2B Active: Outpatient Rehabilitation for Adolescents With Chronic Pain

June 15, 2018 updated by: Maastricht University Medical Center

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)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Limburg
      • Maastricht, Limburg, Netherlands, 6200 MD
        • Maastricht University Medical Center
      • Roermond, Limburg, Netherlands, 6040 AX
        • Laurentius Ziekenhuis Roermond
    • Noord Brabant
      • Breda, Noord Brabant, Netherlands, 4817 JW
        • Revant Revalidatiecentrum Breda
    • Zuid Holland
      • Rotterdam, Zuid Holland, Netherlands, 3015 LJ
        • Rijndam Revalidatiecentrum

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

12 years to 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Multimodal Rehabilitation Program
Multimodal Rehabilitation Program, consisting of a Graded Exposure Module (GE), a Combination Module (HMGE) and a Parent Module (PM)
Behavioral: Multimodal Rehabilitation Program
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).
Other Names:
  • MRP
Active Comparator: Care as Usual
Care as usual is the care currently provided to adolescents with musculoskeletal chronic pain and is based on the principles of Graded Activity.
Behavioral: Care as Usual
Care as usual is the care currently provided to adolescents with musculoskeletal chronic pain and is based on the principles of Graded Activity.
Other Names:
  • CAU

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Functional Disability
Time Frame: Baseline, 8 weeks, 16 weeks, 10 months, 12 months
Adolescent self-reported functional disability
Baseline, 8 weeks, 16 weeks, 10 months, 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Quality of life
Time Frame: Baseline, 8 weeks, 16 weeks, 10 months, 12 months
Adolescent self-reported pain-specific quality of life
Baseline, 8 weeks, 16 weeks, 10 months, 12 months
Change in Fear of Pain
Time Frame: Baseline, 8 weeks, 16 weeks, 10 months, 12 months
Adolescent self-reported fear of pain
Baseline, 8 weeks, 16 weeks, 10 months, 12 months
Change in Fear of Pain
Time Frame: Baseline, 8 weeks, 16 weeks, 10 months, 12 months
Parent proxy report measure
Baseline, 8 weeks, 16 weeks, 10 months, 12 months
Change in Pain Catastrophizing
Time Frame: Baseline, 8 weeks, 16 weeks, 10 months, 12 months
Adolescent self-reported pain catastrophizing
Baseline, 8 weeks, 16 weeks, 10 months, 12 months
Change in Pain Catastrophizing
Time Frame: Baseline, 8 weeks, 16 weeks, 10 months, 12 months
Parental catastrophizing about their child's pain
Baseline, 8 weeks, 16 weeks, 10 months, 12 months
Change in Depressive symptoms
Time Frame: Baseline, 8 weeks, 16 weeks, 10 months, 12 months
Adolescent self-reported depressive symptoms
Baseline, 8 weeks, 16 weeks, 10 months, 12 months
Change in Perceived Harmfulness
Time Frame: Baseline, 8 weeks, 16 weeks, 10 months, 12 months
Adolescent self-reported perceived harmfulness of daily activities
Baseline, 8 weeks, 16 weeks, 10 months, 12 months
Change in Pain Intensity
Time Frame: Baseline, 8 weeks, 16 weeks, 10 months, 12 months
Adolescent self-reported pain intensity
Baseline, 8 weeks, 16 weeks, 10 months, 12 months
Change in Functional Disability
Time Frame: Baseline, 8 weeks, 16 weeks, 10 months, 12 months
Parent-perceived functional disability of their child
Baseline, 8 weeks, 16 weeks, 10 months, 12 months
Change in parental responses to childrens pain
Time Frame: Baseline, 8 weeks, 16 weeks, 10 months, 12 months
Baseline, 8 weeks, 16 weeks, 10 months, 12 months
Treatment expectations
Time Frame: Baseline
Adolescent self-report
Baseline
Treatment expectations
Time Frame: Baseline
Parent self-report
Baseline
Treatment satisfaction/ patient centeredness
Time Frame: 16 weeks
16 weeks
Treatment satisfaction/ family centeredness
Time Frame: 16 weeks
16 weeks
Change in General Health Related Quality of Life
Time Frame: Baseline, 8 weeks, 16 weeks, 10 months, 12 months
Baseline, 8 weeks, 16 weeks, 10 months, 12 months
Cost-diary per month
Time Frame: Baseline, 8 weeks, 16 weeks, 10 months, 12 months
Adolescent self-report of total health care utilization and other costs
Baseline, 8 weeks, 16 weeks, 10 months, 12 months
Cost-diary per month
Time Frame: Baseline, 8 weeks, 16 weeks, 10 months, 12 months
Parent self-reported adolescent related costs
Baseline, 8 weeks, 16 weeks, 10 months, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Maastricht University Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Fonds NutsOhra
Adelante, Centre of Expertise in Rehabilitation and Audiology
Stichting Vooruit

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Marielle Goossens, PhD, Maastricht University, FHML, Department of Rehabilitation Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 2, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 2, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 4, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 18, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NL47323.068.13/METC13-3-062
  • 1202-068 (Other Grant/Funding Number: Fonds NutsOhra)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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