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Trial record 64 of 89 for:    CARBAMAZEPINE AND Psychotropic

Electroacupuncture Therapy for Change of Pain in Classical Trigeminal Neuralgia

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ClinicalTrials.gov Identifier: NCT03580317
Recruitment Status : Not yet recruiting
First Posted : July 9, 2018
Last Update Posted : July 9, 2018
Sponsor:
Collaborator:
Jiaxing TCM Hospital
Information provided by (Responsible Party):
Jianqiao Fang, Zhejiang Chinese Medical University

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Muti-center Randomized Controlled Trials on Acupuncture Treatment for Chronic Pain
Estimated Study Start Date : July 9, 2018
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Change from Baseline Intensity of Pain at 6 months [ Time Frame: 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.

  2. Change from Baseline Brief introduction of 2-week pain [ Time Frame: 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 :
  1. Brief Pain Inventory-Facial scale(BPI-Facial) [ Time Frame: 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.

  2. Patient Global Impression of Change(PGIC) [ Time Frame: Baseline, 2 weeks, 4 weeks, 3 months, 6 months ]
    This index will record the general change impression of pain for CTN.

  3. Short-Form McGill Pain Questionnaire [ Time Frame: 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.

  4. Short-Form 36 Questionnaire [ Time Frame: 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).



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Paroxysm pain involving branches of the 2nd and/or 3rd branch of trigeminal nerve.
  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:

  1. Those patients with epilepsy, head injury or other related neurological diseases.
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03580317


Contacts
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Contact: Jianqiao Fang, Ph.D,M.D 86-13606707532 fangjianqiao7532@163.com
Contact: Jing Sun, Ph.D 86-13429610268 sunjing0268@163.com

Sponsors and Collaborators
Zhejiang Chinese Medical University
Jiaxing TCM Hospital
Investigators
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Principal Investigator: Jianqiao Fang, Ph.D,M.D Zhejiang Chinese Medical University
  Study Documents (Full-Text)

Documents provided by Jianqiao Fang, Zhejiang Chinese Medical University:
Informed Consent Form  [PDF] June 20, 2018


Publications:

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Responsible Party: Jianqiao Fang, Professor, Zhejiang Chinese Medical University
ClinicalTrials.gov Identifier: NCT03580317     History of Changes
Other Study ID Numbers: 2018ZY008-CTN
First Posted: July 9, 2018    Key Record Dates
Last Update Posted: July 9, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jianqiao Fang, Zhejiang Chinese Medical University:
Classical trigeminal neuralgia
Electroacupuncture
Randomized controlled clinical trial
Additional relevant MeSH terms:
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Carbamazepine
Psychotropic Drugs
Trigeminal Neuralgia
Neuralgia
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Trigeminal Nerve Diseases
Facial Neuralgia
Facial Nerve Diseases
Mouth Diseases
Stomatognathic Diseases
Cranial Nerve Diseases
Anticonvulsants
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers