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.

INTRODUCTION

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.

METHODS AND ANALYSIS

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.

CONCLUSION

This study will preliminarily evaluate the efficacy and safety of electroacupuncture (EA) in the treatment of patients with postherpetic neuralgia (PHN).

ETHICS AND DISSEMINATION

Ethical approval for this trial has been obtained from the Institutional Ethics Review Board of the Third Affiliated Hospital of Zhejiang Chinese Medical University (No. ZSLL-KY-2023-029-01) and Zhejiang Hospital (No. 2024-030-K). Before enrollment, participants will be required to sign a form of informed consent.

CLINICAL TRIAL REGISTRATION

Identifier NCT06420778, https://clinicaltrials.gov/study/NCT06420778.