Clinical trial NCT03580317: Electroacupuncture Therapy for Change of Pain in Classical Trigeminal Neuralgia
Official title: Electroacupuncture Therapy for Change of Pain in Classical Trigeminal Neuralgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Trigeminal Neuralgia
Keywords: Classical trigeminal neuralgia
Electroacupuncture
Randomized controlled clinical trial
Lead sponsor: Zhejiang Chinese Medical University
Sponsor class: OTHER_GOV
Collaborators: name: Jiaxing TCM Hospital
First posted: 2018-07-09
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

1. Patients suffer from the pain with electric shock, shooting, stabbing occurs in one or more branches of the 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.

Primary outcomes:
measure: Change from Baseline Intensity of Pain to 28 weeks
timeFrame: Baseline, 2 weeks, 4 weeks, 16 weeks, 28 weeks
Secondary outcomes:
measure: Brief Pain Inventory-Facial scale(BPI-Facial)
timeFrame: Baseline, 2 weeks, 4 weeks, 16 weeks, 28 weeks
measure: Patient Global Impression of Change(PGIC)
timeFrame: Baseline, 2 weeks, 4 weeks, 16 weeks, 28 weeks
measure: Short-Form McGill Pain Questionnaire
timeFrame: Baseline, 2 weeks, 4 weeks, 16 weeks, 28 weeks
measure: Short-Form 36 Questionnaire
timeFrame: Baseline, 2 weeks, 4 weeks, 16 weeks, 28 weeks
measure: The proportion of patients using rescue analgesics
timeFrame: Baseline, 2 weeks, 4 weeks, 16 weeks, 28 weeks
measure: The frequency of CTN attacks
timeFrame: Baseline, 2 weeks, 4 weeks, 16 weeks, 28 weeks
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: the Third affiliated hospital of Zhejiang Chinese Medical university
state: Zhejiang
Study officials:
affiliation: Zhejiang Chinese Medical University
name: Jianqiao Fang, Ph.D,M.D
role: PRINCIPAL_INVESTIGATOR
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