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

Sponsor

Honglan Zhu (Other)

Overall Status

Recruiting

CT.gov ID

NCT05799924

Collaborator

(none)

240

Enrollment

Location

Arms

10.3

Anticipated Duration (Months)

23.4

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Dysmenorrhea	Device: Transcutaneous electrical acupoint stimulation Drug: non steroidal anti inflammatory drugs	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

240 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Care Provider, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 21, 2023

Anticipated Primary Completion Date :

Dec 30, 2023

Anticipated Study Completion Date :

Dec 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Device: 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.
Active Comparator: Women with dysmenorrhea receiving medication Take NSAIDs or birth control pills every six hours during your period when you feel unbearable pain.	Drug: non steroidal anti inflammatory drugs Hormonal contraception can suppress ovulation, NSAIDS can ease pain Other Names: Short-acting birth control pills

Arm

Intervention/Treatment

Experimental: 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.

Device: Transcutaneous electrical acupoint stimulation

Active Comparator: Women with dysmenorrhea receiving medication

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

Drug: non steroidal anti inflammatory drugs

Hormonal contraception can suppress ovulation, NSAIDS can ease pain

Other Names:

Short-acting birth control pills

Outcome Measures

Primary Outcome Measures

Visual Analogue Scale [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.
the Cox Menstrual Symptom Scale [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.
Work Productivity and Activity Impairment [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 [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.

Secondary Outcome Measures

Changes in prostaglandins secretion level [six months]
PGF2α is a marker molecule associated with dysmenorrhea, which is increased during dysmenorrhea.
Changes in β-endorphin level [six months]
β-endorphin is a marker molecule associated with dysmenorrhea, which is increased during dysmenorrhea.
Changes in Nitric Oxide level [six months]
NO is a marker molecule associated with dysmenorrhea, which is reduced during dysmenorrhea.
Changes in endothelin level [six months]
Endothelin is a marker molecule associated with dysmenorrhea, which is increased during dysmenorrhea.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.