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NCT01662934 Clinical Trial

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

Dysmenorrhea Clinical Trial

Clinical Trial Details — Status: Unknown status

Administrative data
NCT number NCT01662934
Other study ID # SNUBH_GO_004
Secondary ID
Status Unknown status
Phase Phase 3
First received August 7, 2012
Last updated March 14, 2013
Start date August 2012
Est. completion date April 2013

Study information
Verified date March 2013
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility
Status Unknown status
Enrollment 118
Est. completion date April 2013
Est. primary completion date April 2013
Accepts healthy volunteers No
Gender Female
Age group 20 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• I RUNE

• sham

Locations
Country Name City State
Korea, Republic of Seoul National University Bundang Hospital Seongnam Si Gyenggi Do

Sponsors (1)
Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Immediately before application of machine and 20minutes after application of machine
Secondary BPI score Brief Pain Inventory score 2nd day of menstrual cycle
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