The Efficacy of Electroacupuncture for Postherpetic Neuralgia Arising from Herpes Zoster Affecting the cephalo-facial Area： Study Protocol for a Double center Randomized Controlled Trial

Pengfei Qiu¹Haiju Sun²Yunfan Xia³Siying Qu³Jianqiao Fang^4*Xiaoyu Li^4*

• ¹Zhejiang Hospital, Hangzhou, China
• ²First Affiliated Hospital, Zhejiang Chinese Medical University, Hangzhou, Zhejiang Province, China
• ³Third Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, Zhejiang Province, China
• ⁴Department of Neurobiology and Acupuncture Research, The Third Clinical Medical College, Zhejiang Chinese Medical University, Hangzhou, Jiangsu Province, China

Postherpetic Neuralgia (PHN) constitutes a severe sequelae following herpes zoster (HZ) Infection, and one of the most problematic issues is the treatment of cephalo-facial PHN in patients over 50 years of age, which severely affects the patient's work mood, sleep and activities of daily living. The efficacy of conventional treatments for PHN remains unsatisfactory.Therefore, there is an urgent need for alternative approaches to explore simpler, more convenient, effective, and inexpensive treatment options in the clinical treatment of PHN. This trial aims to thoroughly evaluate the effectiveness and safety of EA as a therapeutic modality for individuals suffering from cephalo-facial PHN.The protocol outlines a double-center, randomized, and controlled trial design where both patients and assessors are blinded to the intervention being administered. The duration of the trial's therapeutic intervention will span 4 weeks, followed by a 2-month observation period for monitoring any subsequent effects or outcomes. The 124 qualified individuals will be randomly allocated in a balanced 1:1 ratio to either the EA group or the drug group. All variables will undergo evaluation at the start of the study (week 0, baseline), during the treatment period at weeks 2 and 4, and during the follow-up period at weeks 8 and 12. The primary outcome is the Visual Analog Scale (VAS). Secondary outcomes include the Brief pain inventory-Facial scale (BPI-Facial), Pittsburgh Sleep Quality Index Scale (PSQI), Self-rating depression scale (SDS), Hamilton depression scale (HAMD), and Quality of Life Rating Scale (SF-36). The occurrence of any adverse reactions will be monitored and assessed throughout the duration of the trial.This study will preliminarily evaluate the efficacy and safety of electroacupuncture (EA) in the treatment of patients with postherpetic neuralgia (PHN).The clinical trial protocol has been officially registered with the Clinical Trials Registry, assigned with a unique identification number: NCT06420778.