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The Synergism and Attenuation Effects of Electroacupuncture in the Treatment of Trigeminal Neuralgia
Sponsor: Yuanyuan Wu
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. This multicenter, randomized controlled trial aims to evaluate the synergistic efficacy-enhancing and toxicity-reducing effects of the optimized protocol when combined with carbamazepine (CBZ) in treating trigeminal neuralgia (TN), thereby proposing novel therapeutic refinements for electroacupuncture treatment regimens in TN management.
Official title: The Synergism and Attenuation Effects of Electroacupuncture in the Treatment of Trigeminal Neuralgia：Protocol for a Multicentre Pilot Randomised Controlled Trial
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
28
Start Date
2025-07-20
Completion Date
2025-12-31
Last Updated
2025-07-20
Healthy Volunteers
No
Conditions
Interventions
CBZ placebo
Patients received oral administration of one 100 mg placebo tablet three times daily (TID) after meals for four consecutive weeks.
CBZ
In the EA + CBZ + placebo group, patients received oral carbamazepine (CBZ) at a dosage of 100 mg per tablet three times daily (TID) after meals for 4 consecutive weeks. In the sham EA + CBZ group, patients were administered oral CBZ at 200 mg per dose TID after meals for the same 4-week duration.
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 was administered 3 times per week (with 1-2-day intervals between sessions) for 4 consecutive weeks, totaling 12 sessions.
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 or ST7 adjacent +SI18 adjacent or ST7 adjacent +ST6 adjacent) and distal pairs (LI4 adjacent +TE5 adjacent) were connected to a modified electroacupuncture device with severed output wires (preventing current flow while maintaining indicator function), followed by 60-minute needle retention after parameter adjustment. Acupuncture was administered 3 times per week (with 1-2-day intervals between sessions) for 4 consecutive weeks, totaling 12 sessions.