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OBJECTIVE: To evaluate the efficacy of vibro-oscillatory therapy through an electromedical equipment in improving body contour and appearance of cellulite.
SUBJECTS AND METHODS: A prospective and comparative longitudinal clinical study will be performed in 30 women with cellulitis. Patients will be submitted to data collection and evaluation and before and after vibration-oscillatory therapy.
HYPOTHESES: Patients are expected to show improvement in body contour and cellulite after vibration-oscillatory therapy.
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 measures will be used. Tukey's test will be used to compare the groups. The significance level adopted for the statistical tests will be 5% or p <0.05.
After approval by the institutional committee of Research Ethics, the subjects will be approached by the researcher responsible on the day of their evaluation, where they completed the registration form, after a brief analysis of the inclusion and exclusion criteria of the present study, the individuals included in the study will be collection of anthropometric data: weight, height, BMI, perimeter of the treated region, assessment of the degree of gynoid lipodystrophy, clinical inspection and photographic study of the treated area, ultrasound examination to assess the thickness of the dermis and hypodermis and the examination with Cutometer ® to assess the viscoelasticity of the skin.
Patients will be divided according to the degree of cellulite they present and will be treated with vibration therapy, such as the Modellata® electromedical equipment (Ibramed- Brazilian Industry of Electronic Equipment), being performed three times a week for two months totaling 16 sessions by a dermato-functional physiotherapist.
Data collection and evaluation will be performed before and after treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment oscillating vibro | Experimental | treatment such as the Modellata electromedical device (Ibramed), in the abdomen, flanks, thigh posterior, inner thigh and buttocks. Being performed twice a week, with a total duration of 50 minutes to the session, being 10 sessions total to end the treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Modellata | Device | treatment such as the Modellata electromedical device (Ibramed), in the abdomen, flanks, thigh posterior, inner thigh and buttocks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Improve body contour | Perimetry, photos, and ultrasound | 1 hour per session (10 sessions 5 weeks). |
| Measure | Description | Time Frame |
|---|---|---|
| Improve appearance of cellulite | perimetry, photos, ultra son, degree of cellulite | 1 hour per session (10 sessions 5 weeks). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ibramed - Indústria Brasileira de Equipamentos Médicos | Recruiting | Amparo | São Paulo | 13901-080 | Brazil |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 16, 2018 | |
| Reset | Oct 18, 2018 | |
| Release | Mar 18, 2019 | |
| Reset | Mar 22, 2019 | |
| Release | Oct 29, 2019 | |
| Reset | Nov 19, 2019 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 16, 2018 | Oct 18, 2018 | |||
| Mar 18, 2019 |
| ID | Term |
|---|---|
| D002481 | Cellulitis |
| ID | Term |
|---|---|
| D012874 | Skin Diseases, Infectious |
| D007239 | Infections |
| D013492 | Suppuration |
| D003240 | Connective Tissue Diseases |
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| Mar 22, 2019 |
| Oct 29, 2019 | Nov 19, 2019 |
| D017437 |
| Skin and Connective Tissue Diseases |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |