Subcutaneous Fat DisorderNCT05155683
Combination of Light and Ultrasound to Reduce Abdominal Fat
A study testing Photobiomodulation (PBM) with infrared LED, Low-frequency ultrasound (LOFU) and Muscle electrostimulation in people with Subcutaneous Fat Disorder, run by University of Nove de Julho at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 25 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Subcutaneous Fat Disorder
- What is being tested?
- Photobiomodulation (PBM) with infrared LED, Low-frequency ultrasound (LOFU) and Muscle electrostimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 79 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Mar 2022to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study of the Use of Phototherapy and Ultrasound to Reduce Localized Fat
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.
Read the 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.
- Conditions
- Subcutaneous Fat Disorder
- Being tested
- Photobiomodulation (PBM) with infrared LED, Low-frequency ultrasound (LOFU), Muscle electrostimulation
- Keywords
- LLLT, Cavitation, Photobiomodulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photobiomodulation (PBM) with infrared LEDDevice
Also called Low-level light therapy (LLLT)
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.
Low-frequency ultrasound (LOFU)Device
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.
Muscle electrostimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Photobiomodulation | Active comparator | PBM with infrared LED application + sham ultrasound + muscle electrostimulation Receives: Device: Photobiomodulation (PBM) with infrared LED; Device: Muscle electrostimulation |
| low frequency ultrasound | Active comparator | LED sham PBM + LOFU + muscle electrostimulation Receives: Device: Low-frequency ultrasound (LOFU); Device: Muscle electrostimulation |
| Combined treatment (PBM + LOFU) | Active comparator | Combined treatment (PBM + LOFU) + muscle electrostimulation Receives: Device: Photobiomodulation (PBM) with infrared LED; Device: Low-frequency ultrasound (LOFU); Device: Muscle electrostimulation |
| Sham Treatment | Sham comparator | Sham combined treatment + muscle electrostimulation Receives: Device: Muscle electrostimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Before the start (Day 0), after the fourth session (Day 15) and after the treatments (Day 30).
Secondary outcomes (17)
Anthropometric data (body weight)
Body weight will be measured in kilograms (kg) using a calibrated digital scale.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 30.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2021
- Study start1 Mar 2022
- Primary completion30 May 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subcutaneous Fat DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- 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 blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christiane Pavani, University of Nove de Julho
- Investigators
- Michelle M Sena, MSc, Study chair, PhD student
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05155683
- Sponsor's protocol ID
- MMS
- Status last verified
- Dec 2023
- First submitted
- 3 Nov 2021
- Last updated
- 12 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of the Use of Phototherapy and Ultrasound to Reduce Localized Fat
- ClinicalTrials.gov ID
- NCT05155683
- Acronym / sponsor ID
- MMS
- Conditions
- Subcutaneous Fat Disorder
- Keywords
- LLLT, Cavitation, Photobiomodulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 13 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Photobiomodulation | Active comparator | Device: Photobiomodulation (PBM) with infrared LED, Device: Muscle electrostimulationPBM with infrared LED application + sham ultrasound + muscle electrostimulation |
| low frequency ultrasound | Active comparator | Device: Low-frequency ultrasound (LOFU), Device: Muscle electrostimulationLED sham PBM + LOFU + muscle electrostimulation |
| Combined treatment (PBM + LOFU) | Active comparator | Device: Photobiomodulation (PBM) with infrared LED, Device: Low-frequency ultrasound (LOFU), Device: Muscle electrostimulationCombined treatment (PBM + LOFU) + muscle electrostimulation |
| Sham Treatment | Sham comparator | Device: Muscle electrostimulationSham combined treatment + muscle electrostimulation |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Photobiomodulation (PBM) with infrared LEDAlso: Low-level light therapy (LLLT)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. | Device | Combined treatment (PBM + LOFU), Photobiomodulation |
| Low-frequency ultrasound (LOFU)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. | Device | Combined treatment (PBM + LOFU), low frequency ultrasound |
| Muscle electrostimulationThe 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. | Device | Combined treatment (PBM + LOFU), Photobiomodulation, Sham Treatment, low frequency ultrasound |
Primary outcome
Abdominal skinfold change
Time frame: Before the start (Day 0), after the fourth session (Day 15) and after the treatments (Day 30).
This outcome will be measured in millimeters (mm) by direct reading using adipometer (Sanny, American Medical do Brasil Ltda., São Bernardo do Campo, Brazil).
17 secondary outcomes
Anthropometric data (body weight)
Time frame: Day 0, Day 15 and Day 30.
Anthropometric data (height)
Time frame: Day 0.
Anthropometric data (body mass index)
Time frame: Day 0, Day 15 and Day 30.
Anthropometric data (waist circumference)
Time frame: Day 0, Day 15 (body weight, BMI, waist and hip circumferences, abdominal and suprailiac skinfold only), and Day 30.
Anthropometric data (hip circumference)
Time frame: Day 0, Day 15 and Day 30.
Anthropometric data (waist/hip circumference ratio)
Time frame: Day 0, Day 15 and Day 30.
Anthropometric data (skinfold measures)
Time frame: Day 0, Day 15 (abdominal and suprailiac skinfolds only), and Day 30.
Local temperature
Time frame: Day 0 and Day 30.
Bioimpedance analysis (weight)
Time frame: Day 0 and Day 30.
Bioimpedance analysis (fat mass percentage)
Time frame: Day 0 and Day 30.
Bioimpedance analysis (lean mass percentage)
Time frame: Day 0 and Day 30.
Nutritional assessment
Time frame: Day 0, during the study period (3 times per week) and Day 30.
Physical activity assessment
Time frame: Day 0, Day 15 and Day 30.
Quality of life scale
Time frame: Day 0 and Day 30.
Self-esteem scale
Time frame: Day 0 and Day 30.
Visual change assessment
Time frame: Day 0 and Day 30.
Satisfaction degree with treatment
Time frame: Day 30.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2023.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle M Sena, MSc study chair
PhD student
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photobiomodulation (PBM) with infrared LED, Low-frequency ultrasound (LOFU) and Muscle electrostimulation in people with Subcutaneous Fat Disorder, run by University of Nove de Julho at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abdominal skinfold change (time frame: Before the start (Day 0), after the fourth session (Day 15) and after the treatments (Day 30).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2023.