Photobiomodulation Therapy Combined With Static Magnetic Field on the Subsequent Performance

Immediate Effects of Photobiomodulation Therapy Combined With Static Magnetic Field on the Subsequent Performance: a Randomized Crossover Triple-blinded Placebo-controlled Trial

There is evidence about the effects of photobiomodulation therapy (PBMT) alone and combined with static magnetic field (PBMT-sMF) on skeletal muscle fatigue, physical performance and post-exercise recovery in different types of exercise protocols and sports activity. However, it is unknown the effects of PBMT-sMF to improve the subsequent performance after a first set of exercise. Therefore, the aim of this study was to investigate the effects of PBMT-sMF, applied between two sets of exercises, on the subsequent physical performance.

Study Overview

• Status: Completed
• Conditions: Skeletal Muscle Performance
• Intervention / Treatment: Device: Active PBMT-sMF; Device: Placebo PBMT-sMF

Detailed Description

A randomized, crossover, triple-blinded (assessors, therapist and volunteers), placebo-controlled trial was carried out. Healthy non-athletes' male volunteers were randomized and treated with a single application of PBMT-sMF and placebo between two sets of an exercise protocol performed on isokinetic dynamometer.

The order of interventions was randomized.

The primary outcome was fatigue index, measured by isokinetic dynamometer during the exercise protocol. The secondary outcomes were total work and peak torque measured by isokinetic dynamometer during the exercise protocol; and blood lactate, measured by blood samples collected before, 3 minutes after the first set of the exercise protocol, 3 minutes after the application of the intervention and 3 minutes after the second set of the exercise protocol.

Statistical analysis:

The findings were tested for normality using the Kolmogorov-Smirnov test and were determined to have a normal distribution. Data were expressed as the mean and standard deviation, and a two-way repeated measures ANOVA was performed to test between-group differences at each timepoint (treatment effects), mean difference (MD) and 95% confidence intervals (CI), followed by the Bonferroni post hoc test. The significance level was set at p < 0.05.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil
    • Laboratory of Phototherapy and Innovative Technologies in Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion criteria:

• Male healthy volunteers;
• Non-athletes or those who practiced physical activity up to once a week;
• Aged 18-35 years.

Exclusion criteria

• History of musculoskeletal injuries in the hip and knee regions in the two months prior to the study;
• Use of pharmacological agents and nutritional supplements;
• Chronic joint disease in the non-dominant lower limb.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PBMT-sMF; Volunteers underwent intervention (active PBMT-sMF) in the non-dominant lower limb. A single application was performed at each phase of the trial, between the first and second set of the exercise protocol.	Device: Active PBMT-sMF; PBMT-sMF was applied employing the Multi Radiance Medical Super Pulsed Laser MR4 console (Solon, Ohio, USA) with a LaserShower cluster probe as emitter. Six different sites of the knee extensor muscles (two medial, two lateral and two central points) were irradiated at the same time.
Placebo Comparator: Placebo; Volunteers underwent intervention (placebo PBMT-sMF) in the non-dominant lower limb. A single application was performed at each phase of the trial, between the first and second set of the exercise protocol.	Device: Placebo PBMT-sMF; Placebo PBMT-sMF was applied employing the Multi Radiance Medical Super Pulsed Laser MR4 console (Solon, Ohio, USA) with a LaserShower cluster probe as emitter, but without any emission of therapeutic dose. Placebo PBMT-sMF was applied at six different sites of the knee extensor muscles (two medial, two lateral and two central points).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fatigue index	Variable provided directly by the isokinetic dynamometer during the exercise protocol.	1 minute after the end of exercise protocol.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total work	Variable provided directly by the isokinetic dynamometer during the exercise protocol.	1 minute after the end of exercise protocol.
Peak torque	Variable provided directly by the isokinetic dynamometer during the exercise protocol.	1 minute after the end of exercise protocol.
Blood lactate	Measured by blood samples.	3 minutes after the first set of the exercise protocol, 3 minutes after the application of the intervention and 3 minutes after the second set of the exercise protocol.

Collaborators and Investigators

• Sponsor: University of Nove de Julho

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2015
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: June 10, 2021
• First Submitted That Met QC Criteria: June 18, 2021
• First Posted (Actual): June 22, 2021

Study Record Updates

• Last Update Posted (Actual): June 22, 2021
• Last Update Submitted That Met QC Criteria: June 18, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Photobiomodulation Therapy; Static Magnetic Field; Subsequent performance
• Other Study ID Numbers: 665332

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Data will be shared upon request addressed to the principal investigator.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes