Group Physical Therapy for Knee Osteoarthritis

(Group PT Trial)

Overseen By Kelli D Allen, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Previous participation, Current group class, others

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

Compensation: Varies

Number of Visits: 3

Duration: 6 sessions

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests group physical therapy for veterans with knee osteoarthritis, a condition causing joint pain and stiffness. The researchers aim to identify the best methods to implement and sustain these group sessions at 16 VA sites by comparing different strategies to determine which are most effective. Participants will receive either standard support or additional assistance if needed to ensure the program's success. Veterans diagnosed with knee osteoarthritis who are considering group physical therapy might be a good fit for this trial. As an unphased trial, this study offers veterans the chance to contribute to research that could enhance therapy options for knee osteoarthritis.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that Group Physical Therapy is safe for veterans with knee osteoarthritis?

Research has shown that group physical therapy for knee osteoarthritis is generally safe. A review of several studies found no major safety differences between exercise and other treatments, indicating that physical therapy is unlikely to cause serious side effects. Additionally, physical therapy has been proven to reduce pain and improve movement in people with knee osteoarthritis, highlighting its safety and benefits. Although detailed reports on specific side effects are limited, the absence of major safety issues in studies suggests that group physical therapy is a safe option for managing knee osteoarthritis. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to implement group physical therapy for knee osteoarthritis. Unlike standard treatments like pain medications or individual physical therapy sessions, this trial uses two unique strategies: Foundational REP and Enhanced REP. Foundational REP involves engaging stakeholders and using tools like data dashboards and diffusion networks to boost treatment adoption. Enhanced REP takes it a step further by providing personalized support to sites that need extra help meeting adoption and sustainment goals, featuring one-on-one coaching to address specific challenges. These strategies aim to make group physical therapy more effective and accessible, potentially leading to better outcomes for patients with knee osteoarthritis.

What evidence suggests that Group Physical Therapy is effective for knee osteoarthritis?

Research has shown that Group Physical Therapy can help manage knee osteoarthritis. In one study, 53.8% of patients reported improved knee pain by the end of the therapy sessions. Another study found that this therapy was as effective as individual treatments in reducing pain and improving function. Patients experienced benefits such as pain relief, better knee movement, and a higher quality of life. Group Physical Therapy also increases access to care for more people. This trial will compare two implementation strategies for Group Physical Therapy: Foundational REP and Enhanced REP (enREP), to determine the most effective approach for widespread adoption and sustainment. ^{3 6 7 8 9}

Who Is on the Research Team?

Kelli Dominick Allen, PhD

Principal Investigator

Durham VA Medical Center, Durham, NC

Courtney H Van Houtven, PhD

Principal Investigator

Durham VA Medical Center, Durham, NC

Susan N. Hastings, MD MHSc

Principal Investigator

Durham VA Medical Center, Durham, NC

Are You a Good Fit for This Trial?

This trial is for VA sites with staff to evaluate and lead group physical therapy, outpatient PT service, space for group sessions, and a signed agreement. Sites already offering knee OA classes or previously in Function QUERI are excluded.

Inclusion Criteria

Participating sites must submit a signed participation agreement

My healthcare facility has staff for evaluations and group classes.

My treatment center has space for group sessions.

Exclusion Criteria

The one Group PT site that previously participated in Function QUERI (ClinicalTrials.gov Identifier: NCT01058304) will be excluded from enrollment

My treatment center does not offer group classes for knee osteoarthritis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

Implementation of Group PT at VA medical centers using foundational REP or enhanced REP strategies

12 months

Regular site visits and calls every 3 to 4 weeks

Treatment

Participants receive Group PT in a 6-session group outpatient program

6 sessions

Follow-up

Participants are monitored for adoption, penetration, and fidelity of the Group PT program

7-12 months

What Are the Treatments Tested in This Trial?

Interventions

• Group Physical Therapy
• Implementation Strategy: Enhanced REP (enREP)
• Implementation Strategy: Foundational REP

Trial Overview The study tests two strategies (Foundational REP and Enhanced REP) to implement Group Physical Therapy at 16 VA sites for veterans with knee osteoarthritis using an effectiveness-implementation hybrid design framework.

How Is the Trial Designed?

Group I: Enhanced REP Experimental Treatment 1 Intervention

EnREP begins with the same activities as foundational REP. Sites that do not meet EBP-specific a priori benchmarks reflecting adoption within 6 months will continue with foundational REP and will receive higher intensity support for a period of 6 months (enREP). Additionally, sites randomized to enREP that met adoption benchmarks but did do not meet the sustainment benchmark, will also receive intensified implementation support for the remainder of the study period (3 months). The higher intensity support will include one-on-one calls approximately every 3 to 4 weeks between site implementation teams and a trained practice facilitator (from Function QUERI team). The facilitator will coach individual sites using techniques, processes, and activities to help teams make decisions and identify and solve problems. Facilitators' actions will depend on each site's needs and clinical context.

Group II: Foundational REP Active Control 1 Intervention

Foundational REP uses the Replicating Effective Program implementation strategy and includes 5 elements that were developed and tested in our prior Function QUERI work: Stakeholder engagement; Toolkit; SharePoint access for clinical program training materials; Data dashboard to assist sites with tracking their own data; and Diffusion Networks to promote peer-to-peer sharing and implementation support.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12492051/

Implementation of Group Physical Therapy for Knee ... For the fidelity outcome (as well as effectiveness outcomes), we included data from classes that occurred up to 15 months after the cohort ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1746068925000434

A RANDOMIZED CLINICAL CONTROL TRIAL The outcome measures are pain, Knee Flexion ROM, disability, balance, and quality of life, which were measured at baseline, three and six weeks.

3. bmcmusculoskeletdisord.biomedcentral.com bmcmusculoskeletdisord.biomedcentral.com/articles/10.1186/s12891-020-3079-x

Implementation of a group physical therapy program for ... A previous randomized clinical trial found that a Group Physical Therapy (PT) program for knee osteoarthritis yielded similar improvements in pain and function.

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2839540

Implementation of Group Physical Therapy for Knee ... The estimated rate of patients reporting that their ability to deal with knee pain problems was better at the last than the first class was 53.8 ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10571277/

Group physical therapy for knee osteoarthritis This study will evaluate the effects of implementing group physical therapy for knee OA, a model that can improve access and efficiency of care ...

6. bmj.com bmj.com/content/391/bmj-2025-085242

systematic review and network meta-analysis The safety outcome was reported in a small proportion of studies (40 studies, 18%), and no clear differences were observed between exercise ...

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

Knee osteoarthritis: key treatments and implications for ... There is low- to moderate-quality of evidence showing that a period of 8 weeks or more of exercise can improve functional outcomes and physical ...

8. 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 ...

9. 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