HealthyNCT00005770
Investigation of the Effect of Acupuncture Needling on Connective Tissue Using Ultrasound Elastography
An observational study of Healthy, run by National Center for Research Resources (NCRR) at 1 site in United States.
Trial summary
During acupuncture treatment, acupuncture needles are inserted and manipulated until a characteristic local tissue reaction termed "de qi" is observed. De qi can be perceived by the acupuncturist in the form of "needle grasp", a mechanical gripping of the needle by the tissue. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Acupuncture
- Type of treatment
- Medical device
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Observational
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
During acupuncture treatment, acupuncture needles are inserted and manipulated until a characteristic local tissue reaction termed "de qi" is observed. De qi can be perceived by the acupuncturist in the form of "needle grasp", a mechanical gripping of the needle by the tissue. De qi is considered essential to the therapeutic effect of acupuncture. Therefore, the investigator proposes that understanding this local tissue reaction will lead to an understanding of how the therapeutic effect of acupuncture therapy arises. Specifically, it is hypothesized that needle manipulation causes winding of collagen and elastic fibers around the needle. This action induces tension in the collagen network surrounding the needling site and results in a mechanical signal that is transduced into local cells. The objective of the current work is to use ultrasound elastography, a recently developed ultrasound imaging technique, to visualize and quantify changes in the elastic properties of skin and subcutaneous tissue in 12 healthy human volunteers as a result of acupuncture needle manipulation.
- Conditions
- Healthy
- Being tested
- Acupuncture
- Keywords
- elastic property of skin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2000 (estimated)
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
- Observational
- Observational model
- Natural history
- Time perspective
- Cross-sectional
Sponsor and investigators
- Lead sponsor
- National Center for Research Resources (NCRR)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005770
- Sponsor's protocol ID
- NCRR-M01RR00109-0745
- Other IDs
- M01RR000109
- Status last verified
- Nov 2001
- First submitted
- 1 Jun 2000
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Acupuncture Needling on Connective Tissue Using Ultrasound Elastography
- ClinicalTrials.gov ID
- NCT00005770
- Acronym / sponsor ID
- NCRR-M01RR00109-0745
- Conditions
- Healthy
- Keywords
- elastic property of skin
- Study type
- Observational
- Recruitment status
- Unknown status
- Lead sponsor
- National Center for Research Resources (NCRR)US National Institutes of Health
- First posted
- 2 Jun 2000 (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.
During acupuncture treatment, acupuncture needles are inserted and manipulated until a characteristic local tissue reaction termed "de qi" is observed. De qi can be perceived by the acupuncturist in the form of "needle grasp", a mechanical gripping of the needle by the tissue. De qi is considered essential to the therapeutic effect of acupuncture. Therefore, the investigator proposes that understanding this local tissue reaction will lead to an understanding of how the therapeutic effect of acupuncture therapy arises. Specifically, it is hypothesized that needle manipulation causes winding of collagen and elastic fibers around the needle. This action induces tension in the collagen network surrounding the needling site and results in a mechanical signal that is transduced into local cells. The objective of the current work is to use ultrasound elastography, a recently developed ultrasound imaging technique, to visualize and quantify changes in the elastic properties of skin and subcutaneous tissue in 12 healthy human volunteers as a result of acupuncture needle manipulation.
Study design
- Observational model
- Natural history
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Acupuncture | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by National Center for Research Resources (NCRR) 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 1 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 24 Jun 2005. 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?
Results are not available in the source record.
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 24 Jun 2005.