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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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2013 by Seoul National University Hospital.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01662934
First Posted: August 13, 2012
Last Update Posted: March 15, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Seoul National University Hospital
  Purpose
The hypothesis is that a transcutaneous electrical nerve stimulation and heat therapy machine could reduce dysmenorrhea in women with primary or secondary dysmenorrhea.

Condition Intervention Phase
Dysmenorrhea Device: I RUNE Device: sham Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • 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:
  • BPI score [ Time Frame: 2nd day of menstrual cycle ]
    Brief Pain Inventory score


Estimated Enrollment: 118
Study Start Date: August 2012
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

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
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
  Contacts and Locations
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


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

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 Submitted: August 7, 2012
First Posted: August 13, 2012
Last Update Posted: March 15, 2013
Last Verified: March 2013

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

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