The Alternative Effects of Electroacupuncture in the Treatment of Trigeminal Neuralgia

Summary

Trigeminal neuralgia (TN), characterized by its refractory nature and recurrence, frequently leads to anxiety, depression, and insomnia, thereby significantly diminishing patients' quality of life and potentially inducing self-harm. Carbamazepine (CBZ) is the first-line medication for TN, yet it presents adverse effects such as addiction and the absence of analgesic effects upon cessation. Acupuncture, particularly electroacupuncture（EA）, has demonstrated efficacy in TN treatment, although its therapeutic outcomes are influenced by various factors. Consequently, this study aims to evaluate the clinical efficacy of EA for TN and its potential as an alternative to CBZ treatment.

Conditions

• Trigeminal Neuralgia

Interventions

DRUG

Carbarmazepine

Following enrollment, the patient's carbamazepine dosage remained consistent with the pre-enrollment dosage. Orally administered for two consecutive weeks.

PROCEDURE

Sham Electroacupuncture

In this group, superficial needling (0.5-1 mm depth) was performed at non-meridian points located 1 cm lateral to: (1) primary local acupoints ST2 (Sibai), ST7 (Xiaguan), and ST4 (Dicang) on the affected side; (2) branch-specific supplementary points GB1 (Tongziliao) for ophthalmic branch involvement, SI18 (Quanliao) for maxillary branch involvement, and ST6 (Jiache) for mandibular branch involvement; and (3) bilateral distal points LI4 (Hegu) and TE5 (Waiguan). Local acupoint pairs (ST7 adjacent + GB1 adjacent, ST7 adjacent + SI18 adjacent, or ST7 adjacent + ST6 adjacent) and distal pairs (LI4 adjacent + TE5 adjacent) were connected to an electroacupuncture device. The electroacupuncture device was kept in the off state and did not generate any therapeutic current. The needles were retained for 60 minutes.Acupuncture treatment was administered for 5 consecutive days as one course, with a 2-day break between courses. A total of 2 courses were conducted.

DRUG

Carbarmazepine Placebo

CBZ placebo is a tablet with identical packaging and appearance to CBZ but lacks therapeutic effects. Patients were transitioned to a CBZ placebo at an equivalent daily dose post-enrollment. Orally administered for two consecutive weeks.

PROCEDURE

Electroacupuncture

The primary acupoints selected were the affected side's Sibai (ST2), Xiaguan (ST7), and Dicang (ST4). Based on the affected nerve branch, additional acupoints were chosen: for the ophthalmic branch, Tongziliao (GB1); for the maxillary branch, Quanliao (SI18); and for the mandibular branch, Jiache (ST6). Distal acupoints included bilateral Hegu (LI4) and Waiguan (SJ5). Electroacupuncture was applied based on the affected nerve branch. For the ophthalmic branch, the local acupoints selected were Xiaguan + Tongziliao; for the maxillary branch, Xiaguan + Quanliao; and for the mandibular branch, Xiaguan + Jiache. The distal acupoints selected were Hegu + Waiguan. A sparse-dense wave, 2/100Hz, was used, with a treatment duration of 60 minutes. The intensity of the electrical current was adjusted according to the patient's tolerance. Acupuncture treatment is administered in 5 consecutive days as one course, with a 2-day break between courses. A total of 2 courses are conducted.

Sponsors & Collaborators

• Pingyang County Traditional Chinese Medicine Hospital

  collaborator UNKNOWN

• Jiaxing Traditional Chinese Medicine Hospital

  collaborator UNKNOWN

• Yuanyuan Wu

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-03-01

Primary Completion

2028-12-31

Completion

2028-12-31