369 Participants Needed

Models of Care for Musculoskeletal Disorders

(Edu1st Trial)

JT
Overseen ByJean Tittley, PT, MSc
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you have received a corticosteroid injection in the past 3 months or have had an intervention for your condition in the last 6 weeks, you may not be eligible to participate.

What data supports the effectiveness of the treatment for musculoskeletal disorders?

Research shows that structured models of care, like stepped care for osteoarthritis and risk-stratified care for low back pain, can help improve treatment outcomes by tailoring interventions based on patient needs. These models share common features and may be combined to enhance care for musculoskeletal conditions.12345

Is the treatment for musculoskeletal disorders generally safe for humans?

The research articles provided do not contain specific safety data for the treatment of musculoskeletal disorders under the names Medical Care, Rehabilitation Care, or Stepped Care.678910

How does the Stepped Care treatment for musculoskeletal disorders differ from other treatments?

Stepped Care is unique because it adjusts the level of treatment based on how well a patient responds, starting with simpler interventions and only moving to more comprehensive care if needed. This approach is different from other treatments that might not tailor the intensity of care to individual patient responses.16111213

What is the purpose of this trial?

As musculoskeletal disorders (MSKDs) reach epidemic proportions in Canada, access to the public health system for those who suffer from them is increasingly difficult. One of the main barriers is the delays to see a publicly funded health professional. New models of care must therefore be developed to ensure better access. We have previously shown that not all patients with a MSKD need to be closely followed by a health professional as for a large proportion of patients simply educating them is enough to resolve their MSKD. A stepped care model where education would be given first before deciding if patients need a more extensive follow-up should be explored. This project will compare the effectiveness of a Stepped Care Model to that of the two most widely used models of care: Usual Medical Care and Usual Rehabilitation Care. We think that a Stepped Care Model will be as effective to reduce functional limitations, but will lead to lower healthcare costs.Adults (n=369) with a MSKD will be randomly assigned to one of the intervention groups: Stepped Care, Usual Medical Care (physician-led intervention: e.g., advice/education, pharmacological pain management), or Usual Rehabilitation Care (physiotherapist-led intervention: e.g., advice/education, exercises). Participants in the Stepped Care Group will take part in two education sessions during the first 6 weeks. After 6 weeks, those who still have clinically important symptoms will receive follow-up rehabilitation interventions, while those who don't will be considered recovered and will have no further intervention. Primary (functional limitations) and secondary (e.g., pain, quality of life) outcomes will be assessed at baseline, and at 6, 12 and 24 weeks, and costs estimate will be established for each model of care. Knowing the urgent need for an overhaul of services to reduce wait times, the Stepped Care Model proposed could be a solution to improve access to health services without compromising quality of care.

Research Team

JR

Jean-Sebastien Roy, PT, PhD

Principal Investigator

Laval University

Eligibility Criteria

This trial is for adults with musculoskeletal disorders such as low back pain, neck pain, shoulder issues, and patellofemoral syndrome. It's designed to test different care models in Canada due to long wait times for treatment. Participants will be randomly assigned to one of three groups: Stepped Care, Usual Medical Care, or Usual Rehabilitation Care.

Inclusion Criteria

I have pain in my lower back, neck, knee, or shoulder.
I have neck pain that may spread to my arms, scoring at least 21 on the NDI.
I have been experiencing pain for at least 6 weeks.
See 3 more

Exclusion Criteria

My lower back pain is due to a specific condition like a fracture, infection, or nerve pain.
I have been diagnosed with a rheumatoid, inflammatory, or neurodegenerative disease.
Unavailable to participate during the 24 weeks of the study
See 7 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Treatment

Participants in the Stepped Care Group receive two education sessions over 6 weeks. Usual Medical Care involves up to 3 physician appointments, and Usual Rehabilitation Care involves up to 10 physiotherapist appointments over 12 weeks.

6-12 weeks
2 visits (Stepped Care), up to 3 visits (Usual Medical Care), up to 10 visits (Usual Rehabilitation Care)

Follow-up Treatment

Participants in the Stepped Care Group with unresolved symptoms receive up to 5 additional physiotherapy sessions over 6 weeks.

6 weeks
Up to 5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 6, 12, and 24 weeks.

24 weeks

Treatment Details

Interventions

  • Medical Care
  • Rehabilitation Care
  • Stepped Care
Trial Overview The study compares a Stepped Care Model—initial education sessions followed by rehabilitation if needed—with two common approaches: Usual Medical Care (physician-led advice and pain management) and Usual Rehabilitation Care (physiotherapist-led advice and exercises). The goal is to see which model reduces functional limitations most cost-effectively.
Participant Groups
3Treatment groups
Experimental Treatment
Active Control
Group I: Stepped Care GroupExperimental Treatment1 Intervention
During the first 6 weeks, participants will take part in a self-management education program and will be offered two individual educational sessions provided by a physiotherapist (PT). At the 6-week follow-up evaluation, the score on a region-specific patient-reported outcome measure will be used to determine if the condition is resolved or unresolved. Those no longer experiencing clinically important symptoms at the 6-week follow-up will be considered resolved and will have no further intervention. Those with remaining clinically important symptoms will receive follow-up interventions by a PT with up to 5 sessions over 6 weeks. The rehabilitation program will be similar to the one received by the participants in the Usual Rehabilitation Care Group.
Group II: Usual Medical Care GroupActive Control1 Intervention
Participants will take part in a 12-week family physician (FP)-led program based on best practices and CPGs. It will include a maximum of 3 meetings over 12 weeks with a FP.
Group III: Usual Rehabilitation Care GroupActive Control1 Intervention
Participants will take part in a pragmatic 12-week physiotherapist (PT)-led rehabilitation program. It will include a maximum of 10 supervised meetings of 30 minutes each and an individualized home exercise program of 20-30 minutes to be performed 3-4 times per week.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Laval University

Lead Sponsor

Trials
439
Recruited
178,000+

Findings from Research

Current care models for osteoarthritis and low back pain are structured to improve treatment outcomes, with osteoarthritis using stepped care based on treatment response and low back pain utilizing risk stratification for comprehensive care.
There is potential for a unified care model across musculoskeletal conditions that incorporates big data and machine learning to enhance patient-centered care, integrate self-management, and address social factors and comorbidities, ultimately aiming to close the evidence-practice gap.
Risk-stratified and stepped models of care for back pain and osteoarthritis: are we heading towards a common model?Kongsted, A., Kent, P., Quicke, JG., et al.[2020]
This study will track the outcomes of patients with musculoskeletal conditions referred from primary care to Clinical Assessment and Treatment Services over a twelve-month period, aiming to understand their management and recovery.
The research will also develop simple prognostic measures to help identify patients at high risk of poor outcomes, which could improve clinical prioritization and triage in musculoskeletal care.
The Staffordshire arthritis, musculoskeletal, and back assessment (SAMBA) study: a prospective observational study of patient outcome following referral to a primary-secondary care musculoskeletal interface service.Roddy, E., Zwierska, I., Dawes, P., et al.[2021]
This systematic review aims to evaluate the effectiveness of current service delivery models for adult patients with hip and knee pain, addressing the need for improved and consistent care pathways in the UK, especially given the rising demand due to an aging population.
The review will analyze a wide range of data sources, including patient and clinician opinions, to develop recommendations for redesigning care pathways that enhance patient experience and outcomes while ensuring efficient use of NHS resources.
Musculoskeletal care pathways for adults with hip and knee pain at the interface between primary and secondary care: protocol for a systematic review.Button, K., Morgan, F., Hodgson, H., et al.[2018]

References

Risk-stratified and stepped models of care for back pain and osteoarthritis: are we heading towards a common model? [2020]
The Staffordshire arthritis, musculoskeletal, and back assessment (SAMBA) study: a prospective observational study of patient outcome following referral to a primary-secondary care musculoskeletal interface service. [2021]
Musculoskeletal care pathways for adults with hip and knee pain at the interface between primary and secondary care: protocol for a systematic review. [2018]
Clinical Outcomes of Patients with Rheumatoid Arthritis Treated in a Disease Management Program: Real-World Results. [2022]
An Employer-Sponsored Musculoskeletal Care Coordination Service Can Improve Clinical Outcomes and Self-Reported Productivity. [2022]
Impact of an interactive workshop on specialist physiotherapists' practice when implementing a new clinical care pathway for people with musculoskeletal conditions. [2022]
A comparison of routine and case-managed pathways for recovery from musculoskeletal disorders in people in employment. [2023]
Healthcare Utilization and Costs for Musculoskeletal Disorders in Ontario, Canada. [2022]
Minimal clinical data sets for spine-related musculoskeletal disorders in primary care and outpatient settings: a scoping review protocol. [2022]
Implementation of a novel stratified PAthway of CarE for common musculoskeletal (MSK) conditions in primary care: protocol for a multicentre pragmatic randomised controlled trial (the PACE MSK trial). [2023]
Moving from evidence to practice: Models of care for the prevention and management of musculoskeletal conditions. [2022]
Implementation of musculoskeletal Models of Care in primary care settings: Theory, practice, evaluation and outcomes for musculoskeletal health in high-income economies. [2021]
Staff experiences of integrating community and secondary care musculoskeletal services: A qualitative investigation. [2023]
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