Therapeutic Ultrasound for Muscle Recovery After Muscle Fatigue Exercise

NCT07871942 | Not Yet Recruiting

• 2 other identifiers: 96508926.7.0000.53468.356.228
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Delayed Onset Muscle Soreness (DOMS); Muscle Fatigue (C23.888.592.612.612)

Keywords

Ultrasonic Therapy; Myalgia; Post-Exercise Recovery Techniques; Inflammation

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Pre-intervention and immediately after the intervention

Secondary Outcomes (18)

• Perceived Exertion Assessed by Modified Borg Scale (0-10)

  Immediately after the intervention.

• Handgrip Strength Measured by Manual Dynamometry

  Pre-intervention and immediately after the intervention.

• Range of Motion Assessed by Goniometry

  Pre-intervention and immediately after the intervention.

• Wrist Pain and Function Assessed by the Brazilian Patient Rated Wrist Evaluation (PRWE-BR)

  Pre-intervention and immediately after the intervention.

• Blood Lactate Concentration Assessed Using Reagent Strips

  Immediately after completion of the exercise protocol.

Study Arms (2)

Intervention Group

EXPERIMENTAL

Participants will receive pulsed low-intensity therapeutic ultrasound applied to the wrist flexor and extensor muscle regions.

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.

Device: Placebo Therapeutic Ultrasound

Interventions

Pulsed Low-Intensity Therapeutic Ultrasound DEVICE

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.

Intervention Group

Placebo Therapeutic Ultrasound DEVICE

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.

Placebo Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Federal de Santa Maria: lead

Study Sites (1)

Physical-Functional Rehabilitation Laboratory, Federal University of Santa Maria

Santa Maria, Rio Grande do Sul, 97105-900, Brazil

Location

MeSH Terms

Conditions

Myalgia; Inflammation

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Musculoskeletal Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 1, 2026
• First Posted: October 13, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: October 13, 2026

Record last verified: 2026-10

Locations

BR (1)