The Effect of Transcutaneous Electric Nerve Stimulation o... | NCT00229164

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

NCT00229164

Sponsor

National Taiwan University Hospital

Status

Completed

Last Update Posted

Dec 27, 2012Estimated

Enrollment

20Estimated

Phase

Phase 1Phase 2

Conditions

Primary Dysmenorrhea,

Interventions

Transcutaneous Electric Nerve Stimulation (TENS)

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2005

Primary Completion Date

Not provided

Completion Date

Jan 2006

First Submitted Date

Sep 27, 2005

First Submission Date that Met QC Criteria

Sep 27, 2005

First Posted Date

Sep 29, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 26, 2012

Last Update Posted Date

Dec 27, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Name	Type	Description	Arm Group Labels	Other Names
Transcutaneous Electric Nerve Stimulation (TENS)	Device

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

primary Dysmenorrhea

Exclusion Criteria:

subjects with organic disorders

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

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

Locations

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004561	Transcutaneous Electric Nerve Stimulation

Ancestor Terms

ID	Term
D004599	Electric Stimulation Therapy
D013812	Therapeutics
D026741	Physical Therapy Modalities
D012046	Rehabilitation

Browse Leaves

Not provided

Browse Branches

Not provided

Measure	Description	Time Frame
all measure the pain threshold,
self-rating questionnaire