A Phase 3 interventional study of I RUNE and sham in Dysmenorrhea, sponsored by Seoul National University Hospital. Status unknown at 1 site in Korea, Republic of. Open to female participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2013-03-15.
Sponsored by Seoul National University Hospital · Phase 3, Interventional, and Treatment
The hypothesis is that a transcutaneous electrical nerve stimulation and heat therapy machine could reduce dysmenorrhea in women with primary or secondary dysmenorrhea.
Inclusion/Exclusion: Described in Eligibility section. Outcome measures: Change of VAS score before and after use of TENS and heat therapy machine.
398 studies on the registry are indexed under Dysmenorrhea; 96 are open to participants now.
This study's planned enrollment of 118 is above the median of 60 across 333 interventional studies indexed under Dysmenorrhea.
Browse Dysmenorrhea studies →Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion
Using not functioning device
Device: sham
Using functioning device
Device: I RUNE
Also known as: Transcutaneous electrical nerve stimulation and heat therapy machine
Also known as: sham device
Change of VAS before and after application of machine
Measure the change% of VAS between before application of machine (T0) and 20 minutes after application of machine (T20) in every episode of dysmenorrhea during 1 menstrual cycle The mean of change% of VAS is primary outcome measure
Time frame: Immediately before application of machine and 20minutes after application of machine
BPI score
Brief Pain Inventory score
Time frame: 2nd day of menstrual cycle
This study is status unknown, as verified in Mar 2013. You cannot join it, but the record below documents what was studied.
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Seoul National University Hospital