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| Name | Class |
|---|---|
| Jiaxing TCM Hospital | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 2 weeks, 4 weeks, 16 weeks, 28 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jianqiao Fang, Ph.D,M.D | Zhejiang Chinese Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the Third affiliated hospital of Zhejiang Chinese Medical university | Hangzhou | Zhejiang | 310000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25750533 | Background | 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. | |
| 19619267 | Background | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 20, 2018 | Jun 25, 2018 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 20, 2018 | Jun 25, 2018 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D014277 | Trigeminal Neuralgia |
| ID | Term |
|---|---|
| D020433 | Trigeminal Nerve Diseases |
| D005156 | Facial Neuralgia |
| D005155 | Facial Nerve Diseases |
| D009059 | Mouth Diseases |
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| 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. |
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| 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. |
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| 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. |
|
| Patient Global Impression of Change(PGIC) | This index will record the general change impression of pain for CTN. | Baseline, 2 weeks, 4 weeks, 16 weeks, 28 weeks |
| 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. | Baseline, 2 weeks, 4 weeks, 16 weeks, 28 weeks |
| 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). | Baseline, 2 weeks, 4 weeks, 16 weeks, 28 weeks |
| The proportion of patients using rescue analgesics | The proportion of patients using rescue analgesics | Baseline, 2 weeks, 4 weeks, 16 weeks, 28 weeks |
| The frequency of CTN attacks | Calculated from the pain diary | Baseline, 2 weeks, 4 weeks, 16 weeks, 28 weeks |
| 24719027 | Background | 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. |
| 4877400 | Background | 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. |
| 16034977 | Background | 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. |
| 24322588 | Background | 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. |
| 23551937 | Background | 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. |
| 25714602 | Background | 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. |
| 14979299 | Background | 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. |
| 16362674 | Background | 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. |
| 16623330 | Background | 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. |
| 23963805 | Background | 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. |
| 19900765 | Background | 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. |
| 11803297 | Background | 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. |
| 24534115 | Background | Zakrzewska JM, Linskey ME. Trigeminal neuralgia. BMJ. 2014 Feb 17;348:g474. doi: 10.1136/bmj.g474. No abstract available. |
| 38816482 | Derived | 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. |
| D009057 |
| Stomatognathic Diseases |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |