UnknownNot Applicable

Motorized Mechanical Massage Associated With Cosmetics in Improving Body Contour and Appearance of Gynoid Lipodystrophy

Brazil30 participantsStarted 2017-05-30

Plain-language summary

PURPOSE: To evaluate the efficacy of motorized mechanical massage associated with cosmetics in improving body contour and appearance of gynoid lipodystrophy. SUBJECTS AND METHODS: A prospective and comparative longitudinal clinical study will be performed in 30 women with localized fat and gynoid lipodystrophy. Patients will be submitted data collection and assessments and before and after treatment. HYPOTHESES: It is expected that the patients will present improvement in the body contour and in the picture of the gynoid lipodystrophy after the association of the therapies. 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 measurements will be used. Tukey's test will be used to compare groups. The level of significance adopted for the statistical tests will be 5% or p \<0.05.

Who can participate

Age range

18 Years – 50 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Female gender, over 18 years of age; * With a body mass index up to 29.9 considered overweight; * Carriers of GI lipodystrophy; * Non smokers; * That they agree to participate and sign the term of free and informed commitment - TCLE Exclusion Criteria: * Male gender; * Performed esthetic treatment in the gluteal region and thighs in the last month; * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Anthropometric evaluation

Timeframe: Ten minutes

Anthropometric evaluation

Timeframe: Ten Minutes

Evaluation of the degree of cellulite

Timeframe: Ten minutes

Assessment of adipose tissue thickness

Timeframe: Twenty minutes

Assessment of skin elasticity

Timeframe: Twenty minutes

Trial details

NCT IDNCT03199781

SponsorIndústria Brasileira Equipamentos Médicos - IBRAMED

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-08-20

Contact for this trial

Renata M Guidi

38179633 re_guidi@yahoo.com.br

View on ClinicalTrials.gov More Cellulitis of Leg trials