A Randomized, Sham Device Controlled, Single Blinded Trial of Portable Transcutaneous Electrical Nerve Stimulation and Heat Therapy Machine in Women With Dysmenorrhea
This trial is active, not recruiting.
|Treatments||i rune, sham|
|Sponsor||Seoul National University Hospital|
|Start date||August 2012|
|End date||April 2013|
|Trial size||118 participants|
|Trial identifier||NCT01662934, SNUBH_GO_004|
The hypothesis is that a transcutaneous electrical nerve stimulation and heat therapy machine could reduce dysmenorrhea in women with primary or secondary dysmenorrhea.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||single blind (investigator)|
Using not functioning device
Using functioning device
Change of VAS before and after application of machine
time frame: Immediately before application of machine and 20minutes after application of machine
time frame: 2nd day of menstrual cycle
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
|Description||Inclusion/Exclusion: Described in Eligibility section. Outcome measures: Change of VAS score before and after use of TENS and heat therapy machine.|
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