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
Orthopaedic and Arthritis Center for Outcomes Research (OrACORe) and Policy and Innovation eValuation in Orthopedic Treatments (PIVOT), Department of Orthopaedic Surgery, Brigham and Women's Hospital, 60 Fenwood Road, BTM 5016, Boston, MA, 02115, USA.
Department of Physical Therapy, School of Health and Rehabilitation Sciences, University of Pittsburgh, Pittsburgh, PA, USA.
BMC Musculoskelet Disord. 2018 Dec 1;19(1):429. doi: 10.1186/s12891-018-2327-9.
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.
半月板撕裂常伴有膝关节骨关节炎，这种致残性疾病在美国影响着1400万人。虽然有几项随机对照试验比较了物理治疗与手术对膝关节疼痛、半月板撕裂和骨关节炎改变（通过X线片或磁共振成像确定）患者的疗效，但尚无试验评估单纯物理治疗对这些受试者的疗效。
骨关节炎半月板撕裂治疗（TeMPO）试验是一项四臂多中心随机对照临床试验，旨在确定两种门诊物理治疗干预措施（一种侧重于强化训练，另一种包含安慰剂）和两种标准化家庭锻炼计划的比较疗效。
本文的目的是阐述TeMPO试验背后的基本原理，并描述研究设计和实施策略，重点关注方法学和临床挑战。
TeMPO试验于2017年2月14日首次在clinicaltrials.gov上注册，注册号为NCT03059004。
