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后上岛叶深部经颅磁刺激减轻周围神经性疼痛——一项双盲、随机交叉试验性研究。

Posterior-superior insular deep transcranial magnetic stimulation alleviates peripheral neuropathic pain - A pilot double-blind, randomized cross-over study.

作者信息

Dongyang Liu, Fernandes Ana Mércia, da Cunha Pedro Henrique Martins, Tibes Raissa, Sato João, Listik Clarice, Dale Camila, Kubota Gabriel Taricani, Galhardoni Ricardo, Teixeira Manoel Jacobsen, Aparecida da Silva Valquíria, Rosi Jefferson, Ciampi de Andrade Daniel

机构信息

LIM-62, Pain Center, Department of Neurology, University of São Paulo, Av. Dr. Enéas de Carvalho Aguiar, 255, 5th Floor, P.O. Box: 05403-900, São Paulo, SP, Brazil.

LIM-62, Pain Center, Department of Neurology, University of São Paulo, Av. Dr. Enéas de Carvalho Aguiar, 255, 5th Floor, P.O. Box: 05403-900, São Paulo, SP, Brazil; Pain Center Instituto do Câncer Octavio Frias de Oliveira, University of São Paulo, Avenida Dr. Arnaldo 251, P.O. Box: 01246-000, São Paulo, SP, Brazil.

出版信息

Neurophysiol Clin. 2021 Aug;51(4):291-302. doi: 10.1016/j.neucli.2021.06.003. Epub 2021 Jun 24.

Abstract

OBJECTIVES

Peripheral neuropathic pain (pNeP) is prevalent, and current treatments, including drugs and motor cortex repetitive transcranial magnetic stimulation (rTMS) leave a substantial proportion of patients with suboptimal pain relief.

METHODS

We explored the intensity and short-term duration of the analgesic effects produced in pNeP patients by 5 days of neuronavigated deep rTMS targeting the posterior superior insula (PSI) with a double-cone coil in a sham-controlled randomized cross-over trial.

RESULTS

Thirty-one pNeP patients received induction series of five active or sham consecutive sessions of daily deep-rTMS to the PSI in a randomized sequence, with a washout period of at least 21 days between series. The primary outcome [number of responders (>50% pain intensity reduction from baseline in a numerical rating scale ranging from 0 to 10)] was significantly higher after real (58.1%) compared to sham (19.4%) stimulation (p = 0.002). The number needed to treat was 2.6, and the effect size was 0.97 [95% CI (0.6; 1.3)]. One week after the 5th stimulation day, pain scores were no longer different between groups, and no difference in neuropathic pain characteristics and interference with daily living were present. No major side effects occurred, and milder adverse events (i.e., short-lived headaches after stimulation) were reported in both groups. Blinding was effective, and analgesic effects were not affected by sequence of the stimulation series (active-first or sham-first), age, sex or pain duration of participants.

DISCUSSION

PSI deep-rTMS was safe in refractory pNeP and was able to provide significant pain intensity reduction after a five-day induction series of treatments. Post-hoc assessment of neuronavigation targeting confirmed deep-rTMS was delivered within the boundaries of the PSI in all participants.

CONCLUSION

PSI deep-rTMS provided significant pain relief during 5-day induction sessions compared to sham stimulation.

摘要

目的

外周神经性疼痛(pNeP)很常见,目前的治疗方法,包括药物治疗和运动皮层重复经颅磁刺激(rTMS),仍有相当一部分患者的疼痛缓解效果欠佳。

方法

在一项假手术对照的随机交叉试验中,我们使用双锥线圈,针对后上脑岛(PSI)进行5天的神经导航深部rTMS,探讨其对pNeP患者产生的镇痛效果的强度和短期持续时间。

结果

31例pNeP患者按随机顺序接受针对PSI的连续5次每日深部rTMS的诱导系列治疗,每次治疗为主动治疗或假手术治疗,系列治疗之间的洗脱期至少为21天。与假手术刺激(19.4%)相比,真实刺激(58.1%)后的主要结局指标[反应者数量(在0至10的数字评分量表中疼痛强度较基线降低>50%)]显著更高(p = 0.002)。治疗所需人数为2.6,效应大小为0.97 [95%置信区间(0.6;1.3)]。在第5次刺激日之后的一周,两组之间的疼痛评分不再有差异,并且在神经性疼痛特征和对日常生活的干扰方面也没有差异。未发生重大副作用,两组均报告有较轻的不良事件(即刺激后短暂头痛)。盲法有效,镇痛效果不受刺激系列顺序(主动治疗先于假手术治疗或假手术治疗先于主动治疗)、参与者年龄、性别或疼痛持续时间的影响。

讨论

PSI深部rTMS在难治性pNeP中是安全的,并且在为期5天的诱导系列治疗后能够显著降低疼痛强度。对神经导航靶点的事后评估证实,所有参与者的深部rTMS均在PSI的边界内进行。

结论

与假手术刺激相比,PSI深部rTMS在为期5天的诱导治疗期间提供了显著的疼痛缓解。

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