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A Randomized, Sham Device Controlled, Single Blinded Trial of Portable Transcutaneous Electrical Nerve Stimulation and Heat Therapy Machine in Women With Dysmenorrhea

Phase 3
Conditions
Dysmenorrhea
Registration Number
NCT01662934
Lead Sponsor
Seoul National University Hospital
Brief Summary

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

Detailed Description

Inclusion/Exclusion: Described in Eligibility section. Outcome measures: Change of VAS score before and after use of TENS and heat therapy machine.

Recruitment & Eligibility

Status
UNKNOWN
Sex
Female
Target Recruitment
118
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Change of VAS before and after application of machineImmediately before application of machine and 20minutes 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

Secondary Outcome Measures
NameTimeMethod
BPI score2nd day of menstrual cycle

Brief Pain Inventory score

Trial Locations

Locations (1)

Seoul National University Bundang Hospital

🇰🇷

Seongnam Si, Gyenggi Do, Korea, Republic of

Seoul National University Bundang Hospital
🇰🇷Seongnam Si, Gyenggi Do, Korea, Republic of

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