Pharmacist-physiotherapist Collaborative Management for Early Knee Osteoarthritis

NCT06681142 | Recruiting

• 1 other identifier: Pro00145908
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

Brief Summary

Osteoarthritis (OA) is a slowly progressive chronic condition that is associated with aging and is characterized as joint pain. Individuals with early-stage OA usually do not seek medical attention. If and when they do, patients more often present to a pharmacy for over-the-counter medications. The investigators want to leverage community pharmacists' accessibility and scope of practice to best support patients with early knee OA. Given there are no disease-modifying treatments for OA, treatment guidelines center on patient education, self-management, and exercise, with medications playing a supporting role. Self-management is an effective strategy that provides a solid foundation for managing this progressive chronic condition and health care professionals like physiotherapists and pharmacists can help with the development and application of these skills.

Conditions

Osteoarthritis (OA) of the Knee; Physiotherapy; Pharmacy

Outcome Measures

Primary Outcomes (1)

• Disease specific self-report measure for OA

  The Knee Injury in OA Outcome Score (KOOS) from 0-100 where a higher score is a better outcome.

  Baseline, Post Intervention (3 & 6 month after baseline)

Secondary Outcomes (1)

• Patient Activation Measure (PAM)

  Baseline, Post Intervention (3 & 6 month after baseline)

Study Arms (2)

Usual Care (Control) Group

NO INTERVENTION

Pharmacists will provide a general educational pamphlet and will inform the primary care physician of patient participation and referral for further assessment of knee OA. Participants randomized to this group will be offered physiotherapy and/or pharmacy interventions (individual or GLA:D program 3 months after enrollment) and pharmacy options (comprehensive medication review). It will be explained to participants that usual care is 'conservative therapy'. Usual care participants will be eligible to opt in for a comprehensive medication review (pharmacist) and/or the physiotherapy sessions and will be evaluated at 9-months after enrollment.

Intervention Group

EXPERIMENTAL

Pharmacists will provide comprehensive 1:1 patient care, including a SCHOLAR assessment and medication review, provide specific drug therapy recommendation(s) using shared decision making (SDM), and provide comprehensive patient education/resources. Pharmacists will refer to physiotherapy clinics located nearby for patient convenience and to establish community pharmacy/physiotherapy clinic relationships. Participants will be offered a physiotherapy assessment at a nearby physiotherapy clinic within 2 weeks of being assessed by the pharmacist. After the physiotherapy assessment session, participants who are diagnosed with symptomatic knee OA will be offered 1) up to 5 individual physiotherapy sessions within a 6-week period, or 2) the GLA:D program for knee OA which includes 6-weeks of neuromuscular exercises along with 2 education session in a group format.

Other: Pharmacy-Physiotherapy Intervention

Interventions

Pharmacy-Physiotherapy Intervention OTHER

Pharmacists will provide comprehensive 1:1 patient care, including a complete patient assessment and medication review, provide specific drug therapy recommendation(s) using shared decision making (SDM), and provide patient education, including further written materials. Participants will be offered either individual or group physiotherapy sessions at the a private clinic.

Intervention Group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• regularly experiencing pain, aching, or stiffness in and/or around the knee for at least 1 month
• complete the screening PhIT-OA questionnaire

You may not qualify if:

• prior knee surgery
• history of acute knee injury (6 months)
• unable or unwilling to attend physiotherapy
• previous physician diagnoses of inflammatory arthritis or fibromyalgia
• unable to speak/ read English

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

Mint Health & Drugs Festival Place Sherwood Park

Sherwood Park, Alberta, Canada

RECRUITING

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Ross Tsuyuki

  University of Alberta

  PRINCIPAL INVESTIGATOR

• Jill Hall

  University of Alberta

  PRINCIPAL INVESTIGATOR

• Allyson Jones

  University of Alberta

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Allyson Jones

CONTACT

780-492-2020; cajones@ualberta.ca

Jordyn Burgar

CONTACT

burgar@ucalgary.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2024
• First Posted: November 8, 2024
• Study Start: August 13, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: October 2, 2025

Record last verified: 2025-09

Locations

CA (1)