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Trigeminal NeuralgiaNCT06977932

The Alternative Effects of Electroacupuncture in the Treatment of Trigeminal Neuralgia

A study testing Carbarmazepine and Electroacupuncture in people with Trigeminal Neuralgia, run by Yuanyuan Wu.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Trigeminal Neuralgia
What is being tested?
Carbarmazepine and Electroacupuncture
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
126 participants
Where
No sites listed yet
Study dates
1 Mar 2026to 31 Dec 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
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  • ⑥ pregnancy or lactation;
  • ⑦ presence of a cardiac pacemaker or other contraindications to electroacupuncture therapy;
  • ⑧ current participation in another clinical trial.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

About this study

Official title: The Alternative Effects of Electroacupuncture in the Treatment of Trigeminal Neuralgia: Protocol for a Multicentre Randomised Controlled 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.

Read the 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.

Being tested
Carbarmazepine, Sham Electroacupuncture, Carbarmazepine Placebo, Electroacupuncture
Keywords
Electroacupuncture, Randomized Controlled Trial
Medical subject headings
Trigeminal Neuralgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CarbarmazepineDrug

    Following enrollment, the patient's carbamazepine dosage remained consistent with the pre-enrollment dosage. Orally administered for two consecutive weeks.

  • Sham ElectroacupunctureProcedure or surgery

    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) 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 PlaceboDrug

    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.

  • ElectroacupunctureProcedure or surgery

    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 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.

Study groups in NCT06977932
Study groupRoleWhat they receive
sham EA +CBZ groupSham comparatorA cohort of 63 patients with TN will undergo treatment with CBZ in conjunction with a sham EA intervention.
Receives: Drug: Carbarmazepine; Procedure: Sham Electroacupuncture
EA+placebo groupExperimentalA 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.
Receives: Drug: Carbarmazepine Placebo; Procedure: Electroacupuncture

What is being measured

The primary outcome is the main question the study is designed to answer.

  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".

    Measured: Baseline, the end of the 2-week treatment.

Secondary outcomes (10)
  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".

    Measured: 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".

    Measured: 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".

    Measured: 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".

    Measured: Daily from baseline through the end of week 8.

  5. 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".

    Measured: Daily from baseline through the end of week 8.

  6. 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".

    Measured: At the end of weeks 2, 4, and 8.

  7. 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".

    Measured: At baseline, and at the end of weeks 2, 4, and 8.

  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".

    Measured: At baseline, and at the end of weeks 2, 4, and 8.

  9. 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".

    Measured: At baseline, and at the end of weeks 2, 4, and 8.

  10. 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".

    Measured: At baseline, and at the end of weeks 2, 4, and 8.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2025
  2. Study start1 Mar 2026 (estimated)
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
126 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06977932
Sponsor's protocol ID
GZY-KJS-ZJ-2025-006-ALT
Status last verified
Feb 2026
First submitted
11 May 2025
Last updated
5 Mar 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Chen N, Xu M, Wang J, Wang D, Luo K, Hao YB, Chen K, Yang X, Ren H, Fang J, Wu Y. Effect of Electroacupuncture for Trigeminal Neuralgia: Study Protocol for a Multicenter Randomized Controlled Trial. J Pain Res. 2026 Jun 3;19:616735. doi: 10.2147/JPR.S616735. eCollection 2026.

    PubMed 42261299

Questions about this trial

What is this clinical trial studying?

A study testing Carbarmazepine and Electroacupuncture in people with Trigeminal Neuralgia, run by Yuanyuan Wu.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Nisang Chen (+8615990031347, 237247256@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

VAS Response Rate (time frame: Baseline, the end of the 2-week treatment.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06977932, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.

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