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.

腰痛是多年生活的第一名 （CLBP；持续≥3个月的疼痛）。减少CLBP社交伯恩的障碍是大多数治疗方法 仅具有较小的幅度治疗效果（功能限制和疼痛提高了5-10％）。 腰部射频消融（LRFA）是一种最少的侵入性手术，广泛执行 CLBP。它可用于将CLBP隔离到腰部关节的患者，由疼痛缓解定义 （“阳性反应”）与内侧分支神经的局部麻醉介质分支区块（MBB）。 LRFA 将热病变应用于这些神经，暂时减少或消除CLBP。与大多数CLBP不同 治疗，LRFA可导致良好选择的患者改善。但是，LRFA是 神经造影，具有潜在的不利影响，并且有关于其有效性的证据相互矛盾。 尽管一些随机对照试验（RCT）和系统评价支持LRFA的有效性，但 LRFA的多个RCT没有显示出明显的影响，包括迄今为止最大的RCT。专家指出 那些显示没有影响的RCT可以通过（1）LRFA技术不足以充分充分地解释 病变内侧分支，（2）用于鉴定LRFA候选物的次优临床选择标准。 LRFA技术和患者选择的最严格的基于证据的指南是 脊柱干预协会（SIS）。 SIS指南要求技术的各个方面优化媒体 分支病变并随之改进CLBP。它们还包括严格的临床筛查标准 用于确定适当的LRFA候选物，例如需要≥80％的疼痛来定义阳性 MBB响应和2组单独的比较MBB，具有低麻醉体积（<0.5cc）。 拟议的研究将涉及确定的双盲多中心的设计和计划 LRFA的RCT与模拟的LRFA控制程序相比：“射频的优势试验 消融腰痛”（星体）。星体将遵守SIS指南，解决问题 考虑LRFA技术不足和对过去RCT的患者选择。以下目标将是 在1。5年的资金期内解决：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控计划（DSMP）；目标2：证明临床研究 中心（CRC或“站点”）具有足够的参与能力，或者确定 替代站点。站点要求包括足够的LRFA量，MBB和LRFA的程序标准， 与研究兼容的环境和模拟招聘； AIM 3：准备集中的随机化，数据 收集和数据管理；目标4。获得未来的行政和监管部门批准 多中心星体RCT；目标5：提交NIAMS U01合作协议申请以获得资金 对于未来的RCT。