The Alternative Effects of Electroacupuncture in the Treatment of Trigeminal Neuralgia

NCT ID: NCT06977932

Last Updated: 2026-01-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-20
• Study Completion Date: 2028-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

sham EA +CBZ group

A cohort of 63 patients with TN will undergo treatment with CBZ in conjunction with a sham EA intervention.

Group Type: SHAM_COMPARATOR

Carbarmazepine

Intervention Type: DRUG

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

Sham Electroacupuncture

Intervention Type: PROCEDURE

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.

EA+placebo group

A cohort of 63 patients diagnosed with TN will undergo treatment involving a combination of placebo and EA. The EA procedures will be administered by licensed acupuncturists who have received standardized training.

Group Type: EXPERIMENTAL

Carbarmazepine Placebo

Intervention Type: DRUG

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.

Electroacupuncture

Intervention Type: PROCEDURE

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.

Interventions

Carbarmazepine

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

Intervention Type: DRUG

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.

Intervention Type: PROCEDURE

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.

Intervention Type: DRUG

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

All of the following criteria had to be met for study enrollment:

• fulfillment of the TN diagnostic criteria as stated above;

• age between 18 and 80 years, inclusive, irrespective of sex;

• receiving a stable daily dose of carbamazepine (200-400 mg); ④ consciousness clear, with intact pain perception and discrimination, and able to communicate effectively; ⑤ voluntary participation with written informed consent provided by the patient or their legal guardian/authorized representative.

Exclusion Criteria

Participants were excluded if they met any of the following:

• comorbid epilepsy, head injury, or other relevant neurological disorders;

• significant impairment of cardiac, hepatic, or renal function;

• cognitive dysfunction, aphasia, psychiatric conditions, or inability to cooperate with treatment;

• poorly controlled hypertension or hyperglycemia;

⑤ recent diagnosis of severe anxiety or depression;

⑥ pregnancy or lactation;

⑦ presence of a cardiac pacemaker or other contraindications to electroacupuncture therapy;

⑧ current participation in another clinical trial.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pingyang County Traditional Chinese Medicine Hospital

UNKNOWN

Sponsor Role: collaborator

Jiaxing Traditional Chinese Medicine Hospital

UNKNOWN

Sponsor Role: collaborator

Yuanyuan Wu

OTHER

Sponsor Role: lead

Responsible Party

Yuanyuan Wu

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Central Contacts

Nisang Chen

Role: CONTACT

237247256@qq.com

+8615990031347

Other Identifiers

GZY-KJS-ZJ-2025-006-ALT

Identifier Type: -

Identifier Source: org_study_id