An interventional study of Pulsed Low-Intensity Therapeutic Ultrasound and Placebo Therapeutic Ultrasound in Muscle Fatigue (C23.888.592.612.612) and Delayed Onset Muscle Soreness (DOMS), sponsored by Universidade Federal de Santa Maria. Not yet recruiting at 1 site in Brazil. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by Universidade Federal de Santa Maria · Not applicable, Interventional, and Treatment
This randomized, parallel, placebo-controlled, double-blind clinical trial will evaluate the effects of low-intensity therapeutic ultrasound on muscle recovery after a fatiguing handgrip exercise protocol in healthy adults. Eighty volunteers aged 18 to 45 years will be included and assigned to an intervention group or a placebo group.
Participants will perform a handgrip exercise protocol designed to induce muscle fatigue. The intervention group will receive pulsed low-intensity therapeutic ultrasound applied to the wrist flexor and extensor muscles, while the placebo group will undergo the same procedures with the ultrasound intensity set to zero.
The main outcome will be pain. Additional outcomes will include muscle strength, perceived exertion, function, range of motion, inflammatory and muscle damage markers, and oxidative stress parameters. Pain will also be assessed 24, 48, and 72 hours after the exercise protocol.
288 studies on the registry are indexed under Myalgia; 46 are open to participants now.
This study's planned enrollment of 30 is below the median of 44 across 245 interventional studies indexed under Myalgia.
Browse Myalgia studies →Universidade Federal de Santa Maria is the lead sponsor of 37 studies on the registry; 2 are open to participants now.
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Participants will receive pulsed low-intensity therapeutic ultrasound applied to the wrist flexor and extensor muscle regions.
Device: Pulsed Low-Intensity Therapeutic Ultrasound
Participants will undergo the same therapeutic ultrasound procedures as the intervention group, including the same positioning, application sites, frequency, duty cycle, movement, and application time, but with the device intensity set to zero.
Device: Placebo Therapeutic Ultrasound
Pulsed low-intensity therapeutic ultrasound will be applied using a Sonopulse III device at a frequency of 1 MHz, an intensity of 0.4 W/cm² SATA, and a 20% duty cycle (2 ms on, 8 ms off), resulting in an effective average intensity of 0.08 W/cm² SATA. The intervention will be applied for 5 minutes to the wrist flexor muscle region and 5 minutes to the wrist extensor muscle region. A conductive ultrasound gel will be used.
The placebo procedure will be performed using the same positioning, application sites, frequency, waveform, duty cycle, transducer movements, and application time as the active therapeutic ultrasound intervention, but with the device intensity set to zero.
Pain Intensity Assessed by Visual Analog Scale (0-10)
Pain intensity will be assessed using the Visual Analog Scale ranging from 0 to 10; higher scores indicate greater pain.
Time frame: Pre-intervention, immediately after the intervention, and 24, 48, and 72 hours after the exercise protocol.
Pressure Pain Threshold Assessed by Digital Pressure Algometry
Pressure pain threshold will be assessed in the wrist flexor and extensor regions using a digital pressure algometer. Three measurements will be obtained and the mean value will be used.
Time frame: Pre-intervention and immediately after the intervention
Perceived Exertion Assessed by Modified Borg Scale (0-10)
Perceived exertion will be assessed using the Modified Borg Scale ranging from 0 to 10, where 0 indicates no exertion/rest and 10 indicates maximal exertion/exhaustion; higher scores indicate greater perceived exertion.
Time frame: Immediately after the intervention.
Handgrip Strength Measured by Manual Dynamometry
Handgrip strength will be assessed using a manual dynamometer. Three measurements will be performed in each hand.
Time frame: Pre-intervention and immediately after the intervention.
Range of Motion Assessed by Goniometry
Elbow and wrist range of motion will be assessed using a manual goniometer. Three consecutive measurements will be performed for each movement, and the mean value will be used for analysis.
Time frame: Pre-intervention and immediately after the intervention.
Wrist Pain and Function Assessed by the Brazilian Patient Rated Wrist Evaluation (PRWE-BR)
Wrist pain and function will be assessed using the Brazilian version of the Patient Rated Wrist Evaluation (PRWE-BR). The questionnaire contains 15 items, with a total score ranging from 0 to 100; higher scores indicate greater pain or functional limitation.
Time frame: Pre-intervention and immediately after the intervention.
Blood Lactate Concentration Assessed Using Reagent Strips
Blood lactate will be assessed using reagent strips.
Time frame: Immediately after completion of the exercise protocol.
Serum Tumor Necrosis Factor Alpha (TNF-α) Concentration
Serum TNF-α concentration will be assessed by flow cytometry using the Cytometric Bead Array (CBA) technique.
Time frame: Baseline and 2 hours after the intervention.
Serum Interleukin-6 (IL-6) Concentration
Serum IL-6 concentration will be assessed by flow cytometry using the Cytometric Bead Array (CBA) technique.
Time frame: Baseline and 2 hours after the intervention.
Serum Interleukin-10 (IL-10) Concentration
Serum IL-10 concentration will be assessed by flow cytometry using the Cytometric Bead Array (CBA) technique.
Time frame: Baseline and 2 hours after the intervention.
Serum Creatine Kinase (CK) Concentration
Serum creatine kinase concentration will be assessed as a marker of muscle damage.
Time frame: Baseline and 2 hours after the intervention.
Serum Lactate Dehydrogenase (LDH) Concentration
Serum lactate dehydrogenase concentration will be assessed as a marker of muscle damage.
Time frame: Baseline and 2 hours after the intervention.
Serum High-Sensitivity C-Reactive Protein (hs-CRP) Concentration
Serum high-sensitivity C-reactive protein concentration will be assessed as a marker of systemic inflammation.
Time frame: Baseline and 2 hours after the intervention.
Reactive Oxygen Species Production Assessed by H2DCF-DA Fluorescence
Reactive oxygen species production will be determined by oxidation of reduced dichlorofluorescein (H2DCF-DA), with fluorescence quantified using a spectrofluorometer.
Time frame: Baseline and 2 hours after the intervention.
Thiobarbituric Acid Reactive Substances (TBARS) Level Assessed by Spectrophotometry
TBARS levels will be measured spectrophotometrically at 532 nm using an MDA standard curve and corrected for protein content.
Time frame: Baseline and 2 hours after the intervention.
Protein Carbonyl Concentration Assessed by the DNPH Method
Protein carbonyls will be assessed by reaction with 2,4-dinitrophenylhydrazine (DNPH) and measured at 370 nm using a spectrophotometer. Results will be reported as nmol of carbonyls per mg of protein.
Time frame: Baseline and 2 hours after the intervention.
Plasma Total Reactive Antioxidant Potential (TRAP) Assessed by Luminol Luminescence
Plasma total reactive antioxidant potential will be measured by luminescence using 2,2'-azo-bis(2-amidinopropane) and luminol, with Trolox used for calibration.
Time frame: Baseline and 2 hours after the intervention.
Erythrocyte Superoxide Dismutase (SOD) Activity Assessed by Spectrophotometry at 480 nm
Cytosolic Cu/Zn superoxide dismutase activity will be measured in erythrocytes using glycine buffer and adrenaline. The reaction will be measured spectrophotometrically at 480 nm, and enzyme activity will be expressed as units of enzymatic activity per mg of protein.
Time frame: Baseline and 2 hours after the intervention.
Glutathione Peroxidase (GPx) Activity Assessed by NADPH-Coupled Spectrophotometry at 340 nm
Glutathione peroxidase activity will be assessed using a glutathione reductase-coupled spectrophotometric assay by monitoring NADPH oxidation at 340 nm.
Time frame: Baseline and 2 hours after the intervention.
Erythrocyte Catalase (CAT) Activity Assessed by Spectrophotometry at 240 nm
Catalase activity will be measured in erythrocytes by kinetic analysis following the addition of hydrogen peroxide, with the reaction measured spectrophotometrically at 240 nm.
Time frame: Baseline and 2 hours after the intervention.
Plan to share: Undecided
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Start is estimated for Nov 2026; primary completion for Jun 2028, 19 months later.
Of 110 non-industry interventional studies with no phase under Myalgia, half reached primary completion within 6 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 14. This study's planned 19 months is above that.
Counting every sponsor, half of 119 studies reached it within 6 months; a quarter within 3 and three quarters within 14.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Universidade Federal de Santa Maria