Shock Waves for Treatment of Gynoid Lipodystrophy and Localized Fat

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Lipodystrophy, Cellulitis, Adiposity

Intervention / Treatment
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* Device: THORK Shock Wave® (Extracorporeal shock waves)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Extracorporeal shock waves<br>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)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Shock wave, Gynoid lipodystrophy, Cellulits