Electroacupuncture Therapy for Change of Pain in Classical Trigeminal Neuralgia

Sponsor

Zhejiang Chinese Medical University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03580317

Collaborator

Jiaxing TCM Hospital (Other)

120

Enrollment

Location

Arms

53.7

Anticipated Duration (Months)

2.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Trigeminal Neuralgia	Other: EA+ Carbamazepine Other: EA+Placebo Other: sham EA+Carbamazepine Other: sham EA+Placebo	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Electroacupuncture Therapy for Change of Pain in Classical Trigeminal Neuralgia

Actual Study Start Date :

Jul 12, 2018

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

Change from Baseline Intensity of Pain at 6 months [Baseline, 2 weeks, 4 weeks, 3 months, 6 months]
Evaluation of the pain by VAS with 0-10 points which that 0 means painless and 10 means very painful.
Change from Baseline Brief introduction of 2-week pain [Baseline, 2 weeks, 4 weeks, 3 months, 6 months]
According to a verifiable diary card which is recorded the subjects' pain symptoms in 24 hours every day.

Secondary Outcome Measures

Brief Pain Inventory-Facial scale(BPI-Facial) [Baseline, 2 weeks, 4 weeks, 3 months, 6 months]
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) [Baseline, 2 weeks, 4 weeks, 3 months, 6 months]
This index will record the general change impression of pain for CTN.
Short-Form McGill Pain Questionnaire [Baseline, 2 weeks, 4 weeks, 3 months, 6 months]
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 [Baseline, 2 weeks, 4 weeks, 3 months, 6 months]
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Paroxysm pain involving branches of the 2nd and/or 3rd branch of 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.