Comparing cost-effective care models for musculoskeletal disorders
Is a Stepped Model of Care Cost-effective Compared to Usual Care for Musculoskeletal Disorders? a Randomized Controlled Trial
This study is testing a new way of treating musculoskeletal disorders that focuses on patient education first to see if it works better and costs less than standard care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 369 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Laval University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Québec, Quebec) |
| Trial ID | NCT06832852 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of a Stepped Care Model for treating musculoskeletal disorders (MSKDs) compared to Usual Medical Care and Usual Rehabilitation Care. The Stepped Care Model prioritizes patient education before determining the need for further medical intervention, potentially leading to reduced healthcare costs. The trial will involve 369 adults suffering from conditions such as low back pain, neck pain, anterior knee pain, and rotator cuff-related shoulder pain. By assessing functional limitations and associated costs, the study seeks to optimize healthcare resource utilization for MSKDs.
Who should consider this trial
Good fit: Ideal candidates are adults experiencing low back pain, neck pain, anterior knee pain, or rotator cuff-related shoulder pain for at least six weeks.
Not a fit: Patients who are unable to participate for the full duration of the study or do not meet the specific eligibility criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide patients with more accessible and cost-effective treatment options for musculoskeletal disorders.
How similar studies have performed: Previous studies have indicated that educational interventions can effectively resolve MSKDs, suggesting potential success for this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * present with one of the four targeted MSKDs (low back pain, neck pain, anterior knee pain, rotator cuff-related shoulder pain). * have had pain for at least 6 weeks. * For low back pain (LBP): 1) non-specific LBP with or without radiation to the lower limbs, 2) minimal score of 15 on the ODI. * For neck pain : 1) non-specific neck pain with or without radiation to the upper limbs, 2) minimal score of 21 on the NDI. * For anterior knee pain : 1) anterior knee pain during walking, running or going up or down stairs, or during at least two activities among: kneeling, squatting, and resisted knee extension, 2) maximum score of 79 on the KOS-ADL. * For rotator cuff-related shoulder pain : 1) minimal score of 15 on the QuickDASH, and 2) shoulder pain attributed to a rotator cuff-related shoulder pain using diagnostic guidelines of the British Elbow and Shoulder Society. Exclusion Criteria: * Unavailable to participate during the 24 weeks of the study. * Do not understand French or English. * Diagnosis of rheumatoid, inflammatory or neurodegenerative diseases. * Received a corticosteroid injection in the previous 3 months. * Cognitive problems interfering (Mini-Mental State Examination ≥ 24). * Received a corticosteroid injection in the previous 3 months. * Less than 6 weeks since an intervention for their condition (including performing prescribed condition-specific exercises or taking prescribed medication). * For low back pain (LBP): 1) LBP related to specific conditions (e.g., vertebral fracture, infections, neuropathic pain \[\>4 at the DN4 questionnaire\]), 2) history of spine surgery or signs of upper motor neuron lesions (bilateral paresthesia, hyperreflexia or spasticity).. * For neck pain : 1) neck pain related to specific conditions (e.g.; vertebral fracture, infections, neuropathic pain \[\>4 at the DN4 questionnaire\]), 2) history of spine surgery or signs of upper motor neuron lesions. * For anterior knee pain : 1) history of knee surgery or patellar dislocation, 2) pain believed to originate either from meniscus or from any knee ligament. * For rotator cuff-related shoulder pain : 1) history of shoulder surgery, dislocations, fractures or capsulitis, 2) full thickness rotator cuff tear identified by imagery or clinical tests (lag signs and gross weakness).
Where this trial is running
Québec, Quebec
- Centre for interdisciplinary research in rehabilitation and social integration (Cirris) — Québec, Quebec, Canada (Recruiting)
Study contacts
- Principal investigator: Jean-Sebastien Roy, PT, PhD — Laval University
- Study coordinator: Jean Tittley, PT, MSc
- Email: jean.tittley@cirris.ulaval.ca
- Phone: 1-418-529-9141
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.