KCT0012340进行中（未招募）不适用
A Pilot study on the efficacy of acupuncture stimulation at referred points for menstrual distress
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 主要目的
- Other(This clinical study aims to evaluate the effectiveness of acupuncture stimulation at referred points on the calf in relieving menstrual pain in patients with dysmenorrhea.), Intervention Model : Parallel, Blinding/Masking : Single, Blinding Target : Subject, Allocation : RCT
入排标准
- 年龄范围
- 19(Year) 至 No Limit（—）
- 性别
- Female
入选标准
- •Women of reproductive age, 19 years or older
- •Individuals classified as Grade 1 or Grade 2 according to the Menstrual Pain Index
- •Individuals whose total score for pain-related items (Questions 1–6) under “most recent menstruation” on the MDQ (Form C) is at least 5 points higher than the total score for “other days”
- •Individuals who have received a clear explanation of the purpose and nature of the study, have agreed to participate, and have signed the informed consent form
排除标准
- •Individuals with neurological disorders such as epilepsy, meningitis, encephalitis, cerebrovascular disease, multiple sclerosis, tic disorders, headaches, peripheral neuropathy, or sensory nerve disorders
- •Individuals with chronic diseases such as hypertension or arrhythmia
- •Hypertension is defined as an average systolic blood pressure of =140 mmHg or diastolic blood pressure of =90 mmHg, measured twice at intervals of at least 2 minutes using an automated sphygmomanometer after resting in a seated position for more than 5 minutes
- •Arrhythmia confirmed via PPG examination
- •Individuals with allergic reactions to study-related skin-contact materials such as metals or electrode gel
- •Individuals with burns, scars, or skin diseases at the stimulation site
- •Individuals with a history of general anesthesia within the past year
- •Individuals who have taken medications within the past month related to pain relief, psychiatric treatment (e.g., antidepressants), or for endocrine or neurological conditions (e.g., diabetes or hypertension medications)
- •Individuals with irregular menstrual cycles exceeding 10 days of variation
- •Individuals previously diagnosed with gynecological conditions known to cause menstrual pain, such as uterine fibroids, endometriosis, ovarian cysts, polycystic ovary syndrome (PCOS), or pelvic inflammatory disease
- •Individuals with polymenorrhea (menstrual cycle =21 days) or oligomenorrhea (menstrual cycle =35 days)
- •Individuals deemed unable to complete study-related documentation
- •Individuals who have taken other investigational drugs within the past three months
- •Individuals who do not agree to use effective contraception during the study period
- •Any other individuals deemed unsuitable for participation by the investigator
研究者
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