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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention of mechanical massage with cosmetics | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Motorized mechanical massage with the Dermothonus Slim® Ibramed with cosmetics | Device | 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Renata M Guidi | Contact | 38179633 | re_guidi@yahoo.com.br | |
| Débora Modena | Contact | 019991319016 | de_modena@yahoo.com.br |
| Name | Affiliation | Role |
|---|---|---|
| Débora modena | University of Campinas, Brazil | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ibramed - Indústria Brasileira de Equipamentos Médicos | Recruiting | Amparo | São Paulo | 13901-080 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9502849 | Result | Chang P, Wiseman J, Jacoby T, Salisbury AV, Ersek RA. Noninvasive mechanical body contouring: (Endermologie) a one-year clinical outcome study update. Aesthetic Plast Surg. 1998 Mar-Apr;22(2):145-53. doi: 10.1007/s002669900182. | |
| 11420530 | Result | Adcock D, Paulsen S, Jabour K, Davis S, Nanney LB, Shack RB. Analysis of the effects of deep mechanical massage in the porcine model. Plast Reconstr Surg. 2001 Jul;108(1):233-40. doi: 10.1097/00006534-200107000-00038. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 21, 2017 | |
| Reset | Sep 19, 2018 | |
| Release | Oct 29, 2019 |
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|
| 16401454 | Result | Gordon C, Emiliozzi C, Zartarian M. Use of a mechanical massage technique in the treatment of fibromyalgia: a preliminary study. Arch Phys Med Rehabil. 2006 Jan;87(1):145-7. doi: 10.1016/j.apmr.2005.08.125. |
| 18719762 | Result | Milani GB, Natal Filho A, Amado Joao SM. Correlation between lumbar lordosis angle and degree of gynoid lipodystrophy (cellulite) in asymptomatic women. Clinics (Sao Paulo). 2008 Aug;63(4):503-8. doi: 10.1590/s1807-59322008000400015. |
| Reset | Nov 19, 2019 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 21, 2017 | Sep 19, 2018 | |||
| Oct 29, 2019 | Nov 19, 2019 |