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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

Primary Purpose

Dysmenorrhea

Status
Unknown status
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
I RUNE
sham
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dysmenorrhea focused on measuring dysmenorrhea, transcutaneous electrical nerve stimulation, heat therapy

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Bundang Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Sham

Experimental

Arm Description

Using not functioning device

Using functioning device

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

BPI score
Brief Pain Inventory score

Full Information

First Posted
August 7, 2012
Last Updated
March 14, 2013
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01662934
Brief Title
A Randomized, Sham Device Controlled, Single Blinded Trial of Portable Transcutaneous Electrical Nerve Stimulation and Heat Therapy Machine in Women With Dysmenorrhea
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Unknown status
Study Start Date
August 2012 (undefined)
Primary Completion Date
April 2013 (Anticipated)
Study Completion Date
April 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysmenorrhea
Keywords
dysmenorrhea, transcutaneous electrical nerve stimulation, heat therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
118 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sham
Arm Type
Sham Comparator
Arm Description
Using not functioning device
Arm Title
Experimental
Arm Type
Experimental
Arm Description
Using functioning device
Intervention Type
Device
Intervention Name(s)
I RUNE
Other Intervention Name(s)
Transcutaneous electrical nerve stimulation and heat therapy machine
Intervention Type
Device
Intervention Name(s)
sham
Other Intervention Name(s)
sham device
Primary Outcome Measure Information:
Title
Change of VAS before and after application of machine
Description
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
Time Frame
Immediately before application of machine and 20minutes after application of machine
Secondary Outcome Measure Information:
Title
BPI score
Description
Brief Pain Inventory score
Time Frame
2nd day of menstrual cycle

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam Si
State/Province
Gyenggi Do
ZIP/Postal Code
463707
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
26340453
Citation
Lee B, Hong SH, Kim K, Kang WC, No JH, Lee JR, Jee BC, Yang EJ, Cha EJ, Kim YB. Efficacy of the device combining high-frequency transcutaneous electrical nerve stimulation and thermotherapy for relieving primary dysmenorrhea: a randomized, single-blind, placebo-controlled trial. Eur J Obstet Gynecol Reprod Biol. 2015 Nov;194:58-63. doi: 10.1016/j.ejogrb.2015.08.020. Epub 2015 Aug 22.
Results Reference
derived

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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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