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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02907411
First Posted: September 20, 2016
Last Update Posted: September 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Hanger Clinic
Quadrivas Therapy Clinic & Academy Amsterdam
Information provided by (Responsible Party):
KHerbst, University of Arizona
  Purpose
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.

Condition Intervention
Lipedema Other: Quadrivas Therapy

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Quadrivas Therapy® to Reduce Lipedema Subcutaneous Adipose Tissue (QUADRIVAS)

Further study details as provided by KHerbst, University of Arizona:

Primary Outcome Measures:
  • Full Body Fat Percentage [ Time Frame: Baseline and 4 weeks ]
    Change in full body fat percentage after 4 weeks of treatment


Enrollment: 7
Study Start Date: September 1, 2016
Study Completion Date: March 18, 2017
Primary Completion Date: March 18, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Other: Quadrivas Therapy
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.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02907411


Locations
United States, Arizona
The Herbst Clinic
Tucson, Arizona, United States, 85711
Clinical and Translational Sciences Research Center (CATS) at the University of Arizona
Tucson, Arizona, United States, 85724-5099
Sponsors and Collaborators
University of Arizona
Hanger Clinic
Quadrivas Therapy Clinic & Academy Amsterdam
Investigators
Principal Investigator: Karen L Herbst, MD, PhD University of Arizona
  More Information

Additional Information:
Responsible Party: KHerbst, Associate Professor, TREAT Program Director, University of Arizona
ClinicalTrials.gov Identifier: NCT02907411     History of Changes
Other Study ID Numbers: 1607696709
First Submitted: September 13, 2016
First Posted: September 20, 2016
Last Update Posted: September 15, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The data will be shared with investigators who submit a request

Keywords provided by KHerbst, University of Arizona:
Quadrivas
Veins
Lipedema
Lymphedema

Additional relevant MeSH terms:
Lipedema
Connective Tissue Diseases