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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01662934

Enrollment

118

Registered

2012-08-13

Start date

2012-08-31

Completion date

2013-04-30

Last updated

2013-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dysmenorrhea

Keywords

dysmenorrhea, transcutaneous electrical nerve stimulation, heat therapy

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.

Interventions

DEVICEI RUNE

DEVICEsham

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

FEMALE

Age

20 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Change of VAS before and after application of machine	Immediately 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

Measure	Time frame	Description
BPI score	2nd day of menstrual cycle	Brief Pain Inventory score

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026