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.