Overview

This trial is active, not recruiting.

Condition dysmenorrhea
Treatments i rune, sham
Phase phase 3
Sponsor Seoul National University Hospital
Start date August 2012
End date April 2013
Trial size 118 participants
Trial identifier NCT01662934, SNUBH_GO_004

Summary

The hypothesis is that a transcutaneous electrical nerve stimulation and heat therapy machine could reduce dysmenorrhea in women with primary or secondary dysmenorrhea.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (investigator)
Primary purpose treatment
Arm
(Sham Comparator)
Using not functioning device
sham sham device
(Experimental)
Using functioning device
i rune Transcutaneous electrical nerve stimulation and heat therapy machine

Primary Outcomes

Measure
Change of VAS before and after application of machine
time frame: Immediately before application of machine and 20minutes after application of machine

Secondary Outcomes

Measure
BPI score
time frame: 2nd day of menstrual cycle

Eligibility Criteria

Female participants at least 20 years old.

Inclusion - Age>19 - Premenopausal - Moderate or severe dysmenorrhea, mainly in low abdomen area Exclusion - Pregnant - Surgery history on lower abdomen - Recent history of cancer - TENS device use is contraindicated - Ibuprofen use is contraindicated

Additional Information

Description Inclusion/Exclusion: Described in Eligibility section. Outcome measures: Change of VAS score before and after use of TENS and heat therapy machine.
Trial information was received from ClinicalTrials.gov and was last updated in March 2013.
Information provided to ClinicalTrials.gov by Seoul National University Hospital.