Skip to main content
OpenTrials
Completed

NCT Number: NCT03580317

Electroacupuncture Therapy for Change of Pain in Classical Trigeminal Neuralgia

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Trigeminal Neuralgia Cranial Nerve Diseases Facial Nerve Diseases Facial Neuralgia Mouth Diseases Nervous System Diseases Stomatognathic Diseases Trigeminal Nerve Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

the Third affiliated hospital of Zhejiang Chinese Medical university

Hangzhou, Zhejiang, 310000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

EA+ Carbamazepine

Other

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.

EA+Placebo

Other

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.

sham EA+Carbamazepine

Other

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 EA+Placebo

Other

The points selection, positioning and manipulation are same as Shame EA+ Carbamazepine group，placebo are cooperated taken of dose 0.1g, thrice daily.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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).

  5. 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

  6. The frequency of CTN attacks

    Time frame: Baseline, 2 weeks, 4 weeks, 16 weeks, 28 weeks

    Calculated from the pain diary

Sponsors and collaborators

Lead sponsor

Zhejiang Chinese Medical University

Other Gov

Collaborators

  • Jiaxing TCM Hospital

Registry information

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jul 9, 2018
Registry last updated
Sep 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.