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.
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;
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;
Yuanyuan Wu
Lead sponsor
The Third Affiliated hospital of Zhejiang Chinese Medical University
Sponsor institution
Jiaxing Traditional Chinese Medicine Hospital
Collaborator
Pingyang County Traditional Chinese Medicine Hospital
Collaborator