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Treatment of Meniscal Problems in Osteoarthritis: TeMPO

骨关节炎半月板问题的治疗：TeMPO

基本信息

批准号：
10552929
负责人：
Jeffrey Neil Katz
金额：
$ 41.85万
依托单位：
BRIGHAM AND WOMEN'S HOSPITAL
依托单位国家：
美国
项目类别：
财政年份：
2017
资助国家：
美国
起止时间：
2017-04-15 至 2023-03-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10552929
关键词：
Adherence Adult Affect Attention Clinic Clinical Cost Effectiveness Analysis Coupled Data Degenerative polyarthritis Ensure Evidence based treatment Exercise Exercise Therapy General Practices Home Image Individual Knee Osteoarthritis Lead Magnetic Resonance Imaging Manipulative Therapies Mechanics Meniscus structure of joint Methodology Methods Musculoskeletal Outcome Assessment Pain Pamphlets Patients Physical therapy Physical therapy exercises Physiological Placebo Effect Placebos Population Quality-Adjusted Life Years Randomized Controlled Trials Recommendation Regimen Research Series Structure Supervision Surgical Management Symptoms Time arm base cost cost effective cost effectiveness cost-effectiveness evaluation design evidence base exercise adherence exercise prescription exercise program exercise regimen experience functional status innovation meniscal tear multidisciplinary pain relief physical therapist primary outcome programs protocol development radiological imaging randomized trial secondary outcome symptomatic improvement treatment arm treatment choice treatment strategy

项目摘要

Symptomatic meniscal tear with knee osteoarthritis (OA) is a common, disabling and costly problem. Recent trials have shown that physical therapy (PT) -- including therapist-supervised exercises, manual therapy and a home exercise program -- leads to similar levels of pain relief as surgical management in patients with symptomatic meniscal tear and OA. As a result, referral for PT is recommended as the treatment of choice for these patients. However, a PT regimen has never been compared with placebo or simple prescription of home exercise in this population. Therefore, several important questions remain unanswered: How much of the pain relief associated with PT-based regimens can be attributed to physiologic effects vs. attention placebo effects? Is therapist-directed exercise coupled with a home exercise program any more efficacious than a home exercise program alone? Can the efficacy of the home program be optimized by employing innovative methods to maximize exercise adherence? These questions led us to propose the TeMPO (Treatment of Meniscal Problems in Osteoarthritis) Trial. The long term objective of this research is to define the most effective and cost effective nonoperative regimen for managing symptomatic meniscal tear with OA. The specific aims are: Aim 1: To conduct a multicenter, parallel, four-arm RCT in subjects ≥40 years old with symptomatic meniscal tear and radiographic or pre-radiographic OA to establish the efficacy of components of the typical PT regimen. The four arms include: Arm 1: Prescription of an information-based (pamphlet, DVD) home exercise program Arm 2: The information-based home exercise program with adherence optimization Arm 3: Same as Arm 2 plus a clinic-based, therapist-directed sham PT intervention Arm 4: Same as Arm 2 plus clinic-based, therapist-directed exercise and manual therapy The primary outcome is change in pain from baseline to 3 months. Subjects will be followed for 12 months. Aim 2: To evaluate the cost-effectiveness of a home exercise regimen with adherence optimization and a therapist-directed exercise and manual therapy program coupled with an optimized home exercise regimen. The results of the proposed trial and cost-effectiveness analysis will help clinicians, patients and policymakers make evidence-based decisions about management of symptomatic meniscal tear in the presence of OA, one of the most frequent musculoskeletal conditions seen in general practice.

症状性半月板撕裂与膝骨关节炎（OA）是一个常见的，致残和昂贵的问题。最近

项目成果

期刊论文数量（7）

专著数量（0）

科研奖励数量（0）

会议论文数量（0）

专利数量（0）

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

TeMPO 试验（治疗骨关节炎半月板撕裂）：四组随机对照临床试验的基本原理和设计特征。

DOI：
10.1186/s12891-018-2327-9
发表时间：
2018
期刊：
BMC musculoskeletal disorders
影响因子：
2.3
作者：
Sullivan,JamesK;Irrgang,JamesJ;Losina,Elena;Safran-Norton,Clare;Collins,Jamie;Shrestha,Swastina;Selzer,Faith;Bennell,Kim;Bisson,Leslie;Chen,AngelaT;Dawson,CourtneyK;Gil,AlexandraB;Jones,MorganH;Kluczynski,MelissaA;Laffer
通讯作者：
Laffer

Prevalence of Undiagnosed Subchondral Insufficiency Fractures of the Knee in Middle Age Adults with Knee Pain and Suspected Meniscal Tear.