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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 60 Years
Gender All
More Inclusion & Exclusion Criteria

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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03747393
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Brooke Army Medical Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Daniel I Rhon, DSc
Principal Investigator Affiliation Brooke Army Medical Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

U.S. Fed, Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Knee Osteoarthritis
Study Website: View Trial Website
Additional Details

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.

Arms & Interventions

Arms

Active Comparator: DoD/VA CPG Core Set

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

Experimental: DoD/VA CPG Core Set + PT

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).

Interventions

Behavioral: - DoD/VA CPG Core Set + PT

Participants randomized to receive the core set management class and physical therapy will be scheduled for their initial physical therapy evaluation approximately 1 week from their enrollment date. The purpose of the evaluation will be to identify relevant impairments that can be addressed during the physical therapy treatments. After this initial evaluation, the goal is for the patient to receive approximately 4 weeks of physical therapy (about 8-10 sessions in the clinic 2-3 times per week). Consistent with a pragmatic study we will not use placebos to blind patients or attempt to balance provider contact.

Behavioral: - DoD/VA CPG Core Set

The published clinical practice guideline recommends early use of a core set of management strategies to include patient education about their condition and the role of obesity in disease progression, activity and lifestyle modification focusing on physical activity, and a therapeutic exercise program. Implementation of the core set is recommended prior to any referral for consultation about invasive procedures such as intra-articular injections or TKA surgery. All patients with knee pain will be scheduled to receive the core set management strategy class as a part of the usual care route.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Brooke Army Medical Center, San Antonio, Texas

Status

Recruiting

Address

Brooke Army Medical Center

San Antonio, Texas, 78219

Site Contact

Mary Laugesen, DPT

[email protected]

210-808-2575

Wilford Hall Ambulatory Surgical Center, San Antonio, Texas

Status

Recruiting

Address

Wilford Hall Ambulatory Surgical Center

San Antonio, Texas, 78236

Site Contact

Chenae Day, DPT

[email protected]

206-450-0075

Madigan Army Medical Center, Tacoma, Washington

Status

Recruiting

Address

Madigan Army Medical Center

Tacoma, Washington, 98391

Site Contact

Rachel J Mayhew, DPT

[email protected]

206-450-0075