Illness perceptions and activity limitations in chronic low back pain.
| ISRCTN | ISRCTN35108886 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN35108886 |
| Secondary identifying numbers | 014-32-041; WC02-059 |
- Submission date
- 16/02/2010
- Registration date
- 08/03/2010
- Last edited
- 04/04/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mrs Petra Siemonsma
Scientific
Scientific
Dr. Jan van Breemen Institute
Clinimetric Laboratory
Dr. Jan van Breemenstraat 2
Amsterdam
1056 AB
Netherlands
| Phone | +31 (0)20 5896285 |
|---|---|
| p.siemonsma@janvanbreemen.nl |
Study information
| Study design | 3 arm randomised controlled trial predictor and treatment integrity study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details below to request a patient information sheet |
| 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 objectives | 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 Leventhals 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(s) | Medical Ethics Committee of the Slotervaart Hospital, Amsterdam approved on the 16th of June 2003 (ref: protocol no 0514) |
| Health condition(s) or problem(s) studied | Chronic non-specific low back pain (CLBP) |
| Intervention | 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 | Other |
| Primary outcome measure | 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 study start date | 01/12/2004 |
| Completion date | 01/05/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 135 patients (45 per group) |
| Key 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 |
| Key exclusion criteria | Does not match inclusion criteria |
| Date of first enrolment | 01/12/2004 |
| Date of final enrolment | 01/05/2010 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Dr. Jan van Breemen Institute
Amsterdam
1056 AB
Netherlands
1056 AB
Netherlands
Sponsor information
Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)
Government
Government
Laan van Nieuw Oost Indië 334
P.O. Box 93245
Den Haag
2509 AE
Netherlands
| Phone | +31 (0)70 349 5111 |
|---|---|
| info@zonmw.nl | |
| Website | http://www.zonmw.nl |
"ROR" |
https://ror.org/01yaj9a77 |
Funders
Funder type
Government
Netherlands Organization for Health Research and Development (ZonMw) (Netherlands) (ref: 014-32-041)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/12/2008 | Yes | No | |
| Results article | results | 01/02/2010 | Yes | No | |
| Results article | results | 01/04/2013 | Yes | No |
