Effectiveness and Cost-Effectiveness of a Stepped Model of Care for Musculoskeletal Disorders: Protocol for a Multiarm Randomized Controlled Trial (Edu-First Trial)

Abstract

Background: Musculoskeletal disorders (MSKDs) are a leading cause of pain and disability, placing a substantial burden on health care systems. Optimizing resource use through innovative interventions is essential. Evidence from randomized controlled trials suggests that not all individuals with MSKDs require ongoing follow-up with a health care provider; for many, education alone is sufficient for symptom resolution. A stepped care model, which prioritizes patient education as a first-line intervention and reserves usual care for those with persistent symptoms, may enhance health care efficiency and reduce costs.

Objective: The primary objective of this randomized controlled trial is to evaluate the effectiveness of a stepped care model compared to the 2 most common approaches for managing MSKDs: usual medical care and usual rehabilitation care. A secondary objective is to assess cost-effectiveness.

Methods: This pragmatic, noninferiority, multiarm, parallel-group randomized controlled trial will enroll 369 adults with MSKDs, randomly assigned to one of three 12-week intervention groups: stepped care, usual medical care (physician-led), or usual rehabilitation care (physiotherapist-led). Participants in the stepped care group will first complete a 6-week education program. Those with persistent symptoms after 6 weeks will receive rehabilitation interventions, while participants whose symptoms have resolved will receive no further intervention. The primary outcome is functional limitations at 24 weeks. Secondary outcomes include pain severity, health-related quality of life, pain-related fear, and pain self-efficacy, assessed at baseline and at 6, 12, and 24 weeks. Linear mixed models will be used for group comparisons, and incremental cost-effectiveness analyses will evaluate cost-effectiveness. The ethics committee of the CIUSSS-CN approved the project (#2024-2982). Findings will be shared through clinical and community platforms, peer-reviewed publications, and conference presentations.

Results: The Edu-First trial is funded by a project grant from the Canadian Institutes of Health Research (grant #495615). Recruitment began on January 31, 2025. As of September 2025, a total of 65 participants have been enrolled. Recruitment is expected to continue for up to 3 years, targeting approximately 10 new participants per month, and is anticipated to be completed by Winter 2028.

Conclusions: We anticipate that the stepped care model will be noninferior to usual medical care and usual rehabilitation care in terms of treatment effectiveness. Furthermore, it is expected to be cost-effective by reducing reliance on expensive resources, such as provider consultations and medical investigations. By emphasizing education and self-management as the initial approach, the stepped care model may enhance access to care without compromising quality, while empowering patients to actively manage their condition. Findings from this study could inform systemic changes in MSKD care delivery, improving treatment accessibility and reducing the average cost per care episode.

Trial registration: ClinicalTrial.gov NCT06832852; https://clinicaltrials.gov/ct2/show/NCT06832852.

International registered report identifier (irrid): DERR1-10.2196/77574.

Keywords: anterior knee pain; cost-effectiveness; education; low back pain; neck pain.; rehabilitation; shoulder pain.