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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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01662934
First received: August 7, 2012
Last updated: March 14, 2013
Last verified: March 2013
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment

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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   20 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01662934     History of Changes
Other Study ID Numbers: SNUBH_GO_004
Study First Received: August 7, 2012
Last Updated: March 14, 2013
Health Authority: Korea: Korean Food and Drug Administration

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
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013