The Study on the Therapeutic Effect and Mechanism of Transcutaneous Acupoint Electrical Stimulation in Female
April 4, 2023 updated by: Honglan Zhu
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
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
240
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Honglan Zhu, M.D
- Phone Number: 13661316849
- Email: honglanzhu01@163.com
Study Locations
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-
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Beijing, China, 100044
- Recruiting
- Peking University People's Hospital
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Contact:
- Honglan Zhu, M.D
- Phone Number: 13661316849
- Email: honglanzhu01@163.com
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / 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.
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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.
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Active Comparator: Women with dysmenorrhea receiving medication
Take NSAIDs or birth control pills every six hours during your period when you feel unbearable pain.
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Hormonal contraception can suppress ovulation, NSAIDS can ease pain
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analogue Scale
Time Frame: 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.
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six months
|
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the Cox Menstrual Symptom Scale
Time Frame: 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.
|
six months
|
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Work Productivity and Activity Impairment
Time Frame: 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.
|
six months
|
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Hamilton Anxiety Scale
Time Frame: 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.
|
six months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in prostaglandins secretion level
Time Frame: six months
|
PGF2α is a marker molecule associated with dysmenorrhea, which is increased during dysmenorrhea.
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six months
|
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Changes in β-endorphin level
Time Frame: six months
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β-endorphin is a marker molecule associated with dysmenorrhea, which is increased during dysmenorrhea.
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six months
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Changes in Nitric Oxide level
Time Frame: six months
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NO is a marker molecule associated with dysmenorrhea, which is reduced during dysmenorrhea.
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six months
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Changes in endothelin level
Time Frame: six months
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Endothelin is a marker molecule associated with dysmenorrhea, which is increased during dysmenorrhea.
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six months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Honglan Zhu, M.D, Peking University People's Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 21, 2023
Primary Completion (Anticipated)
December 30, 2023
Study Completion (Anticipated)
December 30, 2023
Study Registration Dates
First Submitted
February 21, 2023
First Submitted That Met QC Criteria
April 4, 2023
First Posted (Actual)
April 5, 2023
Study Record Updates
Last Update Posted (Actual)
April 5, 2023
Last Update Submitted That Met QC Criteria
April 4, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Pain
- Neurologic Manifestations
- Menstruation Disturbances
- Pelvic Pain
- Dysmenorrhea
- Physiological Effects of Drugs
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Non-Narcotic
- Antirheumatic Agents
- Anti-Inflammatory Agents
- Anti-Inflammatory Agents, Non-Steroidal
Other Study ID Numbers
- RDL2022-47
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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