The Alternative Effects of Electroacupuncture in the Treatment of Trigeminal Neuralgia
ConditionTrigeminal Neuralgia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorYuanyuan Wu
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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);
electric shock-like, stabbing, or sharp quality;
pain triggered by innocuous stimuli within the affected trigeminal distribution;
exclusion of other facial pain disorders classified in ICHD-3.
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Carbarmazepine
DrugFollowing enrollment, the patient's carbamazepine dosage remained consistent with the pre-enrollment dosage. Orally administered for two consecutive weeks.
Sham Electroacupuncture
Procedure/SurgeryIn this group, superficial needling (0.5-1 mm depth) was performed at non-meridian points located 1 cm lateral to: (1) primary local acupoints ST2 (Sibai), ST7 (Xiaguan), and ST4 (Dicang) on the affected side; (2) branch-specific supplementary points GB1 (Tongziliao) for ophthalmic branch involvement, SI18 (Quanliao) for maxillary branch involvement, and ST6 (Jiache) for mandibular branch involvement; and (3) bilateral distal points LI4 (Hegu) and TE5 (Waiguan). Local acupoint pairs (ST7 adjacent + GB1 adjacent, ST7 adjacent + SI18 adjacent, or ST7 adjacent + ST6 adjacent) and distal pairs (LI4 adjacent + TE5 adjacent) were connected to an electroacupuncture device. The electroacupuncture device was kept in the off state and did not generate any therapeutic current. The needles were retained for 60 minutes.Acupuncture treatment was administered for 5 consecutive days as one course, with a 2-day break between courses. A total of 2 courses were conducted.
Carbarmazepine Placebo
DrugCBZ placebo is a tablet with identical packaging and appearance to CBZ but lacks therapeutic effects. Patients were transitioned to a CBZ placebo at an equivalent daily dose post-enrollment. Orally administered for two consecutive weeks.
Electroacupuncture
Procedure/SurgeryThe primary acupoints selected were the affected side's Sibai (ST2), Xiaguan (ST7), and Dicang (ST4). Based on the affected nerve branch, additional acupoints were chosen: for the ophthalmic branch, Tongziliao (GB1); for the maxillary branch, Quanliao (SI18); and for the mandibular branch, Jiache (ST6). Distal acupoints included bilateral Hegu (LI4) and Waiguan (SJ5). Electroacupuncture was applied based on the affected nerve branch. For the ophthalmic branch, the local acupoints selected were Xiaguan + Tongziliao; for the maxillary branch, Xiaguan + Quanliao; and for the mandibular branch, Xiaguan + Jiache. The distal acupoints selected were Hegu + Waiguan. A sparse-dense wave, 2/100Hz, was used, with a treatment duration of 60 minutes. The intensity of the electrical current was adjusted according to the patient's tolerance. Acupuncture treatment is administered in 5 consecutive days as one course, with a 2-day break between courses. A total of 2 courses are conducted.
Treatment groups
126 Participants
are divided into 2 treatment groupsGroup A: sham EA +CBZ groupSham comparator 2 interventions
Group B: EA+placebo groupExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
VAS Response Rate
The proportion of patients with a reduction in VAS score of ≥50% from baseline at the end of the 2-week treatment.The VAS measures pain intensity on a scale from 0 to 10, where higher scores indicate worse pain. The unit of measure is "Percentage of participants".
Time frame
Baseline, the end of the 2-week treatment.Secondary outcomes
1
Changes in Visual Analog Scale (VAS) scores
Changes in VAS scores from baseline at weeks 2, 4, and 8.The VAS scale ranges from 0 to 10. Higher scores indicate more severe pain. The unit of measure is "Units on a scale".
Time frame
At baseline, and at the end of weeks 2, 4, and 8.2
Total Days of Rescue Medication Use Assessed by Pain Diary
Patients will record any use of non-study pain relief medications (rescue analgesia) in their daily pain diary. While the specific type and dosage of the medications are documented in the diary for safety and protocol monitoring, this specific outcome measure evaluates the cumulative total number of days a patient required rescue medication during the entire observation period. A lower number indicates less reliance on additional analgesics. The unit of measure is "Days".
Time frame
Daily from baseline through the end of week 8.3
Average Daily Frequency of Pain Episodes Assessed by Pain Diary
Patients will record the number of spontaneous and triggered paroxysmal pain episodes daily using a 24-hour pain diary. To capture the continuous trajectory of pain over the entire study period, the daily data will be aggregated and reported as weekly averages. The unit of measure is "Episodes per day".
Time frame
Daily from baseline through the end of week 8.4
Average Daily Pain Intensity Assessed by Pain Diary
Patients will rate their average pain intensity over the past 24 hours daily using a Visual Analog Scale (VAS) within the pain diary. The VAS ranges from 0 to 10, where higher scores indicate more severe pain. To capture the continuous trajectory, the daily scores will be aggregated and reported as weekly averages. The unit of measure is "Units on a scale".
Time frame
Daily from baseline through the end of week 8.Other outcomes
1
Plasma Concentration of Serotonin (5-HT)
Plasma levels of 5-HT will be quantified using Enzyme-Linked Immunosorbent Assay (ELISA). The unit of measure is ng/mL.
Time frame
At baseline, and at the end of weeks 22
Plasma Concentration of Interleukin-6 (IL-6)
Plasma levels of IL-6, a key mediator of neuroinflammation, will be quantified using Enzyme-Linked Immunosorbent Assay (ELISA). The unit of measure is pg/mL.
Time frame
At baseline, and at the end of weeks 2.3
Incidence of Treatment-Related Adverse Events (AEs)
Safety will be evaluated by monitoring the incidence of any adverse events during the study. These include acupuncture-related events (e.g., post-needling pain, subcutaneous hematoma), carbamazepine-related side effects (e.g., dizziness, nausea), and clinically significant laboratory abnormalities identified through Liver Function Tests (LFT) and Renal Function Tests (RFT). The outcome reports the total number of participants experiencing at least one adverse event. The unit of measure is "Number of participants".
Time frame
Baseline up to Week 8Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Yuanyuan Wu
Lead sponsor
The Third Affiliated hospital of Zhejiang Chinese Medical University
Sponsor institution
Pingyang County Traditional Chinese Medicine Hospital
Collaborator
Jiaxing Traditional Chinese Medicine Hospital
Collaborator
Source ClinicalTrials.gov
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