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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-21

Study Completion Date

2023-12-30

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Dysmenorrhea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Transcutaneous electrical acupoint stimulation

Intervention Type DEVICE

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.

Women with dysmenorrhea receiving medication

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

Group Type ACTIVE_COMPARATOR

non steroidal anti inflammatory drugs

Intervention Type DRUG

Hormonal contraception can suppress ovulation, NSAIDS can ease pain

Interventions

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Transcutaneous electrical acupoint stimulation

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.

Intervention Type DEVICE

non steroidal anti inflammatory drugs

Hormonal contraception can suppress ovulation, NSAIDS can ease pain

Intervention Type DRUG

Other Intervention Names

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Short-acting birth control pills

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No