BACKGROUND: This study aimed to assess the effectiveness and safety of percutaneous electrical nerve stimulation (PENS) in migraine treatment. METHODS: Sixty-two patients with at least 2 migration attacks each month were recruited and randomly divided into a verum PENS group and a sham PENS group in a ratio of 1:1. All patients received verum or sham PENS 30 minutes daily, 5 times weekly for 12 weeks. The primary outcomes were change in monthly migraine days (MMD) and the 50% responder rate (RR). Secondary outcomes were evaluated using the monthly migraine attacks (MMA), monthly headache days (MHD), and monthly acute antimigraine drug intake (MAADI). All outcome measurements were performed at treatment initiation to establish a baseline and again after 12 weeks of treatment. RESULTS: At the end of the 12 weeks, the group receiving verum PENS exhibited statistically significant decrease in the mean MMD compared with the group receiving sham PENS intervention (p < 0.05). Additionally, the 50% RR was significantly higher in the verum PENS group than that in the sham PENS group (p < 0.05). Furthermore, the MMA, MHD, and MAADI were also significantly lower in the verum PENS group that those in the sham PENS group (p < 0.05). CONCLUSION: The results of this study demonstrated that verum PENS is more effective and safe than Sham PENS for the treatment of migraine.

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