Contact information
Type
Scientific
Primary contact
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
Additional identifiers
EudraCT number
ClinicalTrials.gov 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.
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 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
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
Trial setting
Hospitals
Trial 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
Phase
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
01/12/2004
Overall trial end date
01/05/2010
Reason abandoned
Eligibility
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
Patient
Age group
Adult
Gender
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
Locations
Countries of recruitment
Netherlands
Trial participating centre
Dr. Jan van Breemen Institute
Amsterdam
1056 AB
Netherlands
Sponsor information
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
Funders
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
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 http://www.ncbi.nlm.nih.gov/pubmed/18821194
2. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20140405
3. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23162040
Publication citations
-
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.
-
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.
-
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.