Centre of Neuromodulation, Department of Neurosurgery, Heinrich-Heine University Hospital, Düsseldorf, Germany.
Neuromodulation. 2012 Jul;15(4):402-7. doi: 10.1111/j.1525-1403.2012.00473.x. Epub 2012 Jun 1.
OBJECTIVES: Spinal cord stimulation (SCS) is an established method for treatment of chronic pain. Cylindrical-type leads can be implanted percutaneously. In contrast, paddle leads (lamitrode) require more invasive surgery (i.e., laminotomy or laminectomy) for placement into the epidural space, thereby offering several advantages over percutaneous leads (octrode), including less lead migration and better paresthesia coverage. The goal of this study was to prospectively demonstrate the safety and efficacy of a percutaneous paddle lead for SCS. MATERIALS AND METHODS: This prospective trial enrolled 81 patients. The mean age was 57 years (range 27-82 years) with an almost equal sex distribution (male 47%, female 53%). Most patients (90%) had failed back surgery syndrome combined with lower extremity pain and lower back pain. A percutaneous paddle lead was implanted using a novel introduction system for percutaneous implantation. All implantations were performed under local anesthesia. Prior to the final implantation of the impulse generator, all patients underwent seven days of trial stimulation with pain assessment using a visual analog scale (VAS). The median follow-up was 12 months. RESULTS: The data showed favorable clinical outcomes for paresthesia coverage and pain reduction (median VAS 8.4 vs. 2.3), with a risk profile comparable with known percutaneous techniques. Compared with the published data (2-22%), the lead migration rate in this study was low (2.5%). No perioperative complications occurred. CONCLUSIONS: This new, minimally invasive percutaneous paddle lead is effective and safe, with a low migration rate. Placement can be done under local anesthesia, allowing an intraoperative assessment of the paresthesia coverage in terms of pain relief. This approach is less invasive and offers a faster and more comfortable procedure compared with laminotomy or laminectomy.
目的:脊髓刺激(SCS)是治疗慢性疼痛的一种成熟方法。可经皮植入圆柱形导联。相比之下,片状导联(lamitrode)需要更具侵入性的手术(即椎板切开术或椎板切除术)才能放置到硬膜外腔,因此与经皮导联(octrode)相比具有多个优势,包括更少的导联迁移和更好的感觉异常覆盖。本研究的目的是前瞻性证明用于 SCS 的经皮片状导联的安全性和有效性。
材料和方法:这项前瞻性试验共纳入 81 例患者。平均年龄为 57 岁(范围 27-82 岁),性别分布几乎相等(男性占 47%,女性占 53%)。大多数患者(90%)患有失败的腰椎手术综合征,伴有下肢疼痛和下腰痛。使用一种新型的经皮植入物导入系统植入经皮片状导联。所有植入均在局部麻醉下进行。在最终植入脉冲发生器之前,所有患者均接受了为期七天的试验刺激,使用视觉模拟评分(VAS)评估疼痛。中位随访时间为 12 个月。
结果:数据显示,感觉异常覆盖和疼痛减轻的临床结果良好(中位数 VAS 为 8.4 对 2.3),风险状况与已知的经皮技术相当。与已发表的数据(2%-22%)相比,本研究中的导联迁移率较低(2.5%)。无围手术期并发症发生。
结论:这种新的微创经皮片状导联安全有效,迁移率低。可在局部麻醉下放置,可在术中评估疼痛缓解方面的感觉异常覆盖。与椎板切开术或椎板切除术相比,这种方法侵入性更小,手术过程更快、更舒适。
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