Allegheny Health Network, Pittsburgh, PA, USA.
Theranica Bio-Electronics, Netanya, Israel.
Adv Ther. 2024 Jan;41(1):170-181. doi: 10.1007/s12325-023-02697-6. Epub 2023 Oct 19.
Migraine is a chronic neurological disorder causing severe pain and disability in more than a billion people worldwide. Ideal treatment should provide long-term efficacy with minimal side effects. Previous studies indicate that remote electrical neuromodulation (REN) is an efficacious and safe treatment option for the acute treatment of migraine in clinical practice. This study examined long-term safety, utilization, and efficacy of REN during 12 consecutive usage months.
Data from patients with migraine across the USA using REN to treat their migraine attacks were electronically collected from the Nerivio device. All patients who used REN during 12 consecutive months were included, and data were compared across months. Safety was assessed by the number and type of adverse events. Utilization was measured by the number of monthly treatments. Efficacy was evaluated as consistent change in headache pain intensity, functional disability, and disappearance of associated symptoms from baseline to 2 h post treatment.
Data were analyzed from 409 people living with migraine who treated with REN for 12 consecutive months, performing a total of 39,531 treatments. The incidence of device-related adverse events (dAEs) was 1.96% (8/409), including two negligible (0.49%), five mild (1.22%), one moderate (0.24%), and no severe events. All patients continued treatment with REN despite dAEs. One-year average monthly utilization was 8.05 treatments (SD 1.15). Month-to-month utilization did not change during 12 months of consecutive use [F(4.895, 1997.204) = 2.014, p = 0.075, repeated-measures ANOVA]. One-year average efficacy showed 74.1% of users reported consistent 2-h pain relief, and 26.0% reported consistent pain freedom. Month-to-month pain relief and pain freedom did not change during 12 months of consecutive use [F(11, 1069) = 0.55, p = 0.873 and F(11, 1295) = 0.69, p = 0.750 respectively; generalized linear mixed model analysis].
REN is a safe and well-tolerated acute migraine treatment, with stable efficacy and utilization over 1 year, making it an advantageous non-drug option for the long-term management of this chronic disease.
NCT05760638.
偏头痛是一种慢性神经系统疾病，全球有超过 10 亿人因此而遭受严重疼痛和残疾。理想的治疗方法应具有长期疗效，且副作用最小。先前的研究表明，远程电神经调节（REN）是一种有效的、安全的治疗选择，可用于临床实践中的偏头痛急性治疗。本研究考察了 REN 在连续 12 个月使用期间的长期安全性、使用情况和疗效。
从美国使用 REN 治疗偏头痛的患者中收集电子数据，患者的偏头痛发作使用 REN 治疗。纳入所有在连续 12 个月内使用 REN 的患者，并逐月比较数据。通过不良反应的数量和类型评估安全性。通过每月治疗次数来衡量使用情况。疗效评估为从基线到治疗后 2 小时头痛疼痛强度、功能障碍和相关症状消失的一致变化。
对 409 名连续使用 REN 治疗 12 个月的偏头痛患者的数据进行了分析，共进行了 39531 次治疗。设备相关不良事件（dAE）的发生率为 1.96%（8/409），包括 2 例轻微（0.49%）、5 例轻度（1.22%）、1 例中度（0.24%）和无严重事件。尽管发生了 dAE，所有患者仍继续接受 REN 治疗。一年平均每月使用率为 8.05 次（SD 1.15）。在连续 12 个月的使用中，每月的使用率没有变化[F(4.895, 1997.204) = 2.014, p = 0.075，重复测量方差分析]。一年的平均疗效显示，74.1%的使用者报告 2 小时持续疼痛缓解，26.0%报告持续无疼痛。在连续 12 个月的使用中，每月的疼痛缓解和疼痛缓解没有变化[F(11, 1069) = 0.55, p = 0.873 和 F(11, 1295) = 0.69, p = 0.750；广义线性混合模型分析]。
REN 是一种安全且耐受性良好的急性偏头痛治疗方法，1 年内疗效和使用率稳定，是治疗这种慢性疾病的一种有利的非药物选择。
NCT05760638。
