NCT03580317

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 2, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 9, 2018

Completed
3 days until next milestone

Study Start

First participant enrolled

July 12, 2018

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2021

Completed
Last Updated

September 16, 2022

Status Verified

September 1, 2022

Enrollment Period

2.6 years

First QC Date

June 2, 2018

Last Update Submit

September 13, 2022

Conditions

Trigeminal Neuralgia

Keywords

Classical trigeminal neuralgiaElectroacupunctureRandomized controlled clinical trial

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline, 2 weeks, 4 weeks, 16 weeks, 28 weeks

Secondary Outcomes (6)

  • Brief Pain Inventory-Facial scale(BPI-Facial)

    Baseline, 2 weeks, 4 weeks, 16 weeks, 28 weeks

  • Patient Global Impression of Change(PGIC)

    Baseline, 2 weeks, 4 weeks, 16 weeks, 28 weeks

  • Short-Form McGill Pain Questionnaire

    Baseline, 2 weeks, 4 weeks, 16 weeks, 28 weeks

  • Short-Form 36 Questionnaire

    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

  • +1 more secondary outcomes

Study Arms (4)

EA + Carbamazepine Group

EXPERIMENTAL

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

EA + Placebo Group

PLACEBO COMPARATOR

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

Sham EA+ Carbamazepine Group

ACTIVE COMPARATOR

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

Sham EA+ Placebo Group

SHAM COMPARATOR

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

Interventions

EA+ CarbamazepineOTHER

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 + Carbamazepine Group
EA+PlaceboOTHER

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.

EA + Placebo Group
sham EA+CarbamazepineOTHER

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+ Carbamazepine Group
sham EA+PlaceboOTHER

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

Sham EA+ Placebo Group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the Third affiliated hospital of Zhejiang Chinese Medical university

Hangzhou, Zhejiang, 310000, China

Location

Related Publications (16)

  • Montano N, Conforti G, Di Bonaventura R, Meglio M, Fernandez E, Papacci F. Advances in diagnosis and treatment of trigeminal neuralgia. Ther Clin Risk Manag. 2015 Feb 24;11:289-99. doi: 10.2147/TCRM.S37592. eCollection 2015.

    PMID: 25750533BACKGROUND

  • van Kleef M, van Genderen WE, Narouze S, Nurmikko TJ, van Zundert J, Geurts JW, Mekhail N; World Institute of Medicine. 1. Trigeminal neuralgia. Pain Pract. 2009 Jul-Aug;9(4):252-9. doi: 10.1111/j.1533-2500.2009.00298.x.

    PMID: 19619267BACKGROUND

  • Wiffen PJ, Derry S, Moore RA, Kalso EA. Carbamazepine for chronic neuropathic pain and fibromyalgia in adults. Cochrane Database Syst Rev. 2014 Apr 10;2014(4):CD005451. doi: 10.1002/14651858.CD005451.pub3.

    PMID: 24719027BACKGROUND

  • Killian JM, Fromm GH. Carbamazepine in the treatment of neuralgia. Use of side effects. Arch Neurol. 1968 Aug;19(2):129-36. doi: 10.1001/archneur.1968.00480020015001. No abstract available.

    PMID: 4877400BACKGROUND

  • Wiffen PJ, McQuay HJ, Moore RA. Carbamazepine for acute and chronic pain. Cochrane Database Syst Rev. 2005 Jul 20;(3):CD005451. doi: 10.1002/14651858.CD005451.

    PMID: 16034977BACKGROUND

  • Zhang R, Lao L, Ren K, Berman BM. Mechanisms of acupuncture-electroacupuncture on persistent pain. Anesthesiology. 2014 Feb;120(2):482-503. doi: 10.1097/ALN.0000000000000101.

    PMID: 24322588BACKGROUND

  • Wu CH, Lv ZT, Zhao Y, Gao Y, Li JQ, Gao F, Meng XF, Tian B, Shi J, Pan HL, Li M. Electroacupuncture improves thermal and mechanical sensitivities in a rat model of postherpetic neuralgia. Mol Pain. 2013 Apr 3;9:18. doi: 10.1186/1744-8069-9-18.

    PMID: 23551937BACKGROUND

  • Aranha MF, Muller CE, Gaviao MB. Pain intensity and cervical range of motion in women with myofascial pain treated with acupuncture and electroacupuncture: a double-blinded, randomized clinical trial. Braz J Phys Ther. 2015 Jan-Feb;19(1):34-43. doi: 10.1590/bjpt-rbf.2014.0066. Epub 2014 Nov 28.

    PMID: 25714602BACKGROUND

  • Headache Classification Subcommittee of the International Headache Society. The International Classification of Headache Disorders: 2nd edition. Cephalalgia. 2004;24 Suppl 1:9-160. doi: 10.1111/j.1468-2982.2003.00824.x. No abstract available.

    PMID: 14979299BACKGROUND

  • Truini A, Galeotti F, Cruccu G. New insight into trigeminal neuralgia. J Headache Pain. 2005 Sep;6(4):237-9. doi: 10.1007/s10194-005-0195-9.

    PMID: 16362674BACKGROUND

  • Cruccu G, Biasiotta A, Galeotti F, Iannetti GD, Innocenti P, Romaniello A, Truini A. Diagnosis of trigeminal neuralgia: a new appraisal based on clinical and neurophysiological findings. Suppl Clin Neurophysiol. 2006;58:171-86. doi: 10.1016/s1567-424x(09)70067-4. No abstract available.

    PMID: 16623330BACKGROUND

  • Chen GQ, Wang XS, Wang L, Zheng JP. Arterial compression of nerve is the primary cause of trigeminal neuralgia. Neurol Sci. 2014 Jan;35(1):61-6. doi: 10.1007/s10072-013-1518-2. Epub 2013 Aug 21.

    PMID: 23963805BACKGROUND

  • Jia DZ, Li G. Bioresonance hypothesis: a new mechanism on the pathogenesis of trigeminal neuralgia. Med Hypotheses. 2010 Mar;74(3):505-7. doi: 10.1016/j.mehy.2009.09.056. Epub 2009 Nov 8.

    PMID: 19900765BACKGROUND

  • Devor M, Amir R, Rappaport ZH. Pathophysiology of trigeminal neuralgia: the ignition hypothesis. Clin J Pain. 2002 Jan-Feb;18(1):4-13. doi: 10.1097/00002508-200201000-00002.

    PMID: 11803297BACKGROUND

  • Zakrzewska JM, Linskey ME. Trigeminal neuralgia. BMJ. 2014 Feb 17;348:g474. doi: 10.1136/bmj.g474. No abstract available.

    PMID: 24534115BACKGROUND

  • Li R, Sun J, Luo K, Luo N, Sun R, Gao F, Wang Y, Xia Y, Li X, Chen L, Ma R, Shao X, Liang Y, Fang J. Electroacupuncture and carbamazepine for patients with trigeminal neuralgia: a randomized, controlled, 2 x 2 factorial trial. J Neurol. 2024 Aug;271(8):5122-5136. doi: 10.1007/s00415-024-12433-x. Epub 2024 May 31.

    PMID: 38816482DERIVED

MeSH Terms

Conditions

Trigeminal Neuralgia

Condition Hierarchy (Ancestors)

Trigeminal Nerve DiseasesFacial NeuralgiaFacial Nerve DiseasesMouth DiseasesStomatognathic DiseasesCranial Nerve DiseasesNervous System Diseases

Study Officials

  • Jianqiao Fang, Ph.D,M.D

    Zhejiang Chinese Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 2, 2018

First Posted

July 9, 2018

Study Start

July 12, 2018

Primary Completion

January 31, 2021

Study Completion

January 31, 2021

Last Updated

September 16, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)