Models of Care for Musculoskeletal Disorders

(Edu1st Trial)

Recruiting at 1 trial location

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to find a better way to treat musculoskeletal disorders (MSKDs) such as back, neck, knee, or shoulder pain. It will compare three treatment models: a new Stepped Care Model, Usual Medical Care, and Usual Rehabilitation Care. The Stepped Care Model starts with education and progresses to more treatment if needed, potentially reducing wait times and healthcare costs without sacrificing quality. The trial seeks adults who have experienced pain for at least six weeks in one of the specified areas. As an unphased trial, it offers the opportunity to contribute to innovative treatment strategies for MSKDs.

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 prior data suggests that these models of care are safe for musculoskeletal disorders?

Research has shown that the Stepped Care model for treating musculoskeletal disorders (MSKDs) is generally well-tolerated. This approach begins with education and progresses to more involved treatments only if symptoms persist. Although no specific study has focused on this model for MSKDs, similar methods have been used successfully in other conditions without serious safety issues.

The Stepped Care method starts with basic education. If symptoms improve, no further treatment is necessary. If not, patients receive additional rehabilitation with a physiotherapist. This step-by-step approach helps avoid unnecessary treatments and potential side effects. Since the treatment primarily involves education and physical therapy, it is considered safe for most people.

Sources suggest that these types of interventions are generally safe and well-received, though individual results can vary. Always discuss any concerns with a healthcare provider before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative models of care for musculoskeletal disorders, focusing on personalized and adaptable treatment approaches. Unlike traditional methods that often rely on a fixed regimen of physiotherapy or medical care, the Stepped Care approach tailors treatment based on individual progress. If symptoms improve early on, participants may avoid further interventions, streamlining care and potentially reducing unnecessary treatments. This flexibility and emphasis on self-management education could lead to more efficient and patient-centered care, which is what makes this trial particularly promising.

What evidence suggests that this trial's treatments could be effective for musculoskeletal disorders?

Research has shown that a Stepped Care Model, one of the treatment options in this trial, can help people with musculoskeletal disorders (MSKDs) improve their symptoms. This approach tailors treatment to each person's needs, leading to better symptom management without unnecessary interventions. For instance, some individuals recover well with basic education alone, reducing the need for frequent doctor visits and saving time and money. Although detailed studies on its effectiveness specifically for MSKDs are limited, evidence suggests it could match traditional methods in effectiveness while offering greater efficiency. This approach holds promise for easing the burden on healthcare systems and enhancing patient access to care. ^{2 6 7 8 9}

Who Is on the Research Team?

Jean-Sebastien Roy, PT, PhD

Principal Investigator

Laval University

Are You a Good Fit for This Trial?

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.

Unavailable to participate during the 24 weeks of the study

I have been diagnosed with a rheumatoid, inflammatory, or neurodegenerative disease.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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In 2013 back pain was the most common reason for health care visits among musculoskeletal disorders, with more than 57 million physician office visits.