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Trigeminal NeuralgiaNCT07074561

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

A study testing CBZ 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 75 years
Conditions the study is for
Trigeminal Neuralgia
What is being tested?
CBZ and Electroacupuncture
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
28 participants
Where
No sites listed yet
Study dates
20 Jul 2025to 31 Dec 2025
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants must meet all of the following criteria to be eligible for this study:
  • 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.
  • Between 18 and 75 years old (inclusive), regardless of gender;
  • Currently prescribed carbamazepine (400-800 mg/day) or oxcarbazepine (800-1600 mg/day);
  • Conscious, alert, and capable of perceiving/differentiating pain, with basic communication abilities;
  • Signed informed consent form and voluntary participation in the study.

Who cannot join

  • Patients meeting any of the following criteria were excluded:
  • Patients with epilepsy, head injury, or other relevant neurological disorders;
  • Patients with severe cardiac, hepatic, or renal impairment;
  • Patients with cognitive dysfunction, aphasia, psychiatric disorders, or those unable to cooperate with treatment;
  • Patients with poorly controlled hypertension or hyperglycemia;
  • Patients with a recent diagnosis of severe anxiety or depression;
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  • Pregnant or breastfeeding patients;
  • Patients with pacemakers or other contraindications to electroacupuncture;
  • Patients concurrently enrolled in other clinical studies.

Trial locations and contacts

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

Nisang Chen contact

+8615990031347

237247256@qq.com

About this study

Official title: The Synergism and Attenuation Effects of Electroacupuncture in the Treatment of Trigeminal Neuralgia：Protocol for a Multicentre Pilot 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. 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.

Being tested
CBZ placebo, CBZ, Electroacupuncture, Sham electroacupuncture
Keywords
Electroacupuncture, Carbamazepine
Medical subject headings
Trigeminal Neuralgia

What participants receive

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

  • CBZ placeboDrug

    Patients received oral administration of one 100 mg placebo tablet three times daily (TID) after meals for four consecutive weeks.

  • CBZDrug

    In the EA + CBZ + placebo group, patients received oral carbamazepine (CBZ) at a dosage of 100 mg per tablet three times daily (TID) after meals for 4 consecutive weeks. In the sham EA + CBZ group, patients were administered oral CBZ at 200 mg per dose TID after meals for the same 4-week duration.

  • 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 was administered 3 times per week (with 1-2-day intervals between sessions) for 4 consecutive weeks, totaling 12 sessions.

  • 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 or ST7 adjacent +SI18 adjacent or ST7 adjacent +ST6 adjacent) and distal pairs (LI4 adjacent +TE5 adjacent) were connected to a modified electroacupuncture device with severed output wires (preventing current flow while maintaining indicator function), followed by 60-minute needle retention after parameter adjustment. Acupuncture was administered 3 times per week (with 1-2-day intervals between sessions) for 4 consecutive weeks, totaling 12 sessions.

Study groups in NCT07074561
Study groupRoleWhat they receive
sham EA +CBZ groupSham comparatorNot described
Receives: Drug: CBZ; Procedure: Sham electroacupuncture
EA+CBZ+placebo groupExperimentalNot described
Receives: Drug: CBZ placebo; Drug: CBZ; Procedure: Electroacupuncture

What is being measured

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

  1. Changes in Visual Analog Scale (VAS) scores from baseline to the end of the 4th week of 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."

    Measured: Baseline, 4 weeks after treatment.

Secondary outcomes (6)

  1. Changes in Visual Analog Scale (VAS) scores

    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.

    Measured: Baseline, 2 weeks after treatment, at 4-week follow-up.

  2. Pain Diary Card

    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.

    Measured: Daily from enrollment through four weeks after treatment completion

  3. Carbamazepine Adverse Reactions

    Measured: Daily from enrollment through four weeks after treatment completion

  4. Hepatorenal function

    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.

    Measured: Baseline, 4 weeks after treatment.

  5. Changes in the The Self-Rating Anxiety Scale (SAS)

    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.

    Measured: Baseline, 2 weeks after treatment, 4 weeks after treatment, at 4-week follow-up.

  6. Changes in the Self-Rating Depression Scale (SDS)

    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.

    Measured: Baseline, 2 weeks after treatment, 4 weeks after treatment, at 4-week follow-up.

Timeline

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

  1. First posted20 Jul 2025
  2. Study start20 Jul 2025 (estimated)
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 2025 (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
28 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07074561
Sponsor's protocol ID
GZY-KJS-ZJ-2025-006-PSA
Status last verified
Jul 2025
First submitted
11 May 2025
Last updated
20 Jul 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing CBZ 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 6 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 20 Jul 2025. 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?

Changes in Visual Analog Scale (VAS) scores from baseline to the end of the 4th week of treatment (time frame: Baseline, 4 weeks after 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 NCT07074561.

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 20 Jul 2025.

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