Electroacupuncture Therapy for Change of Pain in Classical Trigeminal Neuralgia

September 13, 2022 updated by: Jianqiao Fang, Zhejiang Chinese Medical University
The classical trigeminal neuralgia (CTN) is a common neuropathic pain in clinic by recurrent attacks of chronic sharp pain in the distribution of neuropathy branches of trigeminal neuralgia. With the lack of appropriate drug and surgery, acupuncture played a role in analgesia with its effective and few side effects. The study is designed to observe the therapeutic effect and safety of electroacupuncture (EA) in the treatment of CTN.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A total of 120 subjects with CTN who met the inclusion criteria will be included in the study. The subjects will be randomly divided into EA+ Carbamazepine group, EA+placebo group, sham EA+Carbamazepine group and sham EA+placebo group. The indexes of main outcome evaluation are 1)Intensity of pain (Evaluation of the pain by VAS with 0-10 points) and 2)Brief introduction of 2-week pain. The indexes of secondary outcome evaluation are 1) Brief Pain Inventory-Facial scale(BPI-Facial); 2) Patient Global Impression of Change(PGIC); 3) Short-Form McGill Pain Questionnaire; 4) Short- Form 36 Questionnaire. This study will evaluate whether EA has the advantage over carbamazepine in the immediate effect, long-term effect and post effect of the analgesia in CTN. At the same time, the study also will demonstrate whether EA has a synergistic effect with carbamazepine on the treatment of CTN, or even whether EA has an alternative effect on carbamazepine. Furthermore, we will establish a standardized, effective and convenient therapy program of EA to promote according to the results.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • the Third Affiliated Hospital of Zhejiang Chinese Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients suffer from the pain with electric shock, shooting, stabbing occurs in one or more branches of the trigeminal nerve.
  2. The visual analogue score(VAS) baseline score ≥5, have a attack more than 3 times a day, at least 4 days a week.
  3. 18 years ≤ age ≤ 80 years.
  4. Clear consciousness, have the ability of pain perception and resolution, can complete the basic communication.
  5. Signed informed consent and volunteered to participate in this study.

Exclusion Criteria:

  1. Those patients with epilepsy, head injury or other related neurological diseases.
  2. Patients with serious heart, liver, kidney damage or cognitive impairment, aphasia, mental disorders, or unable to cooperate with the treatment.
  3. Combined with hypertension but poor control.
  4. Severe depressive with definitive diagnosis recently.
  5. Pregnant and lactating patients.
  6. Installing pacemakers.
  7. For any other reason that is not suitable for the treatment of EA.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EA + Carbamazepine Group
The subjects in this group will receive 3 times per week, and 4 weeks of continuous intervention for a total of 12 times. The intervention including electroacupuncture(EA) treatment and combined with Carbamazepine (0.1g each time, thrice daily). The follow-up period is 6 months.
Other: EA+ Carbamazepine

Acupoints selection: Si-bai(ST2), Xia-guan(ST7), Di-cang(ST4), Quan-liao(SI18), Jia-che(ST6) and A-shi-xue of affected side. He-gu(LI4) and Wai-guan(TE5) of two sides.

Operation:The needles(0.18×25 mm) will be selected to stimulate the local points with shallow row needling according to the distribution of neuropathy branch of trigeminal neuralgia.The needles(0.25×40mm) will be selected to stimulate the distal acupoints. The Xia-guan(ST7) and Quan-liao(SL18) (or Jia-che(ST6)), He-gu(LI4) and Wai-guan(SJ5) acupoints will be received EA treatment by HuaTuo SDZ-ⅡB acupoint neural stimulator. The EA parameter is 2/100 Hz, 60 minutes and the current intensity is comfortable to subjects. Carbamazepine tablets should be took orally, 0.1g each time, thrice daily.
Placebo Comparator: EA + Placebo Group
The subjects in this group will receive 3 times per week, and 4 weeks of continuous intervention for a total of 12 times. The intervention including EA treatment and combined with placebo of carbamazepine. The follow-up period is 6 months.
Other: EA+Placebo
In this group, the selection, positioning and manipulation of acupoints, the frequency, duration and retaining needle time of treatment are same as EA + Carbamazepine Group; placebo, that appearance and specifications are the same as carbamazepine, are cooperated taken of dose 0.1g, thrice daily.
Active Comparator: Sham EA+ Carbamazepine Group
The subjects in this group will receive 3 times per week, and 4 weeks of continuous intervention for a total of 12 times. The intervention including sham electroacupuncture(sham EA) intervention and combined with carbamazepine. The follow-up period is 6 months.
Other: sham EA+Carbamazepine

Selection of points and locations: the non-meridional points which are means to the points beside 5-10mm of the real acupoints (avoid the trigger point) in the EA group will be selected and needled with more shallow acupuncture (the depth of needling is about 1-2mm).

The operation of shame EA: The HuaTuo SDZ-ⅡB acupoint neural stimulator with damaged electrode wires will be selected to connect the points next to the Xia-guan(ST7) and Quan-liao (SI18) , He-gu (LI4) and Wai-guan(TE5).The frequency, intensity and retaining time will be same as EA group, The subjects can see the display screen and parameter settings of stimulator, however there is no electricity output in fact.

The dosage and frequency of oral carbamazepine tablets are same as above part.
Sham Comparator: Sham EA+ Placebo Group
The subjects in this group will receive 3 times per week, and 4 weeks of continuous intervention for a total of 12 times. The intervention including sham EA intervention and combined with placebo took orally. The follow-up period is 6 months.
Other: sham EA+Placebo
The points selection, positioning and manipulation are same as Shame EA+ Carbamazepine group，placebo are cooperated taken of dose 0.1g, thrice daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline Intensity of Pain to 28 weeks
Time Frame: Baseline, 2 weeks, 4 weeks, 16 weeks, 28 weeks
Evaluation of the pain by VAS with 0-10 points which that 0 means painless and 10 means very painful.
Baseline, 2 weeks, 4 weeks, 16 weeks, 28 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brief Pain Inventory-Facial scale(BPI-Facial)
Time Frame: Baseline, 2 weeks, 4 weeks, 16 weeks, 28 weeks
This instrument is composed of 18 items on a 1-point scale (0-10). 4 questions center on pain intensity, 7 questions deal with the interference of pain with general life activities and the remaining 7 questions deal with the interference of pain with face-specific activities.
Baseline, 2 weeks, 4 weeks, 16 weeks, 28 weeks
Patient Global Impression of Change(PGIC)
Time Frame: Baseline, 2 weeks, 4 weeks, 16 weeks, 28 weeks
This index will record the general change impression of pain for CTN.
Baseline, 2 weeks, 4 weeks, 16 weeks, 28 weeks
Short-Form McGill Pain Questionnaire
Time Frame: Baseline, 2 weeks, 4 weeks, 16 weeks, 28 weeks
The pain rating index has 2 subscales: these words or items are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate and 3 = severe. There's also one item for present pain intensity and one item for a 10cm visual analogue scale for average pain. This version includes 7 additional symptoms related to neuropathic pain, for a total of 22 items with 0-10 numerical response options.
Baseline, 2 weeks, 4 weeks, 16 weeks, 28 weeks
Short-Form 36 Questionnaire
Time Frame: Baseline, 2 weeks, 4 weeks, 16 weeks, 28 weeks
The scale includes: 1.Physical Functioning (PF).2.Physical function (RP).3.Body Pain (BP).4.General Health (GH).5.Vitality.6.Social Functioning (SF)7.Role-emotional (RE).8.Mental Health (MH).
Baseline, 2 weeks, 4 weeks, 16 weeks, 28 weeks
The proportion of patients using rescue analgesics
Time Frame: Baseline, 2 weeks, 4 weeks, 16 weeks, 28 weeks
The proportion of patients using rescue analgesics
Baseline, 2 weeks, 4 weeks, 16 weeks, 28 weeks
The frequency of CTN attacks
Time Frame: Baseline, 2 weeks, 4 weeks, 16 weeks, 28 weeks
Calculated from the pain diary
Baseline, 2 weeks, 4 weeks, 16 weeks, 28 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhejiang Chinese Medical University

Collaborators

Jiaxing TCM Hospital

Investigators

  • Principal Investigator: Jianqiao Fang, Ph.D,M.D, Zhejiang Chinese Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 12, 2018

Primary Completion (Actual)

January 31, 2021

Study Completion (Actual)

January 31, 2021

Study Registration Dates

First Submitted

June 2, 2018

First Submitted That Met QC Criteria

June 25, 2018

First Posted (Actual)

July 9, 2018

Study Record Updates

Last Update Posted (Actual)

September 16, 2022

Last Update Submitted That Met QC Criteria

September 13, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018ZY008-CTN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Trigeminal Neuralgia

Clinical Trials on EA+ Carbamazepine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Rwanda

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe