Pharmacist-physiotherapist Collaborative Management for Knee Arthritis

(PACE-OA Trial)

Overseen By Jordyn Burgar

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alberta

Disqualifiers: Knee surgery, Acute injury, Inflammatory arthritis, Fibromyalgia, others

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

Compensation: Varies

Number of Visits: 10

125 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how pharmacists and physiotherapists can collaborate to assist individuals with early knee osteoarthritis (OA), a condition that causes joint pain. The trial will test whether a combined approach of personalized care from pharmacists and physiotherapists, known as the Pharmacy-Physiotherapy Intervention, can enhance self-management and education. These elements are crucial for managing OA, as no direct cures exist. Participants will receive either usual care or a more personalized intervention, including medication reviews and physiotherapy sessions. The trial seeks individuals who have experienced knee pain, aching, or stiffness for at least a month. As an unphased trial, this study offers a unique opportunity to contribute to innovative care strategies for knee OA.

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

The trial information does not specify whether you need to stop taking your current medications. It seems that medications play a supporting role, so you might be able to continue them, but it's best to confirm with the trial organizers.

What prior data suggests that this pharmacy-physiotherapy intervention is safe for managing knee arthritis?

Research has shown that combining education and exercise can help reduce knee osteoarthritis (OA) symptoms and save money over time. One study found that exercise therapy improved outcomes for knee OA patients, with few side effects reported. Exercise therapy is considered safe for knee OA, with minimal risk of negative effects. These findings suggest that the pharmacy-physiotherapy program is likely well-tolerated and safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the pharmacist-physiotherapist collaborative management for knee arthritis because it brings an innovative, team-based approach to treatment. Unlike traditional options that might rely heavily on medication or surgery, this approach emphasizes personalized care through a combination of comprehensive medication review by pharmacists and targeted physiotherapy interventions. This method fosters shared decision-making and leverages community resources, potentially leading to better management of symptoms and improved patient outcomes. By integrating these services, the treatment aims to enhance convenience and accessibility for patients, which could result in more consistent and effective care for managing knee arthritis.

What evidence suggests that the Pharmacy-Physiotherapy Intervention is effective for knee arthritis?

Research has shown that combining education and exercise can greatly help with knee osteoarthritis (OA). In a large study with 1,767 participants, those who engaged in exercise therapy experienced significant improvement, especially if their symptoms had been present for a shorter duration. Another study found that physical therapy reduced pain and disability more effectively after one year than glucocorticoid injections. Most reviews of exercise therapy for knee OA have also shown improvements with few side effects. In this trial, participants in the intervention group will receive a team approach involving a pharmacist and physiotherapist, including education and exercise, which could effectively manage knee OA symptoms. ^{1 2 3 4 6}

Who Is on the Research Team?

Ross Tsuyuki

Principal Investigator

University of Alberta

Allyson Jones

Principal Investigator

University of Alberta

Jill Hall

Principal Investigator

University of Alberta

Are You a Good Fit for This Trial?

This trial is for individuals who have been experiencing knee pain, aching, or stiffness for at least one month and are likely in the early stages of knee osteoarthritis. Participants must complete a screening questionnaire to be eligible.

Inclusion Criteria

I have had knee pain or stiffness for at least a month.

I have completed the PhIT-OA questionnaire.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person or online)

Baseline Assessment

Participants complete baseline assessments including KOOS and socio-demographics

1 week

1 visit (in-person or online)

Intervention

Participants receive either usual care or comprehensive pharmacist and physiotherapy intervention

6 weeks

Up to 5 physiotherapy sessions and pharmacist consultations

Follow-up

Participants are monitored for safety and effectiveness after treatment

9 months

Evaluations at 3 and 6 months post-intervention

What Are the Treatments Tested in This Trial?

Interventions

• Pharmacy-Physiotherapy Intervention

Trial Overview The study is testing a collaborative approach where pharmacists and physiotherapists work together to manage early knee osteoarthritis. It focuses on patient education, self-management strategies, and exercise rather than medications.

How Is the Trial Designed?

Group I: Intervention Group Experimental Treatment 1 Intervention

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.

Group II: Usual Care (Control) Group Active Control 1 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.

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Citations

1. bmjopen.bmj.com bmjopen.bmj.com/content/15/7/e093163

Effectiveness of exercise therapy in patients with knee ... Furthermore, 63.7% of the systematic reviews revealed that exercise therapy improved all outcomes. The number of intervention-related adverse events was small.

2. thelancet.com thelancet.com/journals/lanrhe/article/PIIS2665-9913(23)00122-4/fulltext

Moderators of the effect of therapeutic exercise for knee ... Moderators of the effect of therapeutic exercise for knee and hip osteoarthritis: a systematic review and individual participant data meta-analysis

3. nejm.org nejm.org/doi/full/10.1056/NEJMoa1905877

Physical Therapy versus Glucocorticoid Injection for ... Patients with osteoarthritis of the knee who underwent physical therapy had less pain and functional disability at 1 year than patients who received an ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7990728/

Knee osteoarthritis: key treatments and implications for ... These results suggest that a combination of education and exercise could result in long-term reductions in the burden of knee OA and its costs ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1836955325000633

Recent highlights and uncertainties in exercise ... Another IPD meta-analysis, including 10 RCTs and 1,767 participants with knee OA, found that people with shorter symptom duration reported greater improvements ...

6. bcmj.org bcmj.org/articles/physiotherapy-and-knee-osteoarthritis

Physiotherapy and knee osteoarthritis Therapeutic exercise is safe for patients with knee osteoarthritis and has shown minimal risk of negative consequences.[9] However, since it is ...