Low Level Laser TherapyNCT04809415
Influence of Power and Wavelength on Photobiomodulation Therapy for Muscle Performance in Healthy Subjects
A study testing Photobiomodulation in people with Low Level Laser Therapy and Photobiomodulation, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
In recent years, photobiomodulation has been studied as a means of increasing muscle performance in athletes and healthy individuals. This is possible due to the physiological changes that photobiomodulation therapy can promote. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Low Level Laser Therapy, Photobiomodulation, Performance
- What is being tested?
- Photobiomodulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteBrazil
- Study dates
- 1 May 2021to 1 Oct 2022
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy individuals;
Who cannot join
- musculoskeletal injury in the last three months;
- cardiovascular diseases;
- use of anabolic, anti-inflammatory and analgesic drugs 72 hours before the evaluations;
- use of alcohol and illicit drugs during the collection period;
Trial locations and contacts
1 site in 1 country.
About this study
In recent years, photobiomodulation has been studied as a means of increasing muscle performance in athletes and healthy individuals. This is possible due to the physiological changes that photobiomodulation therapy can promote. Moreover, given a large number of existing studies on the subject, some directions for future research have been established. For example, future research was established, the relationship between power and time because with high power, it will achieve the same energy with shorter application times. However, irradiation may not be offered for the minimum recommended time. Therefore, this study aims to compare different powers and, consequently, different application times for muscle performance in healthy individuals. For this, 42 participants will be recruited, males between 18 to 40 years old, without recent musculoskeletal injury or cardiorespiratory problems. The participants will participate in 3 evaluations containing functional and physiological variables and ten training sessions of lower limbs with previous photobiomodulation therapy application, comparing devices with a power of 0.864W and 1.864W. 0.864W and 1.2W. Lower limbs training will be composed of stiff and squat exercises twice a week, for five weeks. In the pre- and post-intervention evaluations, the following parameters will be evaluated isokinetic apparatus, body composition, and functionality of the vertical jump. For data analysis, we will use a normality test to verify the distribution and statistical tests will be used for intra and intra and intergroup comparisons, considering two factors in the comparisons time and group. A significance level of 5% will be adopted.
Read the detailed description
It is a blinded randomized clinical trial. The volunteers will undergo pre-evaluation, 5 weeks of training associated with the LED application, being distributed in two applications per week, and a re-evaluation 24 hours after the last application, totaling a total of approximately 7 weeks. Thus, on the first day (Pre-test) volunteers will be submitted to anthropometric evaluation and evaluation by bioimpedance for analysis of detailed body composition. Then, the maximum voluntary contraction test (CVM) will be performed on the isokinetic dynamometer, together with the electromyographic evaluation. Before and after the evaluation with the isokinetic dynamometer, thermography will be collected. Still, will be evaluated the vertical jump test after 15 minutes of passive rest.
After the initial evaluations, the researcher will go apply the respective interventions, which consist of applying LEDs all over the quadriceps and hamstring bilaterally, while the sham group (GS) will receive the LED application off, without the emission of light. The application will occur for five weeks and will occur twice weekly, on days spaced for at least 48 hours. The same will be done in conjunction with the lower limb strength training protocol. It is noteworthy that although the therapy follows the same energy values, two different pieces of equipment will be used, thus changing the wavelength, total power and power density, and the consequent coverage time and area.
The tests performed at the time of pre-application of the LED (Pre-test) will be reapplied in the same order 24 hours after the last application of the interventions. After seven days of the last application, the isokinetic evaluation, electromyography, and vertical jump evaluation will be performed. In addition, at the end of the second and fourth weeks, the volunteer will carry out an evaluation with the isokinetic dynamometer, electromyography, plethysmography, and thermography.
- Conditions
- Low Level Laser Therapy, Photobiomodulation, Performance, Sport
- Being tested
- Photobiomodulation, Sham
- Keywords
- Physical Therapy, Photobiomodulation, Muscle Strength, Power, Athletic Performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhotobiomodulationOther
Photobiomodulation consists of irradiation by light in order to achieve photochemical and photophysical outcomes.
ShamOther
Simulation of the application of photobiomodulation therapy.
| Study group | Role | What they receive |
|---|---|---|
| Sham Group (G-S) | Sham comparator | The LED blanket will be positioned across the quadriceps and hamstring bilaterally, however, there will be no light emission. However, the volunteer will perform the strength training protocol. Receives: Other: Sham |
| 300J Infrared Blanket LED Group (Blanket-300J) | Experimental | The LED blanket with a wavelength of 940nm, energy of 300J, will be applied across the quadriceps and hamstrings bilaterally, just before the strength training protocol. Receives: Other: Photobiomodulation |
| 300J Infrared Cluster LED Group (Cluster-300J) | Experimental | The LED Cluster with a wavelength of 850 nm, energy of 300 J, will be applied to the quadriceps (5 points) and hamstrings (5 points), bilaterally, just before the strength training protocol. Receives: Other: Photobiomodulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference of maximal voluntary contraction
The study was designed to detect a difference of maximal voluntary contraction between the groups, following the interventions
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2021
- Study start1 May 2021
- Primary completion31 Dec 2021
- Study completion1 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Low Level Laser TherapyStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rinaldo Roberto de Jesus Guirro, University of Sao Paulo
- Investigators
- Carlos E Girasol, Student, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04809415
- Sponsor's protocol ID
- DifPower
- Status last verified
- Oct 2022
- First submitted
- 17 Mar 2021
- Last updated
- 21 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The datas will be sharing in form of manuscript.
Publications
American College of Sports Medicine. American College of Sports Medicine position stand. Progression models in resistance training for healthy adults. Med Sci Sports Exerc. 2009 Mar;41(3):687-708. doi: 10.1249/MSS.0b013e3181915670.
PubMed 19204579Ferraresi C, Beltrame T, Fabrizzi F, do Nascimento ES, Karsten M, Francisco Cde O, Borghi-Silva A, Catai AM, Cardoso DR, Ferreira AG, Hamblin MR, Bagnato VS, Parizotto NA. Muscular pre-conditioning using light-emitting diode therapy (LEDT) for high-intensity exercise: a randomized double-blind placebo-controlled trial with a single elite runner. Physiother Theory Pract. 2015 Jul;31(5):354-61. doi: 10.3109/09593985.2014.1003118. Epub 2015 Jan 14.
PubMed 25585514Anders JJ, Lanzafame RJ, Arany PR. Low-level light/laser therapy versus photobiomodulation therapy. Photomed Laser Surg. 2015 Apr;33(4):183-4. doi: 10.1089/pho.2015.9848. No abstract available.
PubMed 25844681
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Power and Wavelength on Photobiomodulation Therapy for Muscle Performance in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04809415
- Acronym / sponsor ID
- DifPower
- Conditions
- Low Level Laser Therapy, Photobiomodulation, Performance, Sport
- Keywords
- Physical Therapy, Photobiomodulation, Muscle Strength, Power, Athletic Performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 22 Mar 2021 (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.
In recent years, photobiomodulation has been studied as a means of increasing muscle performance in athletes and healthy individuals. This is possible due to the physiological changes that photobiomodulation therapy can promote. Moreover, given a large number of existing studies on the subject, some directions for future research have been established. For example, future research was established, the relationship between power and time because with high power, it will achieve the same energy with shorter application times. However, irradiation may not be offered for the minimum recommended time. Therefore, this study aims to compare different powers and, consequently, different application times for muscle performance in healthy individuals. For this, 42 participants will be recruited, males between 18 to 40 years old, without recent musculoskeletal injury or cardiorespiratory problems. The participants will participate in 3 evaluations containing functional and physiological variables and ten training sessions of lower limbs with previous photobiomodulation therapy application, comparing devices with a power of 0.864W and 1.864W. 0.864W and 1.2W. Lower limbs training will be composed of stiff and squat exercises twice a week, for five weeks. In the pre- and post-intervention evaluations, the following parameters will be evaluated isokinetic apparatus, body composition, and functionality of the vertical jump. For data analysis, we will use a normality test to verify the distribution and statistical tests will be used for intra and intra and intergroup comparisons, considering two factors in the comparisons time and group. A significance level of 5% will be adopted.
Detailed description
It is a blinded randomized clinical trial. The volunteers will undergo pre-evaluation, 5 weeks of training associated with the LED application, being distributed in two applications per week, and a re-evaluation 24 hours after the last application, totaling a total of approximately 7 weeks. Thus, on the first day (Pre-test) volunteers will be submitted to anthropometric evaluation and evaluation by bioimpedance for analysis of detailed body composition. Then, the maximum voluntary contraction test (CVM) will be performed on the isokinetic dynamometer, together with the electromyographic evaluation. Before and after the evaluation with the isokinetic dynamometer, thermography will be collected. Still, will be evaluated the vertical jump test after 15 minutes of passive rest.
After the initial evaluations, the researcher will go apply the respective interventions, which consist of applying LEDs all over the quadriceps and hamstring bilaterally, while the sham group (GS) will receive the LED application off, without the emission of light. The application will occur for five weeks and will occur twice weekly, on days spaced for at least 48 hours. The same will be done in conjunction with the lower limb strength training protocol. It is noteworthy that although the therapy follows the same energy values, two different pieces of equipment will be used, thus changing the wavelength, total power and power density, and the consequent coverage time and area.
The tests performed at the time of pre-application of the LED (Pre-test) will be reapplied in the same order 24 hours after the last application of the interventions. After seven days of the last application, the isokinetic evaluation, electromyography, and vertical jump evaluation will be performed. In addition, at the end of the second and fourth weeks, the volunteer will carry out an evaluation with the isokinetic dynamometer, electromyography, plethysmography, and thermography.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sham Group (G-S) | Sham comparator | Other: ShamThe LED blanket will be positioned across the quadriceps and hamstring bilaterally, however, there will be no light emission. However, the volunteer will perform the strength training protocol. |
| 300J Infrared Blanket LED Group (Blanket-300J) | Experimental | Other: PhotobiomodulationThe LED blanket with a wavelength of 940nm, energy of 300J, will be applied across the quadriceps and hamstrings bilaterally, just before the strength training protocol. |
| 300J Infrared Cluster LED Group (Cluster-300J) | Experimental | Other: PhotobiomodulationThe LED Cluster with a wavelength of 850 nm, energy of 300 J, will be applied to the quadriceps (5 points) and hamstrings (5 points), bilaterally, just before the strength training protocol. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy individuals;
Key exclusion criteria (4 listed)
- musculoskeletal injury in the last three months;
- cardiovascular diseases;
- use of anabolic, anti-inflammatory and analgesic drugs 72 hours before the evaluations;
- use of alcohol and illicit drugs during the collection period;
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 |
|---|---|---|
| PhotobiomodulationPhotobiomodulation consists of irradiation by light in order to achieve photochemical and photophysical outcomes. | Other | 300J Infrared Blanket LED Group (Blanket-300J), 300J Infrared Cluster LED Group (Cluster-300J) |
| ShamSimulation of the application of photobiomodulation therapy. | Other | Sham Group (G-S) |
Primary outcome
Difference of maximal voluntary contraction
Time frame: 1 year
The study was designed to detect a difference of maximal voluntary contraction between the groups, following the interventions
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2022.
- Background: PubMed 19204579American College of Sports Medicine. American College of Sports Medicine position stand. Progression models in resistance training for healthy adults. Med Sci Sports Exerc. 2009 Mar;41(3):687-708. doi: 10.1249/MSS.0b013e3181915670.
- Background: PubMed 25585514Ferraresi C, Beltrame T, Fabrizzi F, do Nascimento ES, Karsten M, Francisco Cde O, Borghi-Silva A, Catai AM, Cardoso DR, Ferreira AG, Hamblin MR, Bagnato VS, Parizotto NA. Muscular pre-conditioning using light-emitting diode therapy (LEDT) for high-intensity exercise: a randomized double-blind placebo-controlled trial with a single elite runner. Physiother Theory Pract. 2015 Jul;31(5):354-61. doi: 10.3109/09593985.2014.1003118. Epub 2015 Jan 14.
- Background: PubMed 25844681Anders JJ, Lanzafame RJ, Arany PR. Low-level light/laser therapy versus photobiomodulation therapy. Photomed Laser Surg. 2015 Apr;33(4):183-4. doi: 10.1089/pho.2015.9848. No abstract available.
- Individual participant dataSharing planned: No. The datas will be sharing in form of manuscript.
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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.
Carlos E Girasol, Student principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photobiomodulation in people with Low Level Laser Therapy and Photobiomodulation, run by University of Sao Paulo 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 1 inclusion and 4 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: finished, as of the sponsor's last update on 21 Oct 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Difference of maximal voluntary contraction (time frame: 1 year). 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 NCT04809415, which also lists 3 linked publications.
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 21 Oct 2022.