Predicting Successful Outcome of Interdisciplinary Biopsychosocial Rehabilitation in Osteoarthritis

NCT ID: NCT05661760

Last Updated: 2022-12-22

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

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Recruitment Status

UNKNOWN

Total Enrollment

2309 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-01

Study Completion Date

2023-12-31

Brief Summary

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The goal of this prospective study is to identify variables that can predict whether an interdisciplinary biopsychosocial intervention for patients with osteoarthritis will be successful.

Using an observational design, patients admitted to this program during the 3-year period (2019-2021) will be included and data gathered during routine clinical practice at baseline and end of treatment of patients who gave informed consent, will be used.

With these data a prediction model will be build and internal validation with bootstrapping will be done.

Detailed Description

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Rationale: To predict the probability of a positive outcome of interdisciplinary biopsychosocial intervention in individual patients with osteoarthritis (OA), a prediction model is needed.

Research Question/Objective: The overall goal is to develop a clinical prediction model to facilitate decision making in interdisciplinary biopsychosocial rehabilitation in patients with OA. The model will predict the individual probability (in percentage) of a positive response to the treatment (treatment success).

Design: A retrospective cohort design. Setting: A Dutch rehabilitation facility. Participants: Patients with OA diagnosed by a medical specialist and consisting at least three months.

Intervention and procedures: The intervention of interest is interdisciplinary biopsychosocial rehabilitation. The procedures include the development of a clinical prediction model and assessment of its performance and internal validity.

Measurements: Candidate predictors will be carefully selected. The outcome of the model will be treatment success, defined by the change on the Pain Disability Index (PDI). The model will be built with data gathered as part of routine practice.

Expected outcome of the research: The deliverable will be a clinical predication model, which can be used in follow-up research.

Conditions

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Chronic Pain Osteoarthritis Disability Physical

Keywords

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multimodal treatment interdisciplinary rehabilitation medicine prediction model treatment outcome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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chronic pain osteoarthritis

Patients with chronic pain and disability with osteoarthritis

interdisciplinary multimodal pain treatment

Intervention Type BEHAVIORAL

A combination of physical and psychosocial treatment methods is employed, including Emotional Awareness and Expression Therapy (EAET), Pain Neuroscience Education (PNE), Acceptance and Commitment Therapy (ACT), graded activity, exposure in vivo, and experiential learning through physical training.

Interventions

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interdisciplinary multimodal pain treatment

A combination of physical and psychosocial treatment methods is employed, including Emotional Awareness and Expression Therapy (EAET), Pain Neuroscience Education (PNE), Acceptance and Commitment Therapy (ACT), graded activity, exposure in vivo, and experiential learning through physical training.

Intervention Type BEHAVIORAL

Other Intervention Names

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biopsychosocial treatment

Eligibility Criteria

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Inclusion Criteria

* Chronic musculoskeletal pain \> 3 months and osteoarthritis
* Large personal and social dysfunction
* Interplay of biological, social and psychological factors maintaining pain and/or disability

Exclusion Criteria

* Inability to actively participate in treatment (insufficient motivation, limited Dutch language skills, environmental factors, other pending treatments)
* Disagreement between patient and care providers on content of treatment
* Pending legal procedures that hinder full cooperation
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centrum voor Integrale Revalidatie (CIR)

UNKNOWN

Sponsor Role collaborator

Pfizer

INDUSTRY

Sponsor Role collaborator

Maastricht University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rob J Smeets, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Maastricht University

Locations

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Centrum voor Integrale Revalidatie

Zwolle, Overijssel, Netherlands

Site Status

Countries

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Netherlands

References

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Breugelmans L, Scheffer E, Beckers LWME, Oosterwijk RFA, Nijland G, Smeets RJEM. Systematic description of an interdisciplinary multimodal pain treatment programme for patients with chronic musculoskeletal pain, using the TIDieR checklist. BMC Res Notes. 2022 Oct 11;15(1):320. doi: 10.1186/s13104-022-06211-z.

Reference Type BACKGROUND
PMID: 36221116 (View on PubMed)

Other Identifiers

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41150323011N

Identifier Type: OTHER

Identifier Source: secondary_id

CIR-001

Identifier Type: -

Identifier Source: org_study_id