Effects of Photobiomodulation on Endothelial Function in Healthy Subjects

March 20, 2020 updated by: Rodrigo Della Méa Plentz

Effects of Photobiomodulation on Endothelial Function, Blood and Endothelial Markers, and Nitric Oxide Metabolites in Healthy Subjects.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Detailed Description: 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. It has also been shown an increase in glutathione levels, antioxidant effect and angiogenic potential, which shows a potential vascular effect, and consequently, an improvement in endothelial function. 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 16 healthy 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 irradiation protocol with photobiomodulation an increase in endothelial function and blood markers of endothelial function occurs, and no tissue temperature variation. The primary objective is to evaluate the effects of photobiomodulation on the arterial endothelial function of healthy individuals. The secondary objectives are: 1) To evaluate the time of blood vessel dilation after photobiomodulation. 2) To evaluate the effects of photobiomodulation on blood markers (hemogram) and endothelial markers (cGMP and L-arginine), and Nitric oxide (nitrite and nitrate). 3) To analyze associations between markers and metabolites with endothelial function due to the effects of Photobiomodulation. 3) Analyze the local temperature before and after photobiomodulation. 4) Analyze the local temperature before and after the measurement of Endothelial function. 5) Evaluate possible associations between blood and endothelial markers, nitric oxide pathway metabolites and Endothelial function with local temperature. 6) To compare the effects of energy doses and wavelenghts of photobiosmodulation on endothelial function, blood and endothelial markers, and metabolites of the nitric oxide pathway. The research will be developed in room 709 of the Laboratory of Physiotherapy in building II, UFCSPA and, for randomization, the simple technique will be used through numbers generated by a freely available software. The generation of the sequence of numbers will be done by a blind researcher, after the selection of the individuals by the eligibility criteria. The study will be separated in phases in according to photobiomodulation device employed. Initially, we will use the laser with 658nm, power output of 10mW per point and fluence of 18J, 36J e 54J per area. The individuals will be randomly assigned to: group 1 (energy dose of 18J), group 2 (energy dose of 36J), group 3 (energy dose of 54J), and group 4 (placebo). In the second phase, we will use the laser with 810nm, power density of 714 mW/cm2 and fluence of 30 J per spot. The individuals will be randomly assigned to: group 1 (energy dose of 30J), group 2 (energy dose of 60J) and group 3 (placebo). Finally, we will measure the time of blood vessel dilation after photobiomodulation with 30J and 60J. The normality of the data will be evaluated by the Shapiro-Wilk test. Data with symmetrical distribution will be presented as mean ± standard deviation, and data with asymmetric distribution as median and interquartile range (P25 - P75). The baseline characteristics of the patients will be compared by Student's t-test or Mann-Whitney when the distributions are parametric or non-parametric, respectively. The categorical variables will be compared by the Chi-square test. Variance Analysis (ANOVA) will be used for repeated measures for pre and post-intervention data analysis, or the Mann-Whitney test (asymmetric distribution), followed by Bonferroni post hoc. The Pearson or Sperman correlations will be used for possible association between the analyzed variables. Statistical significance of 5% (p <0.05) will be observed.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90050170
        • Federal University of Health Science of Porto Alegre (UFCSPA)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age between 18-40 years
  • Body mass index (BMI: kg / m2) lower than 30
  • Absence of symptoms of musculoskeletal disorders
  • No use of medications
  • Non-smokers and / or alcoholics
  • Absence of previous diagnosis of diseases Rheumatological, cardiovascular, renal, metabolic, neurological, oncological, immunological, hematological, psychiatric or cognitive.

Exclusion Criteria:

On the days of evaluation and intervention:

  • Individuals who performed high intensity physical activity in the previous 72 hours
  • Individuals who had an inflammatory response (> 3 mg / dL, fibrinogen <200 or> 400mg / dL) or leukocytosis (> 11,000 x103 / Mm3)
  • Individuals who have consumed caffeine, juices or citrus fruits, high-fat foods and alcohol in the 12 hours prior to the test
  • Individuals who are not fasting for 12 hours
  • Individuals who have used anti-inflammatory, antipyretic or analgesic drugs
  • Individuals who having an arterial diameter <0.25 mm or> 5.0 mm
  • Individuals with present endothelial dysfunction evaluated by the FMD technique (dilation <8%).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Phase 1 - Low level laser therapy - 1 (G1)
Low level laser therapy with energy dose of 18J will be applied on left brachial artery of the subject.
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.
Other Names:
  • LLLT
  • Photobiomodulation
Experimental: Phase 1 - Low level laser therapy - 1 (G2)
Low level laser therapy with energy dose of 36J will be applied on left brachial artery of the subject.
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.
Other Names:
  • LLLT
  • Photobiomodulation
Experimental: Phase 1 - Low level laser therapy - 1 (G3)
Low level laser therapy with energy dose of 54J will be applied on left brachial artery of the subject.
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.
Other Names:
  • LLLT
  • Photobiomodulation
Placebo Comparator: Phase 1 - Placebo low level laser therapy - 1 (G4)
Low level laser therapy with equipment turn off (placebo) be applied on left brachial artery of the subject.
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.
Other Names:
  • LLLT
  • Photobiomodulation
Experimental: Phase 2 - Low level laser therapy - 2 (G1)
Low level laser therapy with energy dose of 30J will be applied on left brachial artery of the subject.
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.
Other Names:
  • LLLT
  • Photobiomodulation
Experimental: Phase 2 - Low level laser therapy - 2 (G2)
Low level laser therapy with energy dose of 60J will be applied on left brachial artery of the subject.
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.
Other Names:
  • LLLT
  • Photobiomodulation
Placebo Comparator: Phase 2 - Placebo low level laser therapy - 2 (G3)
Low level laser therapy with equipment turn off (placebo) be applied on left brachial artery of the subject.
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.
Other Names:
  • LLLT
  • Photobiomodulation
Experimental: Phase 3 - Low level laser therapy - 3 (G1)
Low level laser therapy with energy dose of 30J will be applied on left brachial artery of the subject.
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.
Other Names:
  • LLLT
  • Photobiomodulation
Experimental: Phase 3 - Low level laser therapy - 3(G2)
Low level laser therapy with energy dose of 60J will be applied on left brachial artery of the subject.
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.
Other Names:
  • LLLT
  • Photobiomodulation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in arterial endothelial function
Time Frame: The evaluation of the arterial endothelial function will be performed 20 minutes before and 20 minutes after the intervention with photobiostimulation
The assessment of arterial endothelial function will be performed through the technique of flow-mediated dilatation, by high resolution ultrasound
The evaluation of the arterial endothelial function will be performed 20 minutes before and 20 minutes after the intervention with photobiostimulation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in body temperature
Time Frame: The evaluation of the arterial endothelial function will be performed 15 minutes before and 15 minutes after the intervention with photobiostimulation
The local temperature will be evaluated by thermography
The evaluation of the arterial endothelial function will be performed 15 minutes before and 15 minutes after the intervention with photobiostimulation
Change in inflammatory profile
Time Frame: Basal blood collection (5 minutes before) and immediately after each intervention (5 minutes after)
The inflammatory profile will be evaluated by C-reactive protein dosage
Basal blood collection (5 minutes before) and immediately after each intervention (5 minutes after)
Change in arterial endothelial function (vasodilatation)
Time Frame: Basal blood collection (5 minutes before) and immediately after each intervention (5 minutes after)
The vasodilatation will be evaluated by nitrite/nitrate dosage
Basal blood collection (5 minutes before) and immediately after each intervention (5 minutes after)
Time of blood vessel dilation
Time Frame: The measurement of the brachial artery vasodilation time (Cruz 2016; Iida 2006) was made before (baseline), immediately after and every two minutes until completing 20 minutes of evaluation after photobiomodulation
The duration of the vasodilation of brachial artery after photobiomodulation
The measurement of the brachial artery vasodilation time (Cruz 2016; Iida 2006) was made before (baseline), immediately after and every two minutes until completing 20 minutes of evaluation after photobiomodulation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rodrigo Della Méa Plentz

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Federal University of Health Science of Porto Alegre

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Rodrigo DM Plentz, PhD, Federal University of Health Science of Porto Alegre
  • Principal Investigator: Melina Hauck, Me, Federal University of Health Science of Porto Alegre
  • Principal Investigator: Jociane Schardong, PhD, Federal University of Health Science of Porto Alegre
  • Principal Investigator: Camila B Bozzetto, Me, Federal University of Health Science of Porto Alegre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 18, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 17, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 24, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PBMLLLT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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