The Alternative Effects of Electroacupuncture in the Treatment of Trigeminal Neuralgia

NCT06977932 | Not Yet Recruiting

• 1 other identifier: GZY-KJS-ZJ-2025-006-ALT
• Study Type: interventional
• Target: 126
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Trigeminal Neuralgia

Keywords

Electroacupuncture; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• VAS Response Rate

  The proportion of patients with a reduction in VAS score of ≥50% from baseline at the end of the 2-week treatment.The VAS measures pain intensity on a scale from 0 to 10, where higher scores indicate worse pain. The unit of measure is "Percentage of participants".

  Baseline, the end of the 2-week treatment.

Secondary Outcomes (10)

• Changes in Visual Analog Scale (VAS) scores

  At baseline, and at the end of weeks 2, 4, and 8.

• Total Days of Rescue Medication Use Assessed by Pain Diary

  Daily from baseline through the end of week 8.

• Average Daily Frequency of Pain Episodes Assessed by Pain Diary

  Daily from baseline through the end of week 8.

• Average Daily Pain Intensity Assessed by Pain Diary

  Daily from baseline through the end of week 8.

• Highest Daily Pain Intensity Assessed by Pain Diary

  Daily from baseline through the end of week 8.

Other Outcomes (3)

• Plasma Concentration of Serotonin (5-HT)

  At baseline, and at the end of weeks 2

• Plasma Concentration of Interleukin-6 (IL-6)

  At baseline, and at the end of weeks 2.

• Incidence of Treatment-Related Adverse Events (AEs)

  Baseline up to Week 8

Study Arms (2)

sham EA +CBZ group

SHAM COMPARATOR

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

Drug: Carbarmazepine; Procedure: Sham Electroacupuncture

EA+placebo group

EXPERIMENTAL

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.

Drug: Carbarmazepine Placebo; Procedure: Electroacupuncture

Interventions

Carbarmazepine DRUG

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

sham EA +CBZ group

Sham Electroacupuncture 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.

sham EA +CBZ group

Carbarmazepine Placebo 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.

EA+placebo group

Electroacupuncture 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.

EA+placebo group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yuanyuan Wu: lead
• Pingyang County Traditional Chinese Medicine Hospital: collaborator
• Jiaxing Traditional Chinese Medicine Hospital: collaborator

MeSH Terms

Conditions

Trigeminal Neuralgia

Interventions

Electroacupuncture

Condition Hierarchy (Ancestors)

Trigeminal Nerve Diseases; Facial Neuralgia; Facial Nerve Diseases; Mouth Diseases; Stomatognathic Diseases; Cranial Nerve Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia

Central Study Contacts

Nisang Chen

CONTACT

+8615990031347; 237247256@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 11, 2025
• First Posted: May 18, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: March 5, 2026

Record last verified: 2026-02