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

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, 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

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.

Keywords: Meniscal tear; Osteoarthritis; Physical therapy; Placebo; Randomized trial.

Conflict of interest statement

Ethics approval and consent to participate

The TeMPO Trial has IRB approval from a sIRB at Partners HealthCare/Brigham and Women’s Hospital. Written informed consent is obtained from all study participants prior to randomization or any study-ordered imaging or MSK exams.

Consent for publication

The subject in the instructional pamphlet in Additional file 1 has provided written consent to appear.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Exercise Dose Diagrams in the TeMPO Trial. Exercise dose diagram for weeks 1–4 of trial intervention. All subjects complete 100 min of a strengthening based home program (Arms 1–3) or a combination of the home program and therapist-directed manual therapy and exercise per week (Arm 4) per week. Subjects in Arms 2, 3, and 4 receive adherence optimization consisting of motivational adherence support text messages three times a week and a health information pamphlet once every other week. Subjects in Arm 3 receive a placebo physical therapy intervention consisting of placebo ultrasound (US), placebo lotion application, placebo manual therapy (MT), and placebo assessment twice a week. Subjects in Arm 4 receive a true physical therapy intervention consisting of manual therapy (MT) and supervised strengthening/functional exercise two times a week and complete the protocolized home exercise program two times a week. Subjects are not instructed to exercise in any particular order or sequence, only at the designated frequency
Fig. 2
Fig. 2
Exercise dose diagram for weeks 5–8, 10, 12 of trial intervention. All subjects complete 100 min of a strengthening based home program (Arms 1–3) or a combination of the home program and therapist-directed manual therapy and exercise per week (Arm 4) per week. Subjects in Arms 2, 3, and 4 receive adherence optimization consisting of motivational adherence support text messages three times a week and a health information pamphlet once every other week. Subjects in Arm 3 receive a placebo physical therapy intervention consisting of placebo ultrasound (US), placebo lotion application, placebo manual therapy (MT), and placebo assessment twice a week. Subjects in Arm 4 receive a true physical therapy intervention consisting of manual therapy (MT) and supervised strengthening exercise once a week and complete the protocolized home exercise program three times a week. Subjects are not instructed to exercise in any particular order or sequence, only at the designated frequency
Fig. 3
Fig. 3
Exercise dose diagram for weeks 9 and 11 of trial intervention. All subjects complete 100 min per week of a strengthening based home program at home. Subjects in Arms 2, 3, and 4 receive adherence optimization consisting of motivational adherence support text messages three times a week and a health information pamphlet once every other week. Subjects in Arms 3 and 4 do not go to clinic for additional treatment in these weeks. Subjects are not instructed to exercise in any particular order or sequence, only at the designated frequency
Fig. 4
Fig. 4
Flow diagram depicting enrollment and follow-up procedures in the TeMPO trial

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