Effects of Photobiomodulation on Endothelial Function in Healthy Subjects

Summary

The endothelial cell layer is responsible for the control of vascular homeostasis, a process mediated by vasoconstricting and vasodilatory substances. The principal endothelium-dependent vascular dilator is nitric oxide (NO), and the reduction of its synthesis or bioavailability is the main cause for the development of endothelial dysfunction. The use of photobiomodulation may be beneficial in several clinical situations. At the endothelial level, the stimulatory effects on vascular endothelial growth factor, NO secretion, number of capillaries and proliferation of endothelial cells are outstanding. The objective of this study is to evaluate the effects of photobiomodulation on the arterial endothelial function of healthy individuals. The study design will be a randomized, crossover, clinical trial and the sample will be composed of subjects selected by the eligibility criteria, and randomly randomized according to the order of intervention of the groups. The hypothesis is that at the end of the protocol with photobiomodulation an increase in endothelial function and blood markers of endothelial function occurs, and no tissue temperature variation.

Conditions

• Healthy Behavior

Interventions

DEVICE

Low level laser therapy - 1

In the phase 1, the low level laser therapy will be performed with the Fluence device (HTM, Brasil) and the probe from the same manufacturer. For the interventions in groups G1, G2 and G3 (photobiomodulation) will be used, respectively, the energy doses of 18J, 36J and 54J. A 658nm wavelength with an output power of 10mW will be used. Group 4 intervention (placebo photobiomodulation) will be performed with the application of the device turned off. Each intervention will be performed in one day, with an interval of two days between each intervention. Photobiomodulation will be performed on the region of the radial and ulnar arteries of the left arm of each individual. The laser probe will be placed in direct contact with the skin.

DEVICE

Low level laser therapy - 2

In the phase 2, the low level laser therapy will be performed with the Thor DD2 (London, UK) and the cluster probe from the same manufacturer. For the interventions in groups G1 and G2 (photobiomodulation) will be used, respectively, the energy doses of 30J and 60J. A 810nm wavelength and an output power of 200mW will be used. Group 3 intervention (placebo photobiomodulation) will be performed with the application of the device turned off. Each intervention will be performed in one day, with an interval of two days between each intervention. Photobiomodulation will be performed on the region of the radial and ulnar arteries of the left arm of each individual. The laser probe will be placed in direct contact with the skin.

DEVICE

Low level laser therapy - 3

In the phase 3, the low level laser therapy will be performed with the Thor DD2 (London, UK) and the cluster probe from the same manufacturer. For the interventions in groups G1 and G2 (photobiomodulation) will be used, respectively, the energy doses of 30J and 60J. A 810nm wavelength and an output power of 200mW will be used. Each intervention will be performed in one day, with an interval of two days between each intervention. Photobiomodulation will be performed on the region of the radial and ulnar arteries of the left arm of each individual. The laser probe will be placed in direct contact with the skin.

Sponsors & Collaborators

• Federal University of Health Science of Porto Alegre

  collaborator OTHER

• Rodrigo Della Méa Plentz

  lead OTHER

Principal Investigators

• Rodrigo DM Plentz, PhD · Federal University of Health Science of Porto Alegre

• Melina Hauck, Me · Federal University of Health Science of Porto Alegre

• Jociane Schardong, PhD · Federal University of Health Science of Porto Alegre

• Camila B Bozzetto, Me · Federal University of Health Science of Porto Alegre

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

40 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-09-01

Primary Completion

2019-12-30

Completion

2020-12-30

Countries

• Brazil

Study Locations