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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

August 7, 2012
March 14, 2013
August 2012
April 2013   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01662934 on ClinicalTrials.gov Archive Site
BPI score [ Time Frame: 2nd day of menstrual cycle ] [ Designated as safety issue: No ]
Brief Pain Inventory score
Same as current
Not Provided
Not Provided
 
A Randomized, Sham Device Controlled, Single Blinded Trial of Portable Transcutaneous Electrical Nerve Stimulation and Heat Therapy Machine in Women With Dysmenorrhea
Not Provided

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

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

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Dysmenorrhea
  • Device: I RUNE
    Other Name: Transcutaneous electrical nerve stimulation and heat therapy machine
  • Device: sham
    Other Name: sham device
  • Sham Comparator: Sham
    Using not functioning device
    Intervention: Device: sham
  • Experimental: Experimental
    Using functioning device
    Intervention: Device: I RUNE
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
118
April 2013
April 2013   (final data collection date for primary outcome measure)

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
Female
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01662934
SNUBH_GO_004
Yes
Seoul National University Hospital
Seoul National University Hospital
Not Provided
Not Provided
Seoul National University Hospital
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP