The Alternative Effects of Electroacupuncture in the Treatment of Trigeminal Neuralgia

The Alternative Effects of Electroacupuncture in the Treatment of Trigeminal Neuralgia: Protocol for a Multicentre Randomised Controlled Trial

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.

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.

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:

1. 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);

2. 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;

3. pain triggered by innocuous stimuli within the affected trigeminal distribution;

4. 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.