CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 30 enrolled
Drug / intervention
THORK Shock Wave® (Extracorporeal shock waves)device
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03275259
NCT03275259N/ACompleted

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

Indústria Brasileira Equipamentos Médicos - IBRAMED·interventional·Posted Sep 7, 2017·Updated Mar 20, 2019

In Brief

A clinical study evaluating THORK Shock Wave® (Extracorporeal shock waves) for Lipodystrophy and 2 related conditions. Completed, enrolled 30 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBrazil
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedSep 7, 2017
Enrollment StartApr 3, 2017
Primary CompletionJan 1, 2018
Study CompletionDec 1, 2018
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 8.8 years ago

Interventions

THORK Shock Wave® (Extracorporeal shock waves)device

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.