Change in Dielectric Constant, Elasticity and Temperature by Acupuncture

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Acupuncture
• Intervention / Treatment: Other: Systemic acupuncture

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 Type: Interventional
• Enrollment (Anticipated): 360
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elaine C Guirro, PhD; Phone Number: (16)33154584; Email: ecguirro@fmrp.usp.br
• Study Contact Backup: Name: João E Araujo, PhD; Phone Number: (16)33150738; Email: araujoje@fmrp.usp.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 38 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

6

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dielectric constant	MoistureMeterD	10 minutes
Elasticity	ElastiMeterD	10 minutes
Infrared thermography	FLIR Systems T300	15 minutes

Collaborators and Investigators

• Sponsor: University of Sao Paulo

Study record dates

Study Major Dates

• Study Start (Anticipated): August 2, 2021
• Primary Completion (Anticipated): August 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: June 2, 2021
• First Submitted That Met QC Criteria: June 2, 2021
• First Posted (Actual): June 9, 2021

Study Record Updates

• Last Update Posted (Actual): June 9, 2021
• Last Update Submitted That Met QC Criteria: June 2, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Acupuncture; Lower limb
• Other Study ID Numbers: 4749033/2021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No