An interventional study of Photobiomodulation Therapy (PBMT) and Sham Photobiomodulation in Muscle Fatigue (C23.888.592.612.612), Delayed Onset Muscle Soreness (DOMS) and Muscle Damage, sponsored by Federal University of Rio Grande do Sul. Completed at 1 site in Brazil. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-31.
Sponsored by Federal University of Rio Grande do Sul · Not applicable, Interventional, and Basic science
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.
This study utilizes a randomized, single-blind, sham-controlled crossover design to evaluate the acute effects of photobiomodulation therapy (PBMT) on neuromuscular electrical stimulation (NMES)-induced fatigue in healthy individuals.
Participants undergo testing across two intervention blocks separated by a 7-day washout period between limbs:
Intervention Phase: Five minutes prior to an electrically evoked fatigue protocol, participants receive either active PBMT (multi-diode GaAlAs laser cluster; 810 nm; 200 mW per diode; 30 J per point across 8 quadriceps sites; total energy dose: 240 J) or sham PBMT (identical positioning with the device inactive and acoustic blinding).
NMES Fatigue Protocol: The protocol is performed on an isokinetic dynamometer with the knee fixed at 90° flexion. Rectangular biphasic symmetrical pulses (100 Hz; 1 ms pulse width; 5 s on, 10 s off) are delivered over 20 minutes to evoke 60 isometric contractions adjusted to an initial torque of 20% maximal voluntary isometric contraction (MVIC).
Evaluation Timeline: Neuromuscular and functional assessments are conducted at Baseline, Immediately Post-Fatigue, and at 24, 48, and 72 hours post-protocol. Tests include maximal voluntary isometric torque, resting supramaximal evoked twitches, transverse ultrasound echointensity of the rectus femoris and vastus lateralis, pressure pain thresholds via algometry, Visual Analog Scales for discomfort, and horizontal Single Hop Test performance.
Exclusion Criteria:
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)
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
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.
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.
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).
Time frame: Baseline, Immediately post-fatigue protocol, 24 hours, 48 hours, and 72 hours post-fatigue.
Muscle Damage via Ultrasound Echointensity
Quantitative grayscale histogram analysis (0 = black, 255 = white) of transverse ultrasound images (ImageJ software) of the rectus femoris (at 40%, 50%, and 60% of the femur length) and vastus lateralis (at 50% of the femur length) muscles to assess structural muscle damage.
Time frame: Baseline, Immediately post-fatigue protocol, 24 hours, 48 hours, and 72 hours post-fatigue.
Supramaximal Evoked Twitch Torque
Knee extensor evoked torque produced by single supramaximal electrical twitches (1 Hz, 500 µs rectangular biphasic pulses at rest) delivered to the rectus femoris motor point, measured in Newton-meters (N.m) on the isokinetic dynamometer to evaluate peripheral muscle fatigue.
Time frame: Baseline, Immediately post-fatigue protocol, 24 hours, 48 hours, and 72 hours post-fatigue.
Evoked Neuromuscular Efficiency
Ratio between the supramaximal evoked twitch peak torque and the applied current intensity (Nm/mA) during resting single pulses.
Time frame: Baseline, Immediately post-fatigue protocol, 24 hours, 48 hours, and 72 hours post-fatigue.
Sitting Muscle Discomfort
Subjective sensation of discomfort/pain in the quadriceps femoris evaluated while seated at rest using a 10 cm Visual Analog Scale (VAS), where 0 cm represents 'no discomfort' and 10 cm represents 'maximum discomfort'.
Time frame: Baseline, Immediately post-fatigue protocol, 24 hours, 48 hours, and 72 hours post-fatigue.
Pain Pressure Threshold (PPT)
Mechanical pain sensitivity measured using a digital pressure algometer (applied at 90° in kgf/cm²) over the rectus femoris, vastus lateralis, and vastus medialis muscle bellies to identify delayed onset muscle soreness.
Time frame: Baseline, Immediately post-fatigue protocol, 24 hours, 48 hours, and 72 hours post-fatigue.
Single Hop Test (SHT) Functional Performance
Maximal horizontal single-leg hop distance normalized to limb length, calculated as: \[Hop Distance (cm) / Limb Length (cm)\] \* 100.
Time frame: Baseline, Immediately post-fatigue protocol, 24 hours, 48 hours, and 72 hours post-fatigue.
Discomfort During Stair Ascent and Descent
Level of discomfort reported on a 10 cm Visual Analog Scale (VAS) immediately after ascending and descending a 10-step staircase.
Time frame: Baseline, Immediately post-fatigue protocol, 24 hours, 48 hours, and 72 hours post-fatigue.
Total Mechanical Work During Fatigue Protocol
Cumulative mechanical work quantified by the sum of the torque-time integral (TTI) across all 60 evoked contractions during the 20-minute NMES protocol (expressed in N.m.s).
Time frame: During the 20-minute NMES fatigue protocol.
Fatigue Index (% Work Decline)
Percentage reduction in work performed between the first 5 evoked contractions and the last 5 evoked contractions of the NMES fatigue protocol, calculated as: \[(Initial Work - Final Work) / Initial Work\] \* 100.
Time frame: During the 20-minute NMES fatigue protocol.
Plan to share: Undecided — Individual participant data will not be publicly shared to protect participant confidentiality in accordance with the local ethics committee approval.
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Federal University of Rio Grande do Sul