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The Alternative Effects of Electroacupuncture in the Treatment of Trigeminal Neuralgia 126
Clinical Trial NCT06977932 is an interventional study for Trigeminal Neuralgia and is currently not yet recruiting. Enrollment is planned to begin on 1 March 2026 and continue until the study accrues 126 participants. Led by Yuanyuan Wu, this study is expected to complete by 31 December 2028. The latest data from ClinicalTrials.gov was last updated on 5 March 2026.
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 e...Show More
Detailed Description
This study will enroll a total of 126 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.
Official Title
The Alternative Effects of Electroacupuncture in the Treatment of Trigeminal Neuralgia: Protocol for a Multicentre Randomised Controlled Trial
Conditions
Trigeminal NeuralgiaOther Study IDs
- GZY-KJS-ZJ-2025-006-ALT
NCT ID Number
Start Date (Actual)
2026-03-01
Last Update Posted
2026-03-05
Completion Date (Estimated)
2028-12-31
Enrollment (Estimated)
126
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Keywords
Electroacupuncture
Randomized Controlled Trial
Randomized Controlled Trial
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Double
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
Sham Comparatorsham EA +CBZ group A cohort of 63 patients with TN will undergo treatment with CBZ in conjunction with a sham EA intervention. | Carbarmazepine Following enrollment, the patient's carbamazepine dosage remained consistent with the pre-enrollment dosage. Orally administered for two consecutive weeks. Sham Electroacupuncture In 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) bilater...Show More |
ExperimentalEA+placebo group A cohort of 63 patients diagnosed with TN will undergo treatment involving a combination of placebo and EA. The EA procedures will be administered by licensed acupuncturists who have received standardized training. | Carbarmazepine Placebo CBZ 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 The 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 affec...Show More |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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". | Baseline, the end of the 2-week treatment. |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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". | At baseline, and at the end of weeks 2, 4, and 8. |
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". | Daily from baseline through the end of week 8. |
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". | Daily from baseline through the end of week 8. |
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". | Daily from baseline through the end of week 8. |
Highest Daily Pain Intensity Assessed by Pain Diary | Patients will rate their peak 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 worse 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". | Daily from baseline through the end of week 8. |
Changes in the Patient global impression of change （PGIC） | The Patient Global Impression of Change (PGIC) scale is a patient-reported outcome measure used to dynamically monitor the trajectory of health status. This scale employs a seven-point Likert scale (1=very much worse to 7=very much better) to assess the impact of therapeutic interventions on an individual's functional status. Treatment efficacy is categorized into three levels: ① disease progression (scores 0-3) indicates a worsening of symptoms; ② functional stability (score 4) suggests no significant change in symptoms; and ③ clinical improvement (scores 5-7) represents a marked reduction in symptoms. This subjective assessment tool, through longitudinal comparison with baseline data, provides a direct reflection of the patient's perceived treatment benefit. The unit of measure is "Units on a scale". | At the end of weeks 2, 4, and 8. |
Changes in the Short-Form McGill Pain Questionnaire （SF-MPQ） | The Short-Form McGill Pain Questionnaire (SF-MPQ) innovatively integrates qualitative and quantitative analyses of neuropathic pain. This involves: (1) Pain quality assessment: Utilizing 11 sensory descriptors (e.g., pricking, burning) and 4 affective descriptors (e.g., annoying, fearful), a 0-3 intensity rating system is established, synthesizing a Pain Rating Index (PRI = sensory score + affective score); (2) Pain intensity assessment: Employing a Visual Analog Scale (VAS) and the Present Pain Intensity index (PPI) for supplementary quantification. This scale significantly enhances clinical applicability while maintaining assessment validity, and has become a gold standard for neuropathic pain assessment. The Pain Rating Index (PRI) is calculated from the descriptors. The total PRI score ranges from 0 to 45. Higher total scores indicate worse neuropathic pain. The unit of measure is "Units on a scale". | At baseline, and at the end of weeks 2, 4, and 8. |
Changes in the Brief pain inventory-facial scale （BPI-Facial） | The Brief Pain Inventory-Facial Scale (BPI-Facial) is designed to establish a three-dimensional assessment system: ① Pain intensity dimension (4 items) quantifies the frequency and severity of pain; ② Daily function dimension (7 items) assesses the impact of pain on basic life activities (including specific emotional states); ③ Facial function dimension (7 items) detects the degree of limitation in specific facial activities. Eighteen standardized items, measured from multiple perspectives, can systematically evaluate pain-related physiological, psychological, and social functional changes, providing multidimensional data support for efficacy determination. Each item is rated on a numerical scale from 0 to 10, yielding a total score that ranges from 0 to 180, where higher scores indicate more severe pain and greater functional impairment. The unit of measure is "Units on a scale". | At baseline, and at the end of weeks 2, 4, and 8. |
Changes in The Self-Rating Anxiety Scale (SAS) | In assessing anxiety via the Self-Rating Anxiety Scale (SAS), scoring yields two key metrics: the raw sum score (X) and the derived standard score (Y). The latter is calculated as the integer portion of 1.25X, with truncation applied. Per Chinese norms, a standard score (Y) of 50 serves as the threshold for clinical anxiety, with severity stratified as mild (50-59), moderate (60-69), or severe (≥70). The standard score ranges from 25 to 100. Higher scores represent more severe anxiety. The unit of measure is "Units on a scale". | At baseline, and at the end of weeks 2, 4, and 8. |
Changes in the Self-Rating Depression Scale (SDS) | The Self-Rating Depression Scale (SDS) is a brief, self-rated instrument for assessing depressive symptomatology. The total raw score (X) is derived by summing all item responses, which is then converted to a standard score (Y) by multiplying by 1.25 and truncating to an integer. Based on Chinese normative data, a standard score cutoff of 53 is adopted, with scores of 53-62, 63-72, and ≥73 indicating mild, moderate, and severe depression, respectively. The standard score ranges from 25 to 100. Higher scores reflect more severe depressive symptoms. The unit of measure is "Units on a scale". | At baseline, and at the end of weeks 2, 4, and 8. |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
Diagnosis was based on the criteria for trigeminal neuralgia (TN) as defined in the third edition of the International Classification of Headache Disorders (ICHD-3) published by the International Headache Society (IHS) in 2018. The diagnostic criteria included:
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);
pain presenting with all of the following characteristics:
① paroxysmal attacks lasting from a few seconds to 2 minutes;
② severe intensity;
- 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.
All of the following criteria had to be met for study enrollment:
fulfillment of the TN diagnostic criteria as stated above;
age between 18 and 80 years, inclusive, irrespective of sex;
- receiving a stable daily dose of carbamazepine (200-400 mg); ④ consciousness clear, with intact pain perception and discrimination, and able to communicate effectively; ⑤ voluntary participation with written informed consent provided by the patient or their legal guardian/authorized representative.
Participants were excluded if they met any of the following:
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;
⑤ recent diagnosis of severe anxiety or depression;
⑥ pregnancy or lactation;
⑦ presence of a cardiac pacemaker or other contraindications to electroacupuncture therapy;
⑧ current participation in another clinical trial.
Yuanyuan Wu- Pingyang County Traditional Chinese Medicine Hospital
- Jiaxing Traditional Chinese Medicine Hospital
Study Responsible Party
Yuanyuan Wu, Sponsor-Investigator, Associate Professor, The Third Affiliated hospital of Zhejiang Chinese Medical University
Study Central Contact
Contact: Nisang Chen, +8615990031347, [email protected]
No location data.