Frey Michael E, Manchikanti Laxmaiah, Benyamin Ramsin M, Schultz David M, Smith Howard S, Cohen Steven P
Advanced Pain Management and Spine Specialists, Fort Myers, FL 33919, USA.
Pain Physician. 2009 Mar-Apr;12(2):379-97.
Failed back surgery syndrome is common in the United States. Management of post lumbar surgery syndrome with multiple modalities includes interventional techniques, resulting in moderate improvement, leaving a proportion of patients in intractable pain. The systematic reviews of long-term benefits and risks of spinal cord stimulation (SCS) for patients with failed back surgery syndrome showed limited to moderate evidence and cost effectiveness. However, with the exponential increase in surgery in the United States, spinal cord implants are also increasing. Thus, the discussion continues with claims of lack of evidence on one hand and escalating increases in utilization on the other hand.
A systematic review of SCS in patients with failed back surgery syndrome.
This systematic review is undertaken to examine the evidence from randomized controlled trials (RCTs) and observational studies to evaluate the effectiveness of SCS in post lumbar surgery syndrome and to demonstrate clinical and cost effectiveness.
Review of the literature was performed according to the Cochrane Musculoskeletal Review Group Criteria as utilized for interventional techniques for randomized trials and the Agency for Healthcare Research and Quality (AHRQ) criteria for observational studies. The 5 levels of evidence were classified as Level I, II, or III with 3 subcategories in Level II based on the quality of evidence developed by the U.S. Preventive Services Task Force (USPSTF). Data sources included relevant literature of the English language identified through searches of PubMed and EMBASE from 1966 to December 2008, and manual searches of bibliographies of known primary and review articles.
The primary outcome measure was pain relief (short-term relief < or = one-year and long-term > one-year). Secondary outcome measures of improvement in functional status, psychological status, return to work, and reduction in opioid intake were utilized.
The indicated evidence is Level II-1 or II-2 for long-term relief in managing patients with failed back surgery syndrome.
The limitations of this review included the paucity and heterogeneity of the literature.
This systematic review evaluating the effectiveness of SCS in relieving chronic intractable pain of failed back surgery syndrome indicated the evidence to be Level II-1 or II-2 for clinical use on a long-term basis.
腰椎手术失败综合征在美国很常见。采用多种方式治疗腰椎手术后综合征，包括介入技术，虽有一定改善，但仍有部分患者疼痛难以缓解。关于脊髓刺激（SCS）治疗腰椎手术失败综合征患者的长期益处和风险的系统评价显示，证据有限至中等，且成本效益一般。然而，随着美国手术数量呈指数级增长，脊髓植入物的使用也在增加。因此，一方面存在缺乏证据的说法，另一方面使用量却不断攀升，相关讨论仍在继续。
对腰椎手术失败综合征患者的脊髓刺激进行系统评价。
本系统评价旨在审查来自随机对照试验（RCT）和观察性研究的证据，以评估脊髓刺激对腰椎手术后综合征的有效性，并证明其临床和成本效益。
根据Cochrane肌肉骨骼评价组用于随机试验介入技术的标准以及医疗保健研究与质量局（AHRQ）用于观察性研究的标准进行文献综述。根据美国预防服务工作组（USPSTF）制定的证据质量，将5个证据级别分为I级、II级或III级，其中II级有3个子类别。数据来源包括通过检索1966年至2008年12月的PubMed和EMBASE数据库识别出的相关英文文献，以及对已知主要文章和综述文章参考文献的手工检索。
主要结局指标为疼痛缓解（短期缓解≤1年，长期缓解＞1年）。还采用了功能状态改善、心理状态改善、恢复工作以及阿片类药物摄入量减少等次要结局指标。
对于治疗腰椎手术失败综合征患者的长期缓解，所示证据为II-1级或II-2级。
本综述的局限性包括文献数量不足和异质性。
本系统评价评估了脊髓刺激缓解腰椎手术失败综合征慢性顽固性疼痛的有效性，表明长期临床使用的证据为II-1级或II-2级。
