Individualized Acupoint Therapy for Dysmenorrhea: An Exploratory Research Design Based on Meridian Measurement

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-30
SponsorChina Medical University Hospital

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • TI-816-3E3 Portable Laser Phototherapy Device

    Device

    Application 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

    Device

    Application 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

40 Participants
are divided into 2 treatment groups
Group A: Active Control: Standard Acupoint GroupActive comparator 1 intervention
Group B: Experimental: Individualized Meridian-Guided GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
Baseline (Pre-treatment), Mid-treatment (Week 2 of intervention), and Post-treatment (Week 4, immediately following intervention completion).

Secondary outcomes

1

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.

Time frame
Baseline (Pre-treatment), Mid-treatment (Week 2 of intervention), and Post-treatment (Week 4, immediately following intervention completion).
2

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.

Time frame
Baseline (Pre-treatment), Mid-treatment (Week 2 of intervention), and Post-treatment (Week 4, immediately following intervention completion).

Other outcomes

Sponsors and contacts

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