Symptomatic patients with degenerative meniscal tear and knee osteoarthritis (OA) experience considerable pain and disability. Over 300,000 persons with the clinical syndrome undergo arthroscopic partial meniscectomy each year. Several recent randomized trials comparing this surgery with a physical therapy (PT) regimen suggest that nonoperative therapy is a reasonable initial strategy. However, the efficacy of PT has not been established in controlled trials and comprises the focus of this proposed trial and planning grant. We propose a randomized controlled trial in symptomatic patients >45 with OA and meniscal tear. The arms include 1) an exercise-based PT intervention delivered by a physical therapist, with frequent visits to the therapist and prescribed home exercises; 2) a placebo intervention delivered by a physical therapist, also involving frequent patient contact; and, 3) written materials describing the natural history of the condition, stretching and strengthening exercises to be done at home and more general advice about healthy activities -- with no interaction with a treating physical therapist. We hypothesize that subjects receiving the intensive PT regimen (Arm 1) will have greater reduction in pain and improvement in functional status after 12 weeks than those in the placebo group (Arm 2); and that both the PT regimen and the placebo intervention are superior to the written-materials intervention (Arm 3).
The specific aims for this Planning Grant include: 1) Development of protocols and regulatory materials: Develop a Manual of Operating Procedures, obtain IRB approval in all centers and develop the safety monitoring plan. 2) Optimization of enrollment: Gather data on number of eligible subjects from potential collaborating physicians and centers; finalize selection of providers and centers; and, develop subcontracts. 3) Development of intervention materials. Create scripts and materials necessary for the intervention and test and optimize the reliability of intervention delivery. 4) Completion of self-report assessment tools: Draft all questionnaires and other assessments and pilot test the instruments to ensure they have face validity and reasonable respondent burden. 5) Optimization of data management plan: Develop the trial data management plan including a database that has all necessary functions for the trial. Successful completion of these planning activities will position the research team to successfully execute a highly significant and innovative trial, which will provide the basis for evidence-based management of this prevalent and disabling condition.
Patients with knee pain, meniscal tear and osteoarthritis experience considerable disability. Studies indicate that a physical therapy regimen is effective but there is no evidence that exercise-based physical therapy is more effective than placebo or minimal intervention. This randomized trial will compare the outcomes of exercise based physical therapy with sham physical therapy and with simple written advice in symptomatic subjects with meniscal tear and osteoarthritis. The results will yield an evidence-based approach to the nonoperative management of this painful and disabling condition.
| Kerman, Hannah M; Deshpande, Bhushan R; Selzer, Faith et al. (2018) Willingness of older adults to participate in a randomized trial of conservative therapies for knee pain: A prospective preference assessment. Contemp Clin Trials Commun 9:93-97 |
| Deshpande, Bhushan R; Losina, Elena; Smith, Savannah R et al. (2016) Association of MRI findings and expert diagnosis of symptomatic meniscal tear among middle-aged and older adults with knee pain. BMC Musculoskelet Disord 17:154 |
| Katz, J N; Losina, E; Lohmander, L S (2015) OARSI Clinical Trials Recommendations: Design and conduct of clinical trials of surgical interventions for osteoarthritis. Osteoarthritis Cartilage 23:798-802 |
