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NCT Number: NCT06681142

Pharmacist-physiotherapist Collaborative Management for Early Knee Osteoarthritis

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.

Recruiting

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mint Health & Drugs Sherwood Park

Sherwood Park, Alberta, Canada

Location status: Recruiting

Location contact

Jordyn Burgar

CONTACT

[email protected]

780-989-1282

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 total knee replacement or on the waitlist to have your knee replaced
  • Knee surgery within the previous 4 months
  • History of acute injury to knee within previous 6 months
  • Unable to speak and read English
  • Unwilling or unable to visit a physiotherapist at a community physiotherapy clinic (specifically the dates and times of the partnering physiotherapy clinic)
  • Previous physician-diagnosed inflammatory arthritis (including this list): Rheumatoid arthritis, Psoriatic arthritis, Ankylosing spondylitis, Lupus, Gout
  • Physician diagnosed fibromyalgia
  • A sudden, severely painful, hot, swollen joint at any time in the past
  • History of the following medications: csDMARD or bDMARD or tsDMARD, Immunosuppressive, Allopurinol or febuxostat, Colchicine
  • Received a knee joint injection in the past 3 months or have one scheduled in the next 3 months
  • Has completed the GLA:D Hip and Knee program at all in the past

Treatment and study plan

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.

Primary outcomes

  1. Disease specific self-report measure for OA

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

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

Secondary outcomes

  1. Patient Activation Measure (PAM)

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

    Scale from 0-100 where a higher score is a better outcome.

Study contacts

Contact information is provided by the study sponsor or research team.

Allyson Jones

CONTACT

[email protected]

780-492-2020

Jordyn Burgar

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Registry information

Acronym: PACE-OA

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Nov 8, 2024
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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