EFFECTIVENESS OF ULTRASOUND FOR LOCAL FAT TREATMENT

NCT ID: NCT04043182

Last Updated: 2019-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-29

Study Completion Date

2019-09-30

Brief Summary

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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

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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.

Conditions

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Fat Burn

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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group control

You will not receive any type of intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

treatment group (ultrasound)

Will perform protocols of 10 sessions of ultrasound in the region of abdomen

Group Type EXPERIMENTAL

ultrassound

Intervention Type PROCEDURE

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 group

It will perform protocols of 10 sessions of ultrasound in the region of abdomen, but the apparatus will be with zero intensities

Group Type PLACEBO_COMPARATOR

ultrassound

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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São Paulo State University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Jaqueline Lopes

Barra do Garças, Mount, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Jaqueline Lopes, master

Role: CONTACT

66999202206

Aryane Machado, PHD

Role: CONTACT

16981251595

Facility Contacts

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Jaqueline Lopes

Role: primary

66999202206

Other Identifiers

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SaoPSU_univar

Identifier Type: -

Identifier Source: org_study_id

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