- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03416998
Photobiomodulation On Muscle Recovery In Professional Soccer Players
Effect Of Pre-Game Photobiomodulation On Muscle Recovery In Professional Soccer Players: Randomized, Cross-Over, Sham-Controlled, Triple-Blind, Clinical Trial
Background: Photobiomodulation with low-level laser therapy (LLLT) has been widely used in clinical practice for diverse purposes, such as modulation of the inflammatory process, acceleration of the tissue repair process, pain relief and the enhancement of post-exercise recovery. Studies have demonstrated a beneficial interaction between photobiomodulation and the production of creatine kinase, with a reduction in the release of this marker of muscle damage when laser and/or LEDs is administered prior to high-intensity physical activity. The aim of the proposed study is to determine the influence of pre-exercise phototherapy on post-exercise muscle recovery.
Methods: A randomized, cross-over, sham-controlled, double-blind, clinical trial is proposed. The participants will be healthy professional soccer players aged 15 to 20 years from the same team with a body mass index within the ideal range (20 to 25 kg/m2) and no history of lower limb musculoskeletal injuries or surgery or back surgery in the previous six months. The athletes will be allocated to two groups based on the previously calculated sample size and will be blinded to allocation. Creatine kinase will be measured and the subjective perception of fatigue will be determined for each participant. The volunteers will then be randomly allocated to Group A, which will receive active phototherapy, and Group B, which will receive sham phototherapy. The athletes will undergo reevaluations immediately after as well as 48 hours after a football match. The data will be submitted to statistical analysis and the level of significance will be set to 5%.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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São Paulo, Brazil, 01415000
- University of Nove de Julho
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy professional soccer players aged 15 to 20 years from the same team with a body mass index in the ideal range (20 to 25 kg/m2) will be included in the study.
Exclusion Criteria:
- A history of musculoskeletal injuries and/or surgeries in the lower limbs or back surgery in the previous six months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: Phototherapy Active
Phototherapy active group will be administered 30 minutes prior to the soccer match as well as 48 h after the match in direct contact with the skin with light pressure at predetermined sites: nine on the knee extensor muscles, six on the knee flexor muscles and two on the gastrocnemius muscle on both lower limbs.
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Phototherapy will be performed using clusters of 12 diodes (Table 1); four 905 nm diodes (mean power of 0.3125 mW and peak power of 12.5 W for each diode; 250 Hz), four 875 nm diodes (mean power of 17.5 mW for each diode) and four 640 nm diodes (mean power of 15 mW for each diode).
The device manufactured by Multi Radiance Medical® (Solon, OH, USA) will be used due to its high quality, ample use in clinical practice and due to the fact that no national companies manufacture diode clusters with the characteristics required for the proposed project.
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Placebo Comparator: Placebo Phototherapy
Phototherapy placebo group will be administered 30 minutes prior to the soccer match as well as 48 h after the match in direct contact with the skin with light pressure at predetermined sites: nine on the knee extensor muscles, six on the knee flexor muscles and two on the gastrocnemius muscle on both lower limbs. For placebo treatment, the same procedures and treatment times will be employed, but the equipment will be set in placebo mode. Only the researcher in charge of programming the device will have knowledge regarding which treatment is being used. However, the programmer will not participate in the execution of the treatment, evaluations or data analysis |
Phototherapy will be performed using clusters of 12 diodes (Table 1); four 905 nm diodes (mean power of 0.3125 mW and peak power of 12.5 W for each diode; 250 Hz), four 875 nm diodes (mean power of 17.5 mW for each diode) and four 640 nm diodes (mean power of 15 mW for each diode).
The device manufactured by Multi Radiance Medical® (Solon, OH, USA) will be used due to its high quality, ample use in clinical practice and due to the fact that no national companies manufacture diode clusters with the characteristics required for the proposed project.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Muscle recovery
Time Frame: 30 Minutes
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Analysis of creatine kinase
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30 Minutes
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Subjective muscle recovery
Time Frame: 30 Minutes
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Analysis of subjective fatigue scale
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30 Minutes
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- PHOTOBIOMODULATION
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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