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临床试验/NCT05973526
NCT05973526招募中不适用

Comparative Acute Effects of the Application of Percutaneous and Transcutaneous Electrolipolysis on the Female Abdominal Contour: a Cross Over Clinical Trial

Universidade Federal de Pernambuco2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年5月16日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
20
试验地点
2
主要终点
Reduction of Adipose Tissue

研究概览

简要总结

The goal of this clinical trial is to compare the acute effects of percutaneous and transcutaneous eletroclipolysis on abdominal contour in women. The main question it aims to answer are:

• Is there superiority in percutaneous and transcutaneous electrolipolysis techniques?

Participants will undergo 12 sessions of 50 minutes each performed twice a week, totaling 6 weeks, after randomizing the hemibody for each technique.

Researchers will compare the hemibody with the percutaneous technique with the hemibody with the transcutaneous technique to see if there is a reduction of the adipose tissue.

详细描述

Abdominal Adiposity consists of an increase in adipose tissue in the abdomen region, which may be associated as a risk factor for cardiovascular pathologies, metabolic disorders and dyslipidemias, in addition to affecting self-esteem and social life due to aesthetics body provided by the volume increase of the contour. Electrolipolysis proves to be one of the accessible and low-cost resources, capable of promoting good therapeutic results through the passage of electric current to the adipose tissue, either with its percutaneous or transcutaneous technique. The study aims to compare the acute effects of percutaneous and transcutaneous electrolipolysis, considering comfort during execution.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women between with localized abdominal fat
  • Body Mass Index (BMI) between 18.5 and 29.9 kg/m2 (adequate weight and overweight)
  • Who have not undergone any treatment for the condition experienced in the last 6 months
  • Sedentary
  • Not on a supervised diet

排除标准

  • Alcoholics
  • Pregnant women
  • Metabolic and circulatory system disorders
  • Pacemaker
  • Metallic implants
  • Tumors/metastasis
  • Dermatitis
  • In treatment with corticosteroids and/or prolonged progesterone
  • Skin ulcers/lesions
  • Needle phobia (aichmophobia)
  • Sensitivity alteration in the region to be treated
  • Unable to understand the form and/or procedure
  • Not completing the suggested protocol
  • Dietary changes during the research

结局指标

主要结局

Reduction of Adipose Tissue

时间窗: From enrollment to end of treatment at 6 weeks

It is expected to find a reduction in adipose tissue in both techniques, with similar results, verified by ultrasonography and adipometry, from the verification of a variation in the pre- and post-intervention measurements of thickness of adipose tissue in centimeters

次要结局

  • Satisfaction Evaluation(From enrollment to end of treatment at 6 weeks)
  • Vascularization Changes(From enrollment to end of treatment at 6 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rennatha de Moura Medeiros

Principal Investigator

Universidade Federal de Pernambuco

研究点 (2)

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