High-Frequency Electrical Nerve Block for Postamputation Pain: A Pilot Study
High-Frequency Electrical Nerve Block for Postamputation Pain: A Pilot Study
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DOI：
10.1111/ner.12266
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发表时间：
2015-04-01
期刊：
影响因子：
2.8
通讯作者：
Fang, Zi-Ping
中科院分区：
文献类型：
--
作者：
Soin, Amol;Shah, Nemath Syed;Fang, Zi-Ping
ObjectivesThis study aims to assess the painful effect of kilohertz alternating current applied to the severed neurons in amputees affirmed by additional limb pain. Methods10 lower limb amputees with chronic and severe residual limb pain or phantom limb pain who achieved significant pain reduction after local nerve block injection were enrolled.将袖带电极缠绕在坐骨神经或胫神经周围。外部波形发生器用于研究的主要部分，而植入式发生器在9至12个月后被开发并植入应答者体内。在每次受试者启动的治疗期间，施加10 kHz和高达10 V的正弦波形30分钟。一个日记被用来记录疼痛强度之前和之后的每一个session.ResultsAmong的七个受试者谁接受治疗，平均疼痛减轻75%，在三个月的主要终点。这些受试者是根据预定义标准的应答者，即在3个月终点时，在50%的治疗期内实现50%的疼痛减轻。止痛药的使用和疼痛对功能的干扰显著减少。在长达12个月的随访期内，治疗疗效持续。除一例受试者的一个电极脱位和功能丧失外，所有其他器械均按预期发挥功能。残余的运动和感觉功能没有变化observed.ConclusionThis试点研究产生的初步证据的有效性和安全性的千赫电神经阻滞截肢后疼痛，证明监管批准的关键研究。
ObjectivesThis study aimed to assess the analgesic effect of kilohertz alternating current applied to the severed nerves in amputees afflicted by intractable limb pain.MethodsTen lower-limb amputees with chronic and severe residual limb pain or phantom limb pain who attained significant pain reduction after local nerve block injection were enrolled. A cuff electrode was wrapped around the sciatic or tibial nerve. An external waveform generator was used for the main part of the study, while an implantable generator was developed and implanted in the responders after 9 to 12 months. Sinusoidal waveforms of 10kHz and up to 10V were applied for 30min during each subject-initiated treatment session. A diary was used to record pain intensities before and after each session.ResultsAmong the seven subjects who received treatment, the average pain reduction was 75% at the three-month primary end point. These subjects were responders per predefined criterion of achieving 50% pain reduction in 50% of treatment sessions for the three-month end point. Pain medication use and interference of pain on functions was significantly reduced. The treatment efficacy was sustained through the follow-up period of up to 12 months. Besides dislodgement and loss of function for one electrode in one subject, all other devices functioned as intended. No changes of residual motor and sensory function were observed.ConclusionThis pilot study generated preliminary evidence on the efficacy and safety of kilohertz electrical nerve block for postamputation pain, justifying a pivotal study for regulatory approval.