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.

膝盖疼痛和半月板撕裂的综合征在≥45岁的人中普遍存在，并且与 严重的疼痛，残疾和成本。几个随机对照试验（RCT）已经表明 患有这种综合征的人的物理疗法（PT）与相似的缓解疼痛程度有关 进行关节镜的部分半月板切除术（APM）。结果，PT初始治疗现在是标准 照顾。那些不响应PT的人经常被转介给APM，尽管没有任何试验 APM是否在此设置中有效。 该计划赠款为RCT奠定了基础，以解决这一重要证据差距。研究团队 杨百翰和妇女医院（BWH）和布法罗大学计划的RCT招募了膝盖 疼痛，半月板撕裂和骨关节炎变成犯规时期，受试者接受标准化的PT- 基于方案。我们将确定那些持续疼痛目的地的人，并邀请他们随机分配到 APM或包括关节内注射，增强的PT和运动的非手术方案 程序，以及与基于Web的，远程医疗和面对面相遇提供的其他支持 研究和临床团队。我们将在两年内评估缓解疼痛和其他结果。准备 对于RCT，我们申请具有以下特定目的的计划赠款： •最终确定运行和增强的非手术方案，包括选择注射，特定运动， 以及教育和支持材料。 •评估并确保两种治疗策略的物理设备。 •估计每月合格受试者的数量并进行模型招聘 •获得BWH的单一IRB批准作为管理IRB •制定关键的研究文件，包括临床方案，操作程序手册，安全性 监视和数据监视和管理计划，统计分析计划，招聘和保留 计划和培训/认证计划 这项计划赠款将使研究团队为推出有可能改变实践的RCT做好准备。