Electroacupuncture Therapy for Change of Pain in Classical Trigeminal Neuralgia
- Conditions
- Trigeminal Neuralgia
- Interventions
- Other: sham EA+CarbamazepineOther: EA+PlaceboOther: sham EA+PlaceboOther: EA+ Carbamazepine
- Registration Number
- NCT03580317
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
- 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.
- 18 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Sham EA+ Carbamazepine Group sham EA+Carbamazepine 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. EA + Placebo Group EA+Placebo 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. Sham EA+ Placebo Group sham EA+Placebo 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. EA + Carbamazepine Group EA+ Carbamazepine 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.
- Primary Outcome Measures
Name Time Method Change from Baseline Intensity of Pain to 28 weeks Baseline, 2 weeks, 4 weeks, 16 weeks, 28 weeks Evaluation of the pain by VAS with 0-10 points which that 0 means painless and 10 means very painful.
- Secondary Outcome Measures
Name Time Method Patient Global Impression of Change(PGIC) Baseline, 2 weeks, 4 weeks, 16 weeks, 28 weeks This index will record the general change impression of pain for CTN.
Short-Form McGill Pain Questionnaire Baseline, 2 weeks, 4 weeks, 16 weeks, 28 weeks 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.
Brief Pain Inventory-Facial scale(BPI-Facial) Baseline, 2 weeks, 4 weeks, 16 weeks, 28 weeks 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.
The proportion of patients using rescue analgesics Baseline, 2 weeks, 4 weeks, 16 weeks, 28 weeks The proportion of patients using rescue analgesics
Short-Form 36 Questionnaire Baseline, 2 weeks, 4 weeks, 16 weeks, 28 weeks 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).
The frequency of CTN attacks Baseline, 2 weeks, 4 weeks, 16 weeks, 28 weeks Calculated from the pain diary
Trial Locations
- Locations (1)
the Third affiliated hospital of Zhejiang Chinese Medical university
🇨🇳Hangzhou, Zhejiang, China