Mechanical and Physiological Effect of Noncorporeal Shock Wave Therapy Without Biological Stress-histological and Immuno-histochemical Analysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Immunohistochemical procedures
研究概览
简要总结
Informative Summary: Extracorporeal shockwave therapy (ESWT) is a new method for treating aesthetic disorders within the field of aesthetic medicine, its mechanisms of action and physiological effects promise to combat localized fat accumulation, improve skin appearance, favor neocolagenesis and neovascularization. There are currently few studies on ESWT that can claim this benefit, but therapy has been shown to be safe and does not generate adverse reactions to individuals.
Objective: To evaluate the physiological effects and mechanisms of ESWT acting on subcutaneous adipose tissue and adjacent structures through an experimental study.
Methods: A randomized experimental clinical study will be performed in 30 women with grade I, II and III obesity who participated in the multidisciplinary preoperative preparation group for bariatric surgery with previously scheduled surgery. Participants will receive ESWT application within hours of surgery, or in the weeks prior to bariatric surgery, during the surgical procedure a small sample of subcutaneous adipose tissue will be taken for histological and immunohistochemical analysis.
Hypotheses: Through histological and immunohistochemical analysis of the subcutaneous adipose tissue sample, the investigators can identify which real physiological effect and mechanism of action the ESWT has on subcutaneous adipose tissue, epidermis and adjacent structures, thus confirming the benefits of therapy.
Statistical analysis: A descriptive analysis of the results obtained in the histological analysis will be performed initially, 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 groups and session number, the analysis of variance (ANOVA) will be used for repeated measures. For comparison between groups the Tukey test will be used. The significance level adopted for the statistical tests will be 5% or p <0.05.
详细描述
ESWT procedures The participants received seven ESWT therapy sessions twice a week, the last session being about twenty minutes before the surgical procedure of bariatric surgery, the therapy was performed in an area of 150 cm² on the left side of the abdominal region, following the white line, frequently 15Hz, with 4,000,000 shots with 180mJ energy and 15mm stainless steel tip and 2,000,000 shots with 100mJ energy with 15mm plastic tip, for the tip slip a Thork ® Essential Cosmetics Industry Lotion was used LTDA- MED Anvisa nº 25351.419510 / 2017- 95.
For therapy, the THORK Shock Wave® equipment - IBRAMED- Industria Brasileira de Equipamentos Electromédicos EIRELI, approved by Anvisa nº 10360310036, was used.
The direct side of the participants' abdomen was used as a control and did not receive ESWT therapy.
Surgical procedure
After performing the anesthetic procedure at the beginning of the surgical act of bariatric surgery, the surgeon responsible removed two fragments of cutaneous tissue with an average size of 4 cm in diameter, one sample from the region previously demarcated on the left side of the abdomen and the other sample on the side contralateral where there was no demarcation considered as control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
盲法说明
N/D
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •The study will include patients:
- •female gender, over 18 years of age;
- •With obesity grade I, II and III;
- •Patient with surgical indication for bariatric surgery;
- •Roux-en-Y gastric bypass type surgical procedure;
- •Agree to participate and sign the consent form;
排除标准
- •Male gender;
- •cognitive limitations
- •Carriers diabetes mellitus;
- •Performed aesthetic treatment on the abdomen in the last month;
- •Patients with skin lesions such as dermatitis and dermatosis;
- •Patients with acute deep vein thrombosis (DVT);
- •About or near cancerous lesions;
- •Patients with cardiac pacemakers or other implanted electronic devices.
结局指标
主要结局
Immunohistochemical procedures
时间窗: one month
Immunohistochemical reactions were performed on 3μm-thick sections, arranged on silanized slides. The antibodies used were: polyclonal anti-Caspase3 , monoclonal anti-Cleaved Caspase 3 ; monoclonal anti-CD68, monoclonal anti-hormone-sensitive lipase - HSL - and Adipophilin. After preparing the slides, they were analyzed with a DMR microscope (Leica), and photographs were taken at 400x magnification. To quantify the analyses, the ImageJ® software (NIH, Bethesda, USA) was used. All reactions were performed following the manufacturers' protocol and all were standardized by the pathological analysis laboratory of the Hospital de Clínicas da Unicamp. The quantification of immunostaining was performed considering the number of positive cells and intensity, with final scores ranging from 0-300
次要结局
未报告次要终点