Therapeutic Ultrasound for Muscle Recovery After Muscle Fatigue Exercise
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorUniversidade Federal de Santa Maria
About this 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Pulsed Low-Intensity Therapeutic Ultrasound
DevicePulsed 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 Ultrasound
DeviceThe 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.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Intervention GroupExperimental treatment 1 intervention
Group B: Placebo GroupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.2
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 interventionSecondary outcomes
1
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.2
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.3
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.4
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.Sponsors and contacts
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Source ClinicalTrials.gov
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