A double-blind study of capacitively coupled electrical stimulation as an adjunct to lumbar spinal fusions
A double-blind study of capacitively coupled electrical stimulation as an adjunct to lumbar spinal fusions
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DOI：
10.1097/00007632-199907010-00013
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发表时间：
1999-07-01
期刊：
影响因子：
3
通讯作者：
Yuan, HA
中科院分区：
文献类型：
--
作者：
Goodwin, CB;Brighton, CT;Yuan, HA
研究设计.与安慰剂对照的随机双盲前瞻性比较。这份结果报告是正在进行的研究中的第一份。评价无创性电容耦合电刺激对腰椎融合手术成功率的影响，并将活性刺激器与安慰剂刺激器作为当代融合技术的替代品进行比较。先前的研究已经确定了直流电和电磁场刺激作为某些形式的脊柱融合术的辅助手段的有效性。以前关于骨外刺激的安慰剂对照研究都没有包括后外侧融合技术，大多数都是用前几代内固定器械进行的。这项调查由28名美国外科医生进行。选择初步诊断为退行性椎间盘疾病伴或不伴其他退行性病变的患者。研究方案将成功定义为研究者和设盲的独立放射科医生评定为极好或良好的临床结局和记录为牢固的融合。对影像学成功的分歧由第二位盲法独立审查者解决。对于完成治疗和评价的179例患者，活性药物治疗患者的总体方案成功率（临床和影像学结果均被评定为成功）为84.7%，安慰剂I组患者为64.9%。根据Yates校正卡方检验，该差异具有高度显著性（P = 0.0043）。当主动刺激结合后外侧融合（P = 0.006）和内固定（P = 0.013）时，患者结局的改善最佳（20%或更高的成功率）。本研究一致表明，主动刺激改善了各分层的结果，尽管某些分层的患者数量不足，结果不具有统计学意义。假设在内固定中加入电容耦合刺激时，成功率的提高是由于克服了应力屏蔽的生化效应。电容耦合刺激是初次脊柱融合的有效辅助手段，特别是对于后外侧融合和内固定的患者。
Study Design. A randomized double-blind prospective comparison with a placebo control. This report of the results is the first in an ongoing study.Objectives. To evaluate the effect of noninvasive capacitively coupled electrical stimulation on the success rate of lumbar spine fusion surgery, and to compare active with placebo stimulators as adjuncts to contemporary fusion techniques.Summary of Background Data. Previous studies have established the effectiveness of direct current and electromagnetic field stimulation as adjuncts for some forms of spinal fusion. None of the previous placebo-controlled studies on external bone stimulation included posterolateral fusion techniques, and most were conducted with prior generations of internal fixation hardware.Methods. The investigation was conducted by 28 U.S. surgeons. Patients with a primary diagnosis of degenerative disc disease with or without other degenerative changes were selected. The study protocol defined success as a clinical outcome rated as excellent or good and a fusion documented as solid by both the investigator and dhe blinded independent radiologist. Disagreements on radiographic success were resolved by a second blinded independent reviewer.Results. For the 179 patients who completed treatment and evaluation, the overall protocol success rate (both clinical and radiographic results rated as successes) was 84.7% for the active patients and 64.9% for the placebo I-patients. This difference is highly significant according to the Yates corrected chi-square test (P = 0.0043). Best improvements in patient outcomes (20% or greater success rate) occurred when active stimulation was used in conjunction with posterolateral fusion (P = 0.006) and when internal fixation also was incorporated (P = 0.013).Discussion. This study was consistent in that active stimulation improved results for each stratification, although some strata had insufficient numbers of patients for the-results to have statistical significance, Improved success rates when capacitively coupled stimulation is added to internal fixation are hypothesized to result from overcoming the biochemical effects of stress shielding.Conclusions. Capacitively coupled stimulation is an effective adjunct to primary spine fusion, especially for patients with posterolateral fusion and those with internal fixation.