ULTRASOUND FOR LOCAL FAT TREATMENT: A RANDOMIZED AND DOUBLE-BLIND CLINICAL TEST, CONTROLLED BY PLACEBO
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
- change abdominal circumference (centimeters-cm), before and after intervention
研究概览
简要总结
It's evident that the literature shows good results on the use of aesthetic ultrasound in the treatment of localized fat, however, little has been explored so far, about possible psychological influences of this method and therefore, it is believed that it is pertinent to elaborate studies that include a placebo group, in order to measure the real effects from the exclusive application of ultrasound. Therefore, the objective of this study will be to verify the influence of the application of aesthetic ultrasound in the treatment of localized fat, using for both clinical, biochemical and functional parameters.
详细描述
There will be included 30 participants, female gender, communities between 18 and 30 years, apparently Saudi, local abdominal fat, located in three groups: control (n = 10), experimental (n = 10) and placebo (n = 10) . Or group control não recebeu nenhum type of intervention. No experimental group, 10 sessões de ultrassom (Skinner brand, São Paulo) will be carried out in the previous region for 20 minutes. No placebo group will be applied ultrassom (Skinner brand, São Paulo), pormem com zerada intensities. Anthropometric avaliação e of dobras cutâneas will be carried out at this time before applying the treatment protocol. As skin folds will be measured by means of adipometers.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Additional inclusion criteria included body mass index (BMI) equal to or less than 25.0 kg / m2
- •Adipose tissue thickness 2.6 cm or more in the treatment region;
- •Preserved elasticity and local tissue integrity;
- •In addition, participants had to agree not to change their daily routines during the study.
排除标准
- •Pregnancy.
- •Breastfeeding;
- •History of liposuction;
- •Lipolysis by injection therapy;
- •Abdominoplasty or surgery in the treatment region;
- •Weight reduction medication;
- •Recent surgery in the last 12 months;
- •Implantable electrical device;
- •Neurosurgical deviation;
- •Sensory loss or dysesthesia in the treatment region;
- •Circulation problems;
- •Or chronic systemic disease such as diabetes or metabolic syndrome.
研究组 & 干预措施
group control
You will not receive any type of intervention
treatment group (ultrasound)
Will perform protocols of 10 sessions of ultrasound in the region of abdomen
干预措施: ultrassound (Procedure)
placebo group
It will perform protocols of 10 sessions of ultrasound in the region of abdomen, but the apparatus will be with zero intensities
干预措施: ultrassound (Procedure)
结局指标
主要结局
change abdominal circumference (centimeters-cm), before and after intervention
时间窗: before (day 0) and post protocol (post 8 weeks)
To measure values corresponding to the waist / quadrile ratio, metric phyta will be used, which will collect measurements in centimeters (cm). Assim, at waist circumference, it will be measured at umbigo height.
change blood analysis (milligrams per decilitre-mg/dl ) before and after intervention
时间窗: before (day 0) and post protocol (post 8 weeks)
A biochemical analysis will be carried out with the use of soro from blood collection in the antecubital vein, collected at a quantity of 10 mL as participants in the jejum study did not start and end the treatment as ultrassom. As shown below, BIOPLUS 2000 semi-automatic biochemical method will be evaluated for a dosage of parameters such as Triglycerides, Total Cholesterol, High Density Lipoprotein - HDL and Baixa Densidade Lipoprotein Estimates - LDL and Baixíssima Densidade Lipoprotein - VLDL through calculation formula Friedewald As dosagens will be carried out not the Laboratory of Biochemistry of the University Center of Vale do Araguaia - UNIVAR).
weight (centimeters-cm)
时间窗: before (day 0)
stadiometer (Sanny, American Medical do Brasil, São Paulo, Brazil).
次要结局
- change photometry - reduction of waist measurements before and after intervention(before (day 0) and post protocol (post 8 weeks))
- personal satisfaction of the participants treated before and after intervention(before (day 0) and post protocol (post 8 weeks))
- anthropometric characteristics anthropometric characteristics, photometry and personal satisfaction(before (day 0))