基于家庭的经颅直流电刺激对纤维肌痛患者背外侧前额叶的大治疗效应:概念验证的 sham 随机临床试验。

Large Treatment Effect With Extended Home-Based Transcranial Direct Current Stimulation Over Dorsolateral Prefrontal Cortex in Fibromyalgia: A Proof of Concept Sham-Randomized Clinical Study.

机构信息

Post-Graduate Program in Medical Sciences, School of Medicine, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, Brazil; Laboratory of Pain and Neuromodulation at Hospital de Clínicas de Porto Alegre (HCPA), Porto Alegre, Brazil.

Laboratory of Biomedical Engineering at HCPA, Porto Alegre, Brazil.

出版信息

J Pain. 2020 Jan-Feb;21(1-2):212-224. doi: 10.1016/j.jpain.2019.06.013. Epub 2019 Jul 26.

Abstract

This randomized, double-blind controlled trial tested the hypothesis that 60 sessions of home-based anodal (a)-transcranial direct current stimulation (tDCS) over dorsolateral prefrontal cortex (DLPFC) would be better than home-based sham-tDCS to improve the widespread pain and the disability-related to pain. The anodal-tDCS (2 mA for 30 minutes) over the left DLPFC was self-administered with a specially developed device following in-person training. Twenty women, 18 to 65 years old were randomized into 2 groups [active-(a)-tDCS (n = 10) or sham-(s)-tDCS (n = 10)]. Post hoc analysis revealed that after the first 20 sessions of a-tDCS, the cumulative pain scores reduced by 45.65% [7.25 (1.43) vs 3.94 (1.14), active vs sham tDCS, respectively]. After 60 sessions, during the 12-week assessment, pain scores reduced by 62.06% in the actively group [visual analogue scale reduction, 7.25 (1.43) to 2.75 (.85)] compared to 24.92% in the s-tDCS group, [mean (SD) 7.10 (1.81) vs 5.33 (.90)], respectively. It reduced the risk for analgesic use in 55%. Higher serum levels of the brain-derived neurotrophic factor predicted higher decreases on the pain scores across of treatment. PERSPECTIVE: These findings bring 3 important insights: 1) show that an extended period of treatment (60 sessions, to date the largest number of tDCS sessions tested) for fibromyalgia induces large pain decreases (a large effect size of 1.59) and 2) support the feasibility of home-based tDCS as a method of intervention; 3) provide additional data on DLPFC target for the treatment of fibromyalgia. Finally, our findings also highlight that brain-derived neurotrophic factor to index neuroplasticity may be a valuable predictor of the tDCS effect on pain scores decreases across the treatment.

摘要

这项随机、双盲对照试验检验了以下假设,即 60 次基于家庭的阳极(a)-经颅直流电刺激(tDCS)治疗背外侧前额叶皮质(DLPFC),优于基于家庭的假 tDCS,可改善广泛性疼痛和与疼痛相关的残疾。阳极 tDCS(2 mA 持续 30 分钟)通过专门开发的设备在面对面培训后由患者自行施加于左侧 DLPFC。20 名 18 至 65 岁的女性被随机分为 2 组[活性-a-tDCS(n=10)或假-s-tDCS(n=10)]。事后分析显示,在进行 20 次 a-tDCS 治疗后,累积疼痛评分降低了 45.65%[分别为 7.25(1.43)和 3.94(1.14)]。60 次治疗后,在 12 周评估期间,主动组的疼痛评分降低了 62.06%[视觉模拟评分降低,7.25(1.43)至 2.75(0.85)],而 s-tDCS 组仅降低了 24.92%[平均(SD),7.10(1.81)至 5.33(0.90)]。该治疗还降低了 55%的止痛药物使用率。较高的血清脑源性神经营养因子水平预示着治疗过程中疼痛评分的降幅更大。观点:这些发现带来了 3 个重要的见解:1)表明延长治疗时间(60 次治疗,迄今为止测试的最大 tDCS 治疗次数)可使纤维肌痛患者的疼痛明显减轻(效应大小为 1.59);2)支持家庭 tDCS 作为一种干预方法的可行性;3)为 DLPFC 靶点治疗纤维肌痛提供了额外的数据。最后,我们的发现还强调,脑源性神经营养因子可能是 tDCS 降低疼痛评分的一个有价值的预测指标。

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