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

Honglan Zhu

Status: Enrolling

Conditions: Dysmenorrhea

Treatments: Drug: non steroidal anti inflammatory drugs; Device: Transcutaneous electrical acupoint stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05799924

RDL2022-47

Details and patient eligibility

About

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

Full 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.

Enrollment: 240 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. there are symptoms of dysmenorrhea, the duration is more than or equal to 6 months；
2. regular menstruation, menstrual cycle 21 ~ 35 days, menstrual period 3 ~ 7 days.

Exclusion criteria

1. dysmenorrhea caused by abnormality and obstruction of reproductive tract；
2. preparing for pregnancy or being pregnant；
3. endometriosis or adenomyosis with surgical indication；
4. taking NSAIDs within one month or receiving immunosuppressive therapy within three months；
5. implantation of pacemaker or other implanted medical electronic devices；
6. high frequency surgical equipment, artificial heart and lung, medical shortwave and microwave therapeutic apparatus were used；
7. scarring or skin damage at the site of irritation；
8. refused to sign the informed consent form.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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240 participants in 2 patient groups

Women with dysmenorrhea treated with TEAS

Experimental group

Description:

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.

Treatment:

Device: Transcutaneous electrical acupoint stimulation

Women with dysmenorrhea receiving medication

Active Comparator group

Description:

Take NSAIDs or birth control pills every six hours during your period when you feel unbearable pain.

Treatment:

Drug: non steroidal anti inflammatory drugs