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

Primary Purpose

Anxiety, Mild to Moderate

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
HANS non-needle acupuncture
Stimulation of two acupuncture points bi-lateral
Sponsored by
Logan College of Chiropractic
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety, Mild to Moderate

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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 -

Sites / Locations

  • Logan College of Chirpractic

Outcomes

Primary Outcome Measures

Spielberger STAI test

Secondary Outcome Measures

Full Information

First Posted
June 8, 2006
Last Updated
October 16, 2008
Sponsor
Logan College of Chiropractic
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1. Study Identification

Unique Protocol Identification Number
NCT00335946
Brief Title
A Pilot Investigational Study: Treatment of Anxiety With Non-Needle Electro-Acupuncture
Study Type
Interventional

2. Study Status

Record Verification Date
July 2007
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
December 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Logan College of Chiropractic

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Mild to Moderate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (false)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
HANS non-needle acupuncture
Intervention Type
Procedure
Intervention Name(s)
Stimulation of two acupuncture points bi-lateral
Primary Outcome Measure Information:
Title
Spielberger STAI test

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David V. Beavers, DC
Organizational Affiliation
Logan College of Chiropractic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Logan College of Chirpractic
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
9853722
Citation
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.
Results Reference
background
PubMed Identifier
12747204
Citation
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.
Results Reference
background
PubMed Identifier
3516903
Citation
Han JS. Electroacupuncture: an alternative to antidepressants for treating affective diseases? Int J Neurosci. 1986 Mar;29(1-2):79-92. doi: 10.3109/00207458608985638.
Results Reference
background
PubMed Identifier
15462640
Citation
Jorm AF, Christensen H, Griffiths KM, Parslow RA, Rodgers B, Blewitt KA. Effectiveness of complementary and self-help treatments for anxiety disorders. Med J Aust. 2004 Oct 4;181(S7):S29-46. doi: 10.5694/j.1326-5377.2004.tb06352.x.
Results Reference
background
PubMed Identifier
12418362
Citation
Mamtani R, Cimino A. A primer of complementary and alternative medicine and its relevance in the treatment of mental health problems. Psychiatr Q. 2002 Winter;73(4):367-81. doi: 10.1023/a:1020472218839.
Results Reference
background
PubMed Identifier
16139780
Citation
Tang J, Gibson SJ. A psychophysical evaluation of the relationship between trait anxiety, pain perception, and induced state anxiety. J Pain. 2005 Sep;6(9):612-9. doi: 10.1016/j.jpain.2005.03.009.
Results Reference
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A Pilot Investigational Study: Treatment of Anxiety With Non-Needle Electro-Acupuncture

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