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Painrehabilitation: More is Better?


- candidate number12212
- NTR NumberNTR3385
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR6-apr-2012
- Secondary IDs2011.118 METc
- Public TitlePainrehabilitation: More is Better?
- Scientific TitleEffectiveness and Cost effectiveness of Pain Rehabilitation Programs for patients with chronic musculoskeletal pain.
- ACRONYM
- hypothesisPain Rehabilitation Programs (PRPís) are proven effective for patients with chronic musculoskeletal pain (CMP). Evidence about the relationship of dose on the effect of PRP however, is unavailable. We hypothesized that shortening PRP will not be less than 4 points inferior to care as usual. The objective of the study is to analyse the effect of shortening duration of PRP on effectiveness and cost effectiveness of PRP.
- Healt Condition(s) or Problem(s) studiedChronic musculoskeletal pain, Pain Rehabilitation Program
- Inclusion criteriaPatients are eligible for the study when:
1. They participate in the 12, 16 and 20 weeks Pain Rehabilitation Program (PRP) at the University Medical Centre Groningen (UMCG);
2. They have CMP for more than three months without a specific pathological cause;
3. They experience disabilities caused by CMP;
4. WPN 3 and 4. Defined as: social and psychological factors are complex and are relevant regarding maintaining pain related disability;
5. They attend no other kinds of treatment (except for pain medication);
6. They are 18 years or older;
7. They are willing to participate in the study.
- Exclusion criteria1. They are referred to the 8 weeks PRP;
2. They are unable to understand the Dutch language;
3. They have relevant co morbidities such as heart failure, rheumatoid arthritis, psychiatric disorders.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2011
- planned closingdate31-aug-2014
- Target number of participants276
- InterventionsThe content of the control and experimental intervention is the same. The only difference is the dose of the program. The control group of patients will be treated by care as usual, which means they will receive 12, 16 or 20 week PRP as indicated. The experimental group of patients will receive their treatment in less weeks and contact hours. Patients, who are indicated for 20 weeks, will receive 16 weeks PRP. Patients, who are indicated for 16 weeks PRP, will receive 12 weeks PRP. Patients, who are indicated for 12 weeks PRP, will receive 8 weeks PRP.
Prolongation of PRP can occur based on agreement between the patient and the PRP team about the reasons for prolongation. These reasons do not differ from usual care.
- Primary outcomeSelf reported disability will be the main outcome and will be measured with the Pain Disability Index (scale range 0-70).
- Secondary outcomeQuality of life and work productivity will be secondary outcome and will be measured with respectively the Euroqol 5D and the Productivity and Disease Questionnaire (Prodisq).
For cost-effectiveness intervention costs, other direct healthcare, direct non-healthcare and indirect costs due to absenteeism from paid work will be calculated using the handbook for economic evaluations.
- TimepointsAll outcomes will be measured before start, at the end of PRP and at 3 months and 12 months follow up.
- Trial web siteN/A
- statusstopped
- CONTACT FOR PUBLIC QUERIES F.P.C. Waterschoot
- CONTACT for SCIENTIFIC QUERIES M.F. Reneman
- Sponsor/Initiator University Medical Center Groningen (UMCG), Department of Rehabilitation Medicine
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Groningen (UMCG), Department of Rehabilitation Medicine
- PublicationsN/A
- Brief summaryPain Rehabilitation Programs (PRPís) are proven effective for patients with chronic musculoskeletal pain (CMP). Evidence about the relationship of dose on the effect of PRP however, is unavailable. We hypothesized that shortening PRP will not be less than 4 points inferior to care as usual. The objective of the study is to analyse the effect of shortening duration of PRP on effectiveness and cost effectiveness of PRP.
The study is a single blind, 2 armed, randomized controlled clinical trial, with a group sequential non inferiority design.
All patients with CMP referred to PRP of the UMCG (The Netherlands) are potential participants for the study.
The control intervention will be care as usual. The experimental intervention will not differ in content of PRP. The experimental group will receive PRP in 4 weeks less than care as usual.
Pain related disability, measured with the Pain Disability Index (PDI), will be the main outcome. The non-inferiority margin is predefined as 4 points difference on PDI to tolerate as non-inferior. For cost-effectiveness direct and indirect costs will be calculated.
- Main changes (audit trail)
- RECORD6-apr-2012 - 6-nov-2013


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