Effects of Photobiomodulation on Endothelial Function in Healthy Subjects
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ClinicalTrials.gov Identifier: NCT03252184 |
Recruitment Status : Unknown
Verified March 2020 by Rodrigo Della Méa Plentz, Federal University of Health Science of Porto Alegre.
Recruitment status was: Active, not recruiting
First Posted : August 17, 2017
Last Update Posted : March 24, 2020
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Condition or disease | Intervention/treatment | Phase |
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Healthy Behavior | Device: Low level laser therapy - 1 Device: Low level laser therapy - 2 Device: Low level laser therapy - 3 | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 16 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Intervention Model Description: | 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. |
Masking: | Double (Participant, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Effects of Photobiomodulation on Endothelial Function, Blood and Endothelial Markers, and Nitric Oxide Metabolites in Healthy Subjects. |
Actual Study Start Date : | September 1, 2017 |
Actual Primary Completion Date : | December 30, 2019 |
Estimated Study Completion Date : | December 30, 2020 |
Arm | Intervention/treatment |
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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.
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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:
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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:
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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:
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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.
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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:
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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.
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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:
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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:
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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:
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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:
|
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:
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- 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
- 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
- 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
- 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
- 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

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Ages Eligible for Study: | 18 Years to 40 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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%).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03252184
Brazil | |
Federal University of Health Science of Porto Alegre (UFCSPA) | |
Porto Alegre, Rio Grande Do Sul, Brazil, 90050170 |
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 |
Responsible Party: | Rodrigo Della Méa Plentz, Principal Investigator, Federal University of Health Science of Porto Alegre |
ClinicalTrials.gov Identifier: | NCT03252184 |
Other Study ID Numbers: |
PBMLLLT |
First Posted: | August 17, 2017 Key Record Dates |
Last Update Posted: | March 24, 2020 |
Last Verified: | March 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Phototherapy Laser Therapy Endothelium-Dependent |
Vascular Endothelium Low Intensity Light Therapy Relaxing Factors |