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Clinical Trial Summary

Light and ultrasound can be interesting alternatives to reduce abdominal fat. Thus, the main objective of this study will be to evaluate the effects of these isolated techniques and their association in subcutaneous abdominal localized fat. These techniques will be used adding muscle electrostimulation in all groups. A total of 40 female participants will be recruited at the university outpatient, which will be distributed among four experimental groups: light + sham ultrasound + electrostimulation; light sham + ultrasound + electrostimulation; combined treatment (light + ultrasound) + electrostimulation; sham combined treatment + electrostimulation. The treatments will consist of eight sessions, twice a week for a month, being 90 minutes per session.


Clinical Trial Description

The search for the ideal shape and the lifestyle that favours the increase of adipose depots are some factors responsible for the increasing demand for procedures to reduce localized fat. It has been shown that photobiomodulation (PBM) and low-frequency ultrasound (LOFU) can be interesting alternatives to treat this aesthetic dysfunction. However, there is no consensus about the best parameters for the application of these therapeutic resources. Thus, the main objective of this study will be to evaluate the effects of these isolated techniques and their association in subcutaneous abdominal localized fat.This will be a controlled, randomised, double-blind, single-centred clinical trial. Infrared light emitting diode - LED - (830±20 nm, 71 milliwatt per square centimeter mW/cm², 127.8 J/cm²), low-frequency ultrasound (30 kilohertz (kHz), 3 W/cm²) and combination of techniques will be used, adding muscle electrostimulation in all groups (2500 Hz, 30 bps, 50%). A total of 40 female participants will be recruited at the university outpatient, which will be distributed among four experimental groups that will compose the pilot study: PBM + sham ultrasound + electromyostimulation; PBM sham + LOFU + electromyostimulation; combined treatment (PBM + LOFU) + electromyostimulation; sham combined treatment + electromyostimulation. At each session, the participants will receive 30 minutes PBM with an abdominal strap, subsequent demarcation on the target area to be treated with LOFU for 30 minutes and completion with 20 minutes of electrically induced muscle contraction. The treatments will consist of eight sessions, twice a week for a month. The main outcome of this study will be abdominal skinfold reduction and the secondary variables will be including anthropometric data, local temperature, nutritional routine and physical activity data, quality of life, self-esteem, satisfaction grade with the treatment and visual changes. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05155683
Study type Interventional
Source University of Nove de Julho
Contact
Status Completed
Phase N/A
Start date March 1, 2022
Completion date June 30, 2023

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