About this trial
Primary dysmenorrhea is a common condition that significantly affects young women's quality of life. Traditional Chinese Medicine (TCM) acupoint interventions are widely used for symptom relief; however, standardized fixed-acupoint approaches often overlook individual meridian status variations.
This pilot study aims to evaluate the feasibility, preliminary efficacy, and physiological responses of an individualized meridian-guided intervention for primary dysmenorrhea in females aged 18-30. Utilizing non-invasive skin electrical resistance measurements (AETOSCAN) to assess baseline meridian energy status, eligible dysmenorrhea participants will be randomized into two parallel arms: an individualized meridian-guided intervention group and a standardized fixed-acupoint group. Interventions will be administered twice weekly over a 4-week cycle. The primary outcomes focus on changes in pain severity (VAS), menstrual distress scores (MDQ), and objective meridian electrical characteristics.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
20 female participants with a history of primary dysmenorrhea symptoms.
20 healthy female controls without significant dysmenorrhea symptoms.
Age Range: Females aged 18-30 years.
Menstrual Regularity: Regular menstrual cycles, defined as a cycle duration of 21-35 days.
Disqualifiers
History of major gynecological disorders.
Confirmed diagnosis of structural or organic gynecological conditions, including endometriosis, uterine fibroids, or polycystic ovary syndrome (PCOS).
Long-term use of medications that affect the menstrual cycle.
Currently undergoing hormonal therapy or long-term administration of analgesics.
Trial design
Parallel
Treatments tested in this trial
TI-816-3E3 Portable Laser Phototherapy Device
DeviceApplication of low-level laser acupuncture on predefined classic acupoints (SP6, CV4, CV6) for 20 minutes per session, twice per week for 4 consecutive weeks.
TI-816-3E3 Portable Laser Phototherapy Device
DeviceApplication of low-level laser acupuncture tailored to individual meridian imbalance profiles identified by AETOSCAN, for 20 minutes per session, twice per week for 4 consecutive weeks.
Treatment groups
Trial outcomes
Primary outcomes
Change in Dysmenorrhea Pain Severity via Visual Analog Scale (VAS)
The Visual Analog Scale (VAS) is a 0-100 mm continuous scale used to measure subjective menstrual pain severity (0 = no pain, 100 = worst imaginable pain). Higher scores indicate greater pain intensity. Time Frame: Baseline (Pre-treatment), Mid-treatment (Week 2 of intervention), and Post-treatment (Week 4, immediately following intervention completion).
Secondary outcomes
Change in Menstrual Distress Symptoms via Moos Menstrual Distress Questionnaire (MDQ Form C)
The MDQ Form C consists of 46 items across 8 subscales assessed on a 5-point Likert scale (0 = no symptom to 4 = severe symptom). Total scores range from 0 to 184, with higher scores reflecting greater menstrual distress.
Change in Meridian Electrical Resistance Profiles
Objective skin electrical resistance (in microamperes, µA) measured across twelve primary meridian Yuan-Source points using the AETOSCAN system to assess systemic physiological energy shifts.
Sponsors and contacts
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