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

Dysmenorrhea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05799924
• Other study ID #: RDL2022-47
• Status: Recruiting
• Phase: N/A
• Start date: February 21, 2023
• Est. completion date: December 30, 2023

Study information

• Verified date: April 2023
• Source: Peking University People's Hospital
• Contact: Honglan Zhu, M.D
• Phone: 13661316849
• Email: honglanzhu01[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dysmenorrhea

Intervention

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.

Drug:
• non steroidal anti inflammatory drugs
Hormonal contraception can suppress ovulation, NSAIDS can ease pain

Locations

Country	Name	City	State
China	Peking University People's Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Honglan Zhu

Country where clinical trial is conducted

China, 

References & Publications (5)

Banikarim C, Chacko MR, Kelder SH. Prevalence and impact of dysmenorrhea on Hispanic female adolescents. Arch Pediatr Adolesc Med. 2000 Dec;154(12):1226-9. doi: 10.1001/archpedi.154.12.1226. — View Citation

Jamieson DJ, Steege JF. The prevalence of dysmenorrhea, dyspareunia, pelvic pain, and irritable bowel syndrome in primary care practices. Obstet Gynecol. 1996 Jan;87(1):55-8. doi: 10.1016/0029-7844(95)00360-6. — View Citation

Latthe P, Latthe M, Say L, Gulmezoglu M, Khan KS. WHO systematic review of prevalence of chronic pelvic pain: a neglected reproductive health morbidity. BMC Public Health. 2006 Jul 6;6:177. doi: 10.1186/1471-2458-6-177. — View Citation

Nasir L, Bope ET. Management of pelvic pain from dysmenorrhea or endometriosis. J Am Board Fam Pract. 2004 Nov-Dec;17 Suppl:S43-7. doi: 10.3122/jabfm.17.suppl_1.s43. — View Citation

Proctor M, Farquhar C. Diagnosis and management of dysmenorrhoea. BMJ. 2006 May 13;332(7550):1134-8. doi: 10.1136/bmj.332.7550.1134. No abstract available. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Changes in prostaglandins secretion level	PGF2a is a marker molecule associated with dysmenorrhea, which is increased during dysmenorrhea.	six months
Secondary	Changes in ß-endorphin level	ß-endorphin is a marker molecule associated with dysmenorrhea, which is increased during dysmenorrhea.	six months
Secondary	Changes in Nitric Oxide level	NO is a marker molecule associated with dysmenorrhea, which is reduced during dysmenorrhea.	six months
Secondary	Changes in endothelin level	Endothelin is a marker molecule associated with dysmenorrhea, which is increased during dysmenorrhea.	six months