Models of Care for Musculoskeletal Disorders

(Edu1st Trial)

Overseen By Jean Tittley, PT, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Laval University

Must not be taking: Corticosteroids

Disqualifiers: Rheumatoid, Inflammatory, Neurodegenerative, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

369 Participants Needed

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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. ^{1 6 11 12 13}

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

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.

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

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

Group I: Stepped Care Group Experimental Treatment 1 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 Group Active Control 1 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 Group Active Control 1 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.

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

A study of 5078 rheumatoid arthritis patients revealed that an innovative disease-management program significantly improved clinical outcomes compared to conventional care, with a notable increase in remission rates from 20.8% to 58.5%.

Patients in the innovative program also experienced a substantial reduction in high disease activity, decreasing from 18% to 4.7%, indicating that specialized care can lead to better management of rheumatoid arthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Outcomes of Patients with Rheumatoid Arthritis Treated in a Disease Management Program: Real-World Results. Santos-Moreno, P., Castillo, P., Villareal, L., et al.[2022]

A study involving 189 participants in a musculoskeletal care coordination service showed significant improvements in pain, physical function, mood, and self-reported productivity, indicating the service's effectiveness.

With a high net promoter score of 95, the service was well-received, suggesting that employers could enhance employee well-being by integrating such a service for managing common musculoskeletal issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Employer-Sponsored Musculoskeletal Care Coordination Service Can Improve Clinical Outcomes and Self-Reported Productivity. Madhusudhan, DK., Thokala, S., Hagg, HK., et al.[2022]

A 2-day interactive educational workshop significantly improved the knowledge and beliefs of 50 specialist musculoskeletal physiotherapists regarding a new care pathway for managing patients at risk of poor outcomes, with 92% agreeing to provide more targeted interventions.

Despite the positive changes in knowledge and beliefs, only 56% of participants felt that implementing the shared care pathway was easy, indicating that barriers still exist that need to be addressed for effective implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of an interactive workshop on specialist physiotherapists' practice when implementing a new clinical care pathway for people with musculoskeletal conditions. Kang, K., Evans, K., Simic, M., et al.[2022]

Active case-management for musculoskeletal disorders led to greater improvements in health outcomes compared to enhanced routine care, particularly benefiting those with poor baseline mental health.

Shorter waiting times in the case-managed service contributed to better recovery outcomes, highlighting the importance of timely intervention in reducing health inequalities and supporting return to work.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison of routine and case-managed pathways for recovery from musculoskeletal disorders in people in employment. Bergman, BP., Demou, E., Lewsey, J., et al.[2023]

In Ontario, 3.1 million adults (28.5% of the population) sought outpatient care for musculoskeletal disorders (MSDs), leading to over 8 million physician visits, highlighting the widespread impact of these conditions.

The total cost of MSD-related care was $1.8 billion, with a significant portion (40%) attributed to arthritis, indicating a substantial financial burden on the healthcare system that necessitates improved planning and resource allocation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Healthcare Utilization and Costs for Musculoskeletal Disorders in Ontario, Canada. Power, JD., Perruccio, AV., Paterson, JM., et al.[2022]

This scoping review aims to identify and map existing literature on minimal clinical data sets for spine-related musculoskeletal disorders, focusing on their use in primary care and outpatient settings, which is crucial for improving healthcare quality.

The review will include a variety of study designs and languages, ensuring a comprehensive understanding of how these data sets can be utilized to measure and monitor health status in patients, ultimately benefiting clinicians and researchers in the field.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Minimal clinical data sets for spine-related musculoskeletal disorders in primary care and outpatient settings: a scoping review protocol. Mikhail, J., Hofstetter, L., Côté, P., et al.[2022]

The PACE programme, a novel clinical pathway for managing musculoskeletal conditions, will be tested in a multicentre trial involving 716 participants, aiming to provide tailored care based on individual risk of poor outcomes.

Participants identified as low risk will receive up to 3 sessions of guideline-based care, while high-risk individuals will be referred to specialists for comprehensive assessments, potentially improving the effectiveness of treatment for musculoskeletal issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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). Rebbeck, T., Evans, K., Ferreira, P., et al.[2023]

Musculoskeletal conditions are a major global health issue, necessitating effective models of care to prevent and manage related disabilities, as they are the second highest cause of morbidity worldwide.

The review emphasizes the importance of implementing evidence-based guidelines through multidisciplinary teams and digital technologies to enhance patient outcomes, particularly for vulnerable populations, while also addressing the need for better communication with health system decision-makers about the benefits of these models.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Moving from evidence to practice: Models of care for the prevention and management of musculoskeletal conditions. Speerin, R., Slater, H., Li, L., et al.[2022]

Musculoskeletal conditions are a major cause of disability in high-income countries, and effective management in primary care is crucial, yet there is limited evidence on how to improve the adoption of best practices.

The chapter emphasizes the importance of implementing various service delivery models, such as integrated and therapist-led care, to enhance treatment for conditions like joint pain and arthritis, while also identifying key research priorities to address gaps in evidence and improve care outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of musculoskeletal Models of Care in primary care settings: Theory, practice, evaluation and outcomes for musculoskeletal health in high-income economies. Dziedzic, KS., French, S., Davis, AM., et al.[2021]

The study highlighted the importance of a single point of access for musculoskeletal services, including online self-referral, which was implemented but faced challenges due to the volume and quality of information affecting triage decision-making.

Concerns from secondary care staff about the potential for missed diagnoses in complex cases hindered full engagement with the integrated model, suggesting that addressing stakeholder concerns is crucial for successful service restructuring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Staff experiences of integrating community and secondary care musculoskeletal services: A qualitative investigation. Alvarado, N., Hargreaves, G., Storey, K., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Risk-stratified and stepped models of care for back pain and osteoarthritis: are we heading towards a common model? [2020]

2. England pubmed.ncbi.nlm.nih.gov

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]

3. England pubmed.ncbi.nlm.nih.gov

Musculoskeletal care pathways for adults with hip and knee pain at the interface between primary and secondary care: protocol for a systematic review. [2018]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Clinical Outcomes of Patients with Rheumatoid Arthritis Treated in a Disease Management Program: Real-World Results. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

An Employer-Sponsored Musculoskeletal Care Coordination Service Can Improve Clinical Outcomes and Self-Reported Productivity. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Impact of an interactive workshop on specialist physiotherapists' practice when implementing a new clinical care pathway for people with musculoskeletal conditions. [2022]

7. England pubmed.ncbi.nlm.nih.gov

A comparison of routine and case-managed pathways for recovery from musculoskeletal disorders in people in employment. [2023]

8. Canada pubmed.ncbi.nlm.nih.gov

Healthcare Utilization and Costs for Musculoskeletal Disorders in Ontario, Canada. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Minimal clinical data sets for spine-related musculoskeletal disorders in primary care and outpatient settings: a scoping review protocol. [2022]

10. England pubmed.ncbi.nlm.nih.gov

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]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Moving from evidence to practice: Models of care for the prevention and management of musculoskeletal conditions. [2022]

12. Netherlands pubmed.ncbi.nlm.nih.gov

Implementation of musculoskeletal Models of Care in primary care settings: Theory, practice, evaluation and outcomes for musculoskeletal health in high-income economies. [2021]

13. England pubmed.ncbi.nlm.nih.gov

Staff experiences of integrating community and secondary care musculoskeletal services: A qualitative investigation. [2023]