The Alternative Effects of Electroacupuncture in the Treatment of Trigeminal Neuralgia

Official title

The Alternative Effects of Electroacupuncture in the Treatment of Trigeminal Neuralgia: Protocol for a Multicentre 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. 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.

Interventions

• 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 adjacen
• 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 X

Primary outcome measures

• VAS Response Rate [Time frame: Baseline, the end of the 2-week treatment.]

Secondary outcome measures (10)

• Changes in Visual Analog Scale (VAS) scores [Time frame: At baseline, and at the end of weeks 2, 4, and 8.]
• Total Days of Rescue Medication Use Assessed by Pain Diary [Time frame: Daily from baseline through the end of week 8.]
• Average Daily Frequency of Pain Episodes Assessed by Pain Diary [Time frame: Daily from baseline through the end of week 8.]
• Average Daily Pain Intensity Assessed by Pain Diary [Time frame: Daily from baseline through the end of week 8.]
• Highest Daily Pain Intensity Assessed by Pain Diary [Time frame: Daily from baseline through the end of week 8.]
• Changes in the Patient global impression of change （PGIC） [Time frame: At the end of weeks 2, 4, and 8.]
• Changes in the Short-Form McGill Pain Questionnaire （SF-MPQ） [Time frame: At baseline, and at the end of weeks 2, 4, and 8.]
• Changes in the Brief pain inventory-facial scale （BPI-Facial） [Time frame: At baseline, and at the end of weeks 2, 4, and 8.]
• Changes in The Self-Rating Anxiety Scale (SAS) [Time frame: At baseline, and at the end of weeks 2, 4, and 8.]
• Changes in the Self-Rating Depression Scale (SDS) [Time frame: At baseline, and at the end of weeks 2, 4, and 8.]

Eligibility criteria

Diagnostic Criteria

Diagnosis was based on the criteria for trigeminal neuralgia (TN) as defined in the third edition of the International Classification of Headache Disorders (ICHD-3) published by the International Headache Society (IHS) in 2018. The diagnostic criteria included:

• recurrent unilateral facial pain occurring in the distribution of one or more divisions of the trigeminal nerve, without radiation outside the trigeminal territory, and meeting criteria (2) and (3);
• pain presenting with all of the following characteristics:

① paroxysmal attacks lasting from a few seconds to 2 minutes;

② severe intensity;

• electric shock-like, stabbing, or sharp quality;
• pain triggered by innocuous stimuli within the affected trigeminal distribution;
• exclusion of other facial pain disorders classified in ICHD-3.

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.

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.

Publications

• Chen N, Xu M, Wang J, Wang D, Luo K, Hao YB, Chen K, Yang X, Ren H, Fang J, Wu Y. Effect of Electroacupuncture for Trigeminal Neuralgia: Study Protocol for a Multicenter Randomized Controlled Trial. J Pain Res. 2026 Jun 3;19:616735. doi: 10.2147/JPR.S616735. eCollection 2026. PMID 42261299

Identifiers

NCT: NCT06977932 · GZY-KJS-ZJ-2025-006-ALT

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗