Clinical trial NCT02181725: 2B Active: Outpatient Rehabilitation for Adolescents With Chronic Pain
Official title: Effectiveness and Cost-effectiveness of a Multimodal Rehabilitation Programme (MRP) for Adolescents With Chronic Musculoskeletal Pain (12-21 Years) Compared to Care as Usual (CAU); a Randomized Clinical Trial (2B Active)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Keywords: Chronic Pain
Adolescent
Graded Exposure
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Fonds NutsOhra
name: Stichting Vooruit
name: Adelante, Centre of Expertise in Rehabilitation and Audiology
First posted: 2014-07-04
Enrollment: 60
Sex: ALL
Minimum age (years): 12
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate whether a multimodal rehabilitation program effectively reduces functional disability in adolescents with chronic musculoskeletal pain, compared to care as usual.


Eligibility criteria: 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
* Fear of movement
* 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

Primary outcomes:
measure: Change in Functional Disability
timeFrame: Baseline, 8 weeks, 16 weeks, 10 months, 12 months
Secondary outcomes:
measure: Change in Quality of life
timeFrame: Baseline, 8 weeks, 16 weeks, 10 months, 12 months
measure: Change in Fear of Pain
timeFrame: Baseline, 8 weeks, 16 weeks, 10 months, 12 months
measure: Change in Fear of Pain
timeFrame: Baseline, 8 weeks, 16 weeks, 10 months, 12 months
measure: Change in Pain Catastrophizing
timeFrame: Baseline, 8 weeks, 16 weeks, 10 months, 12 months
measure: Change in Pain Catastrophizing
timeFrame: Baseline, 8 weeks, 16 weeks, 10 months, 12 months
measure: Change in Depressive symptoms
timeFrame: Baseline, 8 weeks, 16 weeks, 10 months, 12 months
measure: Change in Perceived Harmfulness
timeFrame: Baseline, 8 weeks, 16 weeks, 10 months, 12 months
measure: Change in Pain Intensity
timeFrame: Baseline, 8 weeks, 16 weeks, 10 months, 12 months
measure: Change in Functional Disability
timeFrame: Baseline, 8 weeks, 16 weeks, 10 months, 12 months
measure: Change in parental responses to childrens pain
timeFrame: Baseline, 8 weeks, 16 weeks, 10 months, 12 months
measure: Treatment expectations
timeFrame: Baseline
measure: Treatment expectations
timeFrame: Baseline
measure: Treatment satisfaction/ patient centeredness
timeFrame: 16 weeks
measure: Treatment satisfaction/ family centeredness
timeFrame: 16 weeks
measure: Change in General Health Related Quality of Life
timeFrame: Baseline, 8 weeks, 16 weeks, 10 months, 12 months
measure: Cost-diary per month
timeFrame: Baseline, 8 weeks, 16 weeks, 10 months, 12 months
measure: Cost-diary per month
timeFrame: Baseline, 8 weeks, 16 weeks, 10 months, 12 months
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
state: Limburg
city: Roermond
country: Netherlands
facility: Laurentius Ziekenhuis Roermond
state: Limburg
city: Breda
country: Netherlands
facility: Revant Revalidatiecentrum Breda
state: Noord Brabant
city: Rotterdam
country: Netherlands
facility: Rijndam Revalidatiecentrum
state: Zuid Holland
Study officials:
affiliation: Maastricht University, FHML, Department of Rehabilitation Medicine
name: Marielle Goossens, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dekker C, van Haastregt JCM, Verbunt JAMCF, de Jong JR, van Meulenbroek T, Pernot HFM, van Velzen AD, Bastiaenen CHG, Goossens MEJB. Pain-related fear in adolescents with chronic musculoskeletal pain: process evaluation of an interdisciplinary graded exposure program. BMC Health Serv Res. 2020 Mar 14;20(1):213. doi: 10.1186/s12913-020-5053-6.
citation: Dekker C, Goossens ME, Bastiaenen CH, Verbunt JA. Study protocol for a multicentre randomized controlled trial on effectiveness of an outpatient multimodal rehabilitation program for adolescents with chronic musculoskeletal pain (2B Active). BMC Musculoskelet Disord. 2016 Jul 28;17:317. doi: 10.1186/s12891-016-1178-5.