Healthy BehaviorNCT03252184
Effects of Photobiomodulation on Endothelial Function in Healthy Subjects
A study testing Low level laser therapy - 1, Low level laser therapy - 2 and Low level laser therapy - 3 in people with Healthy Behavior, run by Rodrigo Della Méa Plentz at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Behavior
- What is being tested?
- Low level laser therapy - 1, Low level laser therapy - 2 and Low level laser therapy - 3
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Sep 2017to 30 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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%).
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Federal University of Health Science of Porto Alegre (UFCSPA)
Porto Alegre, Rio Grande do Sul, 90050170
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy Behavior
- Being tested
- Low level laser therapy - 1, Low level laser therapy - 2, Low level laser therapy - 3
- Keywords
- Phototherapy, Laser Therapy, Endothelium-Dependent, Vascular Endothelium, Low Intensity Light Therapy, Relaxing Factors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low level laser therapy - 1Device
Also called Photobiomodulation, LLLT
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.
Low level laser therapy - 2Device
Also called Photobiomodulation, LLLT
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.
Low level laser therapy - 3Device
Also called Photobiomodulation, LLLT
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.
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 - Low level laser therapy - 1 (G1) | Experimental | Low level laser therapy with energy dose of 18J will be applied on left brachial artery of the subject. Receives: Device: Low level laser therapy - 1 |
| Phase 1 - Low level laser therapy - 1 (G2) | Experimental | Low level laser therapy with energy dose of 36J will be applied on left brachial artery of the subject. Receives: Device: Low level laser therapy - 1 |
| Phase 1 - Low level laser therapy - 1 (G3) | Experimental | Low level laser therapy with energy dose of 54J will be applied on left brachial artery of the subject. Receives: Device: Low level laser therapy - 1 |
| Phase 1 - Placebo low level laser therapy - 1 (G4) | Placebo comparator | Low level laser therapy with equipment turn off (placebo) be applied on left brachial artery of the subject. Receives: Device: Low level laser therapy - 1 |
| Phase 2 - Low level laser therapy - 2 (G1) | Experimental | Low level laser therapy with energy dose of 30J will be applied on left brachial artery of the subject. Receives: Device: Low level laser therapy - 2 |
| Phase 2 - Low level laser therapy - 2 (G2) | Experimental | Low level laser therapy with energy dose of 60J will be applied on left brachial artery of the subject. Receives: Device: Low level laser therapy - 2 |
| Phase 2 - Placebo low level laser therapy - 2 (G3) | Placebo comparator | Low level laser therapy with equipment turn off (placebo) be applied on left brachial artery of the subject. Receives: Device: Low level laser therapy - 2 |
| Phase 3 - Low level laser therapy - 3 (G1) | Experimental | Low level laser therapy with energy dose of 30J will be applied on left brachial artery of the subject. Receives: Device: Low level laser therapy - 3 |
| Phase 3 - Low level laser therapy - 3(G2) | Experimental | Low level laser therapy with energy dose of 60J will be applied on left brachial artery of the subject. Receives: Device: Low level laser therapy - 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in arterial endothelial function
The assessment of arterial endothelial function will be performed through the technique of flow-mediated dilatation, by high resolution ultrasound
Measured: The evaluation of the arterial endothelial function will be performed 20 minutes before and 20 minutes after the intervention with photobiostimulation
Secondary outcomes (4)
Change in body temperature
The local temperature will be evaluated by thermography
Measured: 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
The inflammatory profile will be evaluated by C-reactive protein dosage
Measured: Basal blood collection (5 minutes before) and immediately after each intervention (5 minutes after)
Change in arterial endothelial function (vasodilatation)
The vasodilatation will be evaluated by nitrite/nitrate dosage
Measured: Basal blood collection (5 minutes before) and immediately after each intervention (5 minutes after)
Time of blood vessel dilation
The duration of the vasodilation of brachial artery after photobiomodulation
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2017
- Study start1 Sep 2017
- Primary completion30 Dec 2019
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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 blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rodrigo Della Méa Plentz
- Sponsor type
- University, hospital or other
- Collaborators
- Federal University of Health Science of Porto Alegre
- Responsible party
- Sponsor-investigator, Rodrigo Della Méa Plentz, Federal University of Health Science of Porto Alegre
- Investigators
- Rodrigo DM Plentz, PhD, Study director, Federal University of Health Science of Porto AlegreMelina Hauck, Me, Principal investigator, Federal University of Health Science of Porto AlegreJociane Schardong, PhD, Principal investigator, Federal University of Health Science of Porto AlegreCamila B Bozzetto, Me, Principal investigator, Federal University of Health Science of Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03252184
- Sponsor's protocol ID
- PBMLLLT
- Status last verified
- Mar 2020
- First submitted
- 18 May 2017
- Last updated
- 24 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hauck M, Schardong J, Donini G, Normann TC, Plentz RDM. Effects of photobiomodulation therapy (PBMT) over endothelial function in healthy individuals: a preliminary crossover clinical trial. Lasers Med Sci. 2023 Apr 19;38(1):104. doi: 10.1007/s10103-023-03762-w.
PubMed 37072603
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Photobiomodulation on Endothelial Function, Blood and Endothelial Markers, and Nitric Oxide Metabolites in Healthy Subjects.
- ClinicalTrials.gov ID
- NCT03252184
- Acronym / sponsor ID
- PBMLLLT
- Conditions
- Healthy Behavior
- Keywords
- Phototherapy, Laser Therapy, Endothelium-Dependent, Vascular Endothelium, Low Intensity Light Therapy, Relaxing Factors
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Rodrigo Della Méa PlentzUniversity, hospital or other
- Collaborators
- Federal University of Health Science of Porto Alegre
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 17 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 9
- 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.
| Arm | Type | Receives |
|---|---|---|
| Phase 1 - Low level laser therapy - 1 (G1) | Experimental | Device: Low level laser therapy - 1Low level laser therapy with energy dose of 18J will be applied on left brachial artery of the subject. |
| Phase 1 - Low level laser therapy - 1 (G2) | Experimental | Device: Low level laser therapy - 1Low level laser therapy with energy dose of 36J will be applied on left brachial artery of the subject. |
| Phase 1 - Low level laser therapy - 1 (G3) | Experimental | Device: Low level laser therapy - 1Low level laser therapy with energy dose of 54J will be applied on left brachial artery of the subject. |
| Phase 1 - Placebo low level laser therapy - 1 (G4) | Placebo comparator | Device: Low level laser therapy - 1Low level laser therapy with equipment turn off (placebo) be applied on left brachial artery of the subject. |
| Phase 2 - Low level laser therapy - 2 (G1) | Experimental | Device: Low level laser therapy - 2Low level laser therapy with energy dose of 30J will be applied on left brachial artery of the subject. |
| Phase 2 - Low level laser therapy - 2 (G2) | Experimental | Device: Low level laser therapy - 2Low level laser therapy with energy dose of 60J will be applied on left brachial artery of the subject. |
| Phase 2 - Placebo low level laser therapy - 2 (G3) | Placebo comparator | Device: Low level laser therapy - 2Low level laser therapy with equipment turn off (placebo) be applied on left brachial artery of the subject. |
| Phase 3 - Low level laser therapy - 3 (G1) | Experimental | Device: Low level laser therapy - 3Low level laser therapy with energy dose of 30J will be applied on left brachial artery of the subject. |
| Phase 3 - Low level laser therapy - 3(G2) | Experimental | Device: Low level laser therapy - 3Low level laser therapy with energy dose of 60J will be applied on left brachial artery of the subject. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low level laser therapy - 1Also: Photobiomodulation, LLLTIn 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 | Phase 1 - Low level laser therapy - 1 (G1), Phase 1 - Low level laser therapy - 1 (G2), Phase 1 - Low level laser therapy - 1 (G3), Phase 1 - Placebo low level laser therapy - 1 (G4) |
| Low level laser therapy - 2Also: Photobiomodulation, LLLTIn 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 | Phase 2 - Low level laser therapy - 2 (G1), Phase 2 - Low level laser therapy - 2 (G2), Phase 2 - Placebo low level laser therapy - 2 (G3) |
| Low level laser therapy - 3Also: Photobiomodulation, LLLTIn 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. | Device | Phase 3 - Low level laser therapy - 3 (G1), Phase 3 - Low level laser therapy - 3(G2) |
Primary outcome
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
4 secondary outcomes
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
Change in inflammatory profile
Time frame: 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)
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2020.
- Derived from this study: PubMed 37072603Hauck M, Schardong J, Donini G, Normann TC, Plentz RDM. Effects of photobiomodulation therapy (PBMT) over endothelial function in healthy individuals: a preliminary crossover clinical trial. Lasers Med Sci. 2023 Apr 19;38(1):104. doi: 10.1007/s10103-023-03762-w.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rodrigo DM Plentz, PhD study director
Federal University of Health Science of Porto Alegre
Melina Hauck, Me principal investigator
Federal University of Health Science of Porto Alegre
Jociane Schardong, PhD principal investigator
Federal University of Health Science of Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low level laser therapy - 1, Low level laser therapy - 2 and Low level laser therapy - 3 in people with Healthy Behavior, run by Rodrigo Della Méa Plentz at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03252184, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2020.