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Shock Waves for Treatment of Gynoid Lipodystrophy and Localized Fat

NCT03275259 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2019-03-20

No results posted yet for this study

Summary

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.

Conditions

  • Lipodystrophy
  • Cellulitis
  • Adiposity

Interventions

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.

Sponsors & Collaborators

  • Indústria Brasileira Equipamentos Médicos - IBRAMED

    lead INDUSTRY

Principal Investigators

  • Débora O Modena, M.S · Ibramed - Industria Brasileira de Equipamentos Médicos

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-04-03
Primary Completion
2018-01-01
Completion
2018-12-01

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03275259 on ClinicalTrials.gov