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

NCT03312946 | Unknown

• 1 other identifier: Ibramedmodellata
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Body Fat Distribution; Cellulitis

Outcome Measures

Primary Outcomes (1)

• Improve body contour

  Perimetry, photos, and ultrasound

  1 hour per session (10 sessions 5 weeks).

Secondary Outcomes (1)

• Improve appearance of cellulite

  1 hour per session (10 sessions 5 weeks).

Study Arms (1)

Treatment oscillating vibro

EXPERIMENTAL

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.

Device: Modellata

Interventions

Modellata DEVICE

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

Treatment oscillating vibro

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Indústria Brasileira Equipamentos Médicos - IBRAMED: lead

Study Sites (1)

Ibramed - Indústria Brasileira de Equipamentos Médicos

Amparo, São Paulo, 13901-080, Brazil

RECRUITING

MeSH Terms

Conditions

Cellulitis

Condition Hierarchy (Ancestors)

Skin Diseases, Infectious; Infections; Suppuration; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2017
• First Posted: October 18, 2017
• Study Start: October 13, 2017
• Primary Completion: December 4, 2017
• Study Completion: February 4, 2018
• Last Updated: October 18, 2017

Record last verified: 2017-10

Locations

BR (1)