Effect of Extracorporeal Shock Wave Therapy in the Treatment of Gynoid Lipodystrophy and Localized Fat
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 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 shock waves extracorporea in improving body contour,decrease fat localized 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, decrease fat localized and in the picture of the gynoid lipodystrophy after 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 personal data, anthropometrics and complementary diagnostic tests, such as: ultrasound diagnosis to evaluate the thickness of the adipose tissue and Cutomiter analysis of the Viscoelasticity of skin. They then started treatment with another physiotherapist who will perform the following study protocol: placing a light layer of neutral gel on the treatment area, applying extracorporeal shock waves with the stainless steel tip with 180mJ of energy totaling 4 thousand shots , in abdomens, buttocks and posterior thigh and 2 thousand shots in flanks, then performs the change of the tip to the plastic and performs 2 thousand shots in the regions of abdomens, buttocks, posterior thigh emil shots in the region of flanks. The protocol will be performed twice a week for 1 and 20 hours 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
盲法说明
The participants and evaluator are blinded. They will not be informed about the parameters applied in this study.
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
- •Women older than 18 years of age up to premenopausal age (50 years of age).
- •With body mass index considered eutrophic and / or overweight.
- •Patients with lipodystrophy and localized abdominal fat.
- •non smokers.
- •Who agree to participate and sign the informed consent form.
排除标准
- •Male gender.
- •Possible.
- •Haemophilia carriers and hemorrhagic disorders.
- •Carriers diabetes mellitus.
- •Women in menopause.
- •Performed aesthetic treatment in the gluteal, thigh and abdominal regions in the last 1 months.
- •Patients with skin lesions, such as dermatitis and dermatoses.
- •Patients with acute deep vein thrombosis (DVT).
- •About or close to 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