Electroacupuncture Therapy for Change of Pain in Classical Trigeminal Neuralgia
NCT ID: NCT03580317
Last Updated: 2022-09-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
120 participants
INTERVENTIONAL
2018-07-12
2021-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Synergism and Attenuation Effects of Electroacupuncture in the Treatment of Trigeminal Neuralgia
NCT07074561
The Alternative Effects of Electroacupuncture in the Treatment of Trigeminal Neuralgia
NCT06977932
Efficacy of Electroacupuncture Combined With Pregabalin in the Treatment of Trigeminal Herpetic Neuralgia: a Multicenter Randomized Controlled Trial Study Protocol
NCT06261801
The Clinical Benefits of the Combination Use of Acupuncture and Antihistamine on Trigeminal Neuralgia
NCT04384224
The Treatment of Postherpetic Neuralgia in the Head and Face With Superficial Needling Combined With Electroacupuncture
NCT06420778
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
FACTORIAL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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.
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.
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.
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.
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 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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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.
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 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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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.
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Jiaxing TCM Hospital
UNKNOWN
Zhejiang Chinese Medical University
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Jianqiao Fang
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jianqiao Fang, Ph.D,M.D
Role: PRINCIPAL_INVESTIGATOR
Zhejiang Chinese Medical University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
the Third affiliated hospital of Zhejiang Chinese Medical university
Hangzhou, Zhejiang, China
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Zakrzewska JM, Linskey ME. Trigeminal neuralgia. BMJ. 2014 Feb 17;348:g474. doi: 10.1136/bmj.g474. No abstract available.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2018ZY008-CTN
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.