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脊髓刺激治疗慢性脊柱疼痛的有效性:一项系统评价。

Effectiveness of Spinal Cord Stimulation in Chronic Spinal Pain: A Systematic Review.

作者信息

Grider Jay S, Manchikanti Laxmaiah, Carayannopoulos Alexios, Sharma Manohar Lal, Balog Carl C, Harned Michael E, Grami Vahid, Justiz Rafael, Nouri Kent H, Hayek Salim M, Vallejo Ricardo, Christo Paul J

机构信息

Pain Management Center of Paducah, Paducah, KY, and University of Louisville, Louisville, KY.

Comprehensive Spine Center at Rhode Island Hospital, Providence, RI.

出版信息

Pain Physician. 2016 Jan;19(1):E33-54.

Abstract

BACKGROUND

Chronic neuropathic pain has been recognized as contributing to a significant proportion of chronic pain globally. Among these, spinal pain is of significance with failed back surgery syndrome (FBSS), generating considerable expense for the health care systems with increasing prevalence and health impact.

OBJECTIVE

To assess the role and effectiveness of spinal cord stimulation (SCS) in chronic spinal pain.

STUDY DESIGN

A systematic review of randomized controlled trials (RCTs) of SCS in chronic spinal pain.

METHODS

The available literature on SCS was reviewed. The quality assessment criteria utilized were Cochrane review criteria to assess sources of risk of bias and Interventional Pain Management Techniques - Quality Appraisal of Reliability and Risk of Bias Assessment (IPM - QRB) criteria for randomized trials.The level of evidence was based on a best evidence synthesis with modified grading of qualitative evidence from Level I to Level V.Data sources included relevant literature published from 1966 through March 2015 that were identified through searches of PubMed and EMBASE, manual searches of the bibliographies of known primary and review articles, and all other sources.

OUTCOME MEASURES

RCTs of efficacy with a minimum 12-month follow-up were considered for inclusion. For trials of adaptive stimulation, high frequency stimulation, and burst stimulation, shorter follow-up periods were considered.

RESULTS

Results showed 6 RCTs with 3 efficacy trials and 3 stimulation trials. There were also 2 cost effectiveness studies available. Based on a best evidence synthesis with 3 high quality RCTs, the evidence of efficacy for SCS in lumbar FBSS is Level I to II. The evidence for high frequency stimulation based on one high quality RCT is Level II to III. Based on a lack of high quality studies demonstrating the efficacy of adaptive stimulation or burst stimulation, evidence is limited for these 2 modalities.

LIMITATIONS

The limitations of this systematic review continue to require future studies illustrating effectiveness and also the superiority of high frequency stimulation and potentially burst stimulation.

CONCLUSION

There is significant (Level I to II) evidence of the efficacy of spinal cord stimulation in lumbar FBSS; whereas, there is moderate (Level II to III) evidence for high frequency stimulation; there is limited evidence for adaptive stimulation and burst stimulation.

摘要

背景

慢性神经性疼痛在全球慢性疼痛中占相当大的比例。其中,脊柱疼痛与腰椎手术失败综合征(FBSS)相关,其患病率和健康影响不断增加,给医疗保健系统带来了巨大费用。

目的

评估脊髓刺激(SCS)在慢性脊柱疼痛中的作用和效果。

研究设计

对SCS治疗慢性脊柱疼痛的随机对照试验(RCT)进行系统评价。

方法

回顾了关于SCS的现有文献。采用的质量评估标准是Cochrane评价标准,以评估偏倚风险来源;对于随机试验,采用介入性疼痛管理技术-可靠性质量评估和偏倚风险评估(IPM-QRB)标准。证据水平基于最佳证据综合,对定性证据进行从I级到V级的修改分级。数据来源包括1966年至2015年3月发表的相关文献,这些文献通过检索PubMed和EMBASE、手动检索已知的主要和综述文章的参考文献以及所有其他来源确定。

观察指标

纳入至少随访12个月的疗效RCT。对于适应性刺激、高频刺激和爆发刺激试验,考虑较短的随访期。

结果

结果显示有6项RCT,其中3项疗效试验和3项刺激试验。还有2项成本效益研究。基于3项高质量RCT的最佳证据综合,SCS治疗腰椎FBSS的疗效证据为I级至II级。基于1项高质量RCT的高频刺激证据为II级至III级。由于缺乏高质量研究证明适应性刺激或爆发刺激的疗效,这两种方式的证据有限。

局限性

本系统评价的局限性仍需要未来的研究来说明其有效性以及高频刺激和潜在爆发刺激的优越性。

结论

有显著(I级至II级)证据表明脊髓刺激在腰椎FBSS中有效;而高频刺激有中等(II级至III级)证据;适应性刺激和爆发刺激的证据有限。

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