A Randomized, Sham Device Controlled, Single Blinded Trial of Portable Transcutaneous Electrical Nerve Stimulation and Heat Therapy Machine in Women With Dysmenorrhea

March 14, 2013 updated by: Seoul National University Hospital
The hypothesis is that a transcutaneous electrical nerve stimulation and heat therapy machine could reduce dysmenorrhea in women with primary or secondary dysmenorrhea.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

118

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyenggi Do
      • Seongnam Si, Gyenggi Do, Korea, Republic of, 463707
        • Seoul National University Bundang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Sham
Using not functioning device
Device: sham
Other Names:
  • sham device
Experimental: Experimental
Using functioning device
Device: I RUNE
Other Names:
  • Transcutaneous electrical nerve stimulation and heat therapy machine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Immediately before application of machine and 20minutes after application of machine

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BPI score
Time Frame: 2nd day of menstrual cycle
Brief Pain Inventory score
2nd day of menstrual cycle

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Anticipated)

April 1, 2013

Study Completion (Anticipated)

April 1, 2013

Study Registration Dates

First Submitted

August 7, 2012

First Submitted That Met QC Criteria

August 8, 2012

First Posted (Estimate)

August 13, 2012

Study Record Updates

Last Update Posted (Estimate)

March 15, 2013

Last Update Submitted That Met QC Criteria

March 14, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNUBH_GO_004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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