The Study on the Therapeutic Effect and Mechanism of Transcutaneous Acupoint Electrical Stimulation in Female
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Visual Analogue Scale
研究概览
简要总结
The goal of this clinical trial is to investigate the use of TEAS on female patients with dysmenorrhea. The main questions it aims to answer are:
Questions 1：Effect of TEAS on dysmenorrhea Questions 2：Mechanism of TEAS in treatment of dysmenorrhea Participants will wear TEAS devices to treat dysmenorrhea during menstruation The participants in the control group were treated with oral medication for dysmenorrhea
详细描述
Dysmenorrhea is a common female disease, with an incidence about 20-40% in female, affecting the living quality of the patients. The treatment of dysmenorrhea usually includes hormone drugs to suppress ovulation, and oral non-steroidal anti-inflammatory drugs to relieve pain, but symptoms would relapse after drugs withdrawal. While long-term use of these drugs may cause endocrine disorders, even affect the normal preparation of pregnancy. Recent studies have shown that dysmenorrhea is related to many factors such as immune and neuroendocrine changes. Transcutaneous electric acupoint stimulation (TEAS) is a new therapeutic method derived from traditional acupuncture therapy. In this method, the electrode placed on the surface of the skin of acupoints is used to guide the stimulating current into the body and stimulate the acupoints to achieve the goal of treatment, and can effectively relieve the pain of patients by replacing the traditional mechanical stimulation of hand-twisting needles. The aim of this study is to treat dysmenorrhea in women with TEAS, and to observe the therapeutic effect of TEAS, at the same time, prostaglandins, pain-related factors and immune-related factors were detected in dysmenorrhea women before and after treatment to study the mechanism.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •there are symptoms of dysmenorrhea, the duration is more than or equal to 6 months；
- •regular menstruation, menstrual cycle 21 ~ 35 days, menstrual period 3 ~ 7 days.
排除标准
- •dysmenorrhea caused by abnormality and obstruction of reproductive tract；
- •preparing for pregnancy or being pregnant；
- •endometriosis or adenomyosis with surgical indication；
- •taking NSAIDs within one month or receiving immunosuppressive therapy within three months；
- •implantation of pacemaker or other implanted medical electronic devices；
- •high frequency surgical equipment, artificial heart and lung, medical shortwave and microwave therapeutic apparatus were used；
- •scarring or skin damage at the site of irritation；
- •refused to sign the informed consent form.
研究组 & 干预措施
Women with dysmenorrhea treated with TEAS
The transcutaneous electrical acupoint stimulator applied alternating current (including sine wave, pulse wave and modulation wave) with frequency of 2 ~ 100Hz and intensity of 10-20mA to stimulate corresponding acupoints through skin electrodes. The stimulated acupoints include Hegu acupoints, Luogong acupoints, Neiguan acupoints and Waiguan acupoints.
干预措施: Transcutaneous electrical acupoint stimulation (Device)
Women with dysmenorrhea receiving medication
Take NSAIDs or birth control pills every six hours during your period when you feel unbearable pain.
干预措施: non steroidal anti inflammatory drugs (Drug)
结局指标
主要结局
Visual Analogue Scale
时间窗: six months
The self-rating scale was used to describe the changes of dysmenorrhea symptoms before and after the intervention, with a total score of 0-10, and the greater the number, the more severe the pain.
Work Productivity and Activity Impairment
时间窗: six months
The self-rating scale was used to describe the changes of dysmenorrhea symptoms before and after the intervention, with the total score ranging from 0 to 100. The greater the number, the more severe the pain.
Hamilton Anxiety Scale
时间窗: six months
The self-rating scale was used to describe the changes of dysmenorrhea symptoms before and after the intervention, with the total score ranging from 0 to 100. The greater the number, the more severe the pain.
the Cox Menstrual Symptom Scale
时间窗: six months
The self-rating scale was used to describe the changes of dysmenorrhea symptoms before and after the intervention, with the total score ranging from 0 to 100. The greater the number, the more severe the pain.
次要结局
- Changes in β-endorphin level(six months)
- Changes in Nitric Oxide level(six months)
- Changes in prostaglandins secretion level(six months)
- Changes in endothelin level(six months)
研究者
Honglan Zhu
Chief physician，OBGYN
Peking University People's Hospital