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临床试验/NCT03474523
NCT03474523已完成不适用

Effectiveness of Diathermy-Radiofrecuency Compared With Cavitation in Cellulitis Treatment

University of Cadiz2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2017年10月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
Decrease in perimeter measures

研究概览

简要总结

The aim of the present study is to value the effectiveness of Diathermy-Radiofrecuency treatment compared to Cavitation treatment in woman with cellulitis.

详细描述

The edemato-fibrosclerotic panniculopathy is a segmental disease and lipodystrophy, this disease is localized in subcutaneous connective tissue which is influenced by venous and lymphatic system, when these systems are affected. The secondary vasomotor dysfunction to failure sympathetic nervous system influence on this disease too.

Usually it affects women, influencing their physical and psychological well-being.

The Aesthetic Physiotherapy, known as Aesthetics Plastic and Restorative Physiotherapy, is in their beginnings, there are little studies which present this pathology from the physiotherapy perspective. The investigators believe that their research could make some progress in this matter.

The search found very few clinical trials of scientific rigor about radio frequency and cavitation, and The investigators didn't find studies that compare both. Both treatments show effectiveness in improving the appearance of cellulite, so it would be a good idea compare them and see the most effective.

The investigators are trying to compare the effectiveness of both techniques and the investigators consider innovative and with added value to investigate something that we haven´t found in the reviewed literature.

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 (Participant, Outcomes Assessor)

盲法说明

external evaluator

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • UCA comunity
  • Age 18-40 years
  • Cellulite grade I, II, III (Nürnberg&Müller clasification)
  • Compliance of study timing
  • Acceptance of informed consent and signature of study authorization

排除标准

  • Pacemaker, heart diseases, epilepsy,
  • pregnancy, lactation, last year postpartum, menstrual cycle alterations, climacteric, perimenopause
  • chronic disease, hormonal or circulatory disorder, neoplasia process
  • inflammation, infection, active acne, open wound in the treatment area
  • BMI above 27 Kg/m2, obesity, lipoedema, oedema, circulatory problems
  • Metal implants, prosthesis, intrauterine devices
  • Evolutive diseases
  • Severe Artheryal hipertension
  • High cholesterol levels or non-controlled triglycerides
  • Weight fluctuation above 2 kg in the last six months
  • Drinking more than two daily alcoholic drinks
  • Pharmacological treatment during study: anti-inflammatory, esthetical, cosmetical or dietetic treatment
  • Previous treatment of the studies areas in the last year
  • Surgery intervention in studies areas

结局指标

主要结局

Decrease in perimeter measures

时间窗: At the begining and at the end of the treatment after seven weeks

measuring tape

次要结局

  • Physical activity evaluation(At the begining and at the end of the treatment after seven weeks)
  • Changes in body mass index(At the begining and at the end of the treatment after seven weeks)
  • Changes in weight(At the begining and at the end of the treatment after seven weeks)
  • Degree of cellulitis(At the begining and at the end of the treatment after seven weeks. This scale measures the level of cellulite and takes the values of 0-3, being 0 the value where there is no cellulite and 3 the most serious stage of cellulite.)

研究者

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

Ines Carmona Barrientos

Principal Investigator

University of Cadiz

研究点 (2)

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