Treatment of Meniscal Problems in Osteoarthritis: TeMPO

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Symptomatic meniscal tear with knee osteoarthritis (OA) is a common, disabling and costly problem. Recent trials have shown that physical therapy (PT) -- including therapist-supervised exercises, manual therapy and a home exercise program -- leads to similar levels of pain relief as surgical management in patients with symptomatic meniscal tear and OA. As a result, referral for PT is recommended as the treatment of choice for these patients. However, a PT regimen has never been compared with placebo or simple prescription of home exercise in this population. Therefore, several important questions remain unanswered: How much of the pain relief associated with PT-based regimens can be attributed to physiologic effects vs. attention placebo effects? Is therapist-directed exercise coupled with a home exercise program any more efficacious than a home exercise program alone? Can the efficacy of the home program be optimized by employing innovative methods to maximize exercise adherence? These questions led us to propose the TeMPO (Treatment of Meniscal Problems in Osteoarthritis) Trial. The long term objective of this research is to define the most effective and cost effective nonoperative regimen for managing symptomatic meniscal tear with OA. The specific aims are: Aim 1: To conduct a multicenter, parallel, four-arm RCT in subjects ≥40 years old with symptomatic meniscal tear and radiographic or pre-radiographic OA to establish the efficacy of components of the typical PT regimen. The four arms include: Arm 1: Prescription of an information-based (pamphlet, DVD) home exercise program Arm 2: The information-based home exercise program with adherence optimization Arm 3: Same as Arm 2 plus a clinic-based, therapist-directed sham PT intervention Arm 4: Same as Arm 2 plus clinic-based, therapist-directed exercise and manual therapy The primary outcome is change in pain from baseline to 3 months. Subjects will be followed for 12 months. Aim 2: To evaluate the cost-effectiveness of a home exercise regimen with adherence optimization and a therapist-directed exercise and manual therapy program coupled with an optimized home exercise regimen. The results of the proposed trial and cost-effectiveness analysis will help clinicians, patients and policymakers make evidence-based decisions about management of symptomatic meniscal tear in the presence of OA, one of the most frequent musculoskeletal conditions seen in general practice.