Shock Waves for Treatment of Gynoid Lipodystrophy and Localized Fat (ESWT)

March 18, 2019 updated by: Indústria Brasileira Equipamentos Médicos - IBRAMED

Effect of Extracorporeal Shock Wave Therapy in the Treatment of Gynoid Lipodystrophy and Localized Fat

PURPOSE: To evaluate the efficacy of shock waves extracorporea in improving body contour,decrease fat localized and appearance of gynoid lipodystrophy.

SUBJECTS AND METHODS: A prospective and comparative longitudinal clinical study will be performed in 30 women with localized fat and gynoid lipodystrophy. Patients will be submitted data collection and assessments and before and after treatment.

HYPOTHESES: It is expected that the patients will present improvement in the body contour, decrease fat localized and in the picture of the gynoid lipodystrophy after of the therapies.

STATISTICAL ANALYSIS: A descriptive analysis will be done before and after vibration-oscillatory therapy, with frequency tables for categorical and descriptive variables (mean, standard deviation, median, minimum and maximum values) for continuous or numerical variables. In order to compare the main variables between the groups and the collection times, the analysis of variance (ANOVA) for repeated measurements will be used. Tukey's test will be used to compare groups. The level of significance adopted for the statistical tests will be 5% or p <0.05.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

After signing the informed consent, the participants will be evaluated by two physiotherapists where the data collected will be personal data, anthropometrics and complementary diagnostic tests, such as: ultrasound diagnosis to evaluate the thickness of the adipose tissue and Cutomiter analysis of the Viscoelasticity of skin. They then started treatment with another physiotherapist who will perform the following study protocol: placing a light layer of neutral gel on the treatment area, applying extracorporeal shock waves with the stainless steel tip with 180mJ of energy totaling 4 thousand shots , in abdomens, buttocks and posterior thigh and 2 thousand shots in flanks, then performs the change of the tip to the plastic and performs 2 thousand shots in the regions of abdomens, buttocks, posterior thigh emil shots in the region of flanks. The protocol will be performed twice a week for 1 and 20 hours each, totaling 10 sessions.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • São Paulo
      • Amparo, São Paulo, Brazil, 13901-080
        • Ibramed - Indústria Brasileira de Equipamentos Médicos

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 48 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women older than 18 years of age up to premenopausal age (50 years of age).
  • With body mass index considered eutrophic and / or overweight.
  • Patients with lipodystrophy and localized abdominal fat.
  • non smokers.
  • Who agree to participate and sign the informed consent form.

Exclusion Criteria:

  • Male gender.
  • Possible.
  • Haemophilia carriers and hemorrhagic disorders.
  • Carriers diabetes mellitus.
  • Women in menopause.
  • Performed aesthetic treatment in the gluteal, thigh and abdominal regions in the last 1 months.
  • Patients with skin lesions, such as dermatitis and dermatoses.
  • Patients with acute deep vein thrombosis (DVT).
  • About or close to cancerous lesions.
  • Patients with cardiac pacemaker or other implanted electronic device.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Extracorporeal shock waves
Composed of 30 female patients with glandular lipodystrophy in the buttocks and posterior thigh and fat located in abdomen and flanks that received the treatment of extracorporeal shock waves with energy between 100 and 180mJ, frequency of 15Hz and 6000 shots in abdomen, glutes and thigh Back and flanks 3000 shots with radial applicator and 15mm tip. The treatment is performed twice a week for 1 hour and 30 minutes each session.
Device: THORK Shock Wave® (Extracorporeal shock waves)
Treatment with extracorporeal shock waves: energy between 100 and 180mJ, frequency of 15Hz and 6000 shots in abdomen, glutes and thigh Back and flanks 3000 shots with radial applicator and 15mm tip. The treatment is performed twice a week for 1 hour and 30 minutes each session.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anthropometric evaluation
Time Frame: Ten minutes
BMI (kg / height m2)
Ten minutes
Anthropometric evaluation
Time Frame: Ten Minutes
Perimeter in the region to be treated in centimeters.
Ten Minutes
Evaluation of the degree of cellulite
Time Frame: Ten minutes
Assessment of Gland Lipodystrophy: Cellulite Severity Scale (CSS). Photographic study.
Ten minutes
Assessment of adipose tissue thickness
Time Frame: Twenty minutes
Assessment of the thickness of the dermis or hypodermis (Ultrasound diagnosis)
Twenty minutes
Assessment of skin elasticity
Time Frame: Twenty minutes
Evaluation of skin elasticity (Cutometer® MPA580)
Twenty minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indústria Brasileira Equipamentos Médicos - IBRAMED

Investigators

  • Principal Investigator: Débora O Modena, M.S, Ibramed - Indústria Brasileira de Equipamentos Médicos

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 3, 2017

Primary Completion (Actual)

January 1, 2018

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

July 21, 2017

First Submitted That Met QC Criteria

September 5, 2017

First Posted (Actual)

September 7, 2017

Study Record Updates

Last Update Posted (Actual)

March 20, 2019

Last Update Submitted That Met QC Criteria

March 18, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ibramed -SW

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

The data collected and the results of this study will be shared through scientific papers after the end of the study.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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