Effects of Ultrasound Cavitation Focused on Located Adiposity: Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 主要终点
- Use of Ultrasound Focused Cavitational associated with stereodynamic drainage reduce the layer of fat in the abdominal region.
研究概览
简要总结
The aim of this study is to evaluate the effect of cavitation ultrasound focused on localized adiposity and its effects associated with stereodynamic lymphatic drainage. The investigators aim also to know if this procedure will influence the biochemical profile of the individuals concerned, as well as whether it will be found difference between the group that will receive focused ultrasound cavitation associated with stereodynamic drainage and the group will receive only focused cavitation ultrasound.
详细描述
This study will be a double-blind randomized clinical trial, preceded by a pilot study due to lack of data in the literature impossible to calculate the size of adequate sample.
The overall objective of the study is to evaluate the effect of cavitation ultrasound focadalizado in localized adiposity and its associated lymphatic drainage effects stereodynamic.
The specific objectives are:
Evaluate and compare the effects of focused ultrasound cavitation in reducing hypodermic layer and anthropometric measurements of women; To evaluate the acute and chronic effects of the technique; To evaluate the reduction in adipose tissue layer from the ultrasound image; Evaluate and compare the reduction of the fat layer through intergroup and intragroup photographic image; Evaluating and comparing serum biochemical parameters (total cholesterol, triglycerides, HDL cholesterol, LDL cholesterol, glucose, urea and creatinine) of women undergoing focused ultrasound cavitation; Evaluate and compare the technical efficiency in group A (without stereodynamic drainage) and B (with stereodynamic drainage).
This study will be conducted with 28 volunteers, respecting the criteria for inclusion and exclusion previously cited by reading and signing of the free and clear consent. Participants will be divided into 02 groups randomly. Randomization will be performed by using the local random distribution www.random.org tool, in order to prevent the researcher to identify which intervention will be performed on each patient. The generation of sequence numbers shall be made by the researcher "blind" to the study, after the selection of patients for inclusion and exclusion criteria. The sequence numbers to be used for randomization will be kept confidential until such time as the intervention Participants will undergo a 4-week control period between the first (base) and the second evaluation (pre-treatment), so each participant It will be their own control, ensuring that the possible changes that may be found at the end of the project will be related to the procedure and not influenced by lifestyle habits. During the period the research subjects will be instructed not alterararem their respective routine activities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Females, showing adiposity located in the abdominal area;
- •Body Mass Index values are within normal values, 18.5 kg / m2 and 24.9 kg / m2;
- •Patients must agree and sign the consent form and clarified.
排除标准
- •Individuals who contraceptive hormone therapy was changed for less than 4 weeks of starting treatment;
- •Showing as lower skinfold to 2 cm;
- •Making use of anti-dyslipidemic drugs;
- •Present areas of hypoesthesia at the injection site;
- •Having inflammation or infection in the region to be treated;
- •Woman in pregnancy or breastfeeding;
- •With clinical history of malignancies;
- •Who have metal implants or cardiac pacemaker;
- •Presenting coagulation disorders or making use of medications that alter blood clotting;
- •Patients with osteoporosis and / or diabetes mellitus.
结局指标
主要结局
Use of Ultrasound Focused Cavitational associated with stereodynamic drainage reduce the layer of fat in the abdominal region.
时间窗: Eight weeks
Use of Ultrasound Focused Cavitational reduce the layer of fat in the abdominal area abdominal region.
时间窗: Eight weeks
次要结局
未报告次要终点
研究者
Patricia Viana da Rosa
Adjunct Professor
Federal University of Health Science of Porto Alegre