Clinical trial NCT06977932: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Trigeminal Neuralgia
Keywords: Electroacupuncture
Randomized Controlled Trial
Lead sponsor: The Third Affiliated hospital of Zhejiang Chinese Medical University
Sponsor class: OTHER
Collaborators: name: Pingyang County Traditional Chinese Medicine Hospital
name: Jiaxing Traditional Chinese Medicine Hospital
First posted: 2025-05-18
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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 148 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.

Eligibility criteria: 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 (100-300 mg/day) or oxcarbazepine (200-600 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;

Primary outcomes:
measure: Changes in Visual Analog Scale (VAS) scores from baseline to the end of the 4th week of treatment
timeFrame: Baseline, 4 weeks after treatment.
Secondary outcomes:
measure: Changes in Visual Analog Scale (VAS) scores
timeFrame: Baseline, 2 weeks after treatment, at 4-week follow-up.
measure: Pain Diary Card
timeFrame: Daily from enrollment through four weeks after treatment completion
measure: Changes in the Patient global impression of change （PGIC）
timeFrame: Baseline, 2 weeks after treatment, 4 weeks after treatment, at 4-week follow-up.
measure: Changes in the Brief pain inventory-facial scale （BPI-Facial）
timeFrame: Baseline, 2 weeks after treatment, 4 weeks after treatment, at 4-week follow-up.
measure: Changes in the Short-Form McGill Pain Questionnaire （SF-MPQ）
timeFrame: Baseline, 2 weeks after treatment, 4 weeks after treatment, at 4-week follow-up.
measure: Changes in the The Self-Rating Anxiety Scale (SAS) and Self-Rating Depression Scale (SDS)
timeFrame: Baseline, 2 weeks after treatment, 4 weeks after treatment, at 4-week follow-up.
measure: Changes in the Short-form 36（ SF-36）
timeFrame: Baseline, 2 weeks after treatment, 4 weeks after treatment, at 4-week follow-up.
Other outcomes:
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