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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Women with dysmenorrhea treated with TEAS | Experimental | 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. |
|
| Women with dysmenorrhea receiving medication | Active Comparator | Take NSAIDs or birth control pills every six hours during your period when you feel unbearable pain. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcutaneous electrical acupoint stimulation | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in prostaglandins secretion level | PGF2α is a marker molecule associated with dysmenorrhea, which is increased during dysmenorrhea. | six months |
| Changes in β-endorphin level | β-endorphin is a marker molecule associated with dysmenorrhea, which is increased during dysmenorrhea. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Honglan Zhu, M.D | Contact | 13661316849 | honglanzhu01@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Honglan Zhu, M.D | Peking University People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Recruiting | Beijing | 100044 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16690671 | Background | 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. | |
| 15575029 | Background | 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. |
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| ID | Term |
|---|---|
| D004412 | Dysmenorrhea |
| ID | Term |
|---|---|
| D008599 | Menstruation Disturbances |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017699 | Pelvic Pain |
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|
| non steroidal anti inflammatory drugs | Drug | Hormonal contraception can suppress ovulation, NSAIDS can ease pain |
|
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| six months |
| Changes in Nitric Oxide level | NO is a marker molecule associated with dysmenorrhea, which is reduced during dysmenorrhea. | six months |
| Changes in endothelin level | Endothelin is a marker molecule associated with dysmenorrhea, which is increased during dysmenorrhea. | six months |
| 16824213 | Background | 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. |
| 8532266 | Background | 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. |
| 11115307 | Background | 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. |
| 39929936 | Derived | Wang YL, Zhu HL. The prevalence and associated risk factors of primary dysmenorrhea among women in Beijing: a cross-sectional study. Sci Rep. 2025 Feb 10;15(1):5003. doi: 10.1038/s41598-025-89038-5. |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |