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

Not Applicable

Not yet recruiting

• Conditions: Trigeminal Neuralgia
• Interventions: Drug: CBZ; Drug: CBZ placebo; Procedure: Sham electroacupuncture; Procedure: Electroacupuncture

• Registration Number: NCT07074561
• Lead Sponsor: Yuanyuan Wu

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. 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-05-11
• Status Verified: 2025-07
• Study First Submitted QC: 2025-07-10
• Last Update Submitted: 2025-07-10
• Study Start: 2025-07-20
• Study First Posted: 2025-07-20
• Last Update Posted: 2025-07-20
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 28

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sham EA +CBZ group	CBZ	-
sham EA +CBZ group	Sham electroacupuncture	-
EA+CBZ+placebo group	CBZ placebo	-
EA+CBZ+placebo group	CBZ	-
EA+CBZ+placebo group	Electroacupuncture	-

Primary Outcome Measures

Name	Time	Method
Changes in Visual Analog Scale (VAS) scores from baseline to the end of the 4th week of treatment	Baseline, 4 weeks after treatment.	The Visual Analog Scale (VAS) consists of a 10-cm line, where '0' indicates 'no pain' and '10' represents 'unbearable pain,' with increasing pain intensity from 0 to 10. Patients self-assess their pain level by marking the scale, and the investigator records the score."

Secondary Outcome Measures

Name	Time	Method
Changes in Visual Analog Scale (VAS) scores	Baseline, 2 weeks after treatment, at 4-week follow-up.	Visual Analog Scale (VAS) consists of a 10-cm line, where '0' indicates 'no pain' and '10' represents 'unbearable pain,' with increasing pain intensity from 0 to 10. Patients self-assess their pain level by marking the scale, and the investigator records the score. VAS scores were assessed at baseline, the end of the 2nd week of treatment, and the end of the 4th week post-treatment (follow-up), to observe changes from baseline at the 2nd week of treatment and the 4th week post-treatment respectively.
Pain Diary Card	Daily from enrollment through four weeks after treatment completion	Daily records of carbamazepine (CBZ)/CBZ-placebo medication adherence, pain episode frequency, and adverse reactions in both groups will be maintained until the end of follow-up. The recorded data will be used for intergroup comparisons and intra-group comparisons to evaluate the degree of pain status changes between groups and within individuals.
Carbamazepine Adverse Reactions	Daily from enrollment through four weeks after treatment completion
Hepatorenal function	Baseline, 4 weeks after treatment.	This study will assess the degree of hepatocyte injury and glomerular filtration function. Additionally, the incidence of severe liver or kidney impairment will be evaluated.
Changes in the The Self-Rating Anxiety Scale (SAS)	Baseline, 2 weeks after treatment, 4 weeks after treatment, at 4-week follow-up.	After completing each scale, the raw total score (X) is obtained by summing all item scores. This raw score is then multiplied by 1.25, to derive the standardized score (Y). The SAS cut-off value for clinical significance is a standardized score of 50, with severity classifications as follows: 50-59 indicates mild anxiety, 60-69 moderate anxiety, and scores above 69 severe anxiety.
Changes in the Self-Rating Depression Scale (SDS)	Baseline, 2 weeks after treatment, 4 weeks after treatment, at 4-week follow-up.	The raw scores from each subscale are summed to obtain the total raw score, which is then multiplied by 1.25 to calculate the standard score. For the SDS, the cutoff for depression is a standard score of 53, with scores of 53-62 indicating mild depression, 63-72 indicating moderate depression, and scores above 72 indicating severe depression.