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.

腰痛是导致残疾多年的第一大原因，主要由慢性腰痛引起 （CLBP；疼痛持续≥3 个月）减少 CLBP 社会负担的一个障碍是大多数治疗方法 仅具有较小程度的治疗效果（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，广泛应用于以下领域： CLBP 可用于 CLBP 仅限于腰椎小关节的患者，其定义为疼痛缓解。 （“阳性反应”）对 LRFA 进行局部麻醉内侧分支阻滞（MBB）。 与大多数 CLBP 不同，对这些神经施加热损伤，暂时减少或消除 CLBP。 LRFA 可以为精心挑选的患者带来大幅改善。 神经破坏性，具有潜在的副作用，并且关于其有效性的证据相互矛盾。 虽然一些随机对照试验 (RCT) 和系统评价支持 LRFA 的有效性， LRFA 的多项随机对照试验显示没有显着影响，包括迄今为止最大的随机对照试验。专家指出。 这些 RCT 显示没有效果的原因可能是 (1) LRFA 技术较差，不足以充分 (2) 用于识别 LRFA 候选者的次优临床选择标准。 LRFA 技术和患者选择最严格的循证指南是 脊柱介入协会 (SIS)。 SIS 指令指导优化内侧技术的各个方面。 分支病变和随后的 CLBP 改善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，例如需要 ≥80% 的疼痛改善才能定义阳性 MBB 反应，以及 2 组独立的低麻醉剂量（<0.5cc）的比较 MBB。 拟议的研究将涉及一个明确的、双盲多中心的设计和规划 LRFA 的 RCT 与模拟 LRFA 控制程序相比：“射频的优越性试验 腰痛消融”（ASTRAL）将遵守 SIS 指南，解决相关问题。 关于 LRFA 技术和过去 RCT 患者选择的不足，以下目标是： 在 1.5 年资助期内解决：目标 1：最终确定统计分析计划 (SAP)、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 备用地点要求包括足够的 LRFA 数量、MBB 和 LRFA 的程序标准， 目标 3：为集中随机化、数据准备 目标 4. 获得未来行政和监管部门的批准 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。