Department of Neurology, Hospital Rey Juan Carlos, Universidad Rey Juan Carlos, Móstoles, Madrid, Spain.
Department of Neurology, Hospital Infanta Elena, Valdemoro, Madrid, Spain.
Pain Med. 2020 Feb 1;21(2):415-422. doi: 10.1093/pm/pnz119.
BACKGROUND AND OBJECTIVE: Successful preventive treatment in chronic migraine (CM) remains an unmet need in some cases, and new therapeutic strategies are emerging. We aimed to test the effect of noninvasive, transcutaneous supraorbital nerve stimulation (tSNS) in a group of patients with CM. PATIENTS AND METHODS: This was an open label, quasi-experimental design. Twenty-five CM patients were recruited from two hospital headache clinics. After a one-month baseline period, monthly visits were scheduled during three months. Headache occurrence, its intensity, and symptomatic medication intake were recorded through a diary kept by each patient. Both a per-protocol analysis and an intention-to-treat analysis were performed for the main outcome measures. RESULTS: Twenty-one and 24 patients were included in the per-protocol and the intention-to-treat analyses, respectively. In the per-protocol analysis, a significant four-day decrease in the mean monthly days with moderate or severe headache was observed from baseline to the end of the study (t test, P = 0.0163), and there was a nonsignificant reduction of 2.95 in the mean monthly total headache days. In the intention-to-treat analysis, a nonsignificant 3.37 reduction in the mean monthly days with moderate or severe headache was observed for the same period, and there was a significant 2.75 reduction in the mean monthly days with any headache (t test, P = 0.016). CONCLUSIONS: tSNS could hold preventive properties in the treatment of CM, but the effect may be either mild or controversial. Double blind, sham-controlled studies are essential to confirm these findings and to outline their clinical relevance in the CM therapeutic scenario.
背景与目的:在某些情况下,慢性偏头痛(CM)的成功预防治疗仍然是一个未满足的需求,新的治疗策略正在出现。我们旨在测试非侵入性经皮眶上神经刺激(tSNS)在一组 CM 患者中的效果。
患者与方法:这是一项开放标签、准实验设计。从两家医院头痛诊所招募了 25 名 CM 患者。在一个月的基线期后,每月安排一次就诊,共进行三个月。每位患者通过日记记录头痛发作、其强度和对症药物摄入情况。主要结局指标进行了意向治疗分析和方案分析。
结果:分别有 21 名和 24 名患者纳入了意向治疗分析和方案分析。在方案分析中,从基线到研究结束,平均每月中度或重度头痛天数显著减少了四天(t 检验,P=0.0163),平均每月总头痛天数减少了 2.95。在意向治疗分析中,同一时期平均每月中度或重度头痛天数减少了 3.37,而任何头痛的平均每月天数显著减少了 2.75(t 检验,P=0.016)。
结论:tSNS 在 CM 的治疗中可能具有预防作用,但效果可能轻微或存在争议。双盲、假对照研究对于证实这些发现并阐明其在 CM 治疗中的临床意义至关重要。
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