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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03416998
Other study ID # PHOTOBIOMODULATION
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 3, 2016
Est. completion date February 10, 2018

Study information

Verified date February 2022
Source University of Nove de Julho
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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%.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date February 10, 2018
Est. primary completion date November 10, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 15 Years to 20 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
phototherapy
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.

Locations

Country Name City State
Brazil University of Nove de Julho São Paulo

Sponsors (1)

Lead Sponsor Collaborator
University of Nove de Julho

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Muscle recovery Analysis of creatine kinase 30 Minutes
Secondary Subjective muscle recovery Analysis of subjective fatigue scale 30 Minutes
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