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

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

Inclusion Criteria:

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

  1. 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.
  2. Between 18 and 75 years old (inclusive), regardless of gender;
  3. Currently prescribed carbamazepine (400-800 mg/day) or oxcarbazepine (800-1600 mg/day);
  4. Conscious, alert, and capable of perceiving/differentiating pain, with basic communication abilities;
  5. Signed informed consent form and voluntary participation in the study.

Exclusion Criteria:

• Patients meeting any of the following criteria were excluded:

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