IPM Medical Group, Inc., Walnut Creek, CA.
PRA Health Sciences, Salt Lake City, UT.
Spine (Phila Pa 1976). 2017 Jul 15;42 Suppl 14:S41-S52. doi: 10.1097/BRS.0000000000002217.
STUDY DESIGN: A significant number of lumbar postsurgical patients continue to suffer persistent pain and limited function and are termed to have "Failed back surgery syndrome" (FBSS). This review evaluates clinical trial data for the treatment of FBSS patients. OBJECTIVE: Using an evidence-based approach to evaluate FBSS treatments will assist clinicians in choosing the most effective options for FBSS patients. Furthermore, reducing the utilization of less effective therapies may result in substantial financial savings for this patient population. SUMMARY OF BACKGROUND DATA: Treatments for FBSS may be generally categorized as physical therapy and exercise, medications, interventional procedures, neuromodulation, and reoperation. Careful review and classification of the level of evidence available for each category of treatment for FBSS patients will help guide clinical decision-making. METHODS: A literature review was performed for FBSS treatments. The publications were arranged hierarchically according to the North American Spine Society's guidelines as randomized controlled trials (RCTs), prospective studies, retrospective chart, and systematic reviews. Book chapters, nonsystematic reviews, and expert opinions were excluded. The review focused on studies with at least 20 FBSS patients and 6-month follow-up. RESULTS: Evidence is weak for medications and reoperation, but strong for active exercise and interventional procedures such as adhesiolysis. The strongest evidence for long-term treatment is for spinal cord stimulation (SCS), showing favorable Level I RCT results compared with conventional medical management and reoperation. In addition, high-frequency SCS at 10 kHz has demonstrated superiority over traditional, low-frequency SCS for treating low back and leg pain in a recent Level I RCT. CONCLUSION: Clinicians may increasingly utilize levels of evidence during their evaluation of each FBSS patient to render the best therapeutic plan, likely resulting in improved long-term pain control and reducing costs by avoiding less effective modalities. New directions in SCS show promising results for the treatment of FBSS. LEVEL OF EVIDENCE: 1.
研究设计:大量腰椎术后患者仍持续遭受疼痛和功能受限,被称为“腰椎术后失败综合征”(FBSS)。本综述评估了治疗 FBSS 患者的临床试验数据。
目的:采用循证方法评估 FBSS 的治疗方法,将有助于临床医生为 FBSS 患者选择最有效的治疗方案。此外,减少对疗效较差的治疗方法的应用,可能会为这一患者群体节省大量的费用。
背景资料概述:FBSS 的治疗方法可大致分为物理治疗和锻炼、药物治疗、介入性治疗、神经调节和再次手术。仔细回顾和分类可用于 FBSS 患者的每个治疗类别的证据水平,将有助于指导临床决策。
方法:对 FBSS 的治疗方法进行了文献回顾。根据北美脊柱协会的指南,将出版物按随机对照试验(RCT)、前瞻性研究、回顾性图表和系统评价的层次进行排列。排除了书籍章节、非系统性综述和专家意见。该综述重点关注至少有 20 例 FBSS 患者和 6 个月随访的研究。
结果:药物治疗和再次手术的证据较弱,但积极运动和介入性治疗(如松解粘连)的证据较强。脊髓刺激(SCS)的长期治疗证据最强,与传统的医学管理和再次手术相比,具有有利的 I 级 RCT 结果。此外,高频(10 kHz)SCS 在最近的 I 级 RCT 中显示出优于传统低频 SCS 治疗腰痛和腿痛的优势。
结论:临床医生在评估每个 FBSS 患者时,可能会越来越多地利用证据水平来制定最佳治疗计划,这可能会改善长期疼痛控制,并通过避免效果较差的治疗方式来降低成本。SCS 的新方向为 FBSS 的治疗提供了有希望的结果。
证据等级:1。
Spine (Phila Pa 1976). 2017-7-15
Spine (Phila Pa 1976). 2017-7-15
Pain Physician. 2016-1
Spine (Phila Pa 1976). 2014-5-20