Pharmacist-physiotherapist Collaborative Management for Early Knee Osteoarthritis (PACE-OA)

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.

Study Overview

• Status: Recruiting
• Conditions: Physiotherapy; Pharmacy; Osteoarthritis (OA) of the Knee
• Intervention / Treatment: Other: Pharmacy-Physiotherapy Intervention

Detailed Description

Pharmacists will identify patients with knee pain using two recruitment strategies: (1) Posters placed near the dispensary and 'shelf talkers' placed near the over-the-counter non- steroidal anti-inflammatory drugs, acetaminophen, and natural health products (e.g. glucosamine, collagen) will recommend patients with knee pain talk to their pharmacist and (2) Patients receiving care by a pharmacist for other conditions that have similar risk factors as OA will be asked about symptomatic knee OA (e.g. obesity).

The inclusion criteria is patients 50 years of age or older who have been regularly experiencing pain, aching, or stiffness in and/or around the knee for at least 1 month. The exclusion criteria is patients with prior knee surgery, history of acute knee injury (6 months), unable or unwilling to attend physiotherapy, previous physician diagnoses of inflammatory arthritis or fibromyalgia, and unable to speak/ read English.

For those patients with probable symptomatic knee OA, the study will be explained and upon agreement, written consent will be secured. Following enrollment, the pharmacist will ask participants to complete the baseline assessments (in pharmacy or online):

• Knee injury and OA Outcome Score (KOOS) -Reason for visiting the pharmacy
• Socio-demographics (DOB, sex/gender, education, marital status, employment) -Past medical history (chronic conditions, current medications, height/weight, other joint involvement) -Previous medications/injections trialed for knee pain -Lifestyle activities (smoking, alcohol use, walking tolerance and any assistive walking devices) -Co-interventions (eg. chiropractor, joint injections, naturopath) -Self-management (Patient Activation Measure) The pharmacist will also answer questions that participants may have regarding services and medications.

Participants will be randomized to either the control arm which is usual care or the intervention arm which includes a referral to physiotherapy and a comprehensive medication review. Randomization will occur in variable computer-generated blocks of 4-8 participants. Following the enrolment, the pharmacist will receive a code that randomizes the patients into either the treatment group (comprehensive pharmacist assessment, pharmacologic recommendations, and education with referral to physiotherapy) or usual care (brief assessment and recommendation by the pharmacist, education information brochure).

If participants have a family physician, the pharmacist will provide a notice that the patient likely has knee OA and is enrolled in this study. The name of the pharmacist and physiotherapist will be provided.

• Study Type: Interventional
• Enrollment (Estimated): 125
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Allyson Jones; Phone Number: 780-492-2020; Email: cajones@ualberta.ca
• Study Contact Backup: Name: Jordyn Burgar; Email: burgar@ucalgary.ca

Study Locations

• Canada
  • Alberta
    • Sherwood Park, Alberta, Canada
      • Recruiting
      • Mint Health & Drugs Festival Place Sherwood Park
      • Contact: Davy Sam RPh, APA, BSP; Phone Number: 780-989-1282; Email: paceoa@ualberta.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care (Control) Group; 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.
Experimental: Intervention Group; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Activation Measure (PAM)	Scale from 0-100 where a higher score is a better outcome.	Baseline, Post Intervention (3 & 6 month after baseline)

Collaborators and Investigators

• Sponsor: University of Alberta
• Investigators: Principal Investigator: Ross Tsuyuki, University of Alberta; Principal Investigator: Jill Hall, University of Alberta; Principal Investigator: Allyson Jones, University of Alberta

Study record dates

Study Major Dates

• Study Start (Actual): August 13, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: November 3, 2024
• First Submitted That Met QC Criteria: November 7, 2024
• First Posted (Actual): November 8, 2024

Study Record Updates

• Last Update Posted (Estimated): October 2, 2025
• Last Update Submitted That Met QC Criteria: September 26, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis
• Other Study ID Numbers: Pro00145908

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No