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

Primary Dysmenorrhea, Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00229164
• Other study ID #: 9361701148
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 27, 2005
• Last updated: December 26, 2012
• Start date: October 2005
• Est. completion date: January 2006

Study information

• Verified date: November 2012
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• primary Dysmenorrhea

Exclusion Criteria:

• subjects with organic disorders

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dysmenorrhea
• Primary Dysmenorrhea,

Intervention

Device:
• Transcutaneous Electric Nerve Stimulation (TENS)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	all measure the pain threshold,
Primary	self-rating questionnaire