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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04919746
Other study ID # 4749033/2021
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date August 2, 2021
Est. completion date December 1, 2022

Study information

Verified date June 2021
Source University of Sao Paulo
Contact Elaine C Guirro, PhD
Phone (16)33154584
Email ecguirro@fmrp.usp.br
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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).


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 360
Est. completion date December 1, 2022
Est. primary completion date August 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 38 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Sao Paulo

Outcome

Type Measure Description Time frame Safety issue
Primary Dielectric constant MoistureMeterD 10 minutes
Primary Elasticity ElastiMeterD 10 minutes
Primary Infrared thermography FLIR Systems T300 15 minutes
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