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

Dr. Jan van Breemen Institute
Clinimetric Laboratory
Dr. Jan van Breemenstraat 2
Amsterdam
1056 AB
Netherlands

Phone +31 (0)20 5896285
Email p.siemonsma@janvanbreemen.nl

Study information

Study design3 arm randomised controlled trial predictor and treatment integrity study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use contact details below to request a patient information sheet
Scientific titleIllness perceptions and activity limitations in chronic low back pain. A component approach to innovate rehabilitation programmes for patients with chronic low back pain.
Study objectivesThe 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(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) studiedChronic non-specific low back pain (CLBP)
InterventionPatients 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 typeOther
Primary outcome measurePatient-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 measures1. 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 date01/12/2004
Completion date01/05/2010

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants135 patients (45 per group)
Key inclusion criteria1. 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 criteriaDoes not match inclusion criteria
Date of first enrolment01/12/2004
Date of final enrolment01/05/2010

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Dr. Jan van Breemen Institute
Amsterdam
1056 AB
Netherlands

Sponsor information

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

Laan van Nieuw Oost Indië 334
P.O. Box 93245
Den Haag
2509 AE
Netherlands

Phone +31 (0)70 349 5111
Email info@zonmw.nl
Website http://www.zonmw.nl
ROR logo "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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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