment pain syndromes of the lumbosacral spine
53
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.
54. Chapter 3
54
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.
