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Search / Trial NCT06832852

Which Model of Care is the Most Cost-effective in the Treatment of Musculoskeletal Disorders?

Launched by LAVAL UNIVERSITY · Feb 11, 2025

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Stepped Care Rehabilitation Musculoskeletal Disorders Education Medical Care

ClinConnect Summary

This clinical trial is investigating the best and most cost-effective way to treat common muscle and joint pain conditions, such as low back pain, neck pain, anterior knee pain, and shoulder pain related to the rotator cuff. Researchers want to see if a new approach called the "Stepped Care Model," which starts with educational sessions before deciding if further treatment is needed, is as effective as traditional care methods. The trial will compare this new model with standard medical and rehabilitation care to understand its impact on patients' ability to function, pain levels, and overall quality of life.

To participate, adults aged 18 to 75 who have been experiencing one of these pain conditions for at least six weeks may be eligible. Participants will be randomly assigned to one of the three treatment groups. Those in the Stepped Care group will attend two education sessions in the first six weeks. Follow-ups will be provided based on how well they are doing after these sessions. Throughout the study, researchers will track improvements and costs associated with each care model. It's important to note that individuals with certain health conditions or previous treatments may not qualify for the trial. This study aims to improve access to effective treatments while potentially lowering healthcare costs in the process.

Gender

ALL

Eligibility 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).

About Laval University

Laval University is a prestigious research institution located in Quebec, Canada, renowned for its commitment to advancing knowledge and innovation in various fields, including health sciences. The university actively engages in clinical trials aimed at exploring new therapeutic interventions and improving patient outcomes. With a strong emphasis on ethical standards and rigorous scientific methodologies, Laval University collaborates with multidisciplinary teams of researchers, healthcare professionals, and industry partners to conduct high-quality clinical research. Its state-of-the-art facilities and dedication to fostering a culture of inquiry position Laval University as a leader in clinical research, contributing significantly to the understanding and treatment of diverse medical conditions.

Locations

Quebec City, Quebec, Canada

Patients applied

0 patients applied

Trial Officials

Jean-Sebastien Roy, PT, PhD

Principal Investigator

Laval University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported