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Electroacupuncture Therapy for Change of Pain in Classical Trigeminal Neuralgia

Primary Purpose

Trigeminal Neuralgia

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

EA+ Carbamazepine

EA+Placebo

sham EA+Carbamazepine

sham EA+Placebo

About this trial

This is an interventional treatment trial for Trigeminal Neuralgia focused on measuring Classical trigeminal neuralgia, Electroacupuncture, Randomized controlled clinical trial

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

the Third affiliated hospital of Zhejiang Chinese Medical university

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Active Comparator

Sham Comparator

Arm Label

EA + Carbamazepine Group

EA + Placebo Group

Sham EA+ Carbamazepine Group

Sham EA+ Placebo Group

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Change from Baseline Intensity of Pain to 28 weeks

Evaluation of the pain by VAS with 0-10 points which that 0 means painless and 10 means very painful.

Secondary Outcome Measures

Brief Pain Inventory-Facial scale(BPI-Facial)

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.

Patient Global Impression of Change(PGIC)

This index will record the general change impression of pain for CTN.

Short-Form McGill Pain Questionnaire

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.

Short-Form 36 Questionnaire

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).

The proportion of patients using rescue analgesics

The frequency of CTN attacks

Calculated from the pain diary

Full Information

NCT ID

NCT03580317

First Posted

June 2, 2018

Last Updated

September 13, 2022

Sponsor

Zhejiang Chinese Medical University

Collaborators

Jiaxing TCM Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03580317

Brief Title

Electroacupuncture Therapy for Change of Pain in Classical Trigeminal Neuralgia

Official Title

Electroacupuncture Therapy for Change of Pain in Classical Trigeminal Neuralgia

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Completed

Study Start Date

July 12, 2018 (Actual)

Primary Completion Date

January 31, 2021 (Actual)

Study Completion Date

January 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Zhejiang Chinese Medical University

Collaborators

Jiaxing TCM Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Trigeminal Neuralgia

Keywords

Classical trigeminal neuralgia, Electroacupuncture, Randomized controlled clinical trial

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Factorial Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Arm Title

EA + Carbamazepine Group

Arm Type

Experimental

Arm Description

Arm Title

EA + Placebo Group

Arm Type

Placebo Comparator

Arm Description

Arm Title

Sham EA+ Carbamazepine Group

Arm Type

Active Comparator

Arm Description

Arm Title

Sham EA+ Placebo Group

Arm Type

Sham Comparator

Arm Description

Intervention Type

Other

Intervention Name(s)

EA+ Carbamazepine

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

EA+Placebo

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

sham EA+Carbamazepine

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

sham EA+Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Change from Baseline Intensity of Pain to 28 weeks

Description

Evaluation of the pain by VAS with 0-10 points which that 0 means painless and 10 means very painful.

Time Frame