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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
300
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.
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.
Brooke Army Medical Center
San Antonio, Texas, United States
Wilford Hall Ambulatory Surgical Center
San Antonio, Texas, United States
Madigan Army Medical Center
Tacoma, Washington, United States
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.
Time frame: 2 years
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)
Time frame: 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".
Time frame: 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.
Time frame: 2 years
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