Motorized Mechanical Massage Associated With Cosmetics in Improving Body Contour and Appearance of Gynoid Lipodystrophy

Study Overview
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Brief Summary
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PURPOSE: To evaluate the efficacy of motorized mechanical massage associated with cosmetics in improving body contour 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 and in the picture of the gynoid lipodystrophy after the association 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 from personal data, anthropometric and complementary diagnostic tests such as: ultrasound diagnosis in order to evaluate the thickness of the adipose tissue and Cutomiter analysis of the Viscoelasticity of the skin. Afterwards they will be divided and started the treatment with another physiotherapist who will perform the following protocol of the study: exfoliation of the skin, application of the motorized mechanical massage with the device Dermotonus Slim with 550mg of vacuum, continuous mode, for 20 minutes subdivided into region Abdominal and posterior thigh, after the end will be applied the creams for lipolytic purposes. The protocol will be performed twice a week for 1 hour each, totaling 10 sessions.

Official Title
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Motorized Mechanical Massage Associated With Cosmetics in Improving Body Contour and Appearance of Gynoid Lipodystrophy

Conditions
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Cellulitis of Leg

Intervention / Treatment
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* Device: Motorized mechanical massage with the Dermothonus Slim® Ibramed with cosmetics


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female gender, over 18 years of age; With a body mass index up to 29.9 considered overweight; Carriers of GI lipodystrophy; Non smokers; That they agree to participate and sign the term of free and informed commitment - TCLE Exclusion Criteria: Male gender; Performed esthetic treatment in the gluteal region and thighs in the last month; Patients with skin lesions, such as dermatitis and dermatoses; Patients with capillary fragility; Patients with acute deep vein thrombosis (DVT); On or near 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: Intervention of mechanical massage with cosmetics<br>Patients will be treated with motorized mechanical massage and associated with cosmetics with lipolytic active principle, being performed twice a week totaling 10 sessions by a dermato-functional physiotherapist. | Device: Motorized mechanical massage with the Dermothonus Slim® Ibramed with cosmetics<br>* Patients will be treated with motorized mechanical massage with the Dermothonus Slim® electromedical equipment (Ibramed- Brazilian Industry of Electrical Equipment) associated with cosmetics with lipolytic active principle, being performed twice a week totaling 10 sessions by a dermato-functional physiotherapist.<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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cellulits of leg, Motorized power massage, massage