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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03312946
Other study ID # Ibramedmodellata
Secondary ID
Status Recruiting
Phase N/A
First received October 13, 2017
Last updated October 13, 2017
Start date October 13, 2017
Est. completion date February 4, 2018

Study information

Verified date October 2017
Source Indústria Brasileira Equipamentos Médicos - IBRAMED
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Modellata
treatment such as the Modellata electromedical device (Ibramed), in the abdomen, flanks, thigh posterior, inner thigh and buttocks.

Locations

Country Name City State
Brazil Ibramed - Indústria Brasileira de Equipamentos Médicos Amparo São Paulo

Sponsors (1)

Lead Sponsor Collaborator
Indústria Brasileira Equipamentos Médicos - IBRAMED

Country where clinical trial is conducted

Brazil, 

Outcome

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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