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

This study is not yet open for participant recruitment.

Verified by National Taiwan University Hospital, July 2004

First Received: September 27, 2005 No Changes Posted

Sponsored by:	National Taiwan University Hospital
Information provided by:	National Taiwan University Hospital
ClinicalTrials.gov Identifier:	NCT00229164

Purpose

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.

Condition	Intervention	Phase
Primary Dysmenorrhea,	Device: Transcutaneous Electric Nerve Stimulation (TENS)	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Placebo Control, Crossover Assignment, Efficacy Study
Official Title:	The Effect of Transcutaneous Electric Nerve Stimulation on Primary Dysmenorrhea-a Randomized Control Study

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:

all measure the pain threshold,
self-rating questionnaire

Estimated Enrollment:	20
Study Start Date:	October 2005
Estimated Study Completion Date:	January 2006

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.

Eligibility

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

primary Dysmenorrhea

Exclusion Criteria:

subjects with organic disorders

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00229164

Contacts

Contact: Shwu-Fen Wang, Ph.D

886-2-23123456 ext 7558

sfwang@ntu.edu.tw

Sponsors and Collaborators

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

More Information

No publications provided

Study ID Numbers:	9361701148
Study First Received:	September 27, 2005
Last Updated:	September 27, 2005
ClinicalTrials.gov Identifier:	NCT00229164 History of Changes
Health Authority:	Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:

Primary Dysmenorrhea,
Transcutaneous Electric Nerve Stimulation

Study placed in the following topic categories:

Signs and Symptoms
Pelvic Pain
Menstruation Disturbances
Dysmenorrhea
Pain

Additional relevant MeSH terms:

Signs and Symptoms
Pelvic Pain
Pathologic Processes

Menstruation Disturbances
Dysmenorrhea
Pain

ClinicalTrials.gov processed this record on September 03, 2009