Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Change in Dielectric Constant, Elasticity and Temperature by Acupuncture

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04919746
Recruitment Status : Not yet recruiting
First Posted : June 9, 2021
Last Update Posted : June 9, 2021
Sponsor:
Information provided by (Responsible Party):
Elaine Caldeira de Oliveira Guirro, University of Sao Paulo

Brief Summary:
Evaluate the effect of systemic acupuncture on dielectric constant, elasticity and skin temperature in healthy individuals.

Condition or disease Intervention/treatment Phase
Acupuncture Other: Systemic acupuncture Not Applicable

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).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Change in Dielectric Constant, Elasticity and Temperature by Stimulation of Systemic Acupuncture Points
Estimated Study Start Date : August 2, 2021
Estimated Primary Completion Date : August 1, 2022
Estimated Study Completion Date : December 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture

Arm Intervention/treatment
Experimental: Group Acupuncture 1 - GA1
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.
Other: Systemic acupuncture
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.

Experimental: Group Acupuncture 2 - GA2
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.
Other: Systemic acupuncture
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.

Experimental: Group Acupuncture 3 - GA3
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.
Other: Systemic acupuncture
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.

No Intervention: Group Control 1 - GC1
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.
No Intervention: Group Control 2 - GC2
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.
No Intervention: Group Control 3 - GC3
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.



Primary Outcome Measures :
  1. Dielectric constant [ Time Frame: 10 minutes ]
    MoistureMeterD

  2. Elasticity [ Time Frame: 10 minutes ]
    ElastiMeterD

  3. Infrared thermography [ Time Frame: 15 minutes ]
    FLIR Systems T300



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 38 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Volunteers aged between 18 and 38 years, both genders and without health complaints.

Exclusion Criteria:

  • Pregnant female volunteers or those with a delay in the menstrual cycle for more than 28 days.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04919746


Contacts
Layout table for location contacts
Contact: Elaine C Guirro, PhD (16)33154584 ecguirro@fmrp.usp.br
Contact: João E Araujo, PhD (16)33150738 araujoje@fmrp.usp.br

Sponsors and Collaborators
University of Sao Paulo
Layout table for additonal information
Responsible Party: Elaine Caldeira de Oliveira Guirro, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT04919746    
Other Study ID Numbers: 4749033/2021
First Posted: June 9, 2021    Key Record Dates
Last Update Posted: June 9, 2021
Last Verified: June 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Elaine Caldeira de Oliveira Guirro, University of Sao Paulo:
Acupuncture
Lower limb