Gatzinsky Kliment, Baardsen Roald, Buschman Hendrik P
Department of Neurosurgery, Sahlgrenska University Hospital, Gothenburg, Sweden.
Department of Neurosurgery, Stavanger University Hospital, Stavanger, Norway.
Pain Pract. 2017 Apr;17(4):428-437. doi: 10.1111/papr.12478. Epub 2016 Jul 20.
To evaluate the effectiveness and safety of percutaneous octapolar (8-contact) leads in spinal cord stimulation (SCS) treatment of failed back surgery syndrome (FBSS) patients who have not reached their therapy goals with other treatment interventions.
Our prospective, multicenter, open-label, nonrandomized study included 93 patients ≥ 18 years of age suffering from chronic (≥ 6 months), intractable pain predominantly in the legs. Patients implanted with octapolar lead(s) and a neurostimulator after a successful test trial were followed for 12 months. Patients provided self-reported data on change in visual analog scale (VAS) score for leg pain (primary outcome) and low back pain, quality of life (EuroQol 5 dimensions [EQ-5D] index), sleep, medication use, and paresthesia coverage (secondary outcomes). Adverse events and preferred stimulation settings were documented.
Eighty-one (87%) patients had a successful SCS trial. Patients reported significantly improved leg pain relief; average VAS score was 72 ± 17 prior to SCS treatment and 32 ± 24 at 12 months (P < 0.001). Significant decrease in back pain (P < 0.001), improvement in quality of life (P < 0.001), and improvement in sleep (P < 0.05) was observed. Sixty-three percent and 40% of patients were responders (≥ 50% pain reduction) on leg and back pain, respectively, after 12 months. A decrease in medication use was seen for antidepressants and anticonvulsants. Eighty-eight percent of the patients managed with 1 or 2 programs for optimal effect and paresthesia coverage. Twenty-five SCS-related adverse events were registered in 22 patients (24%). Surgical revision due to lead displacement or dysfunction was needed in 6 (6%) of the patients.
Use of percutaneous octapolar SCS leads gives significant long-term pain relief and improvement in quality of life and sleep in FBSS patients. The outcomes are better than reported on 4-contact leads and indicate that the progress in SCS technology that has taken place during the past decade correlates with therapy improvements.
评估经皮八极（8触点）电极在脊髓刺激（SCS）治疗失败的脊柱手术综合征（FBSS）患者中的有效性和安全性，这些患者采用其他治疗干预措施未达到治疗目标。
我们的前瞻性、多中心、开放标签、非随机研究纳入了93例年龄≥18岁、患有慢性（≥6个月）、主要为腿部顽固性疼痛的患者。在成功进行测试试验后植入八极电极和神经刺激器的患者随访12个月。患者提供关于腿痛（主要结局）和腰痛的视觉模拟量表（VAS）评分变化、生活质量（欧洲五维度健康量表[EQ-5D]指数）、睡眠、药物使用和感觉异常覆盖范围（次要结局）的自我报告数据。记录不良事件和优选的刺激设置。
81例（87%）患者SCS试验成功。患者报告腿痛缓解显著改善；SCS治疗前平均VAS评分为72±17，12个月时为32±24（P<0.001）。观察到腰痛显著减轻（P<0.001）、生活质量改善（P<0.001）和睡眠改善（P<0.05）。12个月后，分别有63%和40%的患者腿痛和腰痛有反应（疼痛减轻≥50%）。抗抑郁药和抗惊厥药的使用减少。88%的患者通过1或2个程序实现了最佳效果和感觉异常覆盖。22例患者（24%）记录了25起与SCS相关的不良事件。6例（6%）患者因电极移位或功能障碍需要进行手术翻修。
使用经皮八极SCS电极可使FBSS患者长期疼痛显著缓解，生活质量和睡眠得到改善。结果优于四触点电极的报道，表明过去十年中SCS技术的进步与治疗改善相关。
