A Superiority Trial of Radiofrequency Ablation for Low Back Pain (ASTRAL)

射频消融治疗腰痛的优越性试验 (ASTRAL)

• 批准号: 10670418
• 负责人: Janna L Friedly
• 金额: $ 13.79万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-08-01 至 2024-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10670418
• 关键词: Address; Adverse effects; Anesthetics; Chronic low back pain; Clinical; Clinical Research; Consensus; Data; Data Collection; Double-Blind Method; Effectiveness; Environment; Facet joint structure; Funding; Future; Goals; Guidelines; Health Care Costs; Intervention; Lesion; Local Anesthetics; Low Back Pain; Manuals; Medial; Meta-Analysis; Methodology; Methods; Monitor; National Institute of Arthritis, and Musculoskeletal, and Skin Diseases; Nerve; Pain; Pain management; Patient Selection; Patients; Persistent pain; Procedures; Protocols documentation; Publishing; Radiofrequency Interstitial Ablation; Randomized; Randomized, Controlled Trials; Recommendation; Reporting; Research; Safety; Sampling; Selection Criteria; Site; Societies; Spinal; Statistical Data Interpretation; Structure; Techniques; U-Series Cooperative Agreements; United States; Vertebral column; comparative; data management; design; disability; effectiveness evaluation; evidence based guidelines; improved; minimally invasive; operation; pain relief; programs; recruit; response; screening; systematic review; treatment effect; trial design; years lived with disability

Low back pain is the #1 contributor to years lived with disability, driven mainly by chronic low back pain (CLBP; pain lasting ≥3 months). An obstacle to reducing the societal burden of CLBP is that most treatments have only small magnitude treatment effects (5-10% improvements in functional limitations and pain). Lumbar radiofrequency ablation (LRFA) is a minimally invasive procedure that is widely performed for CLBP. It can be used in patients for whom CLBP is isolated to the lumbar facet joints, defined by pain relief (“positive responses”) with local anesthetic medial branch blocks (MBBs) to the medial branch nerves. LRFA applies a thermal lesion to these nerves, temporarily reducing or eliminating CLBP. Unlike most CLBP treatments, LRFA can result in large-magnitude improvements in well-selected patients. However, LRFA is neurodestructive, has potential adverse effects, and there is conflicting evidence regarding its effectiveness. While some randomized controlled trials (RCTs) and systematic reviews support the effectiveness of LRFA, multiple RCTs of LRFA show no significant effects, including the largest RCT to date. Experts have noted that those RCTs showing no effects may be explained by (1) poor LRFA technique insufficient to adequately lesion the medial branches, and (2) suboptimal clinical selection criteria for identifying LRFA candidates. The most stringent evidence-based guidelines for LRFA technique and patient selection are those of the Spine Intervention Society (SIS). The SIS guidelines mandate various aspects of technique to optimize medial branch lesioning and consequent improvements in CLBP. They also include stringent clinical screening criteria for determining appropriate LRFA candidates, such as requiring ≥80% pain improvement to define positive MBB responses, and 2 separate sets of comparative MBBs with low anesthetic volume (<0.5cc). The proposed research will involve the design and planning of a definitive, double-blind multicenter RCT of LRFA compared to a simulated LRFA control procedure: “A Superiority Trial of Radiofrequency Ablation for Low Back Pain” (ASTRAL). ASTRAL will adhere to the SIS guidelines, addressing concerns regarding inadequate LRFA technique and patient selection of past RCTs. The following Aims will be addressed over a 1.5-year funding period: Aim 1: Finalize the statistical analysis plan (SAP), study protocol, manual of operations, and data safety monitoring plan (DSMP); Aim 2: Demonstrate that the clinical research centers (CRCs or “sites”) have sufficient capacity for participation in the future ASTRAL RCT, or identify alternate sites. Site requirements include sufficient LRFA volume, procedural standards for MBBs and LRFAs, a research-compatible environment, and mock recruitment; Aim 3: Prepare for centralized randomization, data collection, and data management; Aim 4. Obtain administrative and regulatory approvals for the future multicenter ASTRAL RCT; Aim 5: Submit a NIAMS U01 Cooperative Agreement application to obtain funding for the future RCT.

下腰痛是导致多年来残疾的头号因素，主要由慢性下腰痛驱动 (CLBP；Pain Constaining≥3个月)。减轻CLBP社会负担的一个障碍是，大多数治疗方法 仅有很小的治疗效果(功能限制和疼痛改善5-10%)。 腰椎射频消融术(LRFA)是一种微创手术，广泛用于 CLBP。它可以用于CLBP被隔离到腰椎小关节的患者，定义为疼痛缓解 (“阳性反应”)，局麻药内侧支传导阻滞(MBBS)至内侧支神经。LRFA 对这些神经进行热损伤，暂时减少或消除CLBP。与大多数CLBP不同 通过治疗，LRFA可以在精心挑选的患者中产生巨大的改善。然而，LRFA是 具有神经破坏性，具有潜在的不良影响，关于其有效性有相互矛盾的证据。 虽然一些随机对照试验(RCT)和系统评价支持LRFA的有效性， LRFA的多个随机对照试验没有显著效果，包括迄今最大的随机对照试验。专家们注意到， 这些RCT没有效果的原因可能是：(1)LRFA技术不佳，不足以充分 病变的内侧分支，以及(2)确定LRFA候选者的次佳临床选择标准。 LRFA技术和患者选择的最严格的循证指南是 脊柱干预学会(SIS)。SIS指南要求使用多个方面的技术来优化医疗 分支机构租赁和CLBP中的后续改进。它们还包括严格的临床筛查标准。 用于确定合适的LRFA候选者，例如要求≥80%疼痛改善定义为阳性 MBB反应，以及两组单独的低麻醉量的对照MBBS(&lt；0.5cc)。 拟议的研究将涉及一个确定的双盲多中心的设计和规划 LRFA与模拟LRFA控制程序的RCT比较：射频的优越性试验 消融治疗腰背痛“(Astral)。Astral将遵守SIS的指导方针，解决人们的担忧 关于LRFA技术的不足和过去RCT的患者选择。以下目标将是 在1.5年的资助期内解决：目标1：最后确定统计分析计划、研究方案、 操作手册和数据安全监测计划(DSMP)；目标2：证明临床研究 中心(CRC或“站点”)有足够的能力参与未来的Astral RCT，或确定 备用站点。场地要求包括足够的LRFA容量，MBBS和LRFA的程序标准， 与研究兼容的环境和模拟招募；目标3：为集中随机化做好准备，数据 收集和数据管理；目标4.获得未来的行政和监管批准 多中心Astral RCT；目标5：提交NIAMS U01合作协议申请以获得资金 为未来的随机对照试验。