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临床试验/NCT02907411
NCT02907411已完成不适用

Quadrivas Therapy® to Reduce Lipedema Subcutaneous Adipose Tissue (QUADRIVAS)

University of Arizona4 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2016年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
7
试验地点
4
主要终点
Full Body Fat Percentage

研究概览

简要总结

Quad Rivas Therapy has been developed by Alyna Eekma from the Netherlands for over thirteen years; anecdotally she has been able to significantly reduce lipedema SAT in women with Stage 1 and 2 lipedema, and can reduce lipedema SAT by 80% in women with Stage 3 lipedema. The study will last for one month, for a total of 12 treatments per subject, seven subjects total, to see if there is a change in percent body fat percentage over the course of these treatments.

详细描述

Lipedema

According to an epidemiological study by Földi E and Földi M, lipedema affects 11% of the female population. Rarely, men with hypogonadism, growth hormone deficiency, or liver disease may develop lipedema. Drs. Allen and Hines from the Mayo clinic defined lipedema in 1940 and shortly thereafter provided the diagnostic criteria for lipedema:

  1. Almost exclusive occurrence in women developing by the third decade of life
  2. Bilateral and symmetrical nature with minimal involvement of the feet, resulting in an ''inverse shouldering'', ''bracelet'' or "cuff" effect at the ankle
  3. Minimal pitting edema (non-pitting edema is present)
  4. Pain, tenderness, and easy bruising
  5. Persistent enlargement despite elevation of the extremities or weight loss.
  6. Increased vascular fragility; easy bruising

There are three stages of lipedema Stage 1: Normal skin surface with enlarged hypodermis Stage 2: Uneven skin with a peau d'orange or mattress-like texture with larger mounds of tissue the size of a walnut or apple including the formation of lipomas and angiolipomas, and larger indentations in the fat Stage 3: Much larger mounds or huge lobules of tissue occurs causing deformations especially around the knees

Progression to lymphedema, called lipolymphedema (Stage 4) can develop during any Stage but most commonly occurs in people with Stage 3. Obesity can occur along with lipedema especially in Stage 3. Lifestyle improvements should always be considered for obesity associated with lipedema but lifestyle is not the cause of lipedema nor the cure.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
19 Years 至 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Ambulatory females of any race able to understand the consent process.
  • 19-70 years of age.
  • Diagnosis of lipedema Stage 1 or Stage 2 although early Stage 3 will be considered.
  • Weight stable for past three months per personal report of the subject.
  • Must be able to attend all 12 treatments and pre and post procedures

排除标准

  • Use of medications that might cause weight gain and prevent fat loss (e.g., second generation anti-psychotics, corticosteroids).
  • Current use of weight loss medications.
  • Tobacco or marijuana use which may alter inflammation in the body.
  • Pregnancy due to the risks associated with deep tissue treatment.
  • Two or more alcoholic beverages per day, chronically.

研究组 & 干预措施

Quadrivas Therapy

Experimental

Hands on therapy to improve all aspects of fat tissue including the vessels within. Each of 7 subjects receive 12 treatments in one month time.

干预措施: Quadrivas Therapy (Other)

结局指标

主要结局

Full Body Fat Percentage

时间窗: Baseline and 4 weeks

Change in full body fat percentage after 4 weeks of treatment

次要结局

未报告次要终点

研究者

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

KHerbst

Associate Professor, TREAT Program Director

University of Arizona

研究点 (4)

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