Electroacupuncture Therapy for Change of Pain in Classical Trigeminal Neuralgia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change from Baseline Intensity of Pain to 28 weeks
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: EA+Placebo (Other)
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.
干预措施: EA+ Carbamazepine (Other)
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.
干预措施: sham EA+Carbamazepine (Other)
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.
干预措施: sham EA+Placebo (Other)
结局指标
主要结局
Change from Baseline Intensity of Pain to 28 weeks
时间窗: 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.
次要结局
- Short-Form McGill Pain Questionnaire(Baseline, 2 weeks, 4 weeks, 16 weeks, 28 weeks)
- Patient Global Impression of Change(PGIC)(Baseline, 2 weeks, 4 weeks, 16 weeks, 28 weeks)
- Brief Pain Inventory-Facial scale(BPI-Facial)(Baseline, 2 weeks, 4 weeks, 16 weeks, 28 weeks)
- The proportion of patients using rescue analgesics(Baseline, 2 weeks, 4 weeks, 16 weeks, 28 weeks)
- Short-Form 36 Questionnaire(Baseline, 2 weeks, 4 weeks, 16 weeks, 28 weeks)
- The frequency of CTN attacks(Baseline, 2 weeks, 4 weeks, 16 weeks, 28 weeks)
研究者
Jianqiao Fang
Professor
Zhejiang Chinese Medical University