Efficacy of Electroacupuncture Combined With Pregabalin in the Treatment of Trigeminal Herpetic Neuralgia: a Multicenter Randomized Controlled Trial Study Protocol

The Third People's Hospital of Hangzhou102 enrolled

Overview

Trigeminal herpetic neuralgia is a common type of Zoster-associated Pain (ZAP), which troubles individuals in all ages and burdens society all over the world. Eleactroaupuncture (EA) is increasingly used in the treatment of ZAP due to its advantages such as low price, high safety, no adverse reactions, and high patient acceptance. Therefore, it is necessary to conduct randomized controlled trials to evaluate the effectiveness and safety of EA on ZAP and whether EA can be used as a substitute for pregabalin.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

102

Conditions

Trigeminal Herpetic Neuralgia

Interventions

EA GroupOTHER

Acupoints selection: Ashi acupoint, Sibai acupoint (ST2), Xiaguan acupoint (ST7), and Dicang acupoint (ST4) on the affected side. Acupoints for the diseased branches (all taken from the affected side): eye branch and Tongziliao point (GB1), the maxillary branch is taken from the Quanliao point (SI18), and the mandibular branch is taken from the Jiache point (ST6).Shenting point (DU24), Baihui point (DU20), Hegu point (LI4), Waiguan point (TE5), Yanglingquan point (GB34), and Taichong point (LR3) on the affected side Operation: The EA apparatus will be applied on the Ashi point and (LI4 - TE5). The treatment will last for 30 minutes and the electrical stimulation will be set as 2/100Hz in frequency.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. meet the aforementioned diagnostic criteria for trigeminal ZAP, with a disease duration of 1 to 3 months; 2. have a visual analog scale (VAS) score of 4 points ≤ VAS ≤ 7 points; 3. be between 18 and 85 years old, regardless of gender; 4. have clear consciousness, the ability to distinguish pain, and complete basic communication; 5. voluntarily participate in the study, sign a written informed consent form, and fully understand the plan. Exclusion Criteria: 1. do not meet the above-mentioned inclusion criteria; 2. have concomitant herpes zoster on the trunk or extremities, or other special types of herpes zoster like meningeal herpes zoster or visceral herpes zoster; 3. are pregnant or lactating patients; 4. are allergic to pregabalin or acupuncture stimulation; 5. have severe organ damage, cognitive dysfunction, mental disorder, aphasia, or other serious diseases that hinder cooperation with treatment; 6. have severe skin diseases; 7. have a pacemaker; 8. have been or are currently participating in other clinical studies within the past 3 months.

Outcomes

Primary Outcomes

Visual Analog Score change

Intensity of pain range (lately 3 days' average): 0 =no pain to 10 =worst possible pain. Higher score indicating severe pain.