Surgery vs. conservative care for meniscal tear after unsuccessful PT: an RCT

PT 失败后半月板撕裂的手术与保守治疗：随机对照试验

• 批准号: 10579419
• 负责人: Jeffrey Neil Katz
• 金额: $ 24.99万
• 依托单位: BRIGHAM AND WOMEN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-03-01 至 2025-02-28
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10579419
• 关键词: Address; Adherence; Adverse effects; Age; American; Authorization documentation; Caring; Certification; Clinical; Clinical Protocols; Clinical Trials; Data; Degenerative polyarthritis; Education; Elderly; Elements; Eligibility Determination; Ensure; Equipoise; Exercise; Future; Grant; Hospitals; Hyaluronic Acid; Image; Injection of therapeutic agent; Injections; Institutional Review Boards; Intervention; Intra-Articular Injections; Knee; Knee joint; Long-Term Effects; Manuals; Modeling; Molecular Weight; Monitor; Online Systems; Operative Surgical Procedures; Outcome; Pain; Pain Measurement; Patient Self-Report; Patients; Performance; Persistent pain; Persons; Physical Exercise; Physical therapy; Physicians; Procedures; Protocols documentation; Randomized; Randomized, Controlled Trials; Recommendation; Regimen; Research; Rest; Risk; Running; Safety; Standardization; Statistical Data Interpretation; Symptoms; Syndrome; Therapeutic; Tissues; Training; Triamcinolone; Universities; Woman; Work; authority; comparative efficacy; cost; cost effectiveness; design; disability; effective therapy; exercise program; experience; human very old age (85+); improved; knee pain; knee replacement arthroplasty; meniscal tear; middle age; multimodality; neuromuscular; pain reduction; pain relief; preference; primary outcome; programs; randomized trial; recruit; standard of care; telehealth; treatment strategy; trial enrollment; trial planning

The syndrome of knee pain and meniscal tear is prevalent in persons ≥ 45 years old, and associated with substantial pain, disability, and cost. Several randomized controlled trials (RCTs) have shown that initiating physical therapy (PT) in persons with this syndrome is associated with similar levels of pain relief as performing arthroscopic partial meniscectomy (APM). As a result, initial treatment with PT is now the standard of care. Those who do not respond to PT are often referred for APM, though there have been no trials of whether APM is efficacious in this setting. This planning grant lays groundwork for an RCT to address this important evidence gap. The study team at Brigham and Women’s Hospital (BWH) and University of Buffalo plans an RCT that enrolls persons with knee pain, meniscal tear and osteoarthritic changes into a run-in period in which subjects receive a standardized PT- based regimen. We will identify those with persistent pain despite PT and invite them to be randomized to either APM or a nonoperative regimen that includes intra-articular injections, an enhanced PT and exercise program, and additional support provided with web-based, telehealth, and face-to-face encounters with the research and clinical teams. We will assess pain relief and other outcomes over a two-year period. To prepare for the RCT, we apply for a planning grant with the following specific aims: • Finalize the operative and enhanced nonoperative regimen including choice of injection, specific exercise, and educational and support materials. • Assess and ensure physician equipoise for the two treatment strategies. • Estimate the number of eligible subjects/month and conduct model recruitment • Obtain Single IRB approval with BWH as governing IRB • Develop key study documents including clinical protocol, manual of operating procedures, safety monitoring and data monitoring and management plans, statistical analysis plan, recruitment and retention plan, and training/certification plans This planning grant will prepare the study team to launch an RCT that has the potential to change practice.

膝关节疼痛和踝关节撕裂综合征在≥ 45岁的人群中普遍存在，并与以下因素相关： 巨大的痛苦，残疾和成本。几项随机对照试验（RCT）表明， 物理治疗（PT）与这种综合征患者的疼痛缓解水平相似， 进行关节镜下部分椎间盘切除术（APM）。因此，PT的初始治疗现在是标准 照顾。那些对PT没有反应的人经常被转介接受APM，尽管还没有试验。 APM在这种情况下是否有效。 这项规划补助金为RCT奠定了基础，以解决这一重要的证据缺口。的研究团队 布里格姆妇女医院（BWH）和布法罗大学计划进行一项随机对照试验， 疼痛、尿道撕裂和骨关节炎转变为导入期，在此期间受试者接受标准化PT- 基础养生我们将确定那些尽管接受了PT但仍持续疼痛的患者，并邀请他们随机接受 APM或包括关节内注射、强化PT和运动的非手术方案 计划，并提供额外的支持，以网络为基础，远程医疗，面对面的接触， 研究和临床团队。我们将在两年内评估疼痛缓解和其他结果。准备 我们为这项研究申请规划补助金，具体目的如下： ·最终确定手术和加强非手术方案，包括注射的选择，特定的运动， 以及教育和支持材料。 ·评估并确保医生平衡两种治疗策略。 ·估算每月合格受试者数量并进行模型招募 ·获得BWH作为管理IRB的单一IRB批准 ·制定关键研究文件，包括临床方案，操作程序手册，安全性 监测和数据监测和管理计划、统计分析计划、招聘和留用 培训/认证计划 这项计划补助金将使研究团队做好准备，启动一项有可能改变实践的随机对照试验。