NCT07790016

Brief Summary

Neuromuscular electrical stimulation (NMES) is an effective tool for muscle strengthening and rehabilitation, but its clinical application is often limited by rapid neuromuscular fatigue, muscle discomfort, and potential muscle damage. Photobiomodulation therapy (PBMT) using low-level lasers or LEDs has been proposed as an ergogenic and protective modality capable of attenuating exercise-induced muscle fatigue and damage. However, evidence regarding the acute preventive effects of PBMT on NMES-induced fatigue and muscle damage in humans remains limited and conflicting. The purpose of this randomized, sham-controlled, crossover pilot trial was to evaluate the acute effects of PBMT applied prior to an NMES-induced fatigue protocol on knee extensor neuromuscular fatigability, muscle damage, discomfort, and functional performance in healthy young individuals. Healthy participants had both lower limbs randomized to receive either active PBMT (810 nm, 240 J total per limb across 8 points) or sham PBMT 5 minutes prior to an NMES fatigue protocol (20 minutes of evoked isometric contractions at 20% of maximal voluntary contraction). Primary and secondary outcomes-including maximal voluntary isometric contraction (MVIC) torque, supramaximal twitch torque, muscle damage via ultrasound echointensity (rectus femoris and vastus lateralis), pain pressure thresholds (algometry), visual analog scale (VAS) for discomfort, and functional tests (Single Hop Test and stair ascent/descent)-were assessed at baseline, immediately post-fatigue, and at 24, 48, and 72 hours post-intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2022

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

August 24, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 27, 2026

Completed
Last Updated

August 27, 2026

Status Verified

August 1, 2026

Enrollment Period

9 months

First QC Date

August 24, 2026

Last Update Submit

August 24, 2026

Conditions

Keywords

PhotobiomodulationLow-Level Laser TherapyNeuromuscular Electrical StimulationMuscle FatiguePilot Study

Outcome Measures

Primary Outcomes (1)

  • Maximal Voluntary Isometric Contraction (MVIC) Torque

    Knee extensor peak isometric torque measured on an isokinetic dynamometer (Biodex System 3 Pro) during 5-second maximal isometric contractions with the knee fixed at 90° flexion, expressed in Newton-meters (N.m).

    Baseline, Immediately post-fatigue protocol, 24 hours, 48 hours, and 72 hours post-fatigue.

Secondary Outcomes (9)

  • Muscle Damage via Ultrasound Echointensity

    Baseline, Immediately post-fatigue protocol, 24 hours, 48 hours, and 72 hours post-fatigue.

  • Supramaximal Evoked Twitch Torque

    Baseline, Immediately post-fatigue protocol, 24 hours, 48 hours, and 72 hours post-fatigue.

  • Evoked Neuromuscular Efficiency

    Baseline, Immediately post-fatigue protocol, 24 hours, 48 hours, and 72 hours post-fatigue.

  • Sitting Muscle Discomfort

    Baseline, Immediately post-fatigue protocol, 24 hours, 48 hours, and 72 hours post-fatigue.

  • Pain Pressure Threshold (PPT)

    Baseline, Immediately post-fatigue protocol, 24 hours, 48 hours, and 72 hours post-fatigue.

  • +4 more secondary outcomes

Study Arms (2)

Active PBMT + NMES

EXPERIMENTAL

Participants receive active Photobiomodulation Therapy (PBMT) applied to the knee extensor muscles 5 minutes prior to undergoing a 20-minute neuromuscular electrical stimulation (NMES) fatigue protocol on the randomized lower limb.

Device: Photobiomodulation Therapy (PBMT)

Sham PBMT + NMES

SHAM COMPARATOR

Participants receive sham Photobiomodulation Therapy (device turned off, identical positioning and acoustic blinding) applied to the knee extensor muscles 5 minutes prior to undergoing a 20-minute neuromuscular electrical stimulation (NMES) fatigue protocol on the contralateral lower limb.

Device: Sham Photobiomodulation

Interventions

Multi-diode cluster probe (GaAlAs laser; 5 diodes; wavelength: 810 nm; power output: 200 mW per diode; continuous mode) applied across 8 points over the quadriceps femoris (3 on rectus femoris, 3 on vastus lateralis, and 2 on vastus medialis) for 30 seconds per point (30 J/point), delivering a total energy dose of 240 J per limb.

Active PBMT + NMES

Identical probe positioning over the 8 quadriceps locations for 30 seconds per point with the laser device completely turned off. Auditory headphones are used to blind participants against sound cues.

Sham PBMT + NMES

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male and female adults aged between 18 and 40 years.
  • Engaging in regular physical activity (minimum of twice a week).
  • No history of hospitalization for COVID-19 in the past 12 months.
  • Demonstrated ability to tolerate neuromuscular electrical stimulation (NMES).
  • Capable of fully understanding and complying with the experimental protocol and procedures.

You may not qualify if:

  • Presence of any sensory impairments or neurological alterations.
  • Ingestion of caffeine, coffee, energy drinks, or other stimulants in the 12 hours preceding the testing sessions.
  • Body Mass Index (BMI) greater than 30 kg/m².
  • Any medical contraindication to performing maximal physical exertion or presenting an abnormal cardiovascular/blood pressure response after maximal effort.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laboratório de Pesquisa do Exercício

Porto Alegre, Rio Grande do Sul, 90690200, Brazil

Location

MeSH Terms

Interventions

Low-Level Light Therapy

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsPhototherapy

Study Officials

  • Marco A Vaz, PhD

    Federal University of Rio Grande do Sul

    STUDY CHAIR
  • Marco A Vaz, PhD

    Federal University of Rio Grande do Sul

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor

Study Record Dates

First Submitted

August 24, 2026

First Posted

August 27, 2026

Study Start

November 1, 2022

Primary Completion

August 1, 2023

Study Completion

December 1, 2023

Last Updated

August 27, 2026

Record last verified: 2026-08

Locations