Quadrivas Therapy® to Reduce Lipedema Subcutaneous Adipose Tissue (QUADRIVAS) (QUADRIVAS)
Primary Purpose
Lipedema
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Quadrivas Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Lipedema focused on measuring Quadrivas, Veins, Lipedema, Lymphedema
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Sites / Locations
- The Herbst Clinic
- Clinical and Translational Sciences Research Center (CATS) at the University of Arizona
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Quadrivas Therapy
Arm Description
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.
Outcomes
Primary Outcome Measures
Full Body Fat Percentage
Change in full body fat percentage after 4 weeks of treatment
Secondary Outcome Measures
Full Information
NCT ID
NCT02907411
First Posted
September 13, 2016
Last Updated
September 14, 2017
Sponsor
University of Arizona
Collaborators
Hanger Clinic: Prosthetics & Orthotics, Quadrivas Therapy Clinic & Academy Amsterdam
1. Study Identification
Unique Protocol Identification Number
NCT02907411
Brief Title
Quadrivas Therapy® to Reduce Lipedema Subcutaneous Adipose Tissue (QUADRIVAS)
Acronym
QUADRIVAS
Official Title
Quadrivas Therapy® to Reduce Lipedema Subcutaneous Adipose Tissue (QUADRIVAS)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
September 1, 2016 (undefined)
Primary Completion Date
March 18, 2017 (Actual)
Study Completion Date
March 18, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Arizona
Collaborators
Hanger Clinic: Prosthetics & Orthotics, Quadrivas Therapy Clinic & Academy Amsterdam
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
Women with lipedema have an obvious disparity between the larger quantity of gynoid distributed painful fat on the lower body (hips, buttocks, legs) compared to the trunk, head and face resulting in a low waist to hip ratio (WHR). The disparity results from the failure of lipedema SAT to reduce in response to extreme caloric restriction, including bariatric procedures, or intensive daily exercise. It is unclear why there is a drive to maintain lipedema SAT on the body. The SAT begins in typical gynoid locations (hips, buttocks, legs) and few women with lipedema have diabetes or metabolic syndrome suggesting that the lipedema SAT may be protective against cardiovascular disease similar to gynoid fat. However, in addition to being cosmetically devastating to many women, lipedema fat increases the risk of development of mobility issues, joint damage, chronic pain and lymphedema.
Quad Rivas Therapy®
The Quad Rivas Therapy® is a deep tissue "hands on" touch therapy of SAT which treats the body as an anatomical and physiological unit - all areas containing SAT are treated with a focus to improve functioning of blood vasculature, lymph vasculature, nerves, and the biomechanical system (muscle, tendons and fascia). The Quad Rivas Therapy® ensures these four systems are improved, but focuses on the vascular system. Tissues with decreased blood supply due to enlarged SAT mass, fibrosis or fascia disease need manipulation to be able to function properly again, allowing easy flow through the tissue. The Quad Rivas Therapy, therapist uses specialized grip techniques which enable the therapist to 'open' and 'unravel' tissues for an optimal blood supply. Another tissue technique, called the "hook technique" allows the therapist to ensure stimulation of blood flow. Blood vessels gain elasticity back, fibrosis in the veins resolves and the body is able to repair itself.
The Quad Rivas Therapy® theory is that during puberty under the influence of hormones, the lipedema SAT outgrows the ability of muscles to use and break down fat resulting in excess SAT mass. This in combination with vascular, especially venous, insufficiency, which affects many women at a young age, creates a progressive disease that generates a blockage in metabolism associated due to setting up a hypoxic environment for the fat cells. Stimulating the affected area with Quad Rivas Therapy®, focusing on getting vessels back in top condition ensures the disappearance of lipedema SAT.
Quad Rivas Therapy® results in the following:
Recovery of the walls of the veins;
Increased basal metabolic rate in muscles;
Improved condition of the connective tissue.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lipedema
Keywords
Quadrivas, Veins, Lipedema, Lymphedema
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Quadrivas Therapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Quadrivas Therapy
Intervention Description
Quadrivas therapy will be applied to subjects. Quadrivas therapy is a intensive massage therapy for different tissues. Subjects will receive 12 treatments. The first lasting 2.5 hours and the remaining 11 lasting 1.5 hours.
Primary Outcome Measure Information:
Title
Full Body Fat Percentage
Description
Change in full body fat percentage after 4 weeks of treatment
Time Frame
Baseline and 4 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen L Herbst, MD, PhD
Organizational Affiliation
University of Arizona
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Herbst Clinic
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85711
Country
United States
Facility Name
Clinical and Translational Sciences Research Center (CATS) at the University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724-5099
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The data will be shared with investigators who submit a request
Learn more about this trial
Quadrivas Therapy® to Reduce Lipedema Subcutaneous Adipose Tissue (QUADRIVAS)
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