Pain Management Centers of America, Paducah, KY and Evansville, IN; LSU Health Science Center, New Orleans, LA.
University of Illinois at Urbana-Champaign, College of Liberal Arts and Sciences, Champaign, IL.
Pain Physician. 2022 Oct;25(7):E889-E916.
BACKGROUND: Epidural injections are among the most commonly performed procedures for managing low back and lower extremity pain. Pinto et al and Chou et al previously performed systematic reviews and meta-analyses, which, along with a recent update from Oliveira et al showing the lack of effectiveness of epidural steroid injections in managing lumbar disc herniation, spinal stenosis, and radiculopathy. In contrast to these papers, multiple other systematic reviews and meta-analyses have supported the effectiveness and use of epidural injections utilizing fluoroscopically guided techniques. A major flaw in the review can be related to attributing active-controlled trials to placebo-controlled trials. The assumption that local anesthetics do not provide sustained benefit, despite extensive evidence that local anesthetics provide long-term relief, similar to a combination of local anesthetic with steroids is flawed. STUDY DESIGN: The Cochrane Review of randomized controlled trials (RCTs) of epidural injections in managing chronic low back and lower extremity pain with sciatica or lumbar radiculopathy were reanalyzed using systematic methodology and meta-analysis. OBJECTIVES: To re-evaluate Cochrane data on RCTs of epidural injections in managing chronic low back and lower extremity pain with sciatica or lumbar radiculopathy utilizing qualitative and quantitative techniques with dual-arm and single-arm analysis. METHODS: In this systematic review, we have used the same RCTs from the Cochrane Review of a minimum of 20% change in pain scale or significant pain relief of >= 50%. The outcome measures were pain relief and functional status improvement. Significant improvement was defined as 50% or greater pain relief and functional status improvement. Our review was performed utilizing the Cochrane Review methodologic quality assessment and the Interventional Pain Management Techniques - Quality Appraisal of Reliability and Risk of Bias Assessment (IPM-QRB). Evidence was summarized utilizing the principles of best evidence synthesis and the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) system. Clinical relevance of the pragmatic nature of each study was assessed. RESULTS: In evaluating the RCTs in the Cochrane Review, 10 trials were performed with fluoroscopic guidance. Utilizing conventional dual-arm and single-arm meta-analysis, the evidence is vastly different from the interpretation of the data within the Cochrane Review. The overall combined evidence is Level I, or strong evidence, at one and 3 months, and Level II, or moderate evidence, at 6 and 12 months. LIMITATIONS: The limitation of this study is that only data contained in the Cochrane Review were analyzed. CONCLUSION: A comparative systematic review and meta-analysis of the Cochrane Review of randomized controlled trials (RCTs) of epidural injections in managing chronic low back and lower extremity pain with sciatica or lumbar radiculopathy yielded different results. This review, based on the evidence derived from placebo-controlled trials and active-controlled trials showed Level I, or strong evidence, at one and 3 months and Level II at 6 and 12 months. This review once again emphasizes the importance of the allocation of studies to placebo-control and active-control groups, utilizing standards of practice with inclusion of only the studies performed under fluoroscopic guidance.
背景:硬膜外注射是治疗下腰痛和下肢疼痛最常用的方法之一。Pinto 等人和 Chou 等人之前进行了系统评价和荟萃分析,以及 Oliveira 等人最近的更新表明硬膜外类固醇注射在治疗腰椎间盘突出症、椎管狭窄和神经根病变方面无效。与这些论文相反,多项其他系统评价和荟萃分析支持使用透视引导技术的硬膜外注射的有效性和用途。该综述的一个主要缺陷与将活性对照试验归因于安慰剂对照试验有关。尽管有大量证据表明局部麻醉剂可以提供长期缓解,类似于局部麻醉剂与类固醇的组合,但假设局部麻醉剂不能提供持续益处是有缺陷的。 研究设计:使用系统方法和荟萃分析重新分析了 Cochrane 对管理慢性下腰痛和下肢疼痛伴坐骨神经痛或腰椎神经根病变的硬膜外注射的随机对照试验 (RCT) 的评论。 目的:利用双臂和单臂分析的定性和定量技术,重新评估 Cochrane 关于管理慢性下腰痛和下肢疼痛伴坐骨神经痛或腰椎神经根病变的硬膜外注射的 RCT 数据。 方法:在这项系统评价中,我们使用了来自 Cochrane 综述的相同 RCT,最低 20% 的疼痛量表变化或显著疼痛缓解>=50%。结局指标是疼痛缓解和功能状态改善。显著改善定义为 50%或更高的疼痛缓解和功能状态改善。我们的综述使用了 Cochrane 综述的方法学质量评估和介入性疼痛管理技术-可靠性和偏倚风险评估的质量评估 (IPM-QRB)。使用最佳证据综合和推荐评估、发展和评估 (GRADE) 系统的原则总结证据。评估了每项研究的实际意义。 结果:在评估 Cochrane 综述中的 RCT 时,10 项研究采用透视引导。利用常规的双臂和单臂荟萃分析,证据与 Cochrane 综述中的数据解释有很大不同。总体综合证据在 1 个月和 3 个月时为 I 级,即强证据,在 6 个月和 12 个月时为 II 级,即中证据。 局限性:本研究的局限性在于仅分析了 Cochrane 综述中包含的数据。 结论:对管理慢性下腰痛和下肢疼痛伴坐骨神经痛或腰椎神经根病变的硬膜外注射的 Cochrane 综述的随机对照试验 (RCT) 的系统评价和荟萃分析得出了不同的结果。这项基于来自安慰剂对照试验和活性对照试验的证据的比较系统评价和荟萃分析显示,1 个月和 3 个月时为 I 级,即强证据,6 个月和 12 个月时为 II 级。该综述再次强调了将研究分配到安慰剂对照和活性对照组的重要性,使用实践标准,仅纳入在透视引导下进行的研究。
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