Non-Surgical Management of Knee Osteoarthritis in the Military Health System (MHS)

Brooke Army Medical Center

Status: Enrolling

Conditions: Knee Osteoarthritis

Treatments: Behavioral: DoD/VA CPG Core Set; Behavioral: DoD/VA CPG Core Set + PT

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT03747393

W81XWH-18-1-0788 (Other Grant/Funding Number)

C2018.117d

Details and patient eligibility

About

This study will compare two different treatment approaches for the management of knee osteoarthritis (OA). All subjects will receive a standardized approach consistent with the core set of recommendation from the Department of Defense (DoD) and Veterans Administration (VA) Clinical Practice Guidelines for Non-Surgical Management of Knee Osteoarthritis. Follow-up will occur over a 1 year period.

Full description

There are gaps between actual clinical practice and published guidelines for management of knee OA. The VA/DoD Clinical Practice Guidelines leaves open the question of the effectiveness and cost-effectiveness of early referral to PT alongside the core set of management strategies for patients with knee OA. Prior studies have failed to include robust cost-effectiveness analyses to understand the policy implications of a recommendation to routinely refer patients with knee OA to PT in addition to implementing the core set of recommended management strategies. A comparative effectiveness parallel-group randomized controlled clinical trial examining these questions will be extremely informative for future updates of the VA/DoD Practice Guideline.

The core components of the clinical practice guidelines include education on nutrition and the role of obesity in OA, as well as the role of physical activity and exercise. The physical therapy component will be based on best current evidence, and consist of manual therapy, education for self-management, and exercise.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• TRICARE eligible beneficiaries (active duty, dependents, and military retired) with a primary complaint of knee pain.
• Able to speak and read English well enough to provide informed consent, follow study instructions and independently answer the questionnaires/surveys.
• Able to attend treatment sessions for a 4-week period.
• Age 18-60 years old
• The subject had an initial care visit in the last 90 days with a chief complaint of knee pain, or is scheduled to have one within the week.
• Satisfies American College of Rheumatology (ACR) clinical criteria for diagnosis of knee OA for at least one knee.

Exclusion criteria

• In the last year, the subject has received any invasive interventions including injections (corticosteroid, hyaluronic acid, etc.) or surgery for their knee
• History of Total Knee Arthroplasty (TKA)
• Has previously received formal PT for the same knee (> 2 visits) in the last year
• Has consulted a surgeon for knee pain for either knee in the past year
• History of severe neurologic (e.g., stroke, Parkinson's disease, etc.) or other condition that prevents walking independently for at least 5 minutes or engaging in a physical activity/exercise program.
• Anyone leaving military service for other than regular retirement, pending a medical evaluation board, discharge from the military for medical reasons, or pending or undergoing any litigation for an injury.
• Systemic disease that could otherwise be responsible for the subjects knee pain (e.g. rheumatoid arthritis, gout, or psoriatic arthritis), non-musculoskeletal conditions causing knee pain, personal history of neoplasm, current or recent knee joint infection, recent fall/trauma to knee, acute fracture of knee, lower extremity amputation, or other more likely primary musculoskeletal knee disorders (e.g. patellar tendinopathy, bursitis, runner's knee, etc.)
• Currently has a referral to orthopedics or physical therapy for a knee disorder

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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300 participants in 2 patient groups

DoD/VA CPG Core Set

Active Comparator group

Description:

The standard core set of interventions recommended by the DoD/VA clinical practice guidelines for non-surgical management of knee OA.

Treatment:

Behavioral: DoD/VA CPG Core Set

DoD/VA CPG Core Set + PT

Experimental group

Description:

In addition to DoD/VA clinical practice guidelines, patients will be referred to physical therapy (PT). Physical therapy will consist of evidence-based interventions that can be provided by a PT (exercise, manual therapy, education).

Treatment:

Behavioral: DoD/VA CPG Core Set

Behavioral: DoD/VA CPG Core Set + PT