Quadrivas Therapy® to Reduce Lipedema Subcutaneous Adipose Tissue (QUADRIVAS)
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:
- Almost exclusive occurrence in women developing by the third decade of life
- Bilateral and symmetrical nature with minimal involvement of the feet, resulting in an ''inverse shouldering'', ''bracelet'' or "cuff" effect at the ankle
- Minimal pitting edema (non-pitting edema is present)
- Pain, tenderness, and easy bruising
- Persistent enlargement despite elevation of the extremities or weight loss.
- 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
- 否
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
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
KHerbst
Associate Professor, TREAT Program Director
University of Arizona