Clinical trial NCT04043182: EFFECTIVENESS OF ULTRASOUND FOR LOCAL FAT TREATMENT
Official title: ULTRASOUND FOR LOCAL FAT TREATMENT: A RANDOMIZED AND DOUBLE-BLIND CLINICAL TEST, CONTROLLED BY PLACEBO
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fat Burn
Lead sponsor: São Paulo State University
Sponsor class: OTHER
First posted: 2019-08-02
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: change abdominal circumference (centimeters-cm), before and after intervention
timeFrame: before (day 0) and post protocol (post 8 weeks)
measure: change blood analysis (milligrams per decilitre-mg/dl ) before and after intervention
timeFrame: before (day 0) and post protocol (post 8 weeks)
measure: weight (centimeters-cm)
timeFrame: before (day 0)
Secondary outcomes:
measure: anthropometric characteristics anthropometric characteristics, photometry and personal satisfaction
timeFrame: before (day 0)
measure: change photometry - reduction of waist measurements before and after intervention
timeFrame: before (day 0) and post protocol (post 8 weeks)
measure: personal satisfaction of the participants treated before and after intervention
timeFrame: before (day 0) and post protocol (post 8 weeks)
Other outcomes:
Locations:
city: Barra do Garças
country: Brazil
facility: Jaqueline Lopes
state: Mount
Study officials:
References: