Effect of Vibro-oscillatory Therapy for Improvement of Body Contour and Appearance of Cellulite.
Primary Purpose
Body Fat Distribution, Cellulitis
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Modellata
Sponsored by
About this trial
This is an interventional treatment trial for Body Fat Distribution
Eligibility Criteria
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
Sites / Locations
- Ibramed - Indústria Brasileira de Equipamentos MédicosRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment oscillating vibro
Arm Description
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.
Outcomes
Primary Outcome Measures
Improve body contour
Perimetry, photos, and ultrasound
Secondary Outcome Measures
Improve appearance of cellulite
perimetry, photos, ultra son, degree of cellulite
Full Information
NCT ID
NCT03312946
First Posted
October 13, 2017
Last Updated
October 13, 2017
Sponsor
Indústria Brasileira Equipamentos Médicos - IBRAMED
1. Study Identification
Unique Protocol Identification Number
NCT03312946
Brief Title
Effect of Vibro-oscillatory Therapy for Improvement of Body Contour and Appearance of Cellulite.
Official Title
Effect of Vibro-oscillatory Therapy for Improvement of Body Contour and Appearance of Cellulite.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 13, 2017 (Actual)
Primary Completion Date
December 4, 2017 (Anticipated)
Study Completion Date
February 4, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Indústria Brasileira Equipamentos Médicos - IBRAMED
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Body Fat Distribution, Cellulitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment oscillating vibro
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Modellata
Intervention Description
treatment such as the Modellata electromedical device (Ibramed), in the abdomen, flanks, thigh posterior, inner thigh and buttocks.
Primary Outcome Measure Information:
Title
Improve body contour
Description
Perimetry, photos, and ultrasound
Time Frame
1 hour per session (10 sessions 5 weeks).
Secondary Outcome Measure Information:
Title
Improve appearance of cellulite
Description
perimetry, photos, ultra son, degree of cellulite
Time Frame
1 hour per session (10 sessions 5 weeks).
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Ibramed - Indústria Brasileira de Equipamentos Médicos
City
Amparo
State/Province
São Paulo
ZIP/Postal Code
13901-080
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Débora o Modena, MsC
Phone
19991319016
Email
de_modena@yahoo.com.br
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Effect of Vibro-oscillatory Therapy for Improvement of Body Contour and Appearance of Cellulite.
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