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

Primary Purpose

Dysmenorrhea

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Transcutaneous electrical acupoint stimulation
non steroidal anti inflammatory drugs
Sponsored by
Honglan Zhu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dysmenorrhea focused on measuring Dysmenorrhea, acupuncture, TEAS

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept 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.

Sites / Locations

  • Peking University People's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Women with dysmenorrhea treated with TEAS

Women with dysmenorrhea receiving medication

Arm 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.

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

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

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

Full Information

First Posted
February 21, 2023
Last Updated
April 4, 2023
Sponsor
Honglan Zhu
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1. Study Identification

Unique Protocol Identification Number
NCT05799924
Brief Title
The Study on the Therapeutic Effect and Mechanism of Transcutaneous Acupoint Electrical Stimulation in Female
Official Title
The Study on the Therapeutic Effect and Mechanism of Transcutaneous Acupoint Electrical Stimulation in Female
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 21, 2023 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Honglan Zhu

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysmenorrhea
Keywords
Dysmenorrhea, acupuncture, TEAS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Women with dysmenorrhea treated with TEAS
Arm Type
Experimental
Arm 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.
Arm Title
Women with dysmenorrhea receiving medication
Arm Type
Active Comparator
Arm Description
Take NSAIDs or birth control pills every six hours during your period when you feel unbearable pain.
Intervention Type
Device
Intervention Name(s)
Transcutaneous electrical acupoint stimulation
Intervention 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.
Intervention Type
Drug
Intervention Name(s)
non steroidal anti inflammatory drugs
Other Intervention Name(s)
Short-acting birth control pills
Intervention Description
Hormonal contraception can suppress ovulation, NSAIDS can ease pain
Primary Outcome Measure Information:
Title
Visual Analogue Scale
Description
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.
Time Frame
six months
Title
the Cox Menstrual Symptom Scale
Description
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.
Time Frame
six months
Title
Work Productivity and Activity Impairment
Description
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.
Time Frame
six months
Title
Hamilton Anxiety Scale
Description
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.
Time Frame
six months
Secondary Outcome Measure Information:
Title
Changes in prostaglandins secretion level
Description
PGF2α is a marker molecule associated with dysmenorrhea, which is increased during dysmenorrhea.
Time Frame
six months
Title
Changes in β-endorphin level
Description
β-endorphin is a marker molecule associated with dysmenorrhea, which is increased during dysmenorrhea.
Time Frame
six months
Title
Changes in Nitric Oxide level
Description
NO is a marker molecule associated with dysmenorrhea, which is reduced during dysmenorrhea.
Time Frame
six months
Title
Changes in endothelin level
Description
Endothelin is a marker molecule associated with dysmenorrhea, which is increased during dysmenorrhea.
Time Frame
six months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Honglan Zhu, M.D
Phone
13661316849
Email
honglanzhu01@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Honglan Zhu, M.D
Organizational Affiliation
Peking University People's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University People's Hospital
City
Beijing
ZIP/Postal Code
100044
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Honglan Zhu, M.D
Phone
13661316849
Email
honglanzhu01@163.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
16690671
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.
Results Reference
background
PubMed Identifier
15575029
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.
Results Reference
background
PubMed Identifier
16824213
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.
Results Reference
background
PubMed Identifier
8532266
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.
Results Reference
background
PubMed Identifier
11115307
Citation
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.
Results Reference
background

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

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