2B Active: Outpatient Rehabilitation for Adolescents With Chronic Pain

NCT ID: NCT02181725

Last Updated: 2018-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2018-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Multimodal Rehabilitation Program

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

Group Type EXPERIMENTAL

Multimodal Rehabilitation Program

Intervention Type BEHAVIORAL

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).

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.

Group Type ACTIVE_COMPARATOR

Care as Usual

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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).

Intervention Type 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.

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

MRP CAU

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

12 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Fonds NutsOhra

OTHER

Sponsor Role collaborator

Stichting Vooruit

UNKNOWN

Sponsor Role collaborator

Adelante, Centre of Expertise in Rehabilitation and Audiology

OTHER

Sponsor Role collaborator

Maastricht University Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Marielle Goossens, PhD

Role: PRINCIPAL_INVESTIGATOR

Maastricht University, FHML, Department of Rehabilitation Medicine

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Maastricht University Medical Center

Maastricht, Limburg, Netherlands

Site Status

Laurentius Ziekenhuis Roermond

Roermond, Limburg, Netherlands

Site Status

Revant Revalidatiecentrum Breda

Breda, North Brabant, Netherlands

Site Status

Rijndam Revalidatiecentrum

Rotterdam, South Holland, Netherlands

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Netherlands

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 32171308 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27464953 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1202-068

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

NL47323.068.13/METC13-3-062

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.