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

被引：7

作者：

Sullivan, James K. ^{[1
,2
]}

Irrgang, James J. ^{[3
]}

Losina, Elena ^{[1
,2
,4
,5
,8
]}

Safran-Norton, Clare ^{[9
]}

Collins, Jamie ^{[1
,2
,4
]}

Shrestha, Swastina ^{[1
,2
]}

Selzer, Faith ^{[1
,2
,4
]}

Bennell, Kim ^{[10
]}

Bisson, Leslie ^{[11
]}

Chen, Angela T. ^{[1
,2
]}

Dawson, Courtney K. ^{[4
,12
]}

Gil, Alexandra B. ^{[3
]}

Jones, Morgan H. ^{[13
]}

Kluczynski, Melissa A. ^{[11
]}

Lafferty, Kathleen ^{[11
]}

Lange, Jeffrey ^{[4
,12
]}

Lape, Emma C. ^{[1
,2
]}

Leddy, John ^{[11
]}

Mares, Aaron V. ^{[14
]}

Spindler, Kurt ^{[13
]}

Turczyk, Jennifer ^{[13
]}

Katz, Jeffrey N. ^{[1
,2
,4
,5
,6
,7
]}

机构：

[1] Brigham & Womens Hosp, Dept Orthopaed Surg, Orthopaed & Arthrit Ctr Outcomes Res OrACORe, 60 Fenwood Rd,BTM 5016, Boston, MA 02115 USA

[2] Brigham & Womens Hosp, Dept Orthopaed Surg, Policy & Innovat eValuat Orthoped Treatments PIVO, 60 Fenwood Rd,BTM 5016, Boston, MA 02115 USA

[3] Univ Pittsburgh, Sch Hlth & Rehabil Sci, Dept Phys Therapy, Pittsburgh, PA USA

[4] Harvard Med Sch, Boston, MA 02215 USA

[5] Brigham & Womens Hosp, Div Rheumatol Immunol & Allergy, Sect Clin Sci, 75 Francis St, Boston, MA 02115 USA

[6] Harvard TH Chan Sch Publ Hlth, Dept Epidemiol, Boston, MA USA

[7] Harvard TH Chan Sch Publ Hlth, Dept Environm Hlth, Boston, MA USA

[8] Boston Univ, Sch Publ Hlth, Dept Biostat, Boston, MA 02215 USA

[9] Brigham & Womens Hosp, Dept Rehabil Serv Phys & Occupat Therapy, 75 Francis St, Boston, MA 02115 USA

[10] Univ Melbourne, Sch Hlth Sci, Ctr Hlth Exercise & Sports Med, Parkville, Vic, Australia

[11] SUNY Buffalo, Jacobs Sch Med & Biomed Sci, UBMD Dept Orthopaed & Sports Med, Buffalo, NY USA

[12] Brigham & Womens Hosp, Dept Orthopaed, 75 Francis St, Boston, MA 02115 USA

[13] Cleveland Clin, Dept Orthopaed Surg, Cleveland, OH 44106 USA

[14] Univ Pittsburgh, Med Ctr, Dept Orthopaed Surg, Pittsburgh, PA USA

来源：

BMC MUSCULOSKELETAL DISORDERS | 2018年 / 19卷

基金：

美国国家卫生研究院;

关键词：

Osteoarthritis; Meniscal tear; Randomized trial; Physical therapy; Placebo; KNEE OSTEOARTHRITIS; COST-EFFECTIVENESS; PHYSICAL-THERAPY; BEHAVIOR-CHANGE; DOUBLE-BLIND; MENISCECTOMY; MANAGEMENT; ULTRASOUND; EFFICACY; HEALTH;

D O I：

10.1186/s12891-018-2327-9

中图分类号：

R826.8 [整形外科学]; R782.2 [口腔颌面部整形外科学]; R726.2 [小儿整形外科学]; R62 [整形外科学（修复外科学）];

学科分类号：

摘要：

BackgroundMeniscal 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.MethodsThe 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.DiscussionThe 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 registrationThe TeMPO Trial was first registered at clinicaltrials.gov with registration No. NCT03059004. on February 14, 2017.

引用

页数：14

共 72 条

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