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2B Active: Outpatient Rehabilitation for Adolescents With Chronic Pain

Primary Purpose

Chronic Pain

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Multimodal Rehabilitation Program
Care as Usual
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring Chronic Pain, Adolescent, Graded Exposure

Eligibility Criteria

12 Years - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Maastricht University Medical Center
  • Laurentius Ziekenhuis Roermond
  • Revant Revalidatiecentrum Breda
  • Rijndam Revalidatiecentrum

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Multimodal Rehabilitation Program

Care as Usual

Arm Description

Multimodal Rehabilitation Program, consisting of a Graded Exposure Module (GE), a Combination Module (HMGE) and a Parent Module (PM)

Care as usual is the care currently provided to adolescents with musculoskeletal chronic pain and is based on the principles of Graded Activity.

Outcomes

Primary Outcome Measures

Change in Functional Disability
Adolescent self-reported functional disability

Secondary Outcome Measures

Change in Quality of life
Adolescent self-reported pain-specific quality of life
Change in Fear of Pain
Adolescent self-reported fear of pain
Change in Fear of Pain
Parent proxy report measure
Change in Pain Catastrophizing
Adolescent self-reported pain catastrophizing
Change in Pain Catastrophizing
Parental catastrophizing about their child's pain
Change in Depressive symptoms
Adolescent self-reported depressive symptoms
Change in Perceived Harmfulness
Adolescent self-reported perceived harmfulness of daily activities
Change in Pain Intensity
Adolescent self-reported pain intensity
Change in Functional Disability
Parent-perceived functional disability of their child
Change in parental responses to childrens pain
Treatment expectations
Adolescent self-report
Treatment expectations
Parent self-report
Treatment satisfaction/ patient centeredness
Treatment satisfaction/ family centeredness
Change in General Health Related Quality of Life
Cost-diary per month
Adolescent self-report of total health care utilization and other costs
Cost-diary per month
Parent self-reported adolescent related costs

Full Information

First Posted
July 2, 2014
Last Updated
June 15, 2018
Sponsor
Maastricht University Medical Center
Collaborators
Fonds NutsOhra, Stichting Vooruit, Adelante, Centre of Expertise in Rehabilitation and Audiology
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1. Study Identification

Unique Protocol Identification Number
NCT02181725
Brief Title
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

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
January 2018 (Actual)
Study Completion Date
January 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center
Collaborators
Fonds NutsOhra, Stichting Vooruit, Adelante, Centre of Expertise in Rehabilitation and Audiology

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
Chronic Pain, Adolescent, Graded Exposure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Multimodal Rehabilitation Program
Arm Type
Experimental
Arm Description
Multimodal Rehabilitation Program, consisting of a Graded Exposure Module (GE), a Combination Module (HMGE) and a Parent Module (PM)
Arm Title
Care as Usual
Arm Type
Active Comparator
Arm Description
Care as usual is the care currently provided to adolescents with musculoskeletal chronic pain and is based on the principles of Graded Activity.
Intervention Type
Behavioral
Intervention Name(s)
Multimodal Rehabilitation Program
Other Intervention Name(s)
MRP
Intervention Description
The Multimodal Rehabilitation Program is a Graded exposure based treatment. It consists of a Graded Exposure Module (GE), a Combination Module (HMGE) and a Parent Module (PM).
Intervention Type
Behavioral
Intervention Name(s)
Care as Usual
Other Intervention Name(s)
CAU
Intervention Description
Care as usual is the care currently provided to adolescents with musculoskeletal chronic pain and is based on the principles of Graded Activity.
Primary Outcome Measure Information:
Title
Change in Functional Disability
Description
Adolescent self-reported functional disability
Time Frame
Baseline, 8 weeks, 16 weeks, 10 months, 12 months
Secondary Outcome Measure Information:
Title
Change in Quality of life
Description
Adolescent self-reported pain-specific quality of life
Time Frame
Baseline, 8 weeks, 16 weeks, 10 months, 12 months
Title
Change in Fear of Pain
Description
Adolescent self-reported fear of pain
Time Frame
Baseline, 8 weeks, 16 weeks, 10 months, 12 months
Title
Change in Fear of Pain
Description
Parent proxy report measure
Time Frame
Baseline, 8 weeks, 16 weeks, 10 months, 12 months
Title
Change in Pain Catastrophizing
Description
Adolescent self-reported pain catastrophizing
Time Frame
Baseline, 8 weeks, 16 weeks, 10 months, 12 months
Title
Change in Pain Catastrophizing
Description
Parental catastrophizing about their child's pain
Time Frame
Baseline, 8 weeks, 16 weeks, 10 months, 12 months
Title
Change in Depressive symptoms
Description
Adolescent self-reported depressive symptoms
Time Frame
Baseline, 8 weeks, 16 weeks, 10 months, 12 months
Title
Change in Perceived Harmfulness
Description
Adolescent self-reported perceived harmfulness of daily activities
Time Frame
Baseline, 8 weeks, 16 weeks, 10 months, 12 months
Title
Change in Pain Intensity
Description
Adolescent self-reported pain intensity
Time Frame
Baseline, 8 weeks, 16 weeks, 10 months, 12 months
Title
Change in Functional Disability
Description
Parent-perceived functional disability of their child
Time Frame
Baseline, 8 weeks, 16 weeks, 10 months, 12 months
Title
Change in parental responses to childrens pain
Time Frame
Baseline, 8 weeks, 16 weeks, 10 months, 12 months
Title
Treatment expectations
Description
Adolescent self-report
Time Frame
Baseline
Title
Treatment expectations
Description
Parent self-report
Time Frame
Baseline
Title
Treatment satisfaction/ patient centeredness
Time Frame
16 weeks
Title
Treatment satisfaction/ family centeredness
Time Frame
16 weeks
Title
Change in General Health Related Quality of Life
Time Frame
Baseline, 8 weeks, 16 weeks, 10 months, 12 months
Title
Cost-diary per month
Description
Adolescent self-report of total health care utilization and other costs
Time Frame
Baseline, 8 weeks, 16 weeks, 10 months, 12 months
Title
Cost-diary per month
Description
Parent self-reported adolescent related costs
Time Frame
Baseline, 8 weeks, 16 weeks, 10 months, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marielle Goossens, PhD
Organizational Affiliation
Maastricht University, FHML, Department of Rehabilitation Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maastricht University Medical Center
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6200 MD
Country
Netherlands
Facility Name
Laurentius Ziekenhuis Roermond
City
Roermond
State/Province
Limburg
ZIP/Postal Code
6040 AX
Country
Netherlands
Facility Name
Revant Revalidatiecentrum Breda
City
Breda
State/Province
Noord Brabant
ZIP/Postal Code
4817 JW
Country
Netherlands
Facility Name
Rijndam Revalidatiecentrum
City
Rotterdam
State/Province
Zuid Holland
ZIP/Postal Code
3015 LJ
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
32171308
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.
Results Reference
derived
PubMed Identifier
27464953
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.
Results Reference
derived

Learn more about this trial

2B Active: Outpatient Rehabilitation for Adolescents With Chronic Pain

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