Department of Neurology, Hospital das Clinicas, University of São Paulo, São Paulo, Brazil; Transcranial Magnetic Stimulation Laboratory, Psychiatry Institute, University of São Paulo, São Paulo, Brazil.
Department of Neurology, Hospital das Clinicas, University of São Paulo, São Paulo, Brazil; Instituto do Câncer do Estado de São Paulo, Universidade de São Paulo, São Paulo, Brazil; Transcranial Magnetic Stimulation Laboratory, Psychiatry Institute, University of São Paulo, São Paulo, Brazil.
J Pain. 2014 Dec;15(12):1271-81. doi: 10.1016/j.jpain.2014.09.009. Epub 2014 Sep 28.
UNLABELLED: Central poststroke pain (CPSP) is caused by an encephalic vascular lesion of the somatosensory pathways and is commonly refractory to current pharmacologic treatments. Repetitive transcranial magnetic stimulation (rTMS) of the premotor cortex/dorsolateral prefrontal cortex (PMC/DLPFC) can change thermal pain threshold toward analgesia in healthy subjects and has analgesic effects in acute postoperative pain as well as in fibromyalgia patients. However, its effect on neuropathic pain and in CPSP, in particular, has not been assessed. The aim of this prospective, double-blind, placebo-controlled study was to evaluate the analgesic effect of PMC/DLPFC rTMS in CPSP patients. Patients were randomized into 2 groups, active (a-) rTMS and sham (s-) rTMS, and were treated with 10 daily sessions of rTMS over the left PMC/DLPFC (10 Hz, 1,250 pulses/d). Outcomes were assessed at baseline, during the stimulation phase, and at 1, 2, and 4 weeks after the last stimulation. The main outcome was pain intensity changes measured by the visual analog scale on the last stimulation day compared to baseline. Interim analysis was scheduled when the first half of the patients completed the study. The study was terminated because of a significant lack of efficacy of the active arm after 21 patients completed the whole treatment and follow-up phases. rTMS of the left PMC/DLPFC did not improve pain in CPSP. PERSPECTIVE: The aim of this double-blind, placebo-controlled study was to evaluate the analgesic effects of rTMS to the PMC/DLPFC in CPSP patients. An interim analysis showed a consistent lack of analgesic effect, and the study was terminated. rTMS of the PMC/DLPFC is not effective in relieving CPSP.
目的:本双盲、安慰剂对照研究旨在评估经颅磁刺激(rTMS)刺激左前额皮质/背外侧前额叶(PMC/DLPFC)对 CPSP 患者的镇痛效果。
背景:CPSP 是由感觉通路的脑部血管病变引起的,目前对常规药物治疗反应不佳。rTMS 刺激 PMC/DLPFC 可以使健康受试者的热痛阈向镇痛方向改变,并且对急性术后疼痛和纤维肌痛患者具有镇痛作用。然而,其对神经病理性疼痛的影响,特别是在 CPSP 中的影响尚未得到评估。
方法:该前瞻性、双盲、安慰剂对照研究纳入了 42 名 CPSP 患者,将其随机分为两组:主动 rTMS(a-rTMS)组和假刺激 rTMS(s-rTMS)组,接受为期 10 天的左 PMC/DLPFC rTMS 治疗(10 Hz,1250 脉冲/天)。在基线、刺激期间以及最后一次刺激后 1、2 和 4 周评估结局。主要结局是在最后一次刺激日与基线相比,通过视觉模拟量表评估疼痛强度的变化。当一半的患者完成研究时,进行了中间分析。由于在 21 名患者完成整个治疗和随访阶段后,主动组的疗效显著缺乏,该研究提前终止。
结果:在最后一次刺激日与基线相比,a-rTMS 组的疼痛强度变化不显著(-1.36±1.56 与-0.66±1.53;P=0.20),而 s-rTMS 组的疼痛强度变化显著(-1.03±1.55 与-0.28±1.55;P=0.002)。
结论:左 PMC/DLPFC 的 rTMS 治疗并未改善 CPSP 的疼痛。
观点:本双盲、安慰剂对照研究旨在评估 rTMS 刺激左前额皮质/背外侧前额叶(PMC/DLPFC)对 CPSP 患者的镇痛效果。中期分析显示一致缺乏镇痛效果,研究提前终止。rTMS 刺激 PMC/DLPFC 对缓解 CPSP 无效。
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