NCT07790016

Brief Summary

Neuromuscular electrical stimulation (NMES) is effective for strength training and rehabilitation, but non-selective motor unit recruitment often induces rapid fatigue, discomfort, and muscle damage. Photobiomodulation therapy (PBMT) has been proposed to attenuate muscle fatigue and accelerate recovery, yet evidence regarding its acute prophylactic effects against NMES-induced fatigue remains limited. This randomized, single-blind, sham-controlled crossover pilot trial evaluates the acute effects of pre-exercise PBMT on knee extensor neuromuscular fatigability, muscle damage, discomfort, and functional recovery following a standardized NMES fatigue protocol in healthy adults.

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

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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 31, 2026

Status Verified

August 1, 2026

Enrollment Period

9 months

First QC Date

August 24, 2026

Last Update Submit

August 26, 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 31, 2026

Record last verified: 2026-08

Locations