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

NCT07818044 | Not Yet Recruiting

• 1 other identifier: CMUH115-REC2-152
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Primary Dysmenorrhea (PD)

Keywords

Laser Acupuncture; Electrical Skin Resistance; Meridian Diagnosis; Individualized Acupuncture; Traditional Chinese Medicine; Menstrual Distress Questionnaire; Visual Analog Scale; Primary Dysmenorrhea

Outcome Measures

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).

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

Secondary Outcomes (2)

• Change in Menstrual Distress Symptoms via Moos Menstrual Distress Questionnaire (MDQ Form C)

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

• Change in Meridian Electrical Resistance Profiles

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

Study Arms (2)

Active Control: Standard Acupoint Group

ACTIVE COMPARATOR

Participants in this arm receive standardized, fixed-acupoint laser acupuncture (or sham-like press-needle/seeding on standard dysmenorrhea points such as SP6, CV4, CV6) regardless of their individual meridian electrical resistance profile.

Device: TI-816-3E3 Portable Laser Phototherapy Device

Experimental: Individualized Meridian-Guided Group

EXPERIMENTAL

Participants in this arm receive individualized laser acupuncture based on real-time meridian electrical resistance measurements using AETOSCAN prior to each intervention session.

Device: TI-816-3E3 Portable Laser Phototherapy Device

Interventions

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.

Active Control: Standard Acupoint Group

Eligibility Criteria

• Age: 18 Years - 30 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• female participants with a history of primary dysmenorrhea symptoms.
• 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.
• Menstrual Stability: Relatively stable menstrual patterns within the past 3 months.
• Informed Consent \& Compliance: Willingness to comply with all measurement and intervention protocols, and provided signed written informed consent.
• Medication Management: Agreeing not to use additional analgesics or traditional conditioning treatments during the intervention period (or agreeing to accurately report and record any use).

You may not qualify if:

• Major Gynecological Conditions:
• History of major gynecological disorders.
• Confirmed diagnosis of structural or organic gynecological conditions, including endometriosis, uterine fibroids, or polycystic ovary syndrome (PCOS).
• Pharmacological Interference:
• Long-term use of medications that affect the menstrual cycle.
• Currently undergoing hormonal therapy or long-term administration of analgesics.
• Physiological States: Pregnancy or current breastfeeding.
• General Health Status: Recent acute systemic inflammation or major systemic illnesses.
• Prior Treatment Confounding: Recent receipt of intensive acupuncture, moxibustion, or related meridian-based therapies.

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

China Medical University Hospital

Taichung, 404327, Taiwan

Location

Central Study Contacts

JING-YUN KANG

CONTACT

886-983726861; likestecla@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Department of Acupuncture

Study Record Dates

• First Submitted: September 9, 2026
• First Posted: September 14, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: September 22, 2026

Record last verified: 2026-09

Locations

TW (1)