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

Unknown

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

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • São Paulo
      • Amparo, São Paulo, Brazil, 13901-080
        • Recruiting
        • Ibramed - Indústria Brasileira de Equipamentos Médicos
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 13, 2017

Primary Completion (Anticipated)

December 4, 2017

Study Completion (Anticipated)

February 4, 2018

Study Registration Dates

First Submitted

October 13, 2017

First Submitted That Met QC Criteria

October 13, 2017

First Posted (Actual)

October 18, 2017

Study Record Updates

Last Update Posted (Actual)

October 18, 2017

Last Update Submitted That Met QC Criteria

October 13, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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