A Pilot Investigational Study: Treatment of Anxiety With Non-Needle Electro-Acupuncture - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

June 8, 2006

Last Updated Date

October 16, 2008

Start Date ^†

June 2006

Current Primary Outcome Measures ^†

Spielberger STAI test

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00335946 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

A Pilot Investigational Study: Treatment of Anxiety With Non-Needle Electro-Acupuncture

Official Title ^†

Brief Summary

The purpose of this study is to determine the effects of non-needle electro-acupuncture on mild to moderate anxiety. The hypothesis is that this style of treatment will reduce state anxiety and not trait anxiety as measured by the Spielberger STAI test.

Detailed Description

Persistent and unrelenting stress is defined as anxiety. Anxiety disorders are among the most common mental disorders in society. The NIH estimates that nearly 200 million Americans suffer from anxiety. Anxiety disorders are associated with a lower quality of life, functional impairment and disability, and are also associated with co-morbid physical illness.

Acupuncture, one form of complementary and alternative medicine, has been used to treat anxiety. Non-needle acupuncture is one of the safest methods, with none to rare side effects. This method has been studied in China (Han 1986) and America (Ulett 1998) Pre-intervention testing, then three treatments within one week, will be followed by post intervention testing.

Study Phase

Phase I

Study Type ^†

Interventional

Study Design ^†

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Condition ^†

Anxiety, Mild to Moderate

Intervention ^†

Device: HANS non-needle acupuncture
Procedure: Stimulation of two acupuncture points bi-lateral

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

Completion Date

December 2006

Primary Completion Date

December 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

Inclusion Criteria: Normally healthy persons with mild to moderate anxiety -

Exclusion Criteria: Severe anxiety, depression, pregnancy, and previous experience with HANS non-needle electro-acupuncture treatment

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Yes

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00335946

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

Logan College of Chiropractic

Collaborators ^††

Investigators ^†

Principal Investigator:

David V. Beavers, DC

Logan College of Chiropractic

Information Provided By

Logan College of Chiropractic

Verification Date

July 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.