Treatment of Meniscal Problems in Osteoarthritis: TeMPO

骨关节炎半月板问题的治疗：TeMPO

• 批准号: 9912103
• 负责人: Jeffrey Neil Katz
• 金额: $ 71.13万
• 依托单位: BRIGHAM AND WOMEN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-04-15 至 2022-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9912103
• 关键词: Adherence; Adult; Affect; Attention; Clinic; Clinical; Cost Effectiveness Analysis; Coupled; Data; Degenerative polyarthritis; Diagnostic radiologic examination; Ensure; Evidence based treatment; Exercise; Exercise Therapy; General Practices; Home environment; 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; multidisciplinary; pain relief; physical therapist; primary outcome; programs; protocol development; randomized trial; secondary outcome; symptomatic improvement; treatment arm; treatment choice; treatment strategy

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.

膝关节骨关节炎（OA）有症状的半月板撕裂是一个常见，残疾且昂贵的问题。最近的 试验表明，物理疗法（PT） - 包括治疗师的练习，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 有症状的半月板撕裂和OA。结果，建议将PT转介作为选择的治疗 这些患者。但是，从未将PT方案与安慰剂或家庭的简单处方进行比较 在这个人群中运动。因此，几个重要的问题仍未得到答复：多少痛苦 与基于PT的方案相关的救济可以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比 单独锻炼计划？可以通过采用创新方法来优化家庭计划的效率 最大化运动依从性？这些问题使我们提出了节奏（半月板的处理 骨关节炎的问题）试验。这项研究的长期目标是定义最有效的和 具有成本效益的非手术方案，用于使用OA管理有症状的半月板撕裂。具体目的是： 目标1：在≥40岁的受试者中进行多中心，平行，四臂RCT，有症状的半月板 撕裂和放射线学或前射线学OA，以确定典型PT方案的组件的效率。 四个手臂包括： ARM 1：基于信息的（小册子，DVD）家庭锻炼计划的处方 ARM 2：具有依从性优化的基于信息的家庭锻炼计划 ARM 3：与ARM 2和基于诊所的治疗师指导的假PT干预相同 手臂4：与ARM 2加上基于诊所的治疗师指导的运动和手动治疗相同 主要结果是疼痛从基线变为3个月。受试者将持续12个月。 目标2：以依从性优化评估家庭锻炼方案的成本效益 治疗师指导的运动和手动治疗计划以及优化的家庭运动方案。 拟议的试验和成本效益分析的结果将帮助临床医生，患者和决策者 在OA存在下，对有症状的半月板撕裂的管理做出基于循证的决定，一个 在一般实践中最常见的肌肉骨骼疾病中。