Illness perceptions and activity limitations in chronic low back pain.

Plain English Summary

Not provided at time of registration

Study website

Type

Scientific

Contact name

Mrs Petra Siemonsma

ORCID ID

Contact details

Dr. Jan van Breemen Institute
Clinimetric Laboratory
Dr. Jan van Breemenstraat 2
Amsterdam
1056 AB
Netherlands
+31 (0)20 5896285
p.siemonsma@janvanbreemen.nl

EudraCT/CTIS number

IRAS number

ClinicalTrials.gov number

Protocol/serial number

014-32-041; WC02-059

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.

Acronym

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(s)

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

Interventional

Secondary study design

Randomised controlled trial

Study setting(s)

Hospital

Study type

Treatment

Patient information sheet

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

Condition

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

Overall study end date

01/05/2010

Reason abandoned (if study stopped)

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(s)

Patient

Age group

Adult

Lower age limit

18 Years

Sex

Both

Target number of participants

135 patients (45 per group)

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

01/12/2004

Recruitment end date

01/05/2010

Countries of recruitment

Netherlands

Study participating centre

Dr. Jan van Breemen Institute
Amsterdam
1056 AB
Netherlands

Organisation

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
Netherlands
+31 (0)70 349 5111
info@zonmw.nl

Sponsor type

Government

Website

http://www.zonmw.nl

ROR

https://ror.org/01yaj9a77

Funder type

Government

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Individual participant data (IPD) sharing plan

IPD sharing plan summary

Not provided at time of registration

Study outputs