Effect of Vibro-oscillatory Therapy for Improvement of Body Contour and Appearance of Cellulite.

Cellulitis Clinical Trial

Official title:

Effect of Vibro-oscillatory Therapy for Improvement of Body Contour and Appearance of Cellulite.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03312946
• Other study ID #: Ibramedmodellata
• 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
• 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

Related Conditions & MeSH terms

• Body Fat Distribution
• Cellulite
• Cellulitis

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).