The Study on the Therapeutic Effect and Mechanism of Transcutaneous Acupoint Electrical Stimulation in Female

Study Overview
=================
Brief Summary
-----------------
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

Detailed Description
-----------------
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.

Official Title
-----------------
The Study on the Therapeutic Effect and Mechanism of Transcutaneous Acupoint Electrical Stimulation in Female

Conditions
-----------------
Dysmenorrhea

Intervention / Treatment
-----------------
* Device: Transcutaneous electrical acupoint stimulation
* Drug: non steroidal anti inflammatory drugs


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Women with dysmenorrhea treated with TEAS<br>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. | Device: Transcutaneous electrical acupoint stimulation<br>* 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.<br>|
| Active Comparator: Women with dysmenorrhea receiving medication<br>Take NSAIDs or birth control pills every six hours during your period when you feel unbearable pain. | Drug: non steroidal anti inflammatory drugs<br>* Hormonal contraception can suppress ovulation, NSAIDS can ease pain<br>* Other names: Short-acting birth control pills;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale | 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. | six months | 
| the Cox Menstrual Symptom Scale | 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. | six months | 
| Work Productivity and Activity Impairment | 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. | six months | 
| Hamilton Anxiety Scale | 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. | six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in prostaglandins secretion level | PGF2α is a marker molecule associated with dysmenorrhea, which is increased during dysmenorrhea. | six months | 
| Changes in β-endorphin level | β-endorphin is a marker molecule associated with dysmenorrhea, which is increased during dysmenorrhea. | six months | 
| Changes in Nitric Oxide level | NO is a marker molecule associated with dysmenorrhea, which is reduced during dysmenorrhea. | six months | 
| Changes in endothelin level | Endothelin is a marker molecule associated with dysmenorrhea, which is increased during dysmenorrhea. | six months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dysmenorrhea, acupuncture, TEAS