The Effect of Transcutaneous Electric Nerve Stimulation on Primary Dysmenorrhea-a Randomized Control Study

December 26, 2012 updated by: National Taiwan University Hospital
The purpose of this study is to investigate the effect of high frequency TENS and compare to the placebo effect by sham TENS in a randomized control study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Over 50% of American women suffered from dysmenorrhea and 10% of them will take sick leave for 1-2 days. Previous randomized control studies have demonstrated the pain relief effect of using high frequency TENS in dysmenorrheal pain. However, no investigation has been conducted to investigate the effect of high frequency TENS in female population in our country. The purpose of this study is to investigate the effect of high frequency TENS and compare to the placebo effect by sham TENS in a randomized control study.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2
  • Phase 1

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

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • primary Dysmenorrhea

Exclusion Criteria:

  • subjects with organic disorders

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: Crossover Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
all measure the pain threshold,
self-rating questionnaire

Collaborators and Investigators

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

Sponsor

National Taiwan University Hospital

Investigators

  • Study Director: Shwu-Fen Wang, Ph.D, School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University

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

October 1, 2005

Study Completion

January 1, 2006

Study Registration Dates

First Submitted

September 27, 2005

First Submitted That Met QC Criteria

September 27, 2005

First Posted (Estimate)

September 29, 2005

Study Record Updates

Last Update Posted (Estimate)

December 27, 2012

Last Update Submitted That Met QC Criteria

December 26, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9361701148

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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