Anxiety, Mild to ModeratePhase 1NCT00335946
A Pilot Investigational Study: Treatment of Anxiety With Non-Needle Electro-Acupuncture
A Phase 1 study testing HANS non-needle acupuncture and Stimulation of two acupuncture points bi-lateral in people with Anxiety, Mild to Moderate, run by Logan College of Chiropractic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Mild to Moderate
- What is being tested?
- HANS non-needle acupuncture and Stimulation of two acupuncture points bi-lateral
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to Dec 2006
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
-
Trial locations and contacts
1 site in 1 country.
United States1 site
Logan College of Chirpractic
Chesterfield, Missouri, 63017
About this study
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.
Read the 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.
- Conditions
- Anxiety, Mild to Moderate
- Being tested
- HANS non-needle acupuncture, Stimulation of two acupuncture points bi-lateral
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HANS non-needle acupunctureDevice
Stimulation of two acupuncture points bi-lateralProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Spielberger STAI test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2006 (estimated)
- Study startJun 2006
- Primary completionDec 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Anxiety, Mild to ModerateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- Logan College of Chiropractic
- Sponsor type
- University, hospital or other
- Investigators
- David V. Beavers, DC, Principal investigator, Logan College of Chiropractic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00335946
- Sponsor's protocol ID
- RD0602060019
- Status last verified
- Jul 2007
- First submitted
- 8 Jun 2006
- Last updated
- 17 Oct 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 9853722Zhang 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.
PubMed 12747204Han JS. Electroacupuncture: an alternative to antidepressants for treating affective diseases? Int J Neurosci. 1986 Mar;29(1-2):79-92. doi: 10.3109/00207458608985638.
PubMed 3516903Jorm 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.
PubMed 15462640Mamtani 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.
PubMed 12418362Tang 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.
PubMed 16139780
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Investigational Study: Treatment of Anxiety With Non-Needle Electro-Acupuncture
- ClinicalTrials.gov ID
- NCT00335946
- Acronym / sponsor ID
- RD0602060019
- Conditions
- Anxiety, Mild to Moderate
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- Logan College of ChiropracticUniversity, hospital or other
- Study start
- Jun 2006
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 12 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HANS non-needle acupuncture | Device | – |
| Stimulation of two acupuncture points bi-lateral | Procedure or surgery | – |
Primary outcome
Spielberger STAI test
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2008.
- Background: PubMed 9853722Ulett 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.
- Background: PubMed 12747204Zhang 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.
- Background: PubMed 3516903Han JS. Electroacupuncture: an alternative to antidepressants for treating affective diseases? Int J Neurosci. 1986 Mar;29(1-2):79-92. doi: 10.3109/00207458608985638.
- Background: PubMed 15462640Jorm 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.
- Background: PubMed 12418362Mamtani 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.
- Background: PubMed 16139780Tang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David V. Beavers, DC principal investigator
Logan College of Chiropractic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HANS non-needle acupuncture and Stimulation of two acupuncture points bi-lateral in people with Anxiety, Mild to Moderate, run by Logan College of Chiropractic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spielberger STAI test. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00335946, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2008.