Phase 3
N=88
Low-level Light Therapy for Primary Dysmenorrhea
Primary Dysmenorrhea
Bottom Line
View on ClinicalTrials.gov: NCT02026206 ↗Enrolled (actual)
88
Serious AEs
0.0%
Results posted
Apr 2014
Primary outcome: Primary: Dysmenorrheal Pain Severity — 3.88; 6.31 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- low-level light therapy (Device); Placebo (Device)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Pusan National University
- Primary completion
- Sep 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Dysmenorrheal Pain Severity |
3.88; 6.31 | — |
| SECONDARY Quality of Life |
0.91; 0.84 | — |
Summary
The purpose of this study was to evaluate the effectiveness of a self-therapeutic approach of skin adhesive low-level light therapy (LLLT) in females with primary dysmenorrhea (PD).
Eligibility Criteria
Inclusion Criteria
- clinical diagnosis of primary dysmenorrhea.
- a self-reported visual analog scale (VAS) for menstrual pain intensity over 7 on a scale of 0-10.
Exclusion Criteria
- diagnosis of a serious medical or psychiatric illness, endometriosis or uterine fibroids, uterine adenomyosis, those taking oral contraceptives within the last 1 month, those who were pregnant or in whom the pregnancy test was positive were excluded.
Data sourced from ClinicalTrials.gov (NCT02026206). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.