The Synergism and Attenuation Effects of Electroacupuncture in the Treatment of Trigeminal Neuralgia

Official title

The Synergism and Attenuation Effects of Electroacupuncture in the Treatment of Trigeminal Neuralgia：Protocol for a Multicentre Pilot Randomised Controlled Trial

Overview

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.

Interventions

• Drug CBZ placebo
  Patients received oral administration of one 100 mg placebo tablet three times daily (TID) after meals for four consecutive weeks.
• Drug 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.
• 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 X
• 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 adjacen

Primary outcome measures

• Changes in Visual Analog Scale (VAS) scores from baseline to the end of the 4th week of treatment [Time frame: Baseline, 4 weeks after treatment.]

Secondary outcome measures (6)

• Changes in Visual Analog Scale (VAS) scores [Time frame: Baseline, 2 weeks after treatment, at 4-week follow-up.]
• Pain Diary Card [Time frame: Daily from enrollment through four weeks after treatment completion]
• Carbamazepine Adverse Reactions [Time frame: Daily from enrollment through four weeks after treatment completion]
• Hepatorenal function [Time frame: Baseline, 4 weeks after treatment.]
• Changes in the The Self-Rating Anxiety Scale (SAS) [Time frame: Baseline, 2 weeks after treatment, 4 weeks after treatment, at 4-week follow-up.]
• Changes in the Self-Rating Depression Scale (SDS) [Time frame: Baseline, 2 weeks after treatment, 4 weeks after treatment, at 4-week follow-up.]

Eligibility criteria

Inclusion criteria

• Participants must meet all of the following criteria to be eligible for this study:

• Met the diagnostic criteria for trigeminal neuralgia (TN) as defined in the International Classification of Headache Disorders, 3rd edition (ICHD-3) published by the International Headache Society (IHS) in 2018.
• Between 18 and 75 years old (inclusive), regardless of gender;
• Currently prescribed carbamazepine (400-800 mg/day) or oxcarbazepine (800-1600 mg/day);
• Conscious, alert, and capable of perceiving/differentiating pain, with basic communication abilities;
• Signed informed consent form and voluntary participation in the study.

Exclusion criteria

• Patients meeting any of the following criteria were excluded:

• Patients with epilepsy, head injury, or other relevant neurological disorders;
• Patients with severe cardiac, hepatic, or renal impairment;
• Patients with cognitive dysfunction, aphasia, psychiatric disorders, or those unable to cooperate with treatment;
• Patients with poorly controlled hypertension or hyperglycemia;
• Patients with a recent diagnosis of severe anxiety or depression;
• Pregnant or breastfeeding patients;
• Patients with pacemakers or other contraindications to electroacupuncture;
• Patients concurrently enrolled in other clinical studies.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07074561 · GZY-KJS-ZJ-2025-006-PSA

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗