LipedemaQUADRIVASNCT02907411
Quadrivas Therapy® to Reduce Lipedema Subcutaneous Adipose Tissue (QUADRIVAS)
A study testing Quadrivas Therapy in people with Lipedema, run by University of Arizona at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 70 years, women only
- Conditions the study is for
- Lipedema
- What is being tested?
- Quadrivas Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Sep 2016to 18 Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The Herbst Clinic
Tucson, Arizona, 85711
Clinical and Translational Sciences Research Center (CATS) at the University of Arizona
Tucson, Arizona, 85724-5099
About this study
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.
Read the 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.
- Conditions
- Lipedema
- Being tested
- Quadrivas Therapy
- Keywords
- Quadrivas, Veins, Lipedema, Lymphedema
- Medical subject headings
- Lipedema, Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quadrivas TherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Quadrivas Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Full Body Fat Percentage
Change in full body fat percentage after 4 weeks of treatment
Measured: Baseline and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2016 (estimated)
- Study start1 Sep 2016
- Primary completion18 Mar 2017
- Study completion18 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LipedemaStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- Hanger Clinic: Prosthetics & Orthotics, Quadrivas Therapy Clinic & Academy Amsterdam
- Responsible party
- Principal investigator, KHerbst, University of Arizona
- Investigators
- Karen L Herbst, MD, PhD, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02907411
- Sponsor's protocol ID
- 1607696709
- Acronym
- QUADRIVAS
- Status last verified
- Sep 2017
- First submitted
- 13 Sep 2016
- Last updated
- 15 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: The data will be shared with investigators who submit a request
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quadrivas Therapy® to Reduce Lipedema Subcutaneous Adipose Tissue (QUADRIVAS)
- ClinicalTrials.gov ID
- NCT02907411
- Acronym / sponsor ID
- QUADRIVAS / 1607696709
- Conditions
- Lipedema
- Keywords
- Quadrivas, Veins, Lipedema, Lymphedema
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- Hanger Clinic: Prosthetics & Orthotics, Quadrivas Therapy Clinic & Academy Amsterdam
- Study start
- 1 Sep 2016
- Primary completion
- 18 Mar 2017 (actual)
- Study completion
- 18 Mar 2017 (actual)
- First posted
- 20 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Quadrivas Therapy | Experimental | Other: Quadrivas TherapyHands on therapy to improve all aspects of fat tissue including the vessels within. Each of 7 subjects receive 12 treatments in one month time. |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quadrivas TherapyQuadrivas 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. | Other | Quadrivas Therapy |
Primary outcome
Full Body Fat Percentage
Time frame: Baseline and 4 weeks
Change in full body fat percentage after 4 weeks of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2017.
- Individual participant dataSharing planned: Yes. The data will be shared with investigators who submit a request
Related trials for Lipedema
RecruitingObservational study
Validity and Reliability of the 2-Minute Step Test in Patients With Lipedema
Lipedema
Recruiting
Effectiveness of Kinesio Taping as an Adjunct to Conservative Treatment in Women With Lipedema
Lipedema
Not yet recruiting
Mind-Body Chair Yoga for Functional Mobility in Individuals With Lipedema
Lipedema
Recruiting
Efficacy of Complex Decongestive Therapy, Exercise and Diet in Women With Lipedema
Lipedema
Recruiting
Aquatic Versus Land-Based Exercise in Women With Lipedema
Lipedema
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen L Herbst, MD, PhD principal investigator
University of Arizona
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quadrivas Therapy in people with Lipedema, run by University of Arizona at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Full Body Fat Percentage (time frame: Baseline and 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2017.