Treatment of Meniscal Problems in Osteoarthritis: TeMPO

有症状的半月板撕裂合并膝骨性关节炎(OA)是一种常见的、致残的和昂贵的问题。近期 试验表明，物理治疗(PT)--包括治疗师指导的练习、手动治疗和 家庭锻炼计划--导致与手术治疗相似的疼痛缓解水平 症状半月板撕裂和骨性关节炎。因此，推荐转诊为PT的首选治疗方法。 这些病人。然而，PT方案从未与安慰剂或简单的家庭处方进行比较 在这一人群中进行锻炼。因此，几个重要的问题仍然没有得到回答：有多大的痛苦 与PT方案相关的缓解可归因于生理效应与注意力安慰剂效应？ 治疗师指导的锻炼与家庭锻炼计划相结合是否比家庭锻炼更有效 单独的锻炼计划？家庭计划的效果能否通过使用创新的方法来优化 为了最大限度地坚持锻炼？这些问题促使我们提出了TEMPO(半月板的治疗 骨性关节炎的问题)试验。这项研究的长期目标是定义最有效和 治疗有症状的半月板撕裂合并骨性关节炎的经济有效的非手术方案。具体目标是： 目的1：对40岁有半月板症状的≥受试者进行多中心、平行、四臂随机放射治疗 撕裂和放射或放射前的骨性关节炎以确定典型PT方案各组成部分的疗效。 这四个手臂包括： 手臂1：以信息为基础的(小册子、DVD)家庭锻炼计划的处方 ARM 2：依从性优化的信息化家庭锻炼方案 ARM 3：与ARM 2相同，加上以临床为基础、治疗师指导的假PT干预 手臂4：与手臂2相同，加上以临床为基础、治疗师指导的运动和手动疗法 主要结果是疼痛从基线到3个月的变化。受试者将被跟踪观察12个月。 目的2：评价依从性优化的家庭锻炼方案的成本-效果 治疗师指导的锻炼和手动治疗计划，以及优化的家庭锻炼方案。 拟议的试验和成本效益分析的结果将有助于临床医生、患者和决策者 对存在骨性关节炎的半月板撕裂症状性治疗做出循证决策 在全科医生中最常见的肌肉骨骼疾病。

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.