- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03312946
Effect of Vibro-oscillatory Therapy for Improvement of Body Contour and Appearance of Cellulite.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
São Paulo
-
Amparo, São Paulo, Brazil, 13901-080
- Recruiting
- Ibramed - Indústria Brasileira de Equipamentos Médicos
-
Contact:
- Débora o Modena, MsC
- Phone Number: 19991319016
- Email: de_modena@yahoo.com.br
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment oscillating vibro
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.
|
treatment such as the Modellata electromedical device (Ibramed), in the abdomen, flanks, thigh posterior, inner thigh and buttocks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Improve body contour
Time Frame: 1 hour per session (10 sessions 5 weeks).
|
Perimetry, photos, and ultrasound
|
1 hour per session (10 sessions 5 weeks).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Improve appearance of cellulite
Time Frame: 1 hour per session (10 sessions 5 weeks).
|
perimetry, photos, ultra son, degree of cellulite
|
1 hour per session (10 sessions 5 weeks).
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Ibramedmodellata
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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