Predicting Successful Outcome of Interdisciplinary Biopsychosocial Rehabilitation in Osteoarthritis

Active, not recruiting

• Conditions: Chronic Pain; Osteoarthritis; Disability Physical
• Interventions: Behavioral: interdisciplinary multimodal pain treatment

• Registration Number: NCT05661760
• Lead Sponsor: Maastricht University

Brief Summary

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

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.

Study Timeline

• Study Start: 2019-01-01
• Primary Completion: 2022-01-17
• Status Verified: 2022-11
• Study First Submitted: 2022-11-24
• Study First Submitted QC: 2022-12-21
• Last Update Submitted: 2022-12-21
• Study First Posted: 2022-12-22
• Last Update Posted: 2022-12-22
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 2309

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
chronic pain osteoarthritis	interdisciplinary multimodal pain treatment	Patients with chronic pain and disability with osteoarthritis

Primary Outcome Measures

Name	Time	Method
Pain Disability Index	baseline (start of treatment) and 10 weeks	Measures to which degree pain prevents the patient from participating in daily activities. Improvement equal or higher than Minimal Clinically Important Change (MCID; which is 9 points) is defined as successful treatment, and all others as not successful treatment Population will be dichotomized into successful or non-successful treatment and this will be the dependent variable for the logistic regression analysis used to build the prediction model

Trial Locations

Locations (1)

Centrum voor Integrale Revalidatie; 🇳🇱 Zwolle, Overijssel, Netherlands