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.

膝关节骨性关节炎（OA）的症状性撕裂是一种常见的，致残和昂贵的问题。最近 试验表明，物理治疗（PT）-包括治疗师监督的练习，手动治疗和 家庭锻炼计划-导致类似水平的疼痛缓解手术治疗的患者 症状性尿道撕裂和OA。因此，推荐PT转诊作为以下患者的治疗选择： 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过比较。 在这个人群中锻炼。因此，有几个重要的问题仍然没有答案： 与基于PT的治疗方案相关的缓解可归因于生理效应与注意力安慰剂效应？ 治疗师指导的运动加上家庭锻炼计划是否比家庭锻炼更有效 单独的锻炼计划？家庭计划的功效是否可以通过采用创新方法来优化 最大限度地坚持锻炼吗这些问题促使我们提出了克里思（半月板治疗 骨关节炎的问题）试验。这项研究的长期目标是确定最有效的， 治疗OA伴症状性尿道撕裂的经济有效的非手术方案。具体目标是： 目的1：在≥40岁的症状性糖尿病受试者中开展一项多中心、平行、四组RCT 撕裂和放射学或放射学前OA，以确定典型PT方案组分的有效性。 这四个武器包括： 第1组：基于信息（小册子，DVD）的家庭锻炼计划处方 臂2：基于信息的家庭锻炼计划与坚持优化 第3组：与第2组相同，加基于临床的治疗师指导的假PT干预 第4组：与第2组相同，加上基于诊所的治疗师指导的运动和手动治疗 主要结局是疼痛从基线到3个月的变化。受试者将接受12个月的随访。 目的2：评估家庭锻炼方案的成本效益，坚持优化和 治疗师指导的锻炼和手动治疗计划，再加上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、患者和政策制定者 在OA存在的情况下，对症状性尿道撕裂的管理做出基于证据的决定， 最常见的肌肉骨骼疾病在一般的做法。