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Photobiomodulation Effects on Fatigue and Muscle Damage Induced by NMES

15 maggio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

36

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Brasile
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brasile, 90690200
        • Laboratório de Pesquisa do Exercício
        • Contatto:
        • Investigatore principale:
          • Marco A Vaz, PhD
        • Sub-investigatore:
          • Gustavo N Petter, MSc

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

Sì

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Triplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Photobiomodulation (PBM)
Participants in this arm will receive active photobiomodulation therapy.
Dispositivo: Active Photobiomodulation
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.
Altro: NMES-evoked fatigue protocol
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).
Comparatore fittizio: Sham PBM
Participants in this arm will receive an inactive (placebo) photobiomodulation treatment.
Altro: NMES-evoked fatigue protocol
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).
Dispositivo: Placebo Photobiomodulation
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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Maximal voluntary isometric contraction (MVIC)
Lasso di tempo: 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
Lasso di tempo: 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.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Muscle Echo Intensity
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Vastus Lateralis Pennation Angle
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Federal University of Rio Grande do Sul

Collaboratori

Conselho Nacional de Desenvolvimento Científico e Tecnológico

Investigatori

  • Cattedra di studio: Marco A Vaz, PhD, Federal University of Rio Grande do Sul
  • Direttore dello studio: Marco A Vaz, PhD, Federal University of Rio Grande do Sul
  • Investigatore principale: Marco A Vaz, PhD, Federal University of Rio Grande do Sul

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 giugno 2026

Completamento primario (Stimato)

30 agosto 2026

Completamento dello studio (Stimato)

30 settembre 2026

Date di iscrizione allo studio

Primo inviato

27 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

15 maggio 2026

Primo Inserito (Effettivo)

22 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

22 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

15 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 5.309.992(1)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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