HealthyNCT00521547
To Study the Mechanisms of Acupuncture Through Functional Magnetic Resonance Imaging and Peripheral Neurosensory Testing
A study testing Electroacupuncture in people with Healthy, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.
Trial summary
Acupuncture may affect nerve functions. This study assesses the effect of acupuncture on both the peripheral and the central nerve systems Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Electroacupuncture
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2003to Jan 2007
- Phase
- Interventional
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 to 80
- Male and female
- No acupuncture treatment for the past 2 weeks
- No analgesics for the past 2 weeks
- Absence of neuropathic pain states
Who cannot join
- History of psychological illness
- History of Claustrophobia
- Lack of ability to understand the experimental protocol and to adequately communicate in English
- Pregnancy
- Pending litigation
- History of head trauma
- History of trauma or surgery to lower extremities and pelvic area
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of California, San Diego, Medical Center
La Jolla, California, 92093
About this study
Official title: Healthy Subject Studies to Assess the Effect of Different Electroacupuncture Parameters on Analgesia, Peripheral Sensory Thresholds and Central Pain Processing.
Acupuncture may affect nerve functions. This study assesses the effect of acupuncture on both the peripheral and the central nerve systems
- Conditions
- Healthy
- Being tested
- Electroacupuncture
- Keywords
- Acupuncture, Analgesia, Functional magnetic resonance imaging (fMRI), Neuronal Mechanisms, Quantitative Peripheral Sensory Testings, Normal Volunteers
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectroacupunctureProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2007 (estimated)
- Study startSep 2003
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)
- Sponsor type
- US National Institutes of Health
- Investigators
- Albert Leung, M.D., Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00521547
- Sponsor's protocol ID
- K08AT001695-01
- Other IDs
- 050557
- Status last verified
- Aug 2007
- First submitted
- 24 Aug 2007
- Last updated
- 28 Aug 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Subject Studies to Assess the Effect of Different Electroacupuncture Parameters on Analgesia, Peripheral Sensory Thresholds and Central Pain Processing.
- ClinicalTrials.gov ID
- NCT00521547
- Acronym / sponsor ID
- K08AT001695-01
- Conditions
- Healthy
- Keywords
- Acupuncture, Analgesia, Functional magnetic resonance imaging (fMRI), Neuronal Mechanisms, Quantitative Peripheral Sensory Testings, Normal Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)US National Institutes of Health
- Study start
- Sep 2003
- Study completion
- Jan 2007 (actual)
- First posted
- 28 Aug 2007 (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.
Acupuncture may affect nerve functions. This study assesses the effect of acupuncture on both the peripheral and the central nerve systems
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 to 80
- Male and female
- No acupuncture treatment for the past 2 weeks
- No analgesics for the past 2 weeks
- Absence of neuropathic pain states
Key exclusion criteria (7 listed)
- History of psychological illness
- History of Claustrophobia
- Lack of ability to understand the experimental protocol and to adequately communicate in English
- Pregnancy
- Pending litigation
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 |
|---|---|---|
| Electroacupuncture | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
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 28 Aug 2007.
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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.
Albert Leung, M.D. principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electroacupuncture in people with Healthy, run by National Center for Complementary and Integrative Health (NCCIH) 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?
The sponsor lists 5 inclusion and 7 exclusion criteria. 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 28 Aug 2007. 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.
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.
Where can I read the original study information?
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 28 Aug 2007.