Photobiomodulation On Muscle Recovery In Professional Soccer Players

February 18, 2022 updated by: Daniela Ap. Biasotto-Gonzalez, University of Nove de Julho

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

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • São Paulo, Brazil, 01415000
        • University of Nove de Julho

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 20 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscle recovery
Time Frame: 30 Minutes
Analysis of creatine kinase
30 Minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjective muscle recovery
Time Frame: 30 Minutes
Analysis of subjective fatigue scale
30 Minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 3, 2016

Primary Completion (Actual)

November 10, 2017

Study Completion (Actual)

February 10, 2018

Study Registration Dates

First Submitted

November 26, 2017

First Submitted That Met QC Criteria

January 30, 2018

First Posted (Actual)

January 31, 2018

Study Record Updates

Last Update Posted (Actual)

February 21, 2022

Last Update Submitted That Met QC Criteria

February 18, 2022

Last Verified

February 1, 2022

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)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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