Dysmenorrhea
Conditions
Keywords
Dysmenorrhea, acupuncture, TEAS
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.
Interventions
DEVICETranscutaneous 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.
Hormonal contraception can suppress ovulation, NSAIDS can ease pain
Sponsors
Honglan Zhu
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Contacts
Primary ContactHonglan Zhu, M.D
Outcome results
None listed