NCT06977932

The Alternative Effects of Electroacupuncture in the Treatment of Trigeminal Neuralgia

The Alternative Effects of Electroacupuncture in the Treatment of Trigeminal Neuralgia: Protocol for a Multicentre Randomised Controlled Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 126 (estimated)
• Sponsor: Yuanyuan Wu · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study will enroll a total of 126 patients with TN who meet the inclusion criteria. Participants will be randomized in a 1:1 ratio to either the EA plus placebo group or the sham EA plus CBZ group. This study aims to investigate the clinical efficacy of EA for TN and to determine if EA offers a viable therapeutic alternative for TN management.

Conditions

• Trigeminal Neuralgia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-03-01
• Primary completion: 2028-12-31
• Completion: 2028-12-31
• First posted: 2025-05-18
• Last updated: 2026-03-05