EFFECTIVENESS OF ULTRASOUND FOR LOCAL FAT TREATMENT (n)

ULTRASOUND FOR LOCAL FAT TREATMENT: A RANDOMIZED AND DOUBLE-BLIND CLINICAL TEST, CONTROLLED BY PLACEBO

It's evident that the literature shows good results on the use of aesthetic ultrasound in the treatment of localized fat, however, little has been explored so far, about possible psychological influences of this method and therefore, it is believed that it is pertinent to elaborate studies that include a placebo group, in order to measure the real effects from the exclusive application of ultrasound. Therefore, the objective of this study will be to verify the influence of the application of aesthetic ultrasound in the treatment of localized fat, using for both clinical, biochemical and functional parameters.

Study Overview

• Status: Unknown
• Conditions: Fat Burn
• Intervention / Treatment: Procedure: ultrassound

Detailed Description

There will be included 30 participants, female gender, communities between 18 and 30 years, apparently Saudi, local abdominal fat, located in three groups: control (n = 10), experimental (n = 10) and placebo (n = 10) . Or group control não recebeu nenhum type of intervention. No experimental group, 10 sessões de ultrassom (Skinner brand, São Paulo) will be carried out in the previous region for 20 minutes. No placebo group will be applied ultrassom (Skinner brand, São Paulo), pormem com zerada intensities. Anthropometric avaliação e of dobras cutâneas will be carried out at this time before applying the treatment protocol. As skin folds will be measured by means of adipometers.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jaqueline Lopes, master; Phone Number: 66999202206; Email: jaqueee-santosss@hotmail.com
• Study Contact Backup: Name: Aryane Machado, PHD; Phone Number: 16981251595; Email: ary_machado@hotmail.com

Study Locations

• Brazil
  • Mount
    • Barra do Garças, Mount, Brazil, 78600-000
      • Recruiting
      • Jaqueline Lopes
      • Contact: Jaqueline Lopes; Phone Number: 66999202206; Email: jaqueee-santosss@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Additional inclusion criteria included body mass index (BMI) equal to or less than 25.0 kg / m2
• Adipose tissue thickness 2.6 cm or more in the treatment region;
• Preserved elasticity and local tissue integrity;
• In addition, participants had to agree not to change their daily routines during the study.

Exclusion Criteria:

• Pregnancy.
• Breastfeeding;
• History of liposuction;
• Lipolysis by injection therapy;
• Abdominoplasty or surgery in the treatment region;
• Weight reduction medication;
• Recent surgery in the last 12 months;
• Implantable electrical device;
• Neurosurgical deviation;
• Hernia;
• Sensory loss or dysesthesia in the treatment region;
• Cancer;
• Circulation problems;
• Or chronic systemic disease such as diabetes or metabolic syndrome.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: group control; You will not receive any type of intervention
Experimental: treatment group (ultrasound); Will perform protocols of 10 sessions of ultrasound in the region of abdomen	Procedure: ultrassound; The treatment protocol will consist of 10 sessions, lasting 20 minutes. The energy level corresponding to 59 J / cm2 (177 J / cm2) and frequency of 3 MHZ, applied in the anterior region of the abdomen, in a quadrant previously delimited with a ballpoint pen, will be used. The flanks (lateral of the abdomen) will not be treated.
Placebo Comparator: placebo group; It will perform protocols of 10 sessions of ultrasound in the region of abdomen, but the apparatus will be with zero intensities	Procedure: ultrassound; The treatment protocol will consist of 10 sessions, lasting 20 minutes. The energy level corresponding to 59 J / cm2 (177 J / cm2) and frequency of 3 MHZ, applied in the anterior region of the abdomen, in a quadrant previously delimited with a ballpoint pen, will be used. The flanks (lateral of the abdomen) will not be treated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change abdominal circumference (centimeters-cm), before and after intervention	To measure values corresponding to the waist / quadrile ratio, metric phyta will be used, which will collect measurements in centimeters (cm). Assim, at waist circumference, it will be measured at umbigo height.	before (day 0) and post protocol (post 8 weeks)
change blood analysis (milligrams per decilitre-mg/dl ) before and after intervention	A biochemical analysis will be carried out with the use of soro from blood collection in the antecubital vein, collected at a quantity of 10 mL as participants in the jejum study did not start and end the treatment as ultrassom. As shown below, BIOPLUS 2000 semi-automatic biochemical method will be evaluated for a dosage of parameters such as Triglycerides, Total Cholesterol, High Density Lipoprotein - HDL and Baixa Densidade Lipoprotein Estimates - LDL and Baixíssima Densidade Lipoprotein - VLDL through calculation formula Friedewald As dosagens will be carried out not the Laboratory of Biochemistry of the University Center of Vale do Araguaia - UNIVAR).	before (day 0) and post protocol (post 8 weeks)
weight (centimeters-cm)	stadiometer (Sanny, American Medical do Brasil, São Paulo, Brazil).	before (day 0)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
anthropometric characteristics anthropometric characteristics, photometry and personal satisfaction	It will be measured by meio de uma meio de uma balança (Tanita BC554, Iron Man / Inner Scaner, Tanita, Illinois, United States) and a stadiometer (Sanny, American Medical do Brasil, São Paulo, Brazil). In this way, the height will be measured in centimeters and the weight in kilograms.	before (day 0)
change photometry - reduction of waist measurements before and after intervention	A photograph will be taken with a professional camera of Canon Brand Powershot Sx530 Hs, with a fixed focal length and constant lighting.	before (day 0) and post protocol (post 8 weeks)
personal satisfaction of the participants treated before and after intervention	A satisfação pessoal will be measured by means of a questionnaire, the objective of which will be to investigate these variables in a subjective way. Assim, the participants will be instructed to trace a 10 cm analog visual scale between two extremes, being 0 or "minimum possível" and 10 indicating "or more possível" for each classification. The satisfaction scale ranges from zero to ten.	before (day 0) and post protocol (post 8 weeks)

Collaborators and Investigators

• Sponsor: São Paulo State University

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2019
• Primary Completion (Anticipated): September 25, 2019
• Study Completion (Anticipated): September 30, 2019

Study Registration Dates

• First Submitted: July 12, 2019
• First Submitted That Met QC Criteria: August 1, 2019
• First Posted (Actual): August 2, 2019

Study Record Updates

• Last Update Posted (Actual): August 2, 2019
• Last Update Submitted That Met QC Criteria: August 1, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: SaoPSU_univar

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No