Motorized Mechanical Massage Associated With Cosmetics in Improving Body Contour and Appearance of Gynoid Lipodystrophy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Anthropometric evaluation
研究概览
简要总结
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.
详细描述
After signing the informed consent, the participants will be evaluated by two physiotherapists where the data collected will be from personal data, anthropometric and complementary diagnostic tests such as: ultrasound diagnosis in order to evaluate the thickness of the adipose tissue and Cutomiter analysis of the Viscoelasticity of the skin. Afterwards they will be divided and started the treatment with another physiotherapist who will perform the following protocol of the study: exfoliation of the skin, application of the motorized mechanical massage with the device Dermotonus Slim with 550mg of vacuum, continuous mode, for 20 minutes subdivided into region Abdominal and posterior thigh, after the end will be applied the creams for lipolytic purposes. The protocol will be performed twice a week for 1 hour each, totaling 10 sessions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Anthropometric evaluation
时间窗: Ten Minutes
Perimeter in the region to be treated in centimeters.
Evaluation of the degree of cellulite
时间窗: Ten minutes
Assessment of Gland Lipodystrophy: Cellulite Severity Scale (CSS). Photographic study.
Assessment of adipose tissue thickness
时间窗: Twenty minutes
Assessment of the thickness of the dermis or hypodermis (Ultrasound diagnosis)
Assessment of skin elasticity
时间窗: Twenty minutes
Evaluation of skin elasticity (Cutometer® MPA580)
次要结局
未报告次要终点
研究者
Renata Michelini Guidi
Principal Investigator
Indústria Brasileira Equipamentos Médicos - IBRAMED