A Pilot Investigational Study: Treatment of Anxiety With... | NCT00335946

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

NCT00335946

Sponsor

Logan College of Chiropractic

Status

Completed

Last Update Posted

Oct 17, 2008Estimated

Enrollment

Phase

Phase 1

Conditions

Anxiety, Mild to Moderate

Interventions

HANS non-needle acupuncture
Stimulation of two acupuncture points bi-lateral

Countries

United States

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

Jul 2007

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

Jun 2006

Primary Completion Date

Dec 2006Actual

Completion Date

Dec 2006Actual

First Submitted Date

Jun 8, 2006

First Submission Date that Met QC Criteria

Jun 8, 2006

First Posted Date

Jun 12, 2006Estimated

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

Oct 16, 2008

Last Update Posted Date

Oct 17, 2008Estimated

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 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.

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 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Measure	Description	Time Frame
Spielberger STAI test

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David V. Beavers, DC	Logan College of Chiropractic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Logan College of Chirpractic		Chesterfield	Missouri	63017	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
9853722	Background	Ulett GA, Han J, Han S. Traditional and evidence-based acupuncture: history, mechanisms, and present status. South Med J. 1998 Dec;91(12):1115-20. doi: 10.1097/00007611-199812000-00004.
12747204	Background	Zhang H, Zeng Z, Deng H. Acupuncture treatment for 157 cases of anxiety neurosis. J Tradit Chin Med. 2003 Mar;23(1):55-6. No abstract available.

Name	Type	Description	Arm Group Labels	Other Names
HANS non-needle acupuncture	Device
Stimulation of two acupuncture points bi-lateral	Procedure