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NCT Number: NCT03747393

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brooke Army Medical Center, San Antonio, Texas, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DoD/VA CPG Core Set + PT

Behavioral

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.

DoD/VA CPG Core Set

Behavioral

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.

Primary outcomes

  1. Patient Reported Outcomes Measurement Information Systems (PROMIS) - Physical Function

    Time frame: 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 outcomes

  1. Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC)

    Time frame: 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)

  2. Patient Acceptable Symptom Scale (PASS)

    Time frame: 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".

  3. EuroQoL (EQ-5D)

    Time frame: 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.

Other outcomes

  1. Healthcare Utilization from Electronic Medical Records (EMR)

    Time frame: 2 years

    Healthcare utilization will be extracted for all participants for the 2 year period following . enrollment. Drug prescriptions, medical procedures, and specialty referrals will be identified.

  2. Credibility Expectancy Questionnaire (CEQ)

    Time frame: 2 years

    The CEQ, a 6-item self-report evaluating treatment credibility and expectations for improvement, will be assessed at baseline after treatment group assignment is revealed to provide descriptive information about participants' perceptions of their treatment assignment and optimism for improvement. The CEQ may be used as a covariate if perceptions differ meaningfully between groups as participants' initial perceptions of treatment credibility can impact outcomes.

  3. Marcus 5 Item Exercise Self Efficacy Scale (MESE)

    Time frame: 2 years

    The MESE is a 5 item self report measure of exercise self efficacy with good validity and reliability. Higher scores reflect higher self efficacy. Participants rate their confidence in the ability to participate in regular exercise when faced with barriers and obstacles such as fatigue, vacation or poor weather.

Sponsors and collaborators

Lead sponsor

Brooke Army Medical Center

Fed

Collaborators

  • University of Utah

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2026
Study completion
2027
First posted
Nov 20, 2018
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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