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BMC Musculoskeletal Disorders
Open Access
Study protocol
Effectiveness of behavioural graded activity compared with
physiotherapy treatment in chronic neck pain: design of a
randomised clinical trial [ISRCTN88733332]
Frieke Vonk*1, Arianne P Verhagen1, Mario Geilen2, Cees J Vos1 and
Bart W Koes1
Address: 1Department of General Practice, Erasmus MC, University Medical Centre Rotterdam, the Netherlands and 2Department of Rheumatic
diseases and Chronic pain, Hoensbroek Rehabilitation Centre, the Netherlands
Email: Frieke Vonk* - f.vonk@erasmusmc.nl; Arianne P Verhagen - a.verhagen@erasmusmc.nl; Mario Geilen - m.geilen@srl.nl;
Cees J Vos - c.vos@erasmusmc.nl; Bart W Koes - b.koes@erasmusmc.nl
* Corresponding author
Abstract
Background: Chronic neck pain is a common complaint in the Netherlands with a point
prevalence of 14.3%. Patients with chronic neck pain are often referred to a physiotherapist and,
although many treatments are available, it remains unclear which type of treatment is to be
preferred.
The objective of this article is to present the design of a randomised clinical trial, Ephysion, which
examines the clinical and cost effectiveness of behavioural graded activity compared with a
physiotherapy treatment for patients with chronic non-specific neck pain.
Methods: Eligible patients with non-specific neck pain persisting longer than 3 months will be
randomly allocated to either the behavioural graded activity programme or to the physiotherapy
treatment. The graded activity programme is based on an operant approach, which uses a time-
contingent method to increase the patient's activity level. This treatment is compared with
physiotherapy treatment using a pain-contingent method.
Primary treatment outcome is the patient's global perceived effect concerning recovery from the
complaint. Global perceived effect on daily functioning is also explored as primary outcome to
establish the impact of treatment on daily activity. Direct and indirect costs will also be assessed.
Secondary outcomes include the patient's main complaints, pain intensity, medical consumption,
functional status, quality of life, and psychological variables. Recruitment of patients will take place
up to the end of the year 2004 and follow-up measurement will continue until end 2005.
Background
Prevalence and incidence
Neck pain is a common complaint that causes substantial
morbidity in western countries with a reported prevalence
ranging from 9.5 to 22% [1,2]. Of all musculoskeletal
pains in the Netherlands, neck pain is one of the three
most reported with a point prevalence of 21%; it is more
often reported by women than men [3]. In 1996 total
Published: 06 October 2004
BMC Musculoskeletal Disorders 2004, 5:34 doi:10.1186/1471-2474-5-34
Received: 06 August 2004
Accepted: 06 October 2004
This article is available from: http://www.biomedcentral.com/1471-2474/5/34
© 2004 Vonk et al; licensee BioMed Central Ltd.
This is an open-access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0),
which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
BMC Musculoskeletal Disorders 2004, 5:34 http://www.biomedcentral.com/1471-2474/5/34
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related costs were estimated to be US $686.2 million,
which is about 1% of the total Dutch health care expendi-
tures [4]. Most neck complaints are continuous or recur-
rent [3]. When the neck pain persists for more than 3
months it is defined as chronic, and the related prevalence
is 14.3% [3,5]. Although the prevalence of neck pain is
stable over different age groups, the incidence of chronic
neck pain increases with age [3,6].
There are many potential causes of neck pain, but mostly
no specific underlying pathology is found so that it is des-
ignated as non-specific [7]. Although not a life- threaten-
ing disease, neck pain can negatively affect patients'
quality of life, cause pain and stiffness, and may result in
substantial medical consumption, absenteeism and disa-
bility [4,8].
In the Netherlands, patients with neck pain are often
referred for physiotherapy. Moreover, physiotherapy
accounted for 84% of the total direct medical neck pain
costs in 1996 [4]. Although physiotherapists can apply
various treatments, no formal guidelines are yet available.
Treatment models
Two treatment models have been described in the litera-
ture, both of which are applicable within the field of phys-
iotherapy. The first, a biomedical model, considers pain
to be a sign of physiological damages and treatment
according to this model aims to remove the pathologic
condition so that the pain will no longer occur [9,10].
Moreover, treatment is guided by the amount of pain a
patient experiences, leading to a pain-contingent
approach [11]. According to the second, a biopsychoso-
cial model, pain is not necessarily caused by underlying
pathology or impairment but can persist long after the ini-
tial pathology has healed; psychological and social factors
may be important in the development and maintenance
of complaints [12,13]. According to the principles of this
biopsychosocial model, behavioural therapies assume
that maladaptive behaviours are learned and, therefore,
can be modified through new learning experiences
[10,14]. Three different approaches are known: respond-
ent, operant and, cognitive behavioural therapy [9,15,16].
The present study mainly employs an operant behavioural
approach, as described by Fordyce and applied by Lind-
ström et al [11,17]. According to this approach, the treat-
ment focuses on decreasing pain behaviour (operants)
and increasing healthy behaviour, and consists of behav-
ioural graded activity on a time-contingent basis [11,18].
Available evidence
Many conservative physiotherapeutic treatments are avail-
able for treating neck pain, but there is insufficient evi-
dence to allow to conclude that one type of treatment is
more effective then others [19,20].
In a review on chronic pain, operant behavioural therapy
was found to be beneficial to waiting list control groups
on outcomes such as pain experience, mood effect other
than depression, social role, and for the expression of pain
behaviour [21]. Compared to other treatments, operant
behavioural therapy is only beneficial for the expression
of pain behaviour and role functioning [21]. Another
review showed little evidence that biopsychosocial multi-
disciplinary rehabilitation is more effective than other
rehabilitation methods for neck and shoulder pain, but
the authors found only two relevant studies that satisfied
the criteria for their review [22]. When examining the
effectiveness of behavioural treatment for chronic pain
another difficulty is that no standard protocol exists for
the application of these treatments. As a result, a wide
range of techniques described in the literature has been
labelled as behavioural [23].
In summary, it remains unclear which type of conserva-
tive, including behavioural, treatment is to be preferred in
the management of chronic neck pain. Therefore, this
study, Ephysion (Effectiveness physiotherapy in neck
pain), aims to evaluate the clinical and cost effectiveness
of an operant behavioural programme (i.e. behavioural
graded activity) compared with a physiotherapy treatment
in patients with chronic non-specific neck pain. In addi-
tion, we aim to identify subgroups of patients who benefit
most from one of the two treatments, and to identify the
most important determinants for recovery from chronic
non-specific neck pain.
Why a design article
Because a biased study design can produce incorrect con-
clusions, the design of a trial should be carefully exam-
ined before adopting its conclusions [24]. A design article
allows to examine the design objectively without being
influenced by the study results, to check any resulting arti-
cles for protocol deviations, and may also reduce the
temptation to search for associations during data analysis
rather then presenting hypotheses in advance [25]. Fur-
ther, a published protocol informs others about which
studies are in process thus reducing duplication of
research effort [25]. Finally, a design article prevents pub-
lication bias in the case that future articles are not pub-
lished, because study results can be retrieved from the
author and the study can therefore still be included in
future reviews [25,26].
Methods
Study design
A randomised clinical trial (RCT) has been designed to
assess the effectiveness of behavioural graded activity
compared with physiotherapy treatment in patients with
chronic non-specific neck pain. The study design has been
approved by the Medical Ethics Technical Commission of
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the Erasmus MC, University Medical Centre in Rotterdam
and is in compliance with the Helsinki Declaration.
Selection of patients and informed consent
Forty general practitioners (GP) in region West Brabant in
the Netherlands will select the patients. Patients are eligi-
ble if they are aged between 18 and 70 years old, have suf-
fered from neck pain for over three months, and have an
adequate knowledge of the Dutch language. Excluded are
patients diagnosed with a specific disorder (e.g. a slipped
disc, a tumour or a lesion in the cervical spine), those who
have had physical/manual therapy during the previous six
months, those with a chronic disease (e.g. rheumatoid
arthritis or coronary artery disease), or those who have to
undergo surgery in the near future. Eligible patients will
receive an information leaflet from their GP and the GP
then informs the research department.
Thereafter, the research assistant contacts the patient, pro-
vides additional information about the implications of
participation, re-checks the eligibility of the patient, and
completes the informed consent procedure.
Sample size
The sample size for this study is calculated according to
the global perceived effect (GPE). Based on previous stud-
ies, a 20% difference in GPE is expected after completion
of either treatment (9 weeks) and is considered to be clin-
ically relevant; 160 patients are needed to detect this dif-
ference. In this calculation a power (1 - β) of 80% is taken
into account. Thus, the inclusion of 80 patients per treat-
ment group is planned.
Randomisation
An independent examiner using a computer-generated
randomisation schema performs randomisation. To pre-
vent unequal distribution, patients are pre-stratified based
on three important prognostic factors: gender, age and the
severity of the complaint, which are recorded at baseline
[27]. Further, unequal group sizes are prevented by using
a 6-block randomisation that equalizes allocation to the
two treatment groups per stratum after every sixth patient
[28]. After randomisation, patients choose a physiothera-
pist within the allocated treatment group. Then, to ensure
that the treatment starts as soon as possible, the research
assistant makes the first appointment for treatment.
Blinding
Patients are told to receive physiotherapy but are blinded
to allocation of the two treatments; the content of the
treatments is not described in the information leaflet. This
enhances the quality of the study, because the patients
themselves measure the effect of treatment. GPs are also
blinded for allocation to prevent accidentally informing
the patients of the allocated treatment. The physiothera-
pists are not blinded for allocation, but the physiothera-
pists from each treatment group are kept strictly separate
and are not involved in the outcome measurement.
Finally, the primary investigator is blinded for patients'
allocation but the research assistant is not; neither is
involved in the outcome measurement.
Physiotherapists and Interventions
After receiving written information, 34 physiotherapists
in region West Brabant will participate in either the phys-
iotherapy treatment (PT) or the graded activity pro-
gramme (GAP). To optimise the contrast between the two
treatments, both groups are strictly separated throughout
the study. The PT group consists of 16 physiotherapists
and the GAP group of 18 physiotherapists. The PT physi-
otherapists participate in a meeting to standardize the
physiotherapy treatment. The GAP physiotherapists are
instructed on the behavioural graded activity approach
during a two-day theoretical and practical training course.
Both interventions are performed in an outpatient setting.
A maximum of 18 treatments per patient is set and each
treatment takes about 30 minutes, which is in accordance
with medical insurance policy in the Netherlands. Before
treatment starts, physiotherapists receive a completed
questionnaire about the patient's main complaints [29];
this questionnaire reveals the three daily activities which
are considered the most important complaints to the
patient. Physiotherapists can use these three activities in
the process of formulating the patient's primary therapy
aim. In both treatments, the physiotherapist starts with a
physical examination of the patient and an anamnesis.
Then an individually tailored program will be applied and
the process recorded after each treatment session using a
specially designed form.
The physiotherapy treatment
The content of the physiotherapy treatment is decided by
consensus among the participating PT physiotherapists.
Treatment is according to a biomedical model, which
implies guidance based on the amount and severity of
pain that the patient experiences.
By consensus, the physiotherapy treatment is divided into
the patient's primary therapy aim, three general treatment
goals, and several techniques to attain those goals. The
primary therapy aim is defined as the result the patient
wants to achieve by the end of therapy. A general treat-
ment goal is a goal for each single treatment and could,
therefore, differ per treatment session. Table 1 shows the
three general treatment goals, together with the tech-
niques physiotherapists can choose to attain them. In
daily practice a broad spectrum of treatment techniques
are available, but in this study the techniques to be used
consist of physiotherapy techniques with a strong focus
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on exercises. Moreover, manipulative techniques, acu-
puncture and other (alternative) techniques are excluded,
as are physiotherapeutic applications such as ultrasound
or diathermy.
Behavioural graded activity
An operant approach was the basis of the behavioural
graded activity programme as used in this study. The treat-
ment is according to a biopsychosocial model, which
implies that it is guided by the patients' functional abili-
ties and that time-contingent methods are used to increase
the activity level of the patient [11]. The behavioural
graded activity programme has three phases; a baseline
phase, a treatment phase, and a generalization phase.
These phases are not bound to strict time limits but can
gradually merge into each other.
Before starting the baseline phase, the treatment vision
and the patient's ideas about pain and its causes are dis-
cussed. The development and maintenance of pain will be
explained and patients are reassured that it is safe to move
and to increase their level of activity [11,13,30]. Both are
explained by means of a pain model, which has been
derived from the fear-avoiding-model of Vlaeyen et al.
[13]. Thereafter primary therapy aims are formulated
based on the patient's main complaints, which are
described as three daily activities and were revealed in the
baseline questionnaire. For each of these activities, a base-
line level of intensity is determined based on a pain-con-
tingent measure. This means that patients perform each
activity at least three times, each time until they have to
stop because of their pain. Afterwards, patient and physi-
otherapist together set a start quota and time-contingent
treatment quotas for each activity. The quotas will be
based on the patient's mean baseline scores, primary ther-
apy aims [17], and on the behaviour that can be derived
from the baseline measure. If necessary, facilitating disor-
der-oriented exercises can be added to the treatment as
preparation for the activities that were pointed out as
main complaints. The same approach as used for the main
complaint is used for these exercises.
During the treatment phase, patients systematically
increase the time-contingent quotas to enable them to
reach their personal aims within a pre-set therapy time
period. To ensure a successful experience during the first
exercise, the start quota is below the mean baseline score.
The pre-set exercise quotas have to be strictly followed;
neither over-performance nor under-performance is
allowed. During this phase the patient has to practice at
home and document every activity or exercise on a per-
formance chart. These charts will be discussed in the fol-
lowing treatment session and achievements will be
reinforced while disregarding pain behaviours. Positive
reinforcements of healthy behaviour and the patient's
experiences of success are considered to be important to
enhance the patient's motivations.
The generalization phase takes place at the end of the
treatment phase. In this phase generalization of learned
behaviour and management of relapses will be discussed.
Outcome measurement
Baseline questionnaires are sent after inclusion, which is
as soon as possible after patients have consulted their GP.
Outcome of intervention will be assessed at 4 and 9 weeks
after randomisation; however, if the treatment is not fin-
ished at 9 weeks, the patients will receive an additional
questionnaire (Ts) after finishing the treatment. Follow-
up assessments are planned at 26 and 52 weeks after
randomisation.
Table 1: Treatment goals and techniques that can be used to reach the primary treatment aim.
Treatment goals Techniques
relaxation and preperation for exercise - Massage
- Relaxation exercise
- Thoracal treatment up to thoracal 9.
- Localized 3-d mobilization within physiological boundary of the joint capsule
- Mobilization in al directions within physiological boundaries.
- Traction within physiological boundaries.
- Techniques of Mulliken excluding manipulation
- Techniques of McKenzie excluding manipulation
Education Can take place at the same time as the first treatment target. Education includes patient reassurance;
explanation of (physiological) load and capability of carrying a load; and encouragement of physical activity
Exercise - Passive exercise, guided active exercise, and active exercise
- Exercise at the physiotherapist
- Assign homework
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All outcome measures are reported by means of mailed
questionnaires. Table 2 presents the outcome variables,
the instruments used and the moments at which they are
measured.
Primary treatment outcome of this study is the global per-
ceived effect, which is used to assess recovery from the
complaint [31]. In addition, the global perceived effect in
daily functioning was explored in order to also establish
impact of treatment on daily activity. Both treatment out-
comes (recovery of complaint and functioning in daily
activity), are assessed on a 7-point Likert-scale, ranging
from completely recovered (1) to worse than ever (7).
Costs are measured using a combination of question-
naires to collect data on direct medical costs (e.g. the
amount of received treatment and additional therapy
received), and indirect costs due to sick leave and
disability.
Secondary outcome measures include main complaints,
pain intensity, medical consumption, coping, functional
status, quality of life, and psychological variables. Prog-
nostic factors are measured including demographic varia-
bles, the baseline variables and the psychological
variables (table 2).
Table 2: Overview of variables measured in this study
Variable Time Measured Range of unit
T0 T4 T9 Ts T26 T52
Inclusion and exclusion variables x
Demographic variables x
Baseline variables
Specific complaint characteristics x
Experience of the neck complaint and functioning in
daily activities
x 1–7 (Likert scale)
Co-morbidity x
Additional complaints x
Primary outcome
'Global perceived effect' (neck complaint and
functioning in daily activities) [31]
xxxxx 1–7 (Likert scale)
Secondary outcomes
Main complaint [29] xxxxxx 0–10 (Likert scale)
Pain (VAS) [31] xxxxxx
Medical consumption xxxxxx Dose per day
Coping with Multi-dimensional pain (MPI) Part I-II [32] x x x x 0–6 (Likert scale)
Activity (MPI, part III) x x xxxx 0–6 (likert scale)
Specific functional status (NDI) [33] xxxxxx
Quality of life (SF-36) [34, 35] x x x x
(EQ-5d) [35, 36] xxxxxx
Work activities x x x x Hours/week
Satisfaction about treatment x x x x 1–5 (Likert scale)
Compliance with treatment exercise xxxxx Number and time per week
Additional treatments xxxxxDiscipline and number of treatments
Side-effects xxxxxYes – No and any additional elucidation
Psychological (prognostic) variables
Fear of movement (TSK) [37] x x x 1–4 (likert scale)
Catastrophizing (PCS) [38] x x x 1–5 (likert scale)
Depression (CES-D) [39] x x x 1–4 (likert scale)
Self-efficacy (PSEQ) [40] xxxxxx10–100% (very unsure – very sure)
Stages of change (PSOCQ) [41] x x 1–5 (likert scale)
Note: T0 = baseline measurement, T4, T9, (TS), T26, T52 are follow-up measurements at 4, 9, 26 and 52 weeks, respectively, after randomisation. Ts
was received at the end of treatment, when treatment lasted longer than 9 weeks. MPI, Multidimensional Pain inventory; NDI, Neck Disability Index;
SF-36, Short Form 36; EQ-5d, Euroquol 5-Dutch language version; TSK, Tampa Scale for Kinesiophobia; PCS, Pain Catastrophizing Scale; CES-D,
Centre for Epidemiologic Studies – Depression; PSEQ, Pain Self-Efficacy Scale; PSOCQ, Pain Stages Of Change Questionnaire.
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Analyses
Descriptive statistics will be used to examine comparabil-
ity of baseline data between PT and GAP, and to check if
randomisation was successful. Before this analysis, deci-
sions about differences considered to be clinically relevant
are made and, if necessary, adjustment will be made for
these differences in multivariate analysis. Further, all out-
come data will be screened for normality and, if necessary,
logarithmic transformations or non-parametric methods
of analysis will be applied.
The first aim is to evaluate the clinical and cost effective-
ness of GAP compared to PT. Clinical effectiveness will be
examined with a Student's t-test (continuous), a Chi-
square test (dichotomised) or a Wilcoxon test (not nor-
mally distributed) according to the intention-to-treat
principle. This means that patients will be analysed in the
treatment group to which they are randomly allocated.
For missing data, imputation techniques will be used.
When the dropout rate is 10% or more, or loss to follow-
up is 20% or more, per-protocol analysis will be per-
formed. The results on primary outcome will be dichot-
omised into improved versus not improved. Improved
implies completely recovered and much improved,
whereas not recovered implies slightly improved, not
changed, slightly worsened, much worsened, and worse
than ever [31].
Cost effectiveness will be calculated from a societal per-
spective. Costs (direct as well as indirect) will be related to
the treatment effects, based on the primary outcome
measure, by calculating cost-effectiveness ratios.
The second aim is to identify subgroups of patients that
benefit most from one of the two treatments. The follow-
ing subgroups will be investigated: duration and severity
of the complaint, depression, and fear of movement.
The third aim is to identify important variables for recov-
ery. For this purpose multivariate analysis will be per-
formed to investigate the influence of prognostic variables
and patient characteristics on the outcome. Separate anal-
yses will be conducted to investigate prognostic factors for
short-term (3 months) and long-term (12 months)
recovery.
Discussion
This study is designed to evaluate the clinical and cost
effectiveness of a behavioural graded activity programme
compared with a physiotherapy treatment in patients with
chronic non-specific neck pain. Since physiotherapists
perform both treatments in this study, contrast between
the two treatments is a very important issue. There are
contrasts both in the composition of the treatment and
the way the physiotherapists approach the patient. With
regard to the composition, the graded activity programme
(GAP) starts with a systematically performed baseline
measurement; this is in contrast to the physiotherapy
treatment (PT), where treatment is based on history taking
and physical examination. In GAP quotas are set based on
the patient's behaviour, whereas in PT they are set based
on pain levels and training principles. After quotas are set
GAP uses a time-contingent treatment approach, which
involves a pre-set systematic increase in activities. In con-
trast, PT uses a pain-contingent approach, which means
that treatment is adapted to the patient's reaction to pre-
vious treatment sessions. Furthermore, GAP uses a hands-
off approach, whereas PT may contain hands-on tech-
niques, such as massage, traction etc (Table 1).
This study addresses an important question because
chronic neck pain is a common complaint and it remains
unclear which type of physiotherapeutic treatment is most
effective. Recruitment of patients will take place until up
to the end of 2004; follow-up measurement will continue
up to end 2005.
Competing interests
The authors declare that they have no competing interests.
Authors' contributions
APV and BWK conceived the study, developed the design
of the randomised clinical trial and participated in writing
the article. MG is an expert in the field of graded activity
and contributed to the content of the article. CJV advised
on the content of the article. FV conducts the research,
participated in the completion of the study design and
wrote the article. All authors have read and approved the
final manuscript.
References
1. Wolsko PM, Eisenberg DM, Davis RB, Kessler R, Phillips RS: Pat-
terns and perceptions of care for treatment of back and neck
pain: results of a national survey. Spine 2003, 28:292-7; discus-
sion 298.
2. Andersson HI, Ejlertsson G, Leden I, Rosenberg C: Chronic pain in
a geographically defined general population: studies of differ-
ences in age, gender, social class, and pain localization. Clin J
Pain 1993, 9:174-182.
3. Picavet HS, Schouten JS: Musculoskeletal pain in the Nether-
lands: prevalences, consequences and risk groups, the
DMC(3)-study. Pain 2003, 102:167-178.
4. Borghouts JA, Koes BW, Vondeling H, Bouter LM: Cost-of-illness of
neck pain in The Netherlands in 1996. Pain 1999, 80:629-636.
5. IASP: Classification of chronic pain. Descriptions of chronic
pain syndromes and definitions of pain terms. Prepared by
the International Association for the Study of Pain, Subcom-
mittee on Taxonomy. Pain Suppl 1986, 3:S1-226.
6. Cassou B, Derriennic F, Monfort C, Norton J, Touranchet A:
Chronic neck and shoulder pain, age, and working condi-
tions: longitudinal results from a large random sample in
France. Occup Environ Med 2002, 59:537-544.
7. Bogduk N: Neck pain. Aust Fam Physician 1984, 13:26-30.
8. Korthals-de Bos IB, Hoving JL, van Tulder MW, Rutten-van Molken
MP, Ader HJ, de Vet HC, Koes BW, Vondeling H, Bouter LM: Cost
effectiveness of physiotherapy, manual therapy, and general
practitioner care for neck pain: economic evaluation along-
side a randomised controlled trial. BMJ 2003, 326:911.
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BMC Musculoskeletal Disorders 2004, 5:34 http://www.biomedcentral.com/1471-2474/5/34
Page 7 of 7
(page number not for citation purposes)
9. Turk DC, Flor H: Etiological theories and treatments for
chronic back pain. II. Psychological models and
interventions. Pain 1984, 19:209-233.
10. Fordyce WE, Fowler R. S., Jr., Lehmann JF, Delateur BJ, Sand PL, Tri-
eschmann RB: Operant conditioning in the treatment of
chronic pain. Arch Phys Med Rehabil 1973, 54:399-408.
11. Lindstrom I, Ohlund C, Eek C, Wallin L, Peterson LE, Fordyce WE,
Nachemson AL: The effect of graded activity on patients with
subacute low back pain: a randomized prospective clinical
study with an operant-conditioning behavioral approach. Phys
Ther 1992, 72:279-90; discussion 291-3.
12. Waddell G: 1987 Volvo award in clinical sciences. A new clini-
cal model for the treatment of low-back pain. Spine 1987,
12:632-644.
13. Vlaeyen JW, Kole-Snijders AM, Boeren RG, van Eek H: Fear of
movement/(re)injury in chronic low back pain and its rela-
tion to behavioral performance. Pain 1995, 62:363-372.
14. Linton SJ: Chronic back pain: integrating psychological and
physical therapy--an overview. Behav Med 1994, 20:101-104.
15. Vlaeyen J. W.S., Kole-Snijders, A.M.J., van Eek, H., Heuts, P.H.T.G.:
Gedragstherapeutische toepassing bij (chronische) lage
rugpijn. Medische Psychologie 1995, maart:157-164.
16. Gatchel Robert J., Turk Dennis C.: Psychological Approaches to
Pain Management; A Practitioner's Handbook. Edited by: Rob-
ert J Gatchel and Dennis C Turk. New York London, The Guilford
Press; 1996.
17. Fordyce WE: Behavioral Methods for Chronic Pain and Illness.
St. Louis, C. V. Mosby; 1976.
18. Vlaeyen JW, Haazen IW, Schuerman JA, Kole-Snijders AM, van Eek H:
Behavioural rehabilitation of chronic low back pain: compar-
ison of an operant treatment, an operant-cognitive treat-
ment and an operant-respondent treatment. Br J Clin Psychol
1995, 34:95-118.
19. Aker Peter D, Gross Anita R, Goldsmith Charles H, Peloso Paul:
Conservative management of mechanical neck pain: system-
atic overview and meta-analysis. BMJ 1996, 313:1291-1296.
20. Hoving JL, Gross AR, Gasner D, Kay T, Kennedy C, Hondras MA,
Haines T, Bouter LM: A critical appraisal of review articles on
the effectiveness of conservative treatment for neck pain.
Spine 2001, 26:196-205.
21. Morley S, Eccleston C, Williams A: Systematic review and meta-
analysis of randomized controlled trials of cognitive behav-
iour therapy and behaviour therapy for chronic pain in
adults, excluding headache. Pain 1999, 80:1-13.
22. Karjalainen K, Malmivaara A, van Tulder M, Roine R, Jauhiainen M,
Hurri H, Koes B: Multidisciplinary biopsychosocial rehabilita-
tion for neck and shoulder pain among working age adults: a
systematic review within the framework of the Cochrane
Collaboration Back Review Group. Spine 2001, 26:174-181.
23. Turner JA, Clancy S: Comparison of operant behavioral and
cognitive-behavioral group treatment for chronic low back
pain. J Consult Clin Psychol 1988, 56:261-266.
24. Moore RA: Pain and systematic reviews. Acta Anaestesiol Scand
2001, 45:1136-1139.
25. Godlee F: Publishing study protocols: making them visible will
improve registration, reporting and recruitment. BMC News
and Views 2001, 2:.
26. Ostelo RW, Koke AJ, Beurskens AJ, de Vet HC, Kerckhoffs MR,
Vlaeyen JW, Wolters PM, Berfelo MW, van den Brandt PA: Behav-
ioral-graded activity compared with usual care after first-
time disk surgery: considerations of the design of a rand-
omized clinical trial. J Manipulative Physiol Ther 2000, 23:312-319.
27. Borghouts JA, Koes BW, Bouter LM: The clinical course and
prognostic factors of non-specific neck pain: a systematic
review. Pain 1998, 77:1-13.
28. Roberts C, Torgerson D: Randomisation methods in controlled
trials. BMJ 1998, 317:1301.
29. Beurskens AJ, de Vet HC, Koke AJ, Lindeman E, van der Heijden GJ,
Regtop W, Knipschild PG: A patient-specific approach for meas-
uring functional status in low back pain. J Manipulative Physiol
Ther 1999, 22:144-148.
30. Vlaeyen JWS: Chronic low back pain: assessment and treat-
ment from a behavioral rehabilitation perspective. Amster-
dam, Swets en Zeitlinger; 1991.
31. Beurskens AJ, de Vet HC, Koke AJ: Responsiveness of functional
status in low back pain: a comparison of different
instruments. Pain 1996, 65:71-76.
32. Lousberg R, Van Breukelen GJ, Groenman NH, Schmidt AJ, Arntz A,
Winter FA: Psychometric properties of the Multidimensional
Pain Inventory, Dutch language version (MPI-DLV). Behav Res
Ther 1999, 37:167-182.
33. Wheeler AH, Goolkasian P, Baird AC, Darden B. V., 2nd: Develop-
ment of the Neck Pain and Disability Scale. Item analysis,
face, and criterion-related validity. Spine 1999, 24:1290-1294.
34. Keller SD, Ware J. E., Jr., Bentler PM, Aaronson NK, Alonso J,
Apolone G, Bjorner JB, Brazier J, Bullinger M, Kaasa S, Leplege A, Sul-
livan M, Gandek B: Use of structural equation modeling to test
the construct validity of the SF-36 Health Survey in ten coun-
tries: results from the IQOLA Project. International Quality
of Life Assessment. J Clin Epidemiol 1998, 51:1179-1188.
35. Essink-Bot ML, Krabbe PF, Bonsel GJ, Aaronson NK: An empirical
comparison of four generic health status measures. The
Nottingham Health Profile, the Medical Outcomes Study 36-
item Short-Form Health Survey, the COOP/WONCA
charts, and the EuroQol instrument. Med Care 1997,
35:522-537.
36. Van Agt HM, Essink-Bot ML, Krabbe PF, Bonsel GJ: Test-retest reli-
ability of health state valuations collected with the EuroQol
questionnaire. Soc Sci Med 1994, 39:1537-1544.
37. Swinkels-Meewisse EJ, Swinkels RA, Verbeek AL, Vlaeyen JW, Oost-
endorp RA: Psychometric properties of the Tampa Scale for
kinesiophobia and the fear-avoidance beliefs questionnaire
in acute low back pain. Man Ther 2003, 8:29-36.
38. Osman A, Barrios FX, Gutierrez PM, Kopper BA, Merrifield T, Gritt-
mann L: The Pain Catastrophizing Scale: further psychomet-
ric evaluation with adult samples. J Behav Med 2000, 23:351-365.
39. Bouma J, Ranchor AV, Sanderman R, Van Sonderen FLP.: Het meten
van symptomen van depressie met de CES-D. Een handlei-
ding. Groningen, Noordelijk Centrum voor Gezondheidsvraag-
stukken, Rijksuniversiteit Groningen; 1995:2-24.
40. Anderson KO, Dowds BN, Pelletz RE, Edwards WT, Peeters-Asdou-
rian C: Development and initial validation of a scale to meas-
ure self-efficacy beliefs in patients with chronic pain. Pain
1995, 63:77-84.
41. Kerns RD, Rosenberg R, Jamison RN, Caudill MA, Haythornthwaite J:
Readiness to adopt a self-management approach to chronic
pain: the Pain Stages of Change Questionnaire (PSOCQ).
Pain 1997, 72:227-234.
Pre-publication history
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