Supplementary Material for: Efficacy of Electroacupuncture Combined with Pregabalin in the Treatment of Trigeminal Herpetic Neuralgia: a Multicenter Randomized Controlled Trial Study Protocol

Abstract
Background: Trigeminal herpetic neuralgia, a common type of Zoster-associated Pain (ZAP), affects individuals across all ages groups and poses a significant societal burden all over the world. Electroacupuncture (EA) is increasingly used in the treatment of ZAP due to its affordability, high safety profile, absence of adverse reactions, and high patient acceptance. Consequently, it is essential to conduct randomized controlled trials to evaluate the efficacy and safety of EA in treating ZAP and to determine if EA can be used as an alternative to pregabalin.
Patients and Methods: A total of 102 patients with trigeminal herpetic neuralgia will be enrolled from 2 hospitals and randomly assigned to the EA group, pregabalin group, or EA + pregabalin group in a 1:1:1 ratio using a simple random number table. The study will consist of a 4-week treatment period followed by a 4-week follow-up period. The primary outcome measure will be pain intensity, while secondary outcomes will include mood state, sleep quality, and quality of life. Adverse reactions will be thoroughly evaluated.
Conclusion: This study aims to elucidate the clinical efficacy of EA combined with pregabalin for trigeminal herpetic neuralgia and to objectively compare the efficacy and safety of EA versus oral pregabalin in the treatment of trigeminal herpetic neuralgia.
Ethics and Dissemination: Ethical approval has been obtained from the Ethics Committee of Hangzhou Third People's Hospital (No.2023KA010). Informed consent will be obtained from all participants prior to enrollment. The trial results will be published in international journals and presented at relevant international conferences.
Trial Registration Number: This protocol has been registered in the China Clinical Trial Registration Center with the identification code NCT06261801.

摘要：
背景：三叉神经疱疹后神经痛是带状疱疹相关性疼痛（Zoster-associated Pain，简称ZAP）的常见类型，可累及各年龄段人群，在全球范围内造成了沉重的社会负担。电针（Electroacupuncture，简称EA）因价格低廉、安全性优异、无不良反应且患者接受度高，在ZAP的治疗中应用愈发广泛。因此，开展随机对照试验以评估电针治疗ZAP的疗效与安全性，并明确电针能否作为普瑞巴林（pregabalin）的替代治疗方案，具有重要的临床意义。
患者与方法：本研究将从2家医院招募共102例三叉神经疱疹后神经痛患者，采用简单随机数字表法，按照1:1:1的比例将受试者随机分配至电针组、普瑞巴林组及电针联合普瑞巴林组。研究周期包含4周治疗期与4周随访期。本研究的主要结局指标为疼痛强度，次要结局指标包括情绪状态、睡眠质量及生活质量，并将对不良反应进行全面评估。
结论：本研究旨在阐明电针联合普瑞巴林治疗三叉神经疱疹后神经痛的临床疗效，并客观比较电针与口服普瑞巴林治疗三叉神经疱疹后神经痛的疗效及安全性。
伦理与传播：本研究已获得杭州市第三人民医院伦理委员会批准（编号：2023KA010）。所有受试者在入组前均需签署知情同意书。试验结果将发表于国际期刊，并在相关国际学术会议上进行汇报。
试验注册号：本研究方案已在中国临床试验注册中心完成注册，识别编号为NCT06261801。