Clinical trial NCT05799924: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Dysmenorrhea
Keywords: Dysmenorrhea
acupuncture
TEAS
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2023-04-05
Enrollment: 240
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: six months
measure: the Cox Menstrual Symptom Scale
timeFrame: six months
measure: Work Productivity and Activity Impairment
timeFrame: six months
measure: Hamilton Anxiety Scale
timeFrame: six months
Secondary outcomes:
measure: Changes in prostaglandins secretion level
timeFrame: six months
measure: Changes in β-endorphin level
timeFrame: six months
measure: Changes in Nitric Oxide level
timeFrame: six months
measure: Changes in endothelin level
timeFrame: six months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
Study officials:
affiliation: Peking University People's Hospital
name: Honglan Zhu, M.D
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.