To analyse the effect of shortening duration of PRP on effectiveness and cost effectiveness of PRP.
ID
Source
Brief title
Condition
- Muscle disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Pain related disability, measured with the Pain Disability Index, will be the
main outcome.
Secondary outcome
For cost-effectiveness direct and indirect costs will be calculated.
Background summary
Pain Rehabilitation Programs (PRP*s) are proven to be effective for patients
with chronic musculoskeletal pain (CMP). But there is no available evidence
about the relationship of dose on the effect of PRP. We hypothesized that
shortening PRP will not be less than 4 points inferior on the Pain Disability
Index (PDI) to care as usual.
Study objective
To analyse the effect of shortening duration of PRP on effectiveness and cost
effectiveness of PRP.
Study design
The study is a single blind, 2 armed, randomized controlled clinical trial,
with a group sequential non inferiority design.
Intervention
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.
Study burden and risks
There are no risks associated with participation on the study. Two extra
questionnaires has to be filled in compared to usual care. The number of visits
for PRP will be the same as usual care for the control group and 4 weeks less
for the experimental group.
Dilgtweg 5
9751 ND
NL
Dilgtweg 5
9751 ND
NL
Listed location countries
Age
Inclusion criteria
Patients 1. are referred to the 12,16 or 20 weeks Pain Rehabiltiaton Program (PRP) at the UMCG, 2. have chronic musculoskeletal pain (CMP), 3. experience disability caused by CMP, 4. attend no other kinds of treatment, 5. are 18 years or older, 6. are willing to participate in the study, 7. WPN 3 and 4. Defined as:the social and psychosocial factors are complex and relevant regarding maintaining pain related disability.
Exclusion criteria
Patients 1. are included for 8 weeks of PRP 2. are not willing to participate in the study, 3. are unable to understand the Dutch language, 4. have relevant comorbidities.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL30094.042.11 |