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

Last updated: July 30, 2024
Sponsor: Brooke Army Medical Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Osteoarthritis

Knee Injuries

Treatment

DoD/VA CPG Core Set + PT

DoD/VA CPG Core Set

Clinical Study ID

NCT03747393
C2018.117d
W81XWH-18-1-0788
  • Ages 18-60
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • TRICARE eligible beneficiaries (active duty, dependents, and military retired) witha primary complaint of knee pain.

  • Able to speak and read English well enough to provide informed consent, follow studyinstructions 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 ofknee pain, or is scheduled to have one within the week.

  • Satisfies American College of Rheumatology (ACR) clinical criteria for diagnosis ofknee OA for at least one knee.

Exclusion

Exclusion Criteria:

  • In the last year, the subject has received any invasive interventions includinginjections (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 othercondition that prevents walking independently for at least 5 minutes or engaging ina physical activity/exercise program.

  • Anyone leaving military service for other than regular retirement, pending a medicalevaluation board, discharge from the military for medical reasons, or pending orundergoing 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-musculoskeletalconditions causing knee pain, personal history of neoplasm, current or recent kneejoint infection, recent fall/trauma to knee, acute fracture of knee, lower extremityamputation, 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

Study Design

Total Participants: 300
Treatment Group(s): 2
Primary Treatment: DoD/VA CPG Core Set + PT
Phase:
Study Start date:
June 01, 2019
Estimated Completion Date:
July 01, 2027

Study 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.

Connect with a study center

  • Brooke Army Medical Center

    San Antonio, Texas 78219
    United States

    Active - Recruiting

  • Wilford Hall Ambulatory Surgical Center

    San Antonio, Texas 78236
    United States

    Active - Recruiting

  • Madigan Army Medical Center

    Tacoma, Washington 98391
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.