- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00229164
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.
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
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.
Clinical Trials on Primary Dysmenorrhea,
-
Cynthia del Rocío Márquez BeltránUniversity of HuelvaActive, not recruitingPrimary Dysmenorrhea | Menstrual Pain | Menstrual Distress \(Dysmenorrhea\)Spain
-
Cairo UniversityNot yet recruitingPrimary Dysmenorrhea
-
Hacettepe UniversityRecruitingPrimary DysmenorrheaTurkey
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Tokat Gaziosmanpasa UniversityRecruitingDysmenorrhea | Dysmenorrhea PrimaryTurkey
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Cairo UniversityNot yet recruitingPrimary Dysmenorrhea
-
Ankara Yildirim Beyazıt UniversityNot yet recruitingPrimary Dysmenorrhea
-
Ankara Yildirim Beyazıt UniversityNot yet recruiting
-
Cairo UniversityCompleted
-
University of ValenciaCompleted
-
University of SalamancaCompletedDysmenorrhea PrimarySpain
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Isra UniversityUnknown
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Mayo ClinicNational Cancer Institute (NCI)CompletedPain | Peripheral Neuropathy | TinglingUnited States
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University Hospital, ToulouseMinistry of Health, FranceTerminatedPeripheral Artery DiseaseFrance
-
Vrije Universiteit BrusselUnknown