Time-Varying, Biaxial Magnetic Stimulation in Refractory Carpal Tunnel Syndrome: A Novel Approach. A Pilot Study

Michael I. Weintraub MD, FACP, FAAN , Steven P. Cole PhD
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引用次数: 3

Abstract

A pilot study was conducted to determine whether a cumulative 1-h daily exposure to a portable biaxial pulsed magnetic field stimulator over the carpal tunnel region for a 2-week period could reduce neuropathic pain scores and influence sleep interruption and possibly be an alternative conservative therapy option. Patients with advanced carpal tunnel syndrome (CTS) have often failed conservative therapy and are left with refractory numbness, tingling, and burning pain with disability. Previously, we demonstrated that constant application of static permanent magnets to the wrists for a 1-month period reduced neuropathic pain (NP) and improved motor distal latency of the median nerve compared with placebo. Since pulsed time-varying magnetic fields are capable of inducing changes within biological tissues and influencing signal transduction and reducing musculoskeletal pain, we postulated that nociceptive sensory fibers within the carpal tunnel could be influenced at a neuronal level. Thirty-five symptomatic hands (23 subjects) with medical and/or surgically refractory symptoms were enrolled in this nonplacebo trial. Baseline daily NP and sleep interruption scores (VAS 0-10) were tabulated. A distal median nerve latency was performed at baseline and at end of trial. A portable device (Palm Mag) was given to each patient to take home and apply daily for 1 h. This device generates a minimum to maximum sweep of 8-23 Hz at the target area. There is a maximum sweep of 1400 rotations/s. Daily VAS scores were maintained and statistical analyses (two-tailed t-test) were performed. Twenty-nine hands (19 subjects) completed this 2-week study with 6 dropouts (4 subjects). There was a significant reduction in NP scores, especially in the moderate–severe cohort, VAS 5.0-10, (P < 0.05). Sleep interruption scores were also reduced (P < 0.01). There were no changes in neurological examination or electrophysiological testing serially. There were no safety issues. Despite absence of placebo controls, these novel preliminary pilot data demonstrating short-term antinociceptive benefit suggest the feasibility of future trials using randomized, placebo-controlled design. If biologically positive, it would suggest that time-varying magnetic fields targeting the carpal tunnel region will be a future conservative therapeutic option.

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时变双轴磁刺激治疗难治性腕管综合征:一种新方法。一项初步研究
进行了一项初步研究,以确定在腕管区域每天累计暴露1小时的便携式双轴脉冲磁场刺激器2周是否可以减少神经性疼痛评分和影响睡眠中断,并可能作为一种替代保守治疗选择。晚期腕管综合征(CTS)患者通常保守治疗失败,留下难治性麻木、刺痛和灼痛伴残疾。先前,我们证明了与安慰剂相比,在手腕上持续应用静态永磁体1个月可以减少神经性疼痛(NP),改善正中神经的运动远端潜伏期。由于脉冲时变磁场能够诱导生物组织内的变化,影响信号转导并减少肌肉骨骼疼痛,我们假设腕管内的伤害感觉纤维可能在神经元水平上受到影响。35只有内科和/或手术难治性症状的手(23名受试者)被纳入这项非安慰剂试验。将基线每日NP和睡眠中断评分(VAS 0-10)制成表格。在基线和试验结束时进行远端正中神经潜伏期。给每位患者一个便携式设备(Palm Mag)带回家,每天使用1小时。该设备在目标区域产生最小到最大8-23 Hz的扫描。最大扫描速度为1400转/秒。维持每日VAS评分并进行统计学分析(双尾t检验)。29只手(19名受试者)完成了为期2周的研究,6名受试者(4名受试者)退出。NP评分显著降低,特别是在中重度队列,VAS 5.0-10, (P <0.05)。睡眠中断评分也有所降低(P <0.01)。神经学检查和电生理检查均无明显变化。没有安全问题。尽管缺乏安慰剂对照,这些新颖的初步试验数据显示短期抗痛觉获益,表明未来试验采用随机、安慰剂对照设计的可行性。如果生物学阳性,则表明针对腕管区域的时变磁场将是未来的保守治疗选择。
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