Condition category
Musculoskeletal Diseases
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Mrs Petra Siemonsma


Contact details

Dr. Jan van Breemen Institute
Clinimetric Laboratory
Dr. Jan van Breemenstraat 2
1056 AB
+31 (0)20 5896285

Additional identifiers

EudraCT number number

Protocol/serial number

014-32-041; WC02-059

Study information

Scientific title

Illness perceptions and activity limitations in chronic low back pain. A component approach to innovate rehabilitation programmes for patients with chronic low back pain.


Study hypothesis

The overall objective of this study is innovation of rehabilitation programmes by gaining a better understanding of the working mechanism and applicability of one component of chronic low back pain (CLBP) rehabilitation. This component is cognitive restructuring based on Leventhal’s Self Regulation model (SRM), and is labelled Cognitive Treatment of Illness Perceptions (CTIP). The SRM links illness perceptions (ideas about illness) to activity limitations. The aim of this study is to investigate the question: which patients, with what patient characteristics, will benefit most from cognitive treatment aimed at restructuring illness perceptions. The study comprises three phases. An explorative phase in which is focussed on the design and application of the rehabilitation programme and in which the research design is optimised. An experimental phase testing the rehabilitation programme (effectiveness study and predictor study). And a generalisation phase, researching the generalisability of the results to other settings by focussing on treatment delivery and implementation problems (treatment integrity study). Together these studies aim to provide a clinically relevant and broad evidence base for CTIP.

Conceptualisation of treatment content has finished and been published, and thereby the explorative phase has ended. Hypothesis about patient characteristics predictive of treatment effect were generated in this phase, and include
1. rational approach of problems
2. adequate discussion skills
3. adequate verbal skill
4. being problem focussed

The experimental phase consists of 3 group Randomised Clinical Trial (2x intervention, 1x waiting list). Randomisation followed a predetermined computer-generated block-randomisation schedule, generated before the screening (blocks size 12), and oblique sealed and numbered envelopes were prepared by an independent fellow researcher. The RCT is integrated with a predictor study and treatment integrity study. Both short-term (18 weeks) and longer-term (1 year) effects are studied. Therapists and assessors are blinded for group allocation. Therapists, assessors and patients are blinded for the hypothesized predictor variables.

Ethics approval

Medical Ethics Committee of the Slotervaart Hospital, Amsterdam approved on the 16th of June 2003 (ref: protocol no 0514)

Study design

3 arm randomised controlled trial predictor and treatment integrity study

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet


Chronic non-specific low back pain (CLBP)


Patients were randomised (2:1 ratio) to
1. Cognitive treatment of illness perceptions (CTIP):
14x one-hour sessions over a maximum period of 18 weeks
2. Waiting list control:
CTIP between weeks 18 and 36
The double size of the intervention group is to enable study of predictors of treatment success
Therapists: physiotherapists, occupational therapists and psychologists were trained to deliver the intervention according to the treatment protocol
The total duration of follow up was 52 weeks for the intervention group and 68 weeks for the control group.

Intervention type



Not Specified

Drug names

Primary outcome measures

Patient-specific activity limitations (PSFL). Clinically relevant change =18 mm, measured at 18, 36 and 52 weeks (also at 68 weeks for control group).
18 weeks is theorised to be the first time point where changes are expected.

Secondary outcome measures

1. Secondary outcome: General activity limitations (QBPDS), measured at 18, 36 and 52 weeks (also at 68 weeks for control group).
2. Tertiary outcome: Health care consumption (cost-diary), measured at 18, 36 and 52 weeks (also at 68 weeks for control group).
36 weeks is theorised to be the first time point where changes are expected.

3. Process measure: illness perceptions (IPQ-R), measured at timepoints 18, 36 and 52 weeks (also at 68 weeks for control group).
18 weeks is theorised to be the first time point where changes are expected.

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

1. Age 18 - 70 years
2. Non-specific low back pain with or without radiation to the leg(s) for at least 3 months
3. Current episode of back pain lasting less than 5 years
4. Activity limitations (Roland Disability Questionnaire > 3)
5. No previous multidisciplinary treatment for CLBP
6. No involvement in litigation concerning CLBP
7. Absence of serious psychological or psychiatric problems
8. No substance abuse interfering with treatment or assessment
9. Not pregnant
10. Able to fill in questionnaires without help
11. Written informed consent

Participant type


Age group




Target number of participants

135 patients (45 per group)

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

Dr. Jan van Breemen Institute
1056 AB

Sponsor information


Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)

Sponsor details

Laan van Nieuw Oost Indië 334
P.O. Box 93245
Den Haag
2509 AE
+31 (0)70 349 5111

Sponsor type




Funder type


Funder name

Netherlands Organization for Health Research and Development (ZonMw) (Netherlands) (ref: 014-32-041)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2008 results in
2. 2010 results in
3. 2013 results in

Publication citations

  1. Results

    Siemonsma PC, Schroder CD, Dekker JH, Lettinga AT, The benefits of theory for clinical practice: cognitive treatment for chronic low back pain patients as an illustrative example., Disabil Rehabil, 2008, 30, 17, 1309-1317, doi: 10.1080/09638280701610254.

  2. Results

    Siemonsma PC, Schröder CD, Roorda LD, Lettinga AT, Benefits of treatment theory in the design of explanatory trials: cognitive treatment of illness perception in chronic low back pain rehabilitation as an illustrative example., J Rehabil Med, 2010, 42, 2, 111-116, doi: 10.2340/16501977-0492.

  3. Results

    Siemonsma PC, Stuive I, Roorda LD, Vollebregt JA, Walker MF, Lankhorst GJ, Lettinga AT, Cognitive treatment of illness perceptions in patients with chronic low back pain: a randomized controlled trial., Phys Ther, 2013, 93, 4, 435-448, doi: 10.2522/ptj.20110150.

Additional files

Editorial Notes