NCT04919746

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
360

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2021

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 2, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 9, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

August 2, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

June 9, 2021

Status Verified

June 1, 2021

Enrollment Period

12 months

First QC Date

June 2, 2021

Last Update Submit

June 2, 2021

Conditions

Keywords

AcupunctureLower limb

Outcome Measures

Primary Outcomes (3)

  • Dielectric constant

    MoistureMeterD

    10 minutes

  • Elasticity

    ElastiMeterD

    10 minutes

  • Infrared thermography

    FLIR Systems T300

    15 minutes

Study Arms (6)

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.

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.

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.

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.

Interventions

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.

Group Acupuncture 1 - GA1Group Acupuncture 2 - GA2Group Acupuncture 3 - GA3

Eligibility Criteria

Age18 Years - 38 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Elaine C Guirro, PhD

CONTACT

João E Araujo, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Elaine Caldeira de Oliveira Guirro

Study Record Dates

First Submitted

June 2, 2021

First Posted

June 9, 2021

Study Start

August 2, 2021

Primary Completion

August 1, 2022

Study Completion

December 1, 2022

Last Updated

June 9, 2021

Record last verified: 2021-06