Determining the Impact of a Physiotherapist-led Primary Care Model for Hip and Knee Pain - A Cluster Trial

NCT06358521 | Active Not Recruiting

• 1 other identifier: 6040471
• Study Type: interventional
• Target: 728
• Locations: 1 country
• Sites: 1

Brief Summary

This is a cluster randomized controlled trial to to evaluate the individual and health system impacts of implementing a new physiotherapist-led primary care model for hip and knee pain in Canada.

Conditions

Hip Osteoarthritis; Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Self-Reported Functioning

  Self-report using the Lower Extremity Functional Scale (0-80 score with higher score representing higher function)

  Baseline and 3, 6, 9, and 12 months follow-up

Secondary Outcomes (30)

• Self-Reported Pain Intensity

  Baseline and 3, 6, 9, and 12 months follow-up

• Health-Related Quality of Life

  Baseline and 3, 6, 9, and 12 months follow-up

• Pain Self Efficacy

  Baseline and 3, 6, 9, and 12 months follow-up

• Catastrophic Thinking

  Baseline and 3, 6, 9, and 12 months follow-up

• Fear of Movement

  Baseline and 3, 6, 9, and 12 months follow-up

Other Outcomes (4)

• Baseline Characteristics

  Baseline

• Comorbidities

  Baseline

• Chronicity of Pain

  Baseline

Study Arms (2)

Physiotherapist-led primary care model for hip and knee pain

EXPERIMENTAL

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).

Other: Physiotherapist-led primary care model for hip and knee pain

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

ACTIVE COMPARATOR

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.

Other: Usual physician-led primary care model for hip and knee pain

Interventions

Physiotherapist-led primary care model for hip and knee pain OTHER

1. Initial assessment and screening: The PT will provide a comprehensive assessment according to established clinical practice guidelines. 2. Brief individualized intervention at first visit: The PT intervention will be at the discretion of the PT to reflect real-world PT intervention. 3. Health services navigation: Participants will be provided with options available to them in their community for rehabilitation. For example, they may be referred to community PT for ongoing management. Participants will be assessed regarding the need for specialist referrals or resources available to manage complex clinical presentations. Participants may be referred to the primary care provider if no specialized services are needed or when the PT cannot provide a direct referral. 4. Additional PT care: Patients who require community PT but do not have the appropriate coverage for community-based services will be managed by the PT who provided the assessment in the primary care setting.

Physiotherapist-led primary care model for hip and knee pain

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

The physician led primary care intervention will be unstandardized to best reflect standard clinical practice in Canada.

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

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Adults \>= 19 years who ask to book a primary care visits where the primary reason is for hip or knee pain of any duration.

You may not qualify if:

• Cannot understand, read, and write English
• Known cancer causing hip or knee pain

Sponsors & Collaborators

• Queen's University: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• The Arthritis Society, Canada: collaborator

Study Sites (1)

Queen's University

Kingston, Ontario, K7L3N6, Canada

Location

MeSH Terms

Conditions

Osteoarthritis, Hip; Osteoarthritis, Knee

Interventions

Papaverine

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Benzylisoquinolines; Alkaloids; Heterocyclic Compounds; Opiate Alkaloids; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Jordan Miller, PhD

  Queen's University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Due to the nature of the new model of care and comparison, it is not possible to blind the patient participants or health care providers. Since the primary outcomes are self-reported outcome measures, the assessor is also not blind to the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, School of Rehabilitation Therapy, Queen's University

Model Details: This is a cluster randomized controlled trial randomizing 14 sites to the PT-led primary care model for hip/knee pain or to the usual physician/nurse practitioner-led care model

Study Record Dates

• First Submitted: April 5, 2024
• First Posted: April 10, 2024
• Study Start: October 2, 2023
• Primary Completion: November 25, 2025
• Study Completion: December 19, 2025
• Last Updated: December 11, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)