Combination of Light and Ultrasound to Reduce Abdominal Fat

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparative Study of the Use of Phototherapy and Ultrasound to Reduce Localized Fat

Conditions
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Subcutaneous Fat Disorder

Intervention / Treatment
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* Device: Photobiomodulation (PBM) with infrared LED
* Device: Low-frequency ultrasound (LOFU)
* Device: Muscle electrostimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI of between 18.5 and 27.5 kg/m² (normotrophic or overweight body mass); Fitzpatrick phototype from I to IV; Who have fat located in the abdominal region characterized by abdominal skinfold higher than 20 mm; Who are sedentary of perform physical activity whose intensity is equal to or less than 450 METs/minutes/week (metabolic equivalents = METs); Who have stabilized weight, that is, who have not acquired or eliminated more than 2.5 kg in the 6 months preceding the screening; Absence of signs/symptoms of disease. Exclusion Criteria: Women who have used drugs that alter body composition in the last 3 months prior to starting treatments; who use sensitizing agents, diuretics or are undergoing photodynamic therapy; Participants who are undergoing aesthetic treatments to reduce abdominal/waist circumferences; those who have been previously submitted to abdominoplasty or liposuction surgeries; those who are on a diet therapy monitoring to reduce their measurements; those who are using or have taken drugs or food supplements in last 90 days, in order to reduce their measurements and their weight, which may affect their lipid metabolism, appetite or nutrients absorption; those who have been submitted previously to oophorectomy; those with signs and/or symptoms of climacteric at the menopause; pregnant or lactating women or who are planning a pregnancy before the end of treatment participation. Participants who have abdominal hernia; osteoporosis; phlebitis and thrombophlebitis; autoimmune diseases; cardiovascular problems (hypertension, cardiac insufficiency, arrhythmia, thrombosis); metabolic dysfunctions (diabetes and thyroid disorders); hepatitis or other liver diseases (non-alcoholic fatty liver disease, cirrhosis); respiratory issues (asthma, chronic obstructive pulmonary disease); haematological disturbances (anaemia); renal; dermatological (reduced sensitivity); digestive disorders (gastritis, ulcers); neurological (dementia or schizophrenia), or who have cognitive impairment that may compromise the proper understanding of informed consent; who have already been affected by important inflammatory processes and/or who have a history of cancer; Participants who present tattoos and/or piercings in the region to be treated, who use intrauterine devices, pacemakers, or other electromagnetic implants, as well as joint prostheses.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Photobiomodulation<br>PBM with infrared LED application + sham ultrasound + muscle electrostimulation | Device: Photobiomodulation (PBM) with infrared LED<br>* 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.<br>* Other names: Low-level light therapy (LLLT);Device: Muscle electrostimulation<br>* 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.<br>|
| Active Comparator: low frequency ultrasound<br>LED sham PBM + LOFU + muscle electrostimulation | Device: Low-frequency ultrasound (LOFU)<br>* 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.<br>Device: Muscle electrostimulation<br>* 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.<br>|
| Active Comparator: Combined treatment (PBM + LOFU)<br>Combined treatment (PBM + LOFU) + muscle electrostimulation | Device: Photobiomodulation (PBM) with infrared LED<br>* 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.<br>* Other names: Low-level light therapy (LLLT);Device: Low-frequency ultrasound (LOFU)<br>* 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.<br>Device: Muscle electrostimulation<br>* 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.<br>|
| Sham Comparator: Sham Treatment<br>Sham combined treatment + muscle electrostimulation | Device: Muscle electrostimulation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abdominal skinfold change | This outcome will be measured in millimeters (mm) by direct reading using adipometer (Sanny, American Medical do Brasil Ltda., São Bernardo do Campo, Brazil). | Before the start (Day 0), after the fourth session (Day 15) and after the treatments (Day 30). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anthropometric data (body weight) | Body weight will be measured in kilograms (kg) using a calibrated digital scale. | Day 0, Day 15 and Day 30. | 
| Anthropometric data (height) | Height will be measured in centimeters (cm) and will be collected using a standard stadiometer. | Day 0. | 
| Anthropometric data (body mass index) | The body mass index (BMI) will be calculated from data obtained from the weight (in kilograms) and height (in centimeters) of each participant. The final value will be provided in kg/cm². | Day 0, Day 15 and Day 30. | 
| Anthropometric data (waist circumference) | A properly trained researcher will measure the waist circumference in centimeters (cm), respecting the reference points according to the World Health Organisation (WHO). | Day 0, Day 15 (body weight, BMI, waist and hip circumferences, abdominal and suprailiac skinfold only), and Day 30. | 
| Anthropometric data (hip circumference) | A properly trained researcher will measure the hip circumference in centimeters (cm), respecting the reference points according to the World Health Organisation (WHO). | Day 0, Day 15 and Day 30. | 
| Anthropometric data (waist/hip circumference ratio) | The waist/hip circumference ratio will be obtained by dividing the values obtained in centimeters in order to verify a possible change in the cardiovascular risk profile. | Day 0, Day 15 and Day 30. | 
| Anthropometric data (skinfold measures) | A properly trained researcher will realize the skinfolds evaluation that allows to assess the prediction of body fat based on subcutaneous fat and body density and these will be collected using an adipometer according to the methodology proposed by Pollock and Wilmore (1993) for the measurements referring to the seven skinfolds - tricipital, subscapular, bicipital, suprailiac, abdominal, thigh and leg (medial calf) locations, which will be obtained in millimeters (mm). | Day 0, Day 15 (abdominal and suprailiac skinfolds only), and Day 30. | 
| Local temperature | Thermographic image will be captured using a Compact Thermal Camera (C2, FLIR Systems, Oregon, USA), which calculates the temperature of a given surface through the infrared emission and it will allow verify if there will be any change in local temperature after treatment. | Day 0 and Day 30. | 
| Bioimpedance analysis (weight) | The weight (in kilograms) will be obtained from bioimpedance analysis (Biodynamics Corp., Shoreline - WA, USA) that will allow estimation of body components in a non-invasive way. To obtain legitimate values, each participant will be instructed to drink an average of 2 litres of water and avoid the use of diuretic medication on the day before the exam, do not perform physical activity for at least 12 hours before the test, do not drink alcohol or drinks containing caffeine, not having a menstrual period and, on the day of the exam, fasting of at least 4 hours will be necessary. | Day 0 and Day 30. | 
| Bioimpedance analysis (fat mass percentage) | The fat mass percentage (%) will be obtained from bioimpedance analysis (Biodynamics Corp., Shoreline - WA, USA) that will allow estimation of body components in a non-invasive way. To obtain legitimate values, each participant will be instructed to drink an average of 2 litres of water and avoid the use of diuretic medication on the day before the exam, do not perform physical activity for at least 12 hours before the test, do not drink alcohol or drinks containing caffeine, not having a menstrual period and, on the day of the exam, fasting of at least 4 hours will be necessary. | Day 0 and Day 30. | 
| Bioimpedance analysis (lean mass percentage) | The lean mass percentage (%) will be obtained from bioimpedance analysis (Biodynamics Corp., Shoreline - WA, USA) that will allow estimation of body components in a non-invasive way. To obtain legitimate values, each participant will be instructed to drink an average of 2 litres of water and avoid the use of diuretic medication on the day before the exam, do not perform physical activity for at least 12 hours before the test, do not drink alcohol or drinks containing caffeine, not having a menstrual period and, on the day of the exam, fasting of at least 4 hours will be necessary. | Day 0 and Day 30. | 
| Nutritional assessment | The nutritional routine will be documented as follows: the 24-hour food recall will be collected at the time of the initial evaluation (D0); during treatment, participants will have to fill their daily diet at least three times a week on a nutritional planner, which should contain all the food eaten on those chosen days; and after the end of treatment (D30) the participants will answer again the 24-hour food recall. | Day 0, during the study period (3 times per week) and Day 30. | 
| Physical activity assessment | The physical exercises performed by the participants during the study will be registered using the International Physical Activity Questionnaire (IPAQ), short version. | Day 0, Day 15 and Day 30. | 
| Quality of life scale | The WHOQOL-BREF (Brief version of the World Helath Organization quality of life questionanaire) is the smaller version of the WHOQOL-100 quality of life questionnaire. WHOQOL-BREF consists of 26 questions, whose answers follow a Likert scale (from 1 to 5, the higher the score, better is the quality of life). This questionnaire has 2 questions that assess quality of life in general, being that the others make up 4 domains (physical, psychological, social relations and environment). | Day 0 and Day 30. | 
| Self-esteem scale | The body shape questionnaire (BSQ) has 34 questions and each question has six possible answers, as follows: 1) Never, 2) Rarely, 3) Sometimes, 4) Often, 5) Very often and 6) Always. Quantification of the level of concern in relation to self-image is done through a sum of responses. Result less than or equal to 110 points indicates there is no concern; greater than 110 and less than or equal to 138 points indicates a slight concern; greater than 138 and less than or equal to 167 points indicates moderate concern and if greater than 168 points indicates serious concern. | Day 0 and Day 30. | 
| Visual change assessment | Visual change assessment will be investigated from standardized photograph captures. Participants will be instructed to wear bathing or gym clothes and they will be positioned with their backs to a black background wall, at a distance of 0.7 m from it, on a paper template fixed to the ground, as suggested by Dias et al., (2017). Then, a professional trained for this purpose will be positioned at a distance of 1 m from the participant and will capture four records of her, these being in the anterior, posterior and lateral positions (90° to the right and to the left). Focal length, room lighting and recording mode will also be standardized. | Day 0 and Day 30. | 
| Satisfaction degree with treatment | The participants satisfaction grade with the treatment will be verified by means of a questionnaire containing seven multiple choice questions prepared by our research group based on data contained in the literature. The degree of discomfort during the treatment will be evaluated; if discomfort occurred, for how long did it persist; the degree of satisfaction in relation to the results achieved; the percentage degree of improvement of the complaint; whether the observed effects were below, within or above what was expected; whether she would do the treatment again; and how much would it indicate the treatment for someone close to it with the same complaint. | Day 30. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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LLLT, Cavitation, Photobiomodulation