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BMC Musculoskeletal Disorders
Published in: BMC Musculoskeletal Disorders 1/2018

Open Access 01-12-2018 | Study protocol

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

Authors: James K. Sullivan, James J. Irrgang, Elena Losina, Clare Safran-Norton, Jamie Collins, Swastina Shrestha, Faith Selzer, Kim Bennell, Leslie Bisson, Angela T. Chen, Courtney K. Dawson, Alexandra B. Gil, Morgan H. Jones, Melissa A. Kluczynski, Kathleen Lafferty, Jeffrey Lange, Emma C. Lape, John Leddy, Aaron V. Mares, Kurt Spindler, Jennifer Turczyk, Jeffrey N. Katz

Published in: BMC Musculoskeletal Disorders | Issue 1/2018

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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.
Appendix
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Metadata
Title
The TeMPO trial (treatment of meniscal tears in osteoarthritis): rationale and design features for a four arm randomized controlled clinical trial
Authors
James K. Sullivan
James J. Irrgang
Elena Losina
Clare Safran-Norton
Jamie Collins
Swastina Shrestha
Faith Selzer
Kim Bennell
Leslie Bisson
Angela T. Chen
Courtney K. Dawson
Alexandra B. Gil
Morgan H. Jones
Melissa A. Kluczynski
Kathleen Lafferty
Jeffrey Lange
Emma C. Lape
John Leddy
Aaron V. Mares
Kurt Spindler
Jennifer Turczyk
Jeffrey N. Katz
Publication date
01-12-2018
Publisher
BioMed Central
Published in
BMC Musculoskeletal Disorders / Issue 1/2018
Electronic ISSN: 1471-2474
DOI
https://doi.org/10.1186/s12891-018-2327-9

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