Non-Surgical Management of Knee Osteoarthritis in the Military Health System (MHS)
- Conditions
- Knee Osteoarthritis
- Interventions
- Behavioral: DoD/VA CPG Core Set + PTBehavioral: DoD/VA CPG Core Set
- Registration Number
- NCT03747393
- Lead Sponsor
- Brooke Army Medical Center
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 300
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description DoD/VA CPG Core Set + PT DoD/VA CPG Core Set 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). DoD/VA CPG Core Set 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. DoD/VA CPG Core Set + PT 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).
- Primary Outcome Measures
Name Time Method Patient Reported Outcomes Measurement Information Systems (PROMIS) - Physical Function 2 years The PROMIS is managed and endorsed by the NIH, and will be based on the Computer Adaptive Test, which does not have a set number of questions but instead "adapts" the test and number of questions based on prior answers it receives.
- Secondary Outcome Measures
Name Time Method Patient Acceptable Symptom Scale (PASS) 2 years The PASS is a global, dichotomized single-item score indicating if patients are satisfied with the current state of their symptoms. This tool has been validated in patients with OA. The PASS asks the patient; "Taking into account all the activities you have during your daily life, your level of pain, and also your functional impairment, do you consider that your current state is satisfactory?" Response options are "yes" or "no".
EuroQoL (EQ-5D) 2 years The EQ-5D is a generic quality of life questionnaire that will assess quality of life on a scale that can be referenced to other disease conditions. The EQ-5D covers 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each domain has 3 response categories: level 1, "no problems"; level 2, "some problems"; and level 3, "inability or extreme problems." Responses are combined to give a 5-digit descriptive health state classification (e.g., 11222). The EQ-5D yields a total of 243 possible health states. Valuations for each health state are available. The EQ-5D is commonly used in economic evaluation of interventions and cost-effectiveness analysis.
Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC) 2 years The WOMAC Osteoarthritis score, which consists of 24 questions, and 3 different subscales: pain (Q1-5), stiffness (Q6-7) and physical function (Q8-24)
Trial Locations
- Locations (3)
Madigan Army Medical Center
🇺🇸Tacoma, Washington, United States
Brooke Army Medical Center
🇺🇸San Antonio, Texas, United States
Wilford Hall Ambulatory Surgical Center
🇺🇸San Antonio, Texas, United States