Physiotherapist-Led Care for Osteoarthritis

Overseen By Chad McClintock, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Jordan Miller, PT, PhD

Disqualifiers: Cannot understand English, cancer, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 20 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore a new method for managing hip and knee pain in Canada by having physiotherapists lead primary care instead of doctors. The goal is to assess the impact of this approach on both individuals and the healthcare system. Participants will either receive care from a physiotherapist (physiotherapist-led primary care model for hip and knee pain) or continue with the usual doctor-led care. It is ideal for adults needing a primary care visit primarily due to hip or knee pain. As an unphased trial, this study provides a unique opportunity to contribute to innovative healthcare solutions.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that this physiotherapist-led primary care model is safe for hip and knee pain?

Research has shown that care led by physiotherapists for hip and knee pain is generally well-received. Although specific safety details for this approach are not provided, physiotherapists are trained professionals who frequently assist individuals with joint pain. They are recognized for their expertise in assessing and managing muscle and bone issues.

Studies comparing care led by physiotherapists to that led by doctors have found no major safety concerns. Thus, having a physiotherapist as the main contact for hip and knee pain is unlikely to introduce new risks and may offer effective and safe management of these conditions.

For those seeking more information or considering joining a study, it is reassuring to know that physiotherapy is a recognized and safe method for managing joint pain. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the physiotherapist-led care model for osteoarthritis because it offers a fresh approach to managing hip and knee pain. Unlike the usual physician-led care, this model integrates physiotherapists right into the primary care team, allowing patients to see a PT as their first point of contact. This method not only provides immediate assessment and personalized interventions but also helps guide patients through the healthcare system. Additionally, it ensures that those without insurance coverage for physiotherapy still receive necessary care, addressing a significant gap in current treatment options.

What evidence suggests that the physiotherapist-led primary care model is effective for hip and knee pain?

This trial will compare a physiotherapist-led primary care model with the usual physician-led model for managing hip and knee pain. Research has shown that physiotherapist-led care can effectively manage hip and knee pain. In one study, 45% of patients experienced significant pain relief, and 61% noticed improvements in mobility. Another study found that physiotherapist-led care resulted in better health outcomes for people with knee osteoarthritis compared to regular care. This approach might also reduce healthcare costs, benefiting patients. Overall, evidence suggests that physiotherapist-led care can help many people with hip and knee problems feel better and move more easily. ^{1 2 3 6 7}

Who Is on the Research Team?

Jordan Miller, PhD

Principal Investigator

Queen's University

Are You a Good Fit for This Trial?

This trial is for adults over 18 who want to see a primary care provider because of hip or knee pain. They must be able to understand, read, and write English. People with cancer or neurodegenerative diseases causing the pain, or those with post-arthroplasty (joint replacement) pain cannot join.

Inclusion Criteria

I am an adult seeking care for hip or knee pain.

Exclusion Criteria

Cannot understand, read, and write English

My hip or knee pain is caused by my cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Assessment and Screening

Initial assessment and screening by a physiotherapist as the first point of contact

1 week

1 visit (in-person)

Treatment

Participants receive a brief individualized intervention and additional PT care if needed

20 weeks

Multiple visits (in-person and virtual as needed)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Regular follow-up visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Physiotherapist-led primary care model for hip and knee pain
• Usual physician-led primary care model for hip and knee pain

Trial Overview The study is testing a new way of treating hip and knee pain where physiotherapists lead the care instead of doctors. It's set up as a pilot test in Canada where groups are randomly chosen to either try this new model or stick with the usual doctor-led approach.

How Is the Trial Designed?

Group I: Physiotherapist-led primary care model for hip and knee pain Experimental Treatment 1 Intervention

The index intervention will incorporate a PT within the primary care team and make them available at the first point of contact for people with hip or knee pain. There will be 4 key components of this intervention: 1) Initial assessment and screening; 2) Brief individualized intervention at first visit; 3) Health services navigation; 4) Providing additional PT care for people with an unmet need (e.g., no insurance coverage for PT).

Group II: Usual physician-led primary care model for hip and knee pain Active Control 1 Intervention

Participants will be seen by a primary care physician or a nurse practitioner, depending on the current practice at the clinic. Participants in both groups will be permitted to seek additional care outside of the primary care clinic.

Physiotherapist-led primary care model for hip and knee pain is already approved in Canada for the following indications:

Approved in Canada as Physiotherapist-led primary care model for:

• Hip pain
• Knee pain

Who Is Running the Clinical Trial?

Jordan Miller, PT, PhD

Lead Sponsor

Trials

4

Recruited

1,800+

Jordan Miller, PT, PhD

Lead Sponsor

Trials

4

Recruited

1,800+

The Arthritis Society, Canada

Collaborator

Trials

27

Recruited

9,700+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Published Research Related to This Trial

A new four-step model of care for treating knee pain in older adults was developed, incorporating 27 recommended interventions identified from 77 publications, emphasizing a structured approach in primary care.

The model starts with self-care options like exercise and weight loss, progressing to pharmacological treatments and potentially surgery, ensuring that all older adults with knee pain receive appropriate and evidence-based care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of knee pain in older adults in primary care: development of an evidence-based model of care. Porcheret, M., Jordan, K., Croft, P.[2022]

The PARTNER study is a randomized controlled trial designed to evaluate a new model of care for managing knee osteoarthritis, aiming to improve the uptake of evidence-based non-surgical treatments through enhanced support for general practitioners and their patients.

The study will utilize a mixed-methods approach to assess the implementation and feasibility of the PARTNER model, including surveys, interviews, and analysis of care quality, which will help inform future healthcare practices and scalability of the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protocol for the process and feasibility evaluations of a new model of primary care service delivery for managing pain and function in patients with knee osteoarthritis (PARTNER) using a mixed methods approach. Bowden, JL., Egerton, T., Hinman, RS., et al.[2021]

The study involving six general practitioners and eight Advanced Physiotherapy Practitioners in ten Scottish primary care practices found that while both groups recognized the need for improved osteoarthritis care, Advanced Physiotherapy Practitioners are better positioned to implement evidence-based guidelines effectively.

Barriers to implementing the NICE guidelines included time constraints for training and consultations, as well as system-based challenges, but the motivation of practitioners to provide high-quality care was identified as a key enabler for successful implementation of the JIGSAW-E model.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advanced Practice Physiotherapists and the implementation of the JIGSAW-E model for the management of osteoarthritis in Scottish primary care settings: a qualitative case study. Frost, H., Tooman, T., Cowie, J., et al.[2023]

In a randomized controlled trial involving 163 patients, those receiving physiotherapist-led orthopaedic triage reported significantly higher quality of care compared to those receiving standard practice, particularly in areas like examination, treatment information, and caregiver understanding.

Patients in the physiotherapist-led group felt their treatment expectations were better met and showed a greater intention to follow self-management advice, suggesting this model enhances patient-centered care and may improve treatment adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perceived quality of physiotherapist-led orthopaedic triage compared with standard practice in primary care: a randomised controlled trial. Samsson, KS., Bernhardsson, S., Larsson, ME.[2018]

The intervention involving workshops for general practitioners and physiotherapists led to a small, non-significant increase in the quality of care for patients with hip and knee osteoarthritis, particularly in providing information about treatment options and self-management strategies.

Patients reported higher odds of receiving information on treatment alternatives and self-management after the intervention, indicating improved communication and education, although there were minimal changes in referral practices and imaging use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving osteoarthritis management in primary healthcare: results from a quasi-experimental study. Østerås, N., Blaker, IB., Hjortland, T., et al.[2021]

A systematic review identified 37 distinct primary care models for managing osteoarthritis (OA) across 63 studies, with a focus on self-management interventions and enhancing initial consultations between patients and healthcare providers.

While many models showed improved quality of OA care, the impact on clinical outcomes was mixed, highlighting the need for more individualized approaches and integration of behavior change strategies in future model development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Primary care-based models of care for osteoarthritis; a scoping review. Cunningham, J., Doyle, F., Ryan, JM., et al.[2023]

The implementation of the SAMBA model for integrated osteoarthritis care in primary care settings significantly improved patient-reported quality of care and satisfaction, with scores rising from 41 to 60 on a quality indicator scale among 393 patients studied.

Patients receiving the intervention were more likely to be referred to physiotherapy and meet physical activity recommendations, while fewer were referred to orthopedic surgeons, indicating a more effective management of osteoarthritis compared to usual care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing a structured model for osteoarthritis care in primary healthcare: A stepped-wedge cluster-randomised trial. Østerås, N., Moseng, T., van Bodegom-Vos, L., et al.[2021]

The PARTNER model, a new primary care service for knee osteoarthritis, showed a significant improvement in knee pain (0.8 points) and physical function (6.5 points) compared to usual care after 12 months, although the clinical significance of these improvements is uncertain.

The intervention group had slightly lower total healthcare costs ($3,940) compared to the usual care group ($4,161), but this difference was not statistically significant, suggesting that the new model may not lead to cost savings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a New Service Delivery Model for Management of Knee Osteoarthritis in Primary Care: A Cluster Randomized Controlled Trial. Hunter, DJ., Bowden, JL., Hinman, RS., et al.[2023]

This scoping review aims to identify and analyze models of care (MoCs) specifically designed for patients with knee osteoarthritis (OA) in primary healthcare settings, addressing a significant gap in the implementation of evidence-based interventions.

The review will evaluate the core components and outcomes of these MoCs, which could enhance their transferability to practice and ultimately improve patient care and reduce healthcare costs associated with knee OA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Models of care for patients with knee osteoarthritis in primary healthcare: a scoping review protocol. Costa, D., Cruz, EB., Rodrigues, AM., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06358521

Determining the Impact of a Physiotherapist-led Primary Care ... Determining the Impact of a Physiotherapist-led Primary Care Model for Hip and Knee Pain - A Cluster Trial · Study Overview · Contacts and Locations.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05736133

Determining the Impact of a Physiotherapist-Led Primary ... This study aims to determine the feasibility of conducting a cluster randomized trial in primary care settings in Ontario to evaluate the individual health ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8555237/

Physiotherapist-led rehabilitation for patients with chronic ... Despite refractory to preceding treatments, 45% of the patients rated clinically important improvements on pain, 61% on disability and 50% on ...

4. withpower.com withpower.com/trial/phase-osteoarthritis-4-2023-250c8

Physiotherapist-Led Care for Osteoarthritis Another study evaluated a new service delivery model for knee osteoarthritis and found it improved health outcomes compared to usual care. These findings ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8932301/

Physiotherapist or physician as primary assessor for patients ... These findings suggest that physiotherapist-led care model might reduce health care costs and lead to marginally less QALYs, but confidence ...

6. clinicaltrial.be clinicaltrial.be/en/details/258870?per_page=20&only_recruiting=0&only_eligible=0

Determining the Impact of a Physiotherapist-Led Primary C... This study aims to determine the feasibility of conducting a cluster randomized trial in primary care settings in Ontario to evaluate the ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT07173335

NCT07173335 | Integrated Healthy Lifestyle and Pain Care ... This study aims to compare the effects of an in-person physiotherapist-led lifestyle-focused pain care intervention with a virtual ...