None listed
Conditions
Interventions
Medical Device, Others(Acupuncture stimulation method) : Participants will be divided into two groups: an experimental group receiving stimulation at cutaneous referred points during menstruation, and
Sponsors
Korea Institute of Oriental Medicine
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Women of reproductive age, 19 years or older 2)Individuals classified as Grade 1 or Grade 2 according to the Menstrual Pain Index 3)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” 4)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
Exclusion criteria
Exclusion criteria: 1)Individuals with neurological disorders such as epilepsy, meningitis, encephalitis, cerebrovascular disease, multiple sclerosis, tic disorders, headaches, peripheral neuropathy, or sensory nerve disorders 2)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 3)Individuals with allergic reactions to study-related skin-contact materials such as metals or electrode gel 4)Individuals with burns, scars, or skin diseases at the stimulation site 5)Individuals with a history of general anesthesia within the past year 6)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) 7)Individuals with irregular menstrual cycles exceeding 10 days of variation 8)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 9)Individuals with polymenorrhea (menstrual cycle =21 days) or oligomenorrhea (menstrual cycle =35 days) 10)Individuals deemed unable to complete study-related documentation 11)Individuals who have taken other investigational drugs within the past three months 12)Individuals who do not agree to use effective contraception during the study period 13)Any other individuals deemed unsuitable for participation by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of changes in MDQ (Form T) scores before and after acupuncture stimulation between the referred point stimulation group and the non-referred point stimulation group during the occurrence of menstrual pain | — |
Secondary
| Measure | Time frame |
|---|---|
| Differences in EEG patterns in the somatosensory cortex before and after acupuncture stimulation at referred points;Differences in EEG pattern in the somatosensory cortex during stimulation of referred points versus non-referred points | — |
Countries
Korea, Republic of
Contacts
Public ContactKwang Ho Choi
Korea Institute of Oriental Medicine
Outcome results
None listed