Combination of Light and Ultrasound to Reduce Abdominal Fat
Condition: Subcutaneous Fat Disorder
MeSH terms: Lipid Metabolism Disorders
Study type: Interventional

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.
    

Detailed 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.
    

Intervention name(s): Photobiomodulation (PBM) with infrared LED; Low-frequency ultrasound (LOFU); Muscle electrostimulation
Intervention type(s): Device; Device; Device
Intervention description(s): All participants will receive 30 minutes of PBM (or PBM sham), with an abdominal strap containing 4 LED clusters with 72 devices that emit 830 nm wavelength with 20 nm spectral width, in continuous operating mode, 5 mW average radiant power per LED, 71 mW/cm² power density at aperture, 20.4 cm² of total area irradiated, 71 mW/cm² of irradiance at target, exposure duration of 1800 seconds, 127.8 J/cm² of radiant exposure, 2.6 kJ of radiant energy, per contact application technique, twice a week for a month, totaling 8 sessions.; Subsequently the demarcation of the target area for LOFU treatment (Thoor DGM Electronica, Santo André, São Paulo, Brazil), the application of the neutral conductive gel will occur for the use of low-frequency ultrasound for 30 minutes, which will occur with 22 cm² effective radiating area (ERA) size, <8 BNR emission intensity, 40 kHz frequency, continuous mode, 60W, 100 cm² of total treated area, twice a week for a month, totaling 8 sessions.; The session will end with 20 minutes of Russian Current (Tensor DGM Electronica, Santo André, São Paulo, Brazil), whose carrier frequency occurs in 2500 Hz, which will be adjusted according to the parameters described by Evangelista et al. (2003), which are: pulse frequency of 30 Hz; up/down ramp of 2 seconds each; support/rest time of 13 seconds each. The current intensity used will be the maximum supported by each participant and that is comfortable and sufficient to provide visible contraction. The treatment will consist of eight sessions that will occur twice a week, totaling a month of treatment.
Other intervention name(s): Low-level light therapy (LLLT)
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: The abdomen of the participants will be cleaned by using a neutral cleansing soap. Each participant will receive safety glasses for eye protection, which will also contribute to blindness of the study. PBM will be applied when using abdominal straps as developed by Cosmedical (Mauá, São Paulo, Brazil). The abdomen strap will be covered with a sheet and that will also help with the blindness of the study. After randomization, the study population will be divided into four groups (n= 10 per group), which are: (1) Group A - PBM with infrared LED application + sham ultrasound + muscle electrostimulation; (2) Group B - LED sham PBM + ultrasound + muscle electrostimulation; (3) Group C - combined treatment (PBM + ultrasound) + muscle electrostimulation; (4) Group D - sham combined treatment + muscle electrostimulation.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: LLLT; Cavitation; Photobiomodulation