Motorized Mechanical Massage Associated With Cosmetics in Improving Body Contour and Appearance of Gynoid Lipodystrophy
NCT ID: NCT03199781
Last Updated: 2017-06-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2017-05-30
2017-09-15
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Intervention of mechanical massage with cosmetics
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.
Motorized mechanical massage with the Dermothonus Slim® Ibramed with cosmetics
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.
Interventions
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Motorized mechanical massage with the Dermothonus Slim® Ibramed with cosmetics
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
50 Years
FEMALE
Yes
Sponsors
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Indústria Brasileira Equipamentos Médicos - IBRAMED
INDUSTRY
Responsible Party
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Renata Michelini Guidi
Principal Investigator
Principal Investigators
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Débora modena
Role: PRINCIPAL_INVESTIGATOR
University of Campinas, Brazil
Locations
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Ibramed - Indústria Brasileira de Equipamentos Médicos
Amparo, São Paulo, Brazil
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
Other Identifiers
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Ibramed
Identifier Type: -
Identifier Source: org_study_id
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