1. The TeMPO trial (treatment of meniscal tears in osteoarthritis): rationale and design features for a four arm randomized controlled clinical trial
- Author
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Faith Selzer, John J. Leddy, Elena Losina, Jamie E. Collins, Jennifer Turczyk, James J. Irrgang, Kurt P. Spindler, James K. Sullivan, Aaron V. Mares, Leslie J. Bisson, Kathleen Lafferty, Clare E. Safran-Norton, Angela T. Chen, Jeffrey K. Lange, Kim L Bennell, Swastina Shrestha, Emma C. Lape, Morgan H. Jones, Melissa A. Kluczynski, Courtney K. Dawson, Jeffrey N. Katz, and Alexandra B. Gil
- Subjects
medicine.medical_specialty ,lcsh:Diseases of the musculoskeletal system ,Sports medicine ,Cost effectiveness ,medicine.medical_treatment ,Pain ,Osteoarthritis ,Placebo ,law.invention ,Study Protocol ,03 medical and health sciences ,0302 clinical medicine ,Rheumatology ,Randomized controlled trial ,law ,medicine ,Humans ,Orthopedics and Sports Medicine ,030212 general & internal medicine ,Meniscal tear ,Aged ,Aged, 80 and over ,030203 arthritis & rheumatology ,Rehabilitation ,business.industry ,Resistance Training ,Middle Aged ,Osteoarthritis, Knee ,medicine.disease ,Musculoskeletal Manipulations ,Exercise Therapy ,Tibial Meniscus Injuries ,3. Good health ,Clinical trial ,Knee pain ,Physical therapy ,Patient Compliance ,medicine.symptom ,Randomized trial ,lcsh:RC925-935 ,business - Abstract
Background Meniscal tears often accompany knee osteoarthritis, a disabling condition affecting 14 million individuals in the United States. While several randomized controlled trials have compared physical therapy to surgery for individuals with knee pain, meniscal tear, and osteoarthritic changes (determined via radiographs or magnetic resonance imaging), no trial has evaluated the efficacy of physical therapy alone in these subjects. Methods The Treatment of Meniscal Tear in Osteoarthritis (TeMPO) Trial is a four-arm multi-center randomized controlled clinical trial designed to establish the comparative efficacy of two in-clinic physical therapy interventions (one focused on strengthening and one containing placebo) and two protocolized home exercise programs. Discussion The goal of this paper is to present the rationale behind TeMPO and describe the study design and implementation strategies, focusing on methodologic and clinical challenges. Trial registration The TeMPO Trial was first registered at clinicaltrials.gov with registration No. NCT03059004. on February 14, 2017. Electronic supplementary material The online version of this article (10.1186/s12891-018-2327-9) contains supplementary material, which is available to authorized users.
- Published
- 2018
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