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无痛远程电刺激可缓解发作性偏头痛疼痛。

Nonpainful remote electrical stimulation alleviates episodic migraine pain.

作者信息

Yarnitsky David, Volokh Lana, Ironi Alon, Weller Boaz, Shor Merav, Shifrin Alla, Granovsky Yelena

机构信息

From Rambam Healthcare Campus and Technion Faculty of Medicine (D.Y., M.S., A.S., Y.G.), Haifa; Theranica Ltd. (L.V., A.I.), Netanya; and Bnei Zion Medical Center (B.W.), Haifa, Israel.

出版信息

Neurology. 2017 Mar 28;88(13):1250-1255. doi: 10.1212/WNL.0000000000003760. Epub 2017 Mar 1.

Abstract

OBJECTIVE

To evaluate the efficacy of remote nonpainful electrical upper arm skin stimulation in reducing migraine attack pain.

METHODS

This is a prospective, double-blinded, randomized, crossover, sham-controlled trial. Migraineurs applied skin electrodes to the upper arm soon after attack onset for 20 minutes, at various pulse widths, and refrained from medications for 2 hours. Patients were asked to use the device for up to 20 attacks.

RESULTS

In 71 patients (299 treatments) with evaluable data, 50% pain reduction was obtained for 64% of participants based on best of 200-μs, 150-μs, and 100-μs pulse width stimuli per individual vs 26% for sham stimuli. Greater pain reduction was found for active stimulation vs placebo; for those starting at severe or moderate pain, reduction (1) to mild or no pain occurred in 58% (25/43) of participants (66/134 treatments) for the 200-μs stimulation protocol and 24% (4/17; 8/29 treatments) for placebo ( = 0.02), and (2) to no pain occurred in 30% (13/43) of participants (37/134 treatments) and 6% (1/17; 5/29 treatments), respectively ( = 0.004). Earlier application of the treatment, within 20 minutes of attack onset, yielded better results: 46.7% pain reduction as opposed to 24.9% reduction when started later ( = 0.02).

CONCLUSION

Nonpainful remote skin stimulation can significantly reduce migraine pain, especially when applied early in an attack. This is presumably by activating descending inhibition pathways via the conditioned pain modulation effect. This treatment may be proposed as an attractive nonpharmacologic, easy to use, adverse event free, and inexpensive tool to reduce migraine pain.

CLINICALTRIALSGOV IDENTIFIER

NCT02453399.

CLASSIFICATION OF EVIDENCE

This study provides Class III evidence that for patients with an acute migraine headache, remote nonpainful electrical stimulation on the upper arm skin reduces migraine pain.

摘要

目的

评估上臂皮肤远程无痛电刺激在减轻偏头痛发作疼痛方面的疗效。

方法

这是一项前瞻性、双盲、随机、交叉、假对照试验。偏头痛患者在发作开始后不久将皮肤电极置于上臂,持续20分钟,采用不同的脉冲宽度,且在2小时内不服用药物。患者被要求使用该设备进行多达20次发作的治疗。

结果

在71例(299次治疗)有可评估数据的患者中,基于每个个体200微秒、150微秒和100微秒脉冲宽度刺激中的最佳刺激,64%的参与者疼痛减轻了50%,而假刺激组为26%。与安慰剂相比,主动刺激能使疼痛减轻得更多;对于开始时为重度或中度疼痛的患者,在200微秒刺激方案中,58%(25/43)的参与者(66/134次治疗)疼痛减轻至轻度或无痛,安慰剂组为24%(4/1;8/29次治疗)(P = 0.02),且(2)分别有30%(13/43)的参与者(37/134次治疗)和6%(1/17;5/29次治疗)疼痛减轻至无痛(P = 0.004)。在发作开始后20分钟内更早应用该治疗,效果更好:疼痛减轻46.7%,而稍后开始治疗时疼痛减轻24.9%(P = 0.02)。

结论

无痛远程皮肤刺激可显著减轻偏头痛疼痛,尤其是在发作早期应用时。这可能是通过条件性疼痛调制效应激活下行抑制通路实现的。这种治疗方法可作为一种有吸引力的非药物、易于使用、无不良事件且廉价的减轻偏头痛疼痛的工具。

临床试验注册号

NCT02453399。

证据分级

本研究提供了III级证据,即对于急性偏头痛头痛患者,上臂皮肤远程无痛电刺激可减轻偏头痛疼痛。

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