An interventional study of TI-816-3E3 Portable Laser Phototherapy Device and TI-816-3E3 Portable Laser Phototherapy Device in Primary Dysmenorrhea (PD), sponsored by China Medical University Hospital. Not yet recruiting at 1 site in Taiwan. Open to female participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by China Medical University Hospital · Not applicable, Interventional, and Treatment
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.
430 studies on the registry are indexed under Dysmenorrhea; 107 are open to participants now.
This study's planned enrollment of 40 is below the median of 62 across 363 interventional studies indexed under Dysmenorrhea.
Browse Dysmenorrhea studies →China Medical University Hospital is the lead sponsor of 479 studies on the registry; 115 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Major Gynecological Conditions:
Pharmacological Interference:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
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.
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).
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).
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).
Start is estimated for Sep 2026; primary completion for Aug 2027, 11 months later.
Of 178 non-industry interventional studies with no phase under Dysmenorrhea, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 16. This study's planned 11 months is above that.
Counting every sponsor, half of 188 studies reached it within 8 months; a quarter within 3 and three quarters within 16.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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