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

Seoul National University Hospital118 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

118

Conditions

Dysmenorrhea

Interventions

I RUNEDEVICE

shamDEVICE

Eligibility

Sex: FEMALEMin age: 20 Years

Medical Language ↔ Plain English

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

Locations (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyenggi Do, South Korea

Outcomes

Primary Outcomes

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

Secondary Outcomes

BPI score

Brief Pain Inventory score

Time frame: 2nd day of menstrual cycle

Data from ClinicalTrials.gov

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