Cellulitis Clinical Trial
Official title:
Effect of Vibro-oscillatory Therapy for Improvement of Body Contour and Appearance of Cellulite.
Verified date | October 2017 |
Source | Indústria Brasileira Equipamentos Médicos - IBRAMED |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | February 4, 2018 |
Est. primary completion date | December 4, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: - Female gender, over 18 years of age; - With body mass index considered eutrophic; - Cellulite carriers; - Non smokers; - That they agree to participate and sign the TCLE. Exclusion Criteria: - Male gender; - Menopausal women; - Have undergone aesthetic treatment in the gluteal region and thighs in the last 6 months; - 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 |
Country | Name | City | State |
---|---|---|---|
Brazil | Ibramed - Indústria Brasileira de Equipamentos Médicos | Amparo | São Paulo |
Lead Sponsor | Collaborator |
---|---|
Indústria Brasileira Equipamentos Médicos - IBRAMED |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Improve body contour | Perimetry, photos, and ultrasound | 1 hour per session (10 sessions 5 weeks). | |
Secondary | Improve appearance of cellulite | perimetry, photos, ultra son, degree of cellulite | 1 hour per session (10 sessions 5 weeks). |
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