Photobiomodulation Effects on Fatigue and Muscle Damage Induced by NMES
24 août 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
36
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Marco A Vaz, PhD
- Numéro de téléphone: +555133085853
- E-mail: marco.vaz@ufrgs.br
Lieux d'étude
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Brésil, 90690200
- Recrutement
- Laboratório de Pesquisa do Exercício
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Contact:
- Jeam M Geremia, PhD
- Numéro de téléphone: 5133085853
- E-mail: jeam.geremia@ufrgs.br
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Chercheur principal:
- Marco A Vaz, PhD
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Sous-enquêteur:
- Gustavo N Petter, MSc
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
Oui
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Photobiomodulation (PBM)
Participants in this arm will receive active photobiomodulation therapy.
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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).
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Comparateur factice: Sham PBM
Participants in this arm will receive an inactive (placebo) photobiomodulation treatment.
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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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Maximal voluntary isometric contraction (MVIC)
Délai: 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).
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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).
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Evoked fatigue
Délai: Continuously during the 20-minute fatigue protocol.
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Fall in the evoked torque during the fatigue protocol.
Unit of Measure: Newton-meters (N.m)
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Continuously during the 20-minute fatigue protocol.
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Muscle Echo Intensity
Délai: 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).
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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).
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Pressure Pain Threshold
Délai: 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).
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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)
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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).
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Quadriceps Muscle Thickness
Délai: 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).
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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).
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Countermovement Jump (CMJ) Height
Délai: 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).
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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).
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Lower Limb Joint Kinematics During Jump
Délai: 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).
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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).
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Force-Time Curve Dynamics During Jump
Délai: 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).
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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)
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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).
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Muscle Activation
Délai: 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).
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Surface electromyography (sEMG) to assess muscle activation amplitude during MVIC.
Unit of Measure: Microvolts (uV)
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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).
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Vastus Lateralis Fascicle Length
Délai: Continuously during the 20-minute fatigue protocol on Day 1.
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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.
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Vastus Lateralis Pennation Angle
Délai: Continuously during the 20-minute fatigue protocol on Day 1.
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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.
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Adipose Tissue Thickness
Délai: Baseline
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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)
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Baseline
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chaise d'étude: Marco A Vaz, PhD, Federal University of Rio Grande do Sul
- Directeur d'études: Marco A Vaz, PhD, Federal University of Rio Grande do Sul
- Chercheur principal: Marco A Vaz, PhD, Federal University of Rio Grande do Sul
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 juin 2026
Achèvement primaire (Estimé)
30 août 2026
Achèvement de l'étude (Estimé)
30 septembre 2026
Dates d'inscription aux études
Première soumission
27 avril 2026
Première soumission répondant aux critères de contrôle qualité
15 mai 2026
Première publication (Réel)
22 mai 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
25 août 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
24 août 2026
Dernière vérification
1 août 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 5.309.992(1)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Description du régime 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.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .