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

NCT02907411 | Completed

• 1 other identifier: 1607696709
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 2

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.

Conditions

Lipedema

Keywords

Quadrivas; Veins; Lipedema; Lymphedema

Outcome Measures

Primary Outcomes (1)

• Full Body Fat Percentage

  Change in full body fat percentage after 4 weeks of treatment

  Baseline and 4 weeks

Study Arms (1)

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.

Other: Quadrivas Therapy

Interventions

Quadrivas Therapy OTHER

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.

Quadrivas Therapy

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ambulatory females of any race able to understand the consent process.
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Arizona: lead
• Hanger Clinic: Prosthetics & Orthotics: collaborator
• Quadrivas Therapy Clinic & Academy Amsterdam: collaborator

Study Sites (2)

The Herbst Clinic

Tucson, Arizona, 85711, United States

Location

Clinical and Translational Sciences Research Center (CATS) at the University of Arizona

Tucson, Arizona, 85724-5099, United States

Location

MeSH Terms

Conditions

Lipedema; Lymphedema

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Karen L Herbst, MD, PhD

  University of Arizona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, TREAT Program Director

Study Record Dates

• First Submitted: September 13, 2016
• First Posted: September 20, 2016
• Study Start: September 1, 2016
• Primary Completion: March 18, 2017
• Study Completion: March 18, 2017
• Last Updated: September 15, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will share

Locations

US (2)