Back to results

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

Primary Purpose

Primary Dysmenorrhea,

Status

Completed

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

Transcutaneous Electric Nerve Stimulation (TENS)

About this trial

This is an interventional treatment trial for Primary Dysmenorrhea, focused on measuring Primary Dysmenorrhea,, Transcutaneous Electric Nerve Stimulation

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: primary Dysmenorrhea Exclusion Criteria: subjects with organic disorders

Sites / Locations

Outcomes

Primary Outcome Measures

all measure the pain threshold,

self-rating questionnaire

Secondary Outcome Measures

Full Information

NCT ID

NCT00229164

First Posted

September 27, 2005

Last Updated

December 26, 2012

Sponsor

National Taiwan University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00229164

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2012

Overall Recruitment Status

Completed

Study Start Date

October 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

January 2006 (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Taiwan University Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Primary Dysmenorrhea,

Keywords

Primary Dysmenorrhea,, Transcutaneous Electric Nerve Stimulation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Crossover Assignment

Masking

Single

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Device

Intervention Name(s)

Transcutaneous Electric Nerve Stimulation (TENS)

Primary Outcome Measure Information:

Title

all measure the pain threshold,

Title

self-rating questionnaire

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: primary Dysmenorrhea Exclusion Criteria: subjects with organic disorders

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shwu-Fen Wang, Ph.D

Organizational Affiliation

School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University

Official's Role

Study Director

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs