Low Level Laser TherapyNCT03860766
Photobiomodulation in Different Doses on Strength Capacities and Functional Performance
A study testing Photobiomodulation in people with Low Level Laser Therapy and Performance, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Background: Photobiomodulation has been explored for years, with wide clinical use for wound healing and analgesia in varied orthopedic conditions, but the number of research and clinical use has increased during the last decade. 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, Performance, Sport
- What is being tested?
- Photobiomodulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteBrazil
- Study dates
- 8 Jul 2020to 19 Jul 2021
- 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
- Handball players with the participation of at least one official match in the last year and attend 70% of the team's activities during the current season; or
- 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
Official title: Photobiomodulation With Infrared Light-emitting Diode (LED) in Different Doses on Strength Capacities and Functional Performance of Handball Players and Healthy Individuals
Background: Photobiomodulation has been explored for years, with wide clinical use for wound healing and analgesia in varied orthopedic conditions, but the number of research and clinical use has increased during the last decade. Furthermore, considering the performance, the current literature is conflicting and restricted, with divergences in wavelength, power and energy density applied. Therefore, analyze different doses for a answer in short and long time, associated with capacities of strength, fatigue resistance and functional performance of handball players and healthy individuals becomes necessary. Objective: To analyze the effects of the application of LED photobiomodulation on the capacities of strength, functional efficiency, temperature and fatigue resistance of handball players and healthy individuals. Method: The study sample will be composed of 56 male individuals randomly allocated into four groups: LED 50J (G-50J), LED 240J (G-240J), LED 50-240J (G-50-240J) - progressive dose and Sham (G-S). The volunteers will be submitted to an evaluation of muscle performance and functional performance, metabolic, and physiological evaluation. After initial tests, in five consecutive weeks, the LEDT (940nm - infrared) will be applied to the quadriceps femoris muscle and hamstrings, bilaterally, associated with a muscle strength protocol. After 24 hours of the last application TLED, the tests will be repeated. Seven days after the last intervention will be performed a follow-up. For analysis, normality tests will be used to verify the distribution and adequate statistical tests for the appropriate intra and intergroup comparisons, being considered 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.
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, Performance, Sport
- Being tested
- Photobiomodulation
- Keywords
- Isokinetic, Electromyography, Physiotherapy, Athletic Performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhotobiomodulationOther
An LED blanket with 267 infrared lamps with predetermined doses will be used, given a wavelength of 940nm, for 5 weeks, it will be applied by all extension of the quadriceps and hamstrings bilaterally, just before the force training protocol for the groups intervention or simulation for the sham group. Photochemical or photophysical effects are expected from its application.
| Study group | Role | What they receive |
|---|---|---|
| Sham Group (G-S) | Sham comparator | The LED 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: Photobiomodulation |
| 50J Infrared LED Group (G-50J) | Experimental | The LED with a wavelength of 940nm, 50J power, will be applied throughout the quadriceps and hamstrings bilaterally, just before the strength training protocol. Receives: Other: Photobiomodulation |
| 240J Infrared LED Group (G-240J) | Experimental | The LED with a wavelength of 940nm, 240J power, will be applied across the quadriceps and hamstrings bilaterally, just before the strength training protocol. Receives: Other: Photobiomodulation |
| Progressive dose infrared LED group (G-50-240J) | Experimental | The LED with a wavelength of 940nm, initial energy of 50J with an increment of 38J each week to the final energy of 240J, will be applied throughout extension of the quadriceps and hamstrings bilaterally, immediately prior to the performance of 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: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2019
- Study start8 Jul 2020
- Primary completion19 Jul 2021
- Study completion19 Jul 2021
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.
- 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 56 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 Girasol, Student, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03860766
- Sponsor's protocol ID
- 4.188.366
- Status last verified
- Jul 2021
- First submitted
- 28 Feb 2019
- Last updated
- 21 Jul 2021
- 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 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Photobiomodulation With Infrared Light-emitting Diode (LED) in Different Doses on Strength Capacities and Functional Performance of Handball Players and Healthy Individuals
- ClinicalTrials.gov ID
- NCT03860766
- Acronym / sponsor ID
- 4.188.366
- Conditions
- Low Level Laser Therapy, Performance, Sport
- Keywords
- Isokinetic, Electromyography, Physiotherapy, Athletic Performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 8 Jul 2020 (actual)
- Primary completion
- 19 Jul 2021 (actual)
- Study completion
- 19 Jul 2021 (actual)
- First posted
- 4 Mar 2019 (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.
Background: Photobiomodulation has been explored for years, with wide clinical use for wound healing and analgesia in varied orthopedic conditions, but the number of research and clinical use has increased during the last decade. Furthermore, considering the performance, the current literature is conflicting and restricted, with divergences in wavelength, power and energy density applied. Therefore, analyze different doses for a answer in short and long time, associated with capacities of strength, fatigue resistance and functional performance of handball players and healthy individuals becomes necessary. Objective: To analyze the effects of the application of LED photobiomodulation on the capacities of strength, functional efficiency, temperature and fatigue resistance of handball players and healthy individuals. Method: The study sample will be composed of 56 male individuals randomly allocated into four groups: LED 50J (G-50J), LED 240J (G-240J), LED 50-240J (G-50-240J) - progressive dose and Sham (G-S). The volunteers will be submitted to an evaluation of muscle performance and functional performance, metabolic, and physiological evaluation. After initial tests, in five consecutive weeks, the LEDT (940nm - infrared) will be applied to the quadriceps femoris muscle and hamstrings, bilaterally, associated with a muscle strength protocol. After 24 hours of the last application TLED, the tests will be repeated. Seven days after the last intervention will be performed a follow-up. For analysis, normality tests will be used to verify the distribution and adequate statistical tests for the appropriate intra and intergroup comparisons, being considered 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.
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
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sham Group (G-S) | Sham comparator | Other: PhotobiomodulationThe LED 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. |
| 50J Infrared LED Group (G-50J) | Experimental | Other: PhotobiomodulationThe LED with a wavelength of 940nm, 50J power, will be applied throughout the quadriceps and hamstrings bilaterally, just before the strength training protocol. |
| 240J Infrared LED Group (G-240J) | Experimental | Other: PhotobiomodulationThe LED with a wavelength of 940nm, 240J power, will be applied across the quadriceps and hamstrings bilaterally, just before the strength training protocol. |
| Progressive dose infrared LED group (G-50-240J) | Experimental | Other: PhotobiomodulationThe LED with a wavelength of 940nm, initial energy of 50J with an increment of 38J each week to the final energy of 240J, will be applied throughout extension of the quadriceps and hamstrings bilaterally, immediately prior to the performance of the strength training protocol |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Handball players with the participation of at least one official match in the last year and attend 70% of the team's activities during the current season; or
- 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 |
|---|---|---|
| PhotobiomodulationAn LED blanket with 267 infrared lamps with predetermined doses will be used, given a wavelength of 940nm, for 5 weeks, it will be applied by all extension of the quadriceps and hamstrings bilaterally, just before the force training protocol for the groups intervention or simulation for the sham group. Photochemical or photophysical effects are expected from its application. | Other | 240J Infrared LED Group (G-240J), 50J Infrared LED Group (G-50J), Progressive dose infrared LED group (G-50-240J), Sham Group (G-S) |
Primary outcome
difference of maximal voluntary contraction
Time frame: 3 years
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 Jul 2021.
- 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 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 Performance, 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 2 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 Jul 2021. 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: 3 years). 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 NCT03860766, 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 Jul 2021.