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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

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ClinicalTrials.gov Identifier: NCT01662934
Recruitment Status : Unknown
Verified March 2013 by Seoul National University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : August 13, 2012
Last Update Posted : March 15, 2013
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Dysmenorrhea Device: I RUNE Device: sham Phase 3

Detailed Description:
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  (Clinical Trial)
Estimated Enrollment : 118 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Study Start Date : August 2012
Estimated Primary Completion Date : April 2013
Estimated Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Period Pain
U.S. FDA Resources

Arm Intervention/treatment
Sham Comparator: Sham
Using not functioning device
Device: sham
Other Name: sham device
Experimental: Experimental
Using functioning device
Device: I RUNE
Other Name: Transcutaneous electrical nerve stimulation and heat therapy machine

Primary Outcome Measures :
  1. Change of VAS before and after application of machine [ Time Frame: 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 Outcome Measures :
  1. BPI score [ Time Frame: 2nd day of menstrual cycle ]
    Brief Pain Inventory score

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • Age>19
  • Premenopausal
  • Moderate or severe dysmenorrhea, mainly in low abdomen area


  • Pregnant
  • Surgery history on lower abdomen
  • Recent history of cancer
  • TENS device use is contraindicated
  • Ibuprofen use is contraindicated

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01662934

Korea, Republic of
Seoul National University Bundang Hospital
Seongnam Si, Gyenggi Do, Korea, Republic of, 463707
Sponsors and Collaborators
Seoul National University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01662934     History of Changes
Other Study ID Numbers: SNUBH_GO_004
First Posted: August 13, 2012    Key Record Dates
Last Update Posted: March 15, 2013
Last Verified: March 2013

Keywords provided by Seoul National University Hospital:
transcutaneous electrical nerve stimulation
heat therapy

Additional relevant MeSH terms:
Menstruation Disturbances
Pathologic Processes
Pelvic Pain
Neurologic Manifestations
Signs and Symptoms