NCT03416998

Brief 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%.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 3, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2017

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

November 26, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 31, 2018

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2018

Completed
Last Updated

February 21, 2022

Status Verified

February 1, 2022

Enrollment Period

1.7 years

First QC Date

November 26, 2017

Last Update Submit

February 18, 2022

Conditions

Keywords

PhotherapyPhotobiomodulationCreatine KinaseSoccerMuscle Recovery

Outcome Measures

Primary Outcomes (1)

  • Muscle recovery

    Analysis of creatine kinase

    30 Minutes

Secondary Outcomes (1)

  • Subjective muscle recovery

    30 Minutes

Study Arms (2)

Phototherapy Active

ACTIVE COMPARATOR

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.

Other: phototherapy

Placebo Phototherapy

PLACEBO COMPARATOR

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

Other: phototherapy

Interventions

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.

Phototherapy ActivePlacebo Phototherapy

Eligibility Criteria

Age15 Years - 20 Years
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • A history of musculoskeletal injuries and/or surgeries in the lower limbs or back surgery in the previous six months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nove de Julho

São Paulo, 01415000, Brazil

Location

MeSH Terms

Interventions

Phototherapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

November 26, 2017

First Posted

January 31, 2018

Study Start

March 3, 2016

Primary Completion

November 10, 2017

Study Completion

February 10, 2018

Last Updated

February 21, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations