Evaluation of the Effectiveness of Percutaneous Octapolar Leads in Pain Treatment with Spinal Cord Stimulation of Patients with Failed Back Surgery Syndrome During a 1-Year Follow-Up: A Prospective Multicenter International Study
Evaluation of the Effectiveness of Percutaneous Octapolar Leads in Pain Treatment with Spinal Cord Stimulation of Patients with Failed Back Surgery Syndrome During a 1-Year Follow-Up: A Prospective Multicenter International Study
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DOI：
10.1111/papr.12478
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发表时间：
2017-04-01
期刊：
影响因子：
2.6
通讯作者：
Buschman, Hendrik P.
中科院分区：
文献类型：
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作者：
Gatzinsky, Kliment;Baardsen, Roald;Buschman, Hendrik P.
目的评价经皮八极（8接触）导联脊髓刺激（SCS）治疗经其他治疗手段均未达到治疗目的的失败背部手术综合征（FBSS）患者的有效性和安全性。方法一项前瞻性、多中心、开放标签、非随机研究包括93例18岁的慢性（6个月）顽固性疼痛患者，主要发生在腿部。试验成功后，患者植入八极导联和神经刺激器，随访12个月。患者提供了关于腿部疼痛（主要结局）和腰痛的视觉模拟量表（VAS）评分变化、生活质量（EuroQol 5维度[EQ-5D]指数）、睡眠、药物使用和感觉异常覆盖（次要结局）的自我报告数据。记录不良事件和首选刺激设置。结果81例（87%）患者SCS试验成功。患者报告腿部疼痛明显缓解；治疗前平均VAS评分为7217分，12个月时平均VAS评分为32 +/- 24分（P < 0.05）
ObjectiveTo 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.MethodsOur prospective, multicenter, open-label, nonrandomized study included 93 patients 18years of age suffering from chronic (6months), intractable pain predominantly in the legs. Patients implanted with octapolar lead(s) and a neurostimulator after a successful test trial were followed for 12months. 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.ResultsEighty-one (87%) patients had a successful SCS trial. Patients reported significantly improved leg pain relief; average VAS score was 7217 prior to SCS treatment and 32 +/- 24 at 12 months (P