AcupunctureNCT04919746
Change in Dielectric Constant, Elasticity and Temperature by Acupuncture
A study testing Systemic acupuncture in people with Acupuncture, run by University of Sao Paulo.
Trial summary
Evaluate the effect of systemic acupuncture on dielectric constant, elasticity and skin temperature in healthy individuals. Read more about this study
- Who is it for?
- Ages 18 to 38 yearsHealthy volunteers can take part
- Conditions the study is for
- Acupuncture
- What is being tested?
- Systemic acupuncture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- No sites listed yet
- Study dates
- 2 Aug 2021to 1 Dec 2022
- 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 38 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Volunteers aged between 18 and 38 years, both genders and without health complaints.
Who cannot join
- Pregnant female volunteers or those with a delay in the menstrual cycle for more than 28 days.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Change in Dielectric Constant, Elasticity and Temperature by Stimulation of Systemic Acupuncture Points
Evaluate the effect of systemic acupuncture on dielectric constant, elasticity and skin temperature in healthy individuals.
Read the detailed description
Systemic acupuncture is a therapeutic resource in Chinese Medicine that uses needles at specific points in the body, consistent with a system called acupuncture meridians. The aim of the study is to evaluate the effect of systemic acupuncture on dielectric constant, elasticity and skin temperature in healthy individuals. Will be evaluated 360 volunteers aged between 18 and 38 years and both sexes divided into six homogeneous groups. Pregnant women or those with a delay in the menstrual cycle for more than 28 days will be excluded. The evaluation will consist of measuring the dielectric constant at different depths of the skin, elasticity and infrared thermography of systemic acupuncture points. The procedure will be performed in three moments: pre systemic acupuncture (prior to stimulation), immediate post-systemic acupuncture (20 minutes after the start of stimulation), and post systemic acupuncture (40 minutes after the start of stimulation). Systemic acupuncture will be performed on the lower limb, bilaterally, at points E36 (Zusanli) and BP6 (Sanyinjiao), lasting 20 minutes. The multiple comparison ANOVA test will be performed, with statistical significance of 5% (p < 0.05).
- Conditions
- Acupuncture
- Being tested
- Systemic acupuncture
- Keywords
- Acupuncture, Lower limb
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Systemic acupunctureOther
Systemic acupuncture will be performed on the lower limb, bilaterally, at points E36 (Zusanli) and BP6 (Sanyinjiao). Point location specificity will be determined using the anatomical and directional F-cun reference method. Stimulation of pre-defined points will be performed using needles with a threadlike, sterile, disposable character and size 0.25 x 30.0 mm, within a period of 20 minutes. The insertion of the needle will be at a depth of 0.5 inches, aiming to obtain the De Qi, sensation of energy at the point and in the corresponding meridian, referring to the effectiveness of systemic acupuncture.
| Study group | Role | What they receive |
|---|---|---|
| Group Acupuncture 1 - GA1 | Experimental | Healthy individuals aged between 18 and 38 years. The dielectric constant will be evaluated with a depth measurement of 0.5 mm, elasticity and infrared thermography in the region of the systemic acupuncture points. Receives: Other: Systemic acupuncture |
| Group Acupuncture 2 - GA2 | Experimental | Healthy individuals aged between 18 and 38 years. The dielectric constant will be evaluated with a depth measurement of 2.5 mm, elasticity and infrared thermography in the region of the systemic acupuncture points. Receives: Other: Systemic acupuncture |
| Group Acupuncture 3 - GA3 | Experimental | Healthy individuals aged between 18 and 38 years. The dielectric constant will be evaluated with a depth measurement of 5.0 mm, elasticity and infrared thermography in the region of the systemic acupuncture points. Receives: Other: Systemic acupuncture |
| Group Control 1 - GC1 | No intervention | Healthy individuals aged between 18 and 38 years. The dielectric constant will be evaluated with a depth measurement of 0.5 mm, elasticity and infrared thermography in the region of the systemic acupuncture points. |
| Group Control 2 - GC2 | No intervention | Healthy individuals aged between 18 and 38 years. The dielectric constant will be evaluated with a depth measurement of 2.5 mm, elasticity and infrared thermography in the region of the systemic acupuncture points. |
| Group Control 3 - GC3 | No intervention | Healthy individuals aged between 18 and 38 years. The dielectric constant will be evaluated with a depth measurement of 5.0 mm, elasticity and infrared thermography in the region of the systemic acupuncture points. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dielectric constant
MoistureMeterD
Measured: 10 minutes
Elasticity
ElastiMeterD
Measured: 10 minutes
Infrared thermography
FLIR Systems T300
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2021
- Study start2 Aug 2021 (estimated)
- Primary completion1 Aug 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcupunctureStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elaine Caldeira de Oliveira Guirro, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04919746
- Sponsor's protocol ID
- 4749033/2021
- Status last verified
- Jun 2021
- First submitted
- 2 Jun 2021
- Last updated
- 9 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Change in Dielectric Constant, Elasticity and Temperature by Stimulation of Systemic Acupuncture Points
- ClinicalTrials.gov ID
- NCT04919746
- Acronym / sponsor ID
- 4749033/2021
- Conditions
- Acupuncture
- Keywords
- Acupuncture, Lower limb
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 2 Aug 2021 (estimated)
- Primary completion
- 1 Aug 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 9 Jun 2021 (actual)
- 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.
Evaluate the effect of systemic acupuncture on dielectric constant, elasticity and skin temperature in healthy individuals.
Detailed description
Systemic acupuncture is a therapeutic resource in Chinese Medicine that uses needles at specific points in the body, consistent with a system called acupuncture meridians. The aim of the study is to evaluate the effect of systemic acupuncture on dielectric constant, elasticity and skin temperature in healthy individuals. Will be evaluated 360 volunteers aged between 18 and 38 years and both sexes divided into six homogeneous groups. Pregnant women or those with a delay in the menstrual cycle for more than 28 days will be excluded. The evaluation will consist of measuring the dielectric constant at different depths of the skin, elasticity and infrared thermography of systemic acupuncture points. The procedure will be performed in three moments: pre systemic acupuncture (prior to stimulation), immediate post-systemic acupuncture (20 minutes after the start of stimulation), and post systemic acupuncture (40 minutes after the start of stimulation). Systemic acupuncture will be performed on the lower limb, bilaterally, at points E36 (Zusanli) and BP6 (Sanyinjiao), lasting 20 minutes. The multiple comparison ANOVA test will be performed, with statistical significance of 5% (p < 0.05).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group Acupuncture 1 - GA1 | Experimental | Other: Systemic acupunctureHealthy individuals aged between 18 and 38 years. The dielectric constant will be evaluated with a depth measurement of 0.5 mm, elasticity and infrared thermography in the region of the systemic acupuncture points. |
| Group Acupuncture 2 - GA2 | Experimental | Other: Systemic acupunctureHealthy individuals aged between 18 and 38 years. The dielectric constant will be evaluated with a depth measurement of 2.5 mm, elasticity and infrared thermography in the region of the systemic acupuncture points. |
| Group Acupuncture 3 - GA3 | Experimental | Other: Systemic acupunctureHealthy individuals aged between 18 and 38 years. The dielectric constant will be evaluated with a depth measurement of 5.0 mm, elasticity and infrared thermography in the region of the systemic acupuncture points. |
| Group Control 1 - GC1 | No intervention | –Healthy individuals aged between 18 and 38 years. The dielectric constant will be evaluated with a depth measurement of 0.5 mm, elasticity and infrared thermography in the region of the systemic acupuncture points. |
| Group Control 2 - GC2 | No intervention | –Healthy individuals aged between 18 and 38 years. The dielectric constant will be evaluated with a depth measurement of 2.5 mm, elasticity and infrared thermography in the region of the systemic acupuncture points. |
| Group Control 3 - GC3 | No intervention | –Healthy individuals aged between 18 and 38 years. The dielectric constant will be evaluated with a depth measurement of 5.0 mm, elasticity and infrared thermography in the region of the systemic acupuncture points. |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Volunteers aged between 18 and 38 years, both genders and without health complaints.
Key exclusion criteria (1 listed)
- Pregnant female volunteers or those with a delay in the menstrual cycle for more than 28 days.
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 |
|---|---|---|
| Systemic acupunctureSystemic acupuncture will be performed on the lower limb, bilaterally, at points E36 (Zusanli) and BP6 (Sanyinjiao). Point location specificity will be determined using the anatomical and directional F-cun reference method. Stimulation of pre-defined points will be performed using needles with a threadlike, sterile, disposable character and size 0.25 x 30.0 mm, within a period of 20 minutes. The insertion of the needle will be at a depth of 0.5 inches, aiming to obtain the De Qi, sensation of energy at the point and in the corresponding meridian, referring to the effectiveness of systemic acupuncture. | Other | Group Acupuncture 1 - GA1, Group Acupuncture 2 - GA2, Group Acupuncture 3 - GA3 |
Primary outcome
Dielectric constant
Time frame: 10 minutes
MoistureMeterD
Elasticity
Time frame: 10 minutes
ElastiMeterD
Infrared thermography
Time frame: 15 minutes
FLIR Systems T300
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2021.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Systemic acupuncture in people with Acupuncture, run by University of Sao Paulo.
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 1 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 9 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Elaine C Guirro, PhD ((16)33154584, ecguirro@fmrp.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dielectric constant (time frame: 10 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 9 Jun 2021.