Muscle Fatigue (C23.888.592.612.612)NCT07871942
Therapeutic Ultrasound for Muscle Recovery After Muscle Fatigue Exercise
A study testing Pulsed Low-Intensity Therapeutic Ultrasound in people with Muscle Fatigue (C23.888.592.612.612) and Delayed Onset Muscle Soreness (DOMS), run by Universidade Federal de Santa Maria at 1 site in Brazil.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Fatigue (C23.888.592.612.612), Delayed Onset Muscle Soreness (DOMS)
- What is being tested?
- Pulsed Low-Intensity Therapeutic Ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Nov 2026to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men and women aged 18 to 45 years.
- Literate participants.
- Normotensive participants, defined as systolic blood pressure <120 mmHg and diastolic blood pressure <80 mmHg.
- Participants in good physical and mental health.
Who cannot join
- Obesity, defined as body mass index (BMI) >30 kg/m².
- Smoking.
- Continuous medication use.
- Previous diagnosis of rheumatological, metabolic, cardiovascular, neurological, oncological, immunological, or hematological diseases.
- Psychiatric and/or cognitive disorders.
- Musculoskeletal dysfunction or pain on the day of assessment.
- Consumption of alcoholic or caffeinated beverages or foods on the day of assessment.
- Performance of intense physical activity within 48 hours before the assessments.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site
Physical-Functional Rehabilitation Laboratory, Federal University of Santa Maria
Santa Maria, Rio Grande do Sul, 97105-900
About this study
Official title: Effects of Therapeutic Ultrasound on Muscle Recovery After Muscle Fatigue Exercise: A Randomized Clinical Trial
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.
- Being tested
- Pulsed Low-Intensity Therapeutic Ultrasound, Placebo Therapeutic Ultrasound
- Keywords
- Ultrasonic Therapy, Myalgia, Post-Exercise Recovery Techniques, Inflammation
- Medical subject headings
- Myalgia, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsed Low-Intensity Therapeutic UltrasoundDevice
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.
Placebo Therapeutic UltrasoundDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Participants will receive pulsed low-intensity therapeutic ultrasound applied to the wrist flexor and extensor muscle regions. Receives: Device: Pulsed Low-Intensity Therapeutic Ultrasound |
| Placebo Group | Placebo comparator | 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. Receives: Device: Placebo Therapeutic Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Pre-intervention and immediately after the intervention
Secondary outcomes (18)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Pre-intervention and immediately after the intervention.
Blood Lactate Concentration Assessed Using Reagent Strips
Blood lactate will be assessed using reagent strips.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 2 hours after the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle Fatigue (C23.888.592.612.612)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Santa Maria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luis Ulisses Signori, Universidade Federal de Santa Maria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07871942
- Sponsor's protocol ID
- 96508926.7.0000.5346
- Other IDs
- 8.356.228
- Status last verified
- Oct 2026
- First submitted
- 1 Oct 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Therapeutic Ultrasound on Muscle Recovery After Muscle Fatigue Exercise: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07871942
- Acronym / sponsor ID
- 96508926.7.0000.5346
- Keywords
- Ultrasonic Therapy, Myalgia, Post-Exercise Recovery Techniques, Inflammation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universidade Federal de Santa MariaUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 13 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Device: Pulsed Low-Intensity Therapeutic UltrasoundParticipants will receive pulsed low-intensity therapeutic ultrasound applied to the wrist flexor and extensor muscle regions. |
| Placebo Group | Placebo comparator | Device: Placebo Therapeutic UltrasoundParticipants 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Men and women aged 18 to 45 years.
- Literate participants.
- Normotensive participants, defined as systolic blood pressure <120 mmHg and diastolic blood pressure <80 mmHg.
- Participants in good physical and mental health.
Key exclusion criteria (8 listed)
- Obesity, defined as body mass index (BMI) >30 kg/m².
- Smoking.
- Continuous medication use.
- Previous diagnosis of rheumatological, metabolic, cardiovascular, neurological, oncological, immunological, or hematological diseases.
- Psychiatric and/or cognitive disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulsed Low-Intensity Therapeutic UltrasoundPulsed 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. | Device | Intervention Group |
| Placebo Therapeutic UltrasoundThe 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. | Device | Placebo Group |
Primary outcome
Pain Intensity Assessed by Visual Analog Scale (0-10)
Time frame: Pre-intervention, immediately after the intervention, and 24, 48, and 72 hours after the exercise protocol.
Pain intensity will be assessed using the Visual Analog Scale ranging from 0 to 10; higher scores indicate greater pain.
Pressure Pain Threshold Assessed by Digital Pressure Algometry
Time frame: Pre-intervention and immediately after the intervention
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.
18 secondary outcomes
Perceived Exertion Assessed by Modified Borg Scale (0-10)
Time frame: Immediately after the intervention.
Handgrip Strength Measured by Manual Dynamometry
Time frame: Pre-intervention and immediately after the intervention.
Range of Motion Assessed by Goniometry
Time frame: Pre-intervention and immediately after the intervention.
Wrist Pain and Function Assessed by the Brazilian Patient Rated Wrist Evaluation (PRWE-BR)
Time frame: Pre-intervention and immediately after the intervention.
Blood Lactate Concentration Assessed Using Reagent Strips
Time frame: Immediately after completion of the exercise protocol.
Serum Tumor Necrosis Factor Alpha (TNF-α) Concentration
Time frame: Baseline and 2 hours after the intervention.
Serum Interleukin-6 (IL-6) Concentration
Time frame: Baseline and 2 hours after the intervention.
Serum Interleukin-10 (IL-10) Concentration
Time frame: Baseline and 2 hours after the intervention.
Serum Creatine Kinase (CK) Concentration
Time frame: Baseline and 2 hours after the intervention.
Serum Lactate Dehydrogenase (LDH) Concentration
Time frame: Baseline and 2 hours after the intervention.
Serum High-Sensitivity C-Reactive Protein (hs-CRP) Concentration
Time frame: Baseline and 2 hours after the intervention.
Reactive Oxygen Species Production Assessed by H2DCF-DA Fluorescence
Time frame: Baseline and 2 hours after the intervention.
Thiobarbituric Acid Reactive Substances (TBARS) Level Assessed by Spectrophotometry
Time frame: Baseline and 2 hours after the intervention.
Protein Carbonyl Concentration Assessed by the DNPH Method
Time frame: Baseline and 2 hours after the intervention.
Plasma Total Reactive Antioxidant Potential (TRAP) Assessed by Luminol Luminescence
Time frame: Baseline and 2 hours after the intervention.
Erythrocyte Superoxide Dismutase (SOD) Activity Assessed by Spectrophotometry at 480 nm
Time frame: Baseline and 2 hours after the intervention.
Glutathione Peroxidase (GPx) Activity Assessed by NADPH-Coupled Spectrophotometry at 340 nm
Time frame: Baseline and 2 hours after the intervention.
Erythrocyte Catalase (CAT) Activity Assessed by Spectrophotometry at 240 nm
Time frame: Baseline and 2 hours after the intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulsed Low-Intensity Therapeutic Ultrasound in people with Muscle Fatigue (C23.888.592.612.612) and Delayed Onset Muscle Soreness (DOMS), run by Universidade Federal de Santa Maria at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity Assessed by Visual Analog Scale (0-10) (time frame: Pre-intervention, immediately after the intervention, and 24, 48, and 72 hours after the exercise protocol.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026; AzTrials last refreshed its copy on 8 Nov 2026.