Combination of Light and Ultrasound to Reduce Abdominal Fat
NCT ID: NCT05155683
Last Updated: 2023-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
79 participants
INTERVENTIONAL
2022-03-01
2023-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
FACTORIAL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Photobiomodulation
PBM with infrared LED application + sham ultrasound + muscle electrostimulation
Photobiomodulation (PBM) with infrared LED
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.
Muscle electrostimulation
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.
low frequency ultrasound
LED sham PBM + LOFU + muscle electrostimulation
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.
Muscle electrostimulation
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.
Combined treatment (PBM + LOFU)
Combined treatment (PBM + LOFU) + muscle electrostimulation
Photobiomodulation (PBM) with infrared LED
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)
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 electrostimulation
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.
Sham Treatment
Sham combined treatment + muscle electrostimulation
Muscle electrostimulation
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Photobiomodulation (PBM) with infrared LED
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)
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 electrostimulation
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 Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
25 Years
45 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Nove de Julho
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Christiane Pavani
Clinical Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Michelle M Sena, MSc
Role: STUDY_CHAIR
PhD student
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Universidade Nove de Julho
São Paulo, , Brazil
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MMS
Identifier Type: -
Identifier Source: org_study_id