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Photobiomodulation Effects on Fatigue and Muscle Damage Induced by NMES

15. maj 2026 opdateret af: Marco Aurélio Vaz, PhD, Federal University of Rio Grande do Sul

Effects of Photobiomodulation on Fatigue and Muscle Damage Induced by Neuromuscular Electrical Stimulation in Healthy Individuals: a Randomized Clinical Trial

Neuromuscular electrical stimulation (NMES) is widely used to improve muscle strength and mitigate atrophy. However, its clinical efficacy is often limited by early neuromuscular fatigue, muscle damage, and discomfort, which reduce patient tolerance and contraction time. Photobiomodulation (PBM) has emerged as a potential therapy to enhance muscle performance and accelerate recovery by minimizing fatigue and damage. Despite its potential, few studies have investigated the effects of PBM applied specifically before an NMES-evoked fatigue protocol. This randomized, double-blind, placebo-controlled trial aims to evaluate the acute effects of PBM on neuromuscular fatigue, muscle damage, and functional outcomes in healthy young subjects. Participants will receive either active PBM (cluster probe: 5 lasers 810nm/200mW; 4 LEDs 660nm/10mW; Total Energy: 249.6 J per limb) or sham treatment 5 minutes before a fatiguing NMES protocol (80 contractions at 20% MVIC, 80 Hz, 1ms pulse width) applied to the quadriceps muscle. Assessments will be performed at baseline, immediately post-intervention, and at 24h, 48h, and 72h post-intervention. Primary outcomes include maximum and evoked isometric strength, mechanical work, and electrical muscle activity. Secondary outcomes include muscle damage (ultrasound echo-intensity), delayed onset muscle soreness (DOMS), functional performance (unilateral vertical jump), and clinical discomfort. The study seeks to determine if PBM can effectively modulate NMES-induced fatigue and muscle damage, potentially optimizing its clinical application.

Studieoversigt

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

36

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brasilien, 90690200
        • Laboratório de Pesquisa do Exercício
        • Kontakt:
        • Ledende efterforsker:
          • Marco A Vaz, PhD
        • Underforsker:
          • Gustavo N Petter, MSc

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ja

Beskrivelse

Inclusion Criteria:

  • Healthy male and female volunteers.
  • Age between 18 and 45 years.
  • Practice physical activity regularly
  • No history of musculoskeletal injuries in the lower limbs in the last 6 months
  • Ability to tolerate NMES

Exclusion Criteria:

  • Have sensory intolerable changes due to NMES
  • Consumed coffee or another stimulant in the last 12 hours
  • Have a body mass index (BMI) greater than 30 kg/m2 (grade I obesity)
  • Present any contraindication for the performance of maximum effort
  • Abnormal increase in blood pressure after maximal exertion

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Photobiomodulation (PBM)
Participants in this arm will receive active photobiomodulation therapy.
Application of PBMT using a cluster probe (Thor-DD2; 5 laser diodes: 810nm, 200mW; 4 LEDs: 660nm, 10mW). The treatment involves 8 points on the quadriceps (2 on vastus medialis, 3 on vastus lateralis, and 3 on rectus femoris). Each point is irradiated for 30 seconds in continuous mode with direct contact and slight pressure. Total energy: 31.2 J per point and 249.6 J per limb. Both therapist and participant will wear protective goggles.
Neuromuscular Electrical Stimulation (Myomed 932) applied to the quadriceps. Parameters: 80 Hz frequency, 1 ms pulse width (biphasic rectangular pulse), 5s:10s ON:OFF ratio with 1s ramp-up/down. The protocol lasts 20 minutes, totaling 80 evoked isometric contractions. Current intensity is adjusted to generate an initial torque of 20% of the baseline Maximum Voluntary Isometric Contraction (MVIC).
Sham-komparator: Sham PBM
Participants in this arm will receive an inactive (placebo) photobiomodulation treatment.
Neuromuscular Electrical Stimulation (Myomed 932) applied to the quadriceps. Parameters: 80 Hz frequency, 1 ms pulse width (biphasic rectangular pulse), 5s:10s ON:OFF ratio with 1s ramp-up/down. The protocol lasts 20 minutes, totaling 80 evoked isometric contractions. Current intensity is adjusted to generate an initial torque of 20% of the baseline Maximum Voluntary Isometric Contraction (MVIC).
The procedure is identical to the active PBMT (8 points, 30 seconds per point, same pressure and positioning), but the device will be turned off. To ensure blinding, participants will wear protective goggles and a blindfold to prevent visual perception of the light.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Maximal voluntary isometric contraction (MVIC)
Tidsramme: Baseline (pre-intervention) on Day 1; immediately after the fatigue protocol on Day 1; and at 24, 48, and 72 hours after the fatigue protocol (on Days 2, 3, and 4, respectively).

Largest knee extensor torque generated isometrically and voluntarily on an isokinetic dynamometer.

Unit of Measure: Newton-meters (N.m)

Baseline (pre-intervention) on Day 1; immediately after the fatigue protocol on Day 1; and at 24, 48, and 72 hours after the fatigue protocol (on Days 2, 3, and 4, respectively).
Evoked fatigue
Tidsramme: Continuously during the 20-minute fatigue protocol.
Fall in the evoked torque during the fatigue protocol. Unit of Measure: Newton-meters (N.m)
Continuously during the 20-minute fatigue protocol.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Muscle Echo Intensity
Tidsramme: Baseline (pre-intervention) on Day 1; immediately after the fatigue protocol on Day 1; and at 24, 48, and 72 hours after the fatigue protocol (on Days 2, 3, and 4, respectively).

Quantitative analysis of muscle ultrasound images to assess changes in echo intensity, reflecting acute edema and changes in muscle quality. Analysis will be performed specifically on the Rectus Femoris (RF), Vastus Medialis (VM), and Vastus Lateralis (VL).

Unit of Measure: Arbitrary Units (au) on a 0-255 grayscale

Baseline (pre-intervention) on Day 1; immediately after the fatigue protocol on Day 1; and at 24, 48, and 72 hours after the fatigue protocol (on Days 2, 3, and 4, respectively).
Pressure Pain Threshold
Tidsramme: Baseline (pre-intervention) on Day 1; immediately after the fatigue protocol on Day 1; and at 24, 48, and 72 hours after the fatigue protocol (on Days 2, 3, and 4, respectively).
The minimum pressure at which a subject perceives a stimulus as painful, measured via pressure algometry on the quadriceps muscle bellies to quantify delayed onset muscle soreness (DOMS). Unit of Measure: Newtons (N)
Baseline (pre-intervention) on Day 1; immediately after the fatigue protocol on Day 1; and at 24, 48, and 72 hours after the fatigue protocol (on Days 2, 3, and 4, respectively).
Quadriceps Muscle Thickness
Tidsramme: Baseline (pre-intervention) on Day 1; immediately after the fatigue protocol on Day 1; and at 24, 48, and 72 hours after the fatigue protocol (on Days 2, 3, and 4, respectively).

Ultrasound assessment of structural changes in the quadriceps muscle group, for the Rectus Femoris (RF), Vastus Medialis (VM), and Vastus Lateralis (VL). This variable evaluates acute morphological changes or edema-induced swelling following the NMES protocol.

Unit of Measure: Millimeters (mm)

Baseline (pre-intervention) on Day 1; immediately after the fatigue protocol on Day 1; and at 24, 48, and 72 hours after the fatigue protocol (on Days 2, 3, and 4, respectively).
Countermovement Jump (CMJ) Height
Tidsramme: Baseline (pre-intervention) on Day 1; immediately after the fatigue protocol on Day 1; and at 24, 48, and 72 hours after the fatigue protocol (on Days 2, 3, and 4, respectively).

Measure Description: Maximum jump height achieved during a vertical countermovement jump on a force platform to assess dynamic muscle power.

Unit of Measure: Centimeters (cm)

Baseline (pre-intervention) on Day 1; immediately after the fatigue protocol on Day 1; and at 24, 48, and 72 hours after the fatigue protocol (on Days 2, 3, and 4, respectively).
Lower Limb Joint Kinematics During Jump
Tidsramme: Baseline (pre-intervention) on Day 1; immediately after the fatigue protocol on Day 1; and at 24, 48, and 72 hours after the fatigue protocol (on Days 2, 3, and 4, respectively).

Measure Description: Sagittal plane kinematic analysis for the ankle, knee, hip, and trunk joints to evaluate movement strategies and joint range of motion during the countermovement jump.

Unit of Measure: Degrees (°)

Baseline (pre-intervention) on Day 1; immediately after the fatigue protocol on Day 1; and at 24, 48, and 72 hours after the fatigue protocol (on Days 2, 3, and 4, respectively).
Force-Time Curve Dynamics During Jump
Tidsramme: Baseline (pre-intervention) on Day 1; immediately after the fatigue protocol on Day 1; and at 24, 48, and 72 hours after the fatigue protocol (on Days 2, 3, and 4, respectively).
Analysis of the vertical ground reaction force-time curve during the propulsion phase of the countermovement jump. The primary parameter will be the Vertical Impulse, calculated as the integral of force over time. Unit of Measure: Newton-seconds (N.s)
Baseline (pre-intervention) on Day 1; immediately after the fatigue protocol on Day 1; and at 24, 48, and 72 hours after the fatigue protocol (on Days 2, 3, and 4, respectively).
Muscle Activation
Tidsramme: Baseline (pre-intervention) on Day 1; immediately after the fatigue protocol on Day 1; and at 24, 48, and 72 hours after the fatigue protocol (on Days 2, 3, and 4, respectively).
Surface electromyography (sEMG) to assess muscle activation amplitude during MVIC. Unit of Measure: Microvolts (uV)
Baseline (pre-intervention) on Day 1; immediately after the fatigue protocol on Day 1; and at 24, 48, and 72 hours after the fatigue protocol (on Days 2, 3, and 4, respectively).
Vastus Lateralis Fascicle Length
Tidsramme: Continuously during the 20-minute fatigue protocol on Day 1.

Measure Description: Assessment of real-time changes in the fascicle length of the Vastus Lateralis muscle during the fatigue protocol using continuous ultrasound imaging.

Unit of Measure: Millimeters (mm)

Continuously during the 20-minute fatigue protocol on Day 1.

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Vastus Lateralis Pennation Angle
Tidsramme: Continuously during the 20-minute fatigue protocol on Day 1.

Measure Description: Assessment of real-time changes in the pennation angle of the Vastus Lateralis muscle during the fatigue protocol using continuous ultrasound imaging.

Unit of Measure: Degrees (°)

Continuously during the 20-minute fatigue protocol on Day 1.
Adipose Tissue Thickness
Tidsramme: Baseline
Measurement of the fat layer thickness overlying the Rectus Femoris, Vastus Medialis, and Vastus Lateralis using ultrasound imaging. This measure is used to characterize the sample's morphology and will serve as a covariate to adjust the delivered PBM dose and NMES current penetration analysis. Unit of Measure: Millimeters (mm)
Baseline

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Studiestol: Marco A Vaz, PhD, Federal University of Rio Grande do Sul
  • Studieleder: Marco A Vaz, PhD, Federal University of Rio Grande do Sul
  • Ledende efterforsker: Marco A Vaz, PhD, Federal University of Rio Grande do Sul

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juni 2026

Primær færdiggørelse (Anslået)

30. august 2026

Studieafslutning (Anslået)

30. september 2026

Datoer for studieregistrering

Først indsendt

27. april 2026

Først indsendt, der opfyldte QC-kriterier

15. maj 2026

Først opslået (Faktiske)

22. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 5.309.992(1)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

A final decision regarding the sharing of individual participant data has not yet been made. The study team intends to evaluate this possibility following the primary data analysis, in accordance with institutional guidelines and ethical committee requirements.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Kliniske forsøg med Active Photobiomodulation

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