Spinal cord stimulation electrode design: A prospective, randomized, controlled trial comparing percutaneous with laminectomy electrodes: Part II - Clinical outcomes
Spinal cord stimulation electrode design: A prospective, randomized, controlled trial comparing percutaneous with laminectomy electrodes: Part II - Clinical outcomes
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DOI：
10.1227/01.neu.0000180030.00167.b9
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发表时间：
2005-11-01
期刊：
影响因子：
4.8
通讯作者：
Dorsi, MJ
中科院分区：
文献类型：
--
作者：
North, RB;Kidd, DH;Dorsi, MJ
目的：脊髓电刺激，在使用超过30年，已发展成为一种易于实施的技术，涉及经皮或椎板切除术电极放置。在一项随机比较中，将四触点经皮和四触点绝缘椎板切除术电极放置在背侧硬膜外中线的相同水平，刺激器性能的定量测量显示椎板切除术电极具有显著的技术优势。我们的前瞻性，随机，对照试验比较这些相同patients.METHODS：公正的第三方遵循我们的系列24例腰椎手术失败综合征的临床结果数据。我们将“成功”定义为至少50%的疼痛持续缓解和患者对治疗结果的满意度。结果：在平均1.9年的随访中，12例接受椎板切除术电极的患者中有10例和12例接受经皮电极的患者中有5例报告了成功的结果（P < 0.05）。平均2.9年的随访显示，使用椎板切除术电极的12名患者中有5名患者保持了该结果，使用经皮电极的12名患者中有3名患者保持了该结果（无统计学意义）。许多患者报告大多数日常生活活动改善，功能丧失罕见。另外，9例椎板切除电极组和4例经皮电极组患者减少或消除镇痛剂摄入（P < 0.05），2例恢复工作。没有电极迁移observed.CONCLUSION：椎板切除术电极放置，虽然比经皮放置更具侵入性，产生显着更好的临床效果，在平均1.9年的随访失败的背部手术综合征的患者。然而，在我们的小样本中，这一优势的统计学意义在平均2.9年随访时消失。
OBJECTIVE: Spinal cord stimulation, in use for more than 30 years, has evolved into an easily implemented technique involving percutaneous or laminectomy electrode placement. In a randomized comparison of four-contact percutaneous and four-contact insulated laminectomy electrodes placed at the same level in the dorsal, epidural midline, quantitative measures of stimulator performance revealed significant technical advantages for the laminectomy electrodes. Our prospective, randomized, controlled trial compares clinical results in these same patients.METHODS: Impartial third parties followed our series of 24 patients with failed back surgery syndrome to gather clinical outcome data. We defined "success" as at least 50% sustained relief of pain and patient satisfaction with the result of treatment.RESULTS: At a mean follow-up of 1.9 years, 10 of 12 patients receiving the laminectomy electrode and 5 of 12 patients receiving the percutaneous electrode reported a successful outcome (P < 0.05). Follow-up at a mean of 2.9 years showed that this result was maintained in 5 of 12 patients with the laminectomy electrode and 3 of 12 with the percutaneous electrode (not statistically significant). Many patients reported improvements in most activities of daily living, and loss of function was rare. In addition, 9 patients with laminectomy electrodes and 4 with percutaneous electrodes reducted or eliminated analgesic intake (P < 0.05), and 2 returned to work. No electrode migration was observed.CONCLUSION: Laminectomy electrode placement, although more invasive than percutaneous placement, yields significantly better clinical results in patients with failed back surgery syndrome at mean 1.9 years follow-up. In our small sample, however, the statistical significance of this advantage disappeared at mean 2.9 years follow-up.