The primary objective of this study is to evaluate the effectiveness and cost effectiveness of a multimodal rehabilitation program (MRP) in reducing functional disability (measured with the Functional Disability Inventory) for adolescents with…
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Brief title
Condition
- Other condition
Synonym
Health condition
Chronische pijn
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome measure for this study is mean difference in FDI-score between
MRP and CAU. The FDI (Functional Disability Inventory) measures functional
disability
Secondary outcome
Secondary outcome variables are Quality of life, fear of pain, catastrophizing,
depressive symptoms, perceived harmfulness, pain intensity, daily activity,
balance and muscle strength. For the economic evaluation, total direct and
indirect costs and quality of life are measured and for the process evaluation,
protocol adherence, patient centeredness and treatment expectations will be
measured
Background summary
Chronic musculoskeletal pain is a common problem amongst adolescents. Living
with chronic pain not only impacts on the adolescent*s functioning and
well-being, but also has negative consequences for the family and society
(costs). According to the Fear Avoidance Model, fear of movement and pain
catastrophizing play an important role in the occurrence and maintenance of
chronic pain complaints. It is hypothesized that a multimodal rehabilitation
program, aimed at reducing fear of movement and pain catastrophizing will
decrease disability in adolescents with chronic musculoskeletal pain, compared
to care as usual.
Study objective
The primary objective of this study is to evaluate the effectiveness and cost
effectiveness of a multimodal rehabilitation program (MRP) in reducing
functional disability (measured with the Functional Disability Inventory) for
adolescents with chronic musculoskeletal pain by comparing to care as usual
(CAU). Secondary objectives are to evaluate the effect of MRP on reducing fear
of movement, improving quality of life and improving physical fitness, to
evaluate MRP in terms of treatment fidelity and patient centeredness and to
explore whether parental behaviour affects adolescent treatment outcome
(reduced disability).
Study design
A multicentre randomized clinical trial, allocating participants to either MRP
or CAU with a ratio of 1:1.
Intervention
The MRP consists of 3 treatment modules. The Graded Exposure (GE) module aims
to improve functional ability and reducing pain-related fear by means of
exposing adolescents to fear-provoking activities. The combined hypermobility
and graded exposure (HMGE) module for patient with hypermobility syndrome and
chronic pain starts with physical training before exposure is offered. All
adolescents* parents will be offered the parent module, in which parents are
assisted to gain insight in how they can provide the right context in which
their adolescent can improve. The control condition, CAU consists of the care
currently provided in Dutch rehabilitation centres, based on a national
consensus report for treatment of adolescents with chronic fatigue and pain.
Study burden and risks
Risks of participating in this trial are considered negligible. Measurements
are non-invasive and the burden for the participants consists of 3 extra
measurements, next to the two measurements that take place as part of medical
care. Measurements consist mainly of a questionnaire, which take approximately
45 minutes each to complete. Measurement of health care utilization consists of
filling in a diary once a month. Completion time is about 5 minutes. For the
Maastricht population, the physical fitness measures take 15 minutes to
complete and they will be asked to wear the accelerometer for 7 days each
measurement moment. This trial is considered a therapeutic trial.
Universiteitssingel 40
Maastricht 6229 ER
NL
Universiteitssingel 40
Maastricht 6229 ER
NL
Listed location countries
Age
Inclusion criteria
* Age 12-21 years at the start of the study
* Complaints of chronic non-specific musculoskeletal pain of a duration * 3 months
* Considerable activity limitations / disability according to the expert opinion of the consultant in rehabilitation medicine.
* Fear of movement according to the expert opinion of the consultant in rehabilitation medicine.
* Indication for outpatient multidisciplinary rehabilitation treatment
* Adequate Dutch literacy to complete the assessments (which mainly comprise questionnaires)
Exclusion criteria
* Any suspicion of a medical (orthopaedic, rheumatic or neurological) disease, that can explain the current pain complaints
* Any suspicion of an (underlying) psychiatric disease, for which psychiatric treatment is better suited, according to the expert opinion of the consultant in rehabilitation medicine
* Pregnancy
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 | NL47323.068.13 |