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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Exploring the Value of the Veterans Affairs (VA) and Department of Defense (DoD) Clinical Practice Guidelines for Non-Surgical Management of Knee Osteoarthritis in the Military Health System

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Behavioral: DoD/VA CPG Core Set + PT
* Behavioral: DoD/VA CPG Core Set


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Comparative effectiveness parallel-group randomized controlled clinical trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: DoD/VA CPG Core Set<br>The standard core set of interventions recommended by the DoD/VA clinical practice guidelines for non-surgical management of knee OA. | Behavioral: DoD/VA CPG Core Set<br>* 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.<br>|
| Experimental: DoD/VA CPG Core Set + PT<br>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). | Behavioral: DoD/VA CPG Core Set + PT<br>* 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.<br>Behavioral: DoD/VA CPG Core Set<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Reported Outcomes Measurement Information Systems (PROMIS) - Physical Function | 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. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC) | The WOMAC Osteoarthritis score, which consists of 24 questions, and 3 different subscales: pain (Q1-5), stiffness (Q6-7) and physical function (Q8-24) | 2 years | 
| Patient Acceptable Symptom Scale (PASS) | 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. | 2 years | 
| EuroQoL (EQ-5D) | 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. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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knee osteoarthritis, physical therapy, clinical practice guidelines, military service members, self-management