The TeMPO trial (treatment of meniscal tears in osteoarthritis): rationale and design features for a four arm randomized controlled clinical trial

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...

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Bibliographic Details
Published in:	BMC musculoskeletal disorders Vol. 19; no. 1; pp. 429 - 14
Main Authors:	Sullivan, James K, Irrgang, James J, Losina, Elena, Safran-Norton, Clare, Collins, Jamie, Shrestha, Swastina, Selzer, Faith, Bennell, Kim, Bisson, Leslie, Chen, Angela T, Dawson, Courtney K, Gil, Alexandra B, Jones, Morgan H, Kluczynski, Melissa A, Lafferty, Kathleen, Lange, Jeffrey, Lape, Emma C, Leddy, John, Mares, Aaron V, Spindler, Kurt, Turczyk, Jennifer, Katz, Jeffrey N
Format:	Journal Article
Language:	English
Published:	England BioMed Central Ltd 01-12-2018 BioMed Central BMC
Subjects:	Aged Aged, 80 and over Arthritis Care and treatment Clinical trials Exercise Therapy - adverse effects Exercise Therapy - methods Humans Injuries Knee Magnetic resonance imaging Meniscal tear Meniscus Middle Aged Multicenter Studies as Topic Musculoskeletal diseases Musculoskeletal Manipulations - adverse effects NMR Nuclear magnetic resonance Osteoarthritis Osteoarthritis, Knee - complications Osteoarthritis, Knee - diagnostic imaging Osteoarthritis, Knee - physiopathology Pain Pain - prevention & control Patient Compliance Physical therapy Placebo Radiography Randomized Controlled Trials as Topic Randomized trial Resistance Training - adverse effects Study Protocol Surgery Tibial Meniscus Injuries - therapy United States Meniscal tear Randomized trial Osteoarthritis Physical therapy Placebo
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Summary:	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. 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. 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. The TeMPO Trial was first registered at clinicaltrials.gov with registration No. NCT03059004 . on February 14, 2017.
ISSN:	1471-2474 1471-2474
DOI:	10.1186/s12891-018-2327-9