A Multicenter, Prospective Trial to Assess the Safety and Performance of the Spinal Modulation Dorsal Root Ganglion Neurostimulator System in the Treatment of Chronic Pain
A Multicenter, Prospective Trial to Assess the Safety and Performance of the Spinal Modulation Dorsal Root Ganglion Neurostimulator System in the Treatment of Chronic Pain
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DOI：
10.1111/ner.12072
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发表时间：
2013-09-01
期刊：
影响因子：
2.8
通讯作者：
Kramer, Jeffery
中科院分区：
文献类型：
--
作者：
Liem, Liong;Russo, Marc;Kramer, Jeffery
这项多中心前瞻性试验旨在评估一种新的神经刺激系统的临床性能，该系统旨在通过背根节(DRG)神经生理上与肢体和/或躯干疼痛区域的电调节来治疗慢性疼痛。对刺激期间的疼痛评分进行了6个月的随访，并与基线评分进行了比较。受试者还完成了两个不同的反转期，其中短暂停止刺激以确定干预的效果。结果在所有评估中，超过一半的受试者报告疼痛缓解50%或更好。术后6个月，平均总体疼痛评分比基线低58%(p
ObjectivesThis multicenter prospective trial was conducted to evaluate the clinical performance of a new neurostimulation system designed to treat chronic pain through the electrical neuromodulation of the dorsal root ganglia (DRG) neurophysiologically associated with painful regions of the limbs and/or trunk.Materials and MethodsThirty-two subjects were implanted with a novel neuromodulation device. Pain ratings during stimulation were followed up to six months and compared with baseline ratings. Subjects also completed two separate reversal periods in which stimulation was briefly stopped in order to establish the effects of the intervention.ResultsAt all assessments, more than half of subjects reported pain relief of 50% or better. At six months postimplant, average overall pain ratings were 58% lower than baseline (p