Clinical trial NCT03634462: Complete Decongestive Therapy With Negative Pressure for Lipedema and Lymphedema Therapy
Official title: Complete Decongestive Therapy With Negative Pressure for Lipedema and Lymphedema Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lipedema
Secondary Lymphedema
Keywords: lipedema
lymphedema
therapy
sodium
swelling
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: Lipedema Foundation
First posted: 2018-08-16
Enrollment: 10
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects with lipedema or secondary leg lymphedema will receive standard manual lymphatic drainage therapy with negative pressure.
Primary purpose: TREATMENT

Brief summary: This study is designed to investigate the therapy outcomes from routine physical therapy in persons with lipedema and secondary limb lymphedema. Complete decongestive therapy (CDT) is a common conservative treatment to optimize lymphatic functioning using exercise, compression, lymphatic stimulation and skin care. PhysioTouch is a gentle graded negative pressure device designed to enhance lymphatic stimulation that is used by the skilled therapist in conjunction with hands on techniques of tissue mobilization for enhanced clearance of lymph stasis in persons with lymphedema. This study will investigate the conservative treatment impact in patients with lipedema and lower extremity lymphedema using this conservative available technique.

Detailed description: This study will assess the treatment impact of complete decongestive therapy (CDT) in conjunction with negative pressure application using PhysioTouch (R) in women with lipedema or secondary lymphedema. Lipedema is an adipose tissue disorder in which persons experience pain and swelling in their legs and lower quadrants. Lipedema is a disorder that almost exclusively effects females, is frequently inherited, and is triggered by hormonal changes. Symptomatology includes symmetric swelling of the hypodermis of the legs, indentations in the fat causing uneven skin which may include large extruding mounds of tissue, is often accompanied by lymphedema, and is unresponsive to diet or exercise.

Women with secondary limb lymphedema in this study are persons who have developed lymphedema following cancer treatment. Persons with lymphedema or lipedema often receive CDT. CDT is a common conservative treatment to optimize lymphatic functioning using exercise, compression, lymphatic stimulation and skin care. An adjunct component of therapy is the use of gentle graded negative pressure to further enhance lymphatic stimulation. PhysioTouch is a gentle graded negative pressure device designed to enhance lymphatic stimulation.

The investigators will evaluate to what extent CDT with graded negative pressure impacts lymphatic functioning in patients with lipedema or lymphedema of the lower extremities. Additionally, the investigators will also noninvasively evaluate lymphatic function using Magnetic Resonance (MR) lymphangiography without contrast, and whether tissue sodium and fat composition are associated with reduced lymphatic pumping dynamics in the study's group cohorts. This will provide new information on the mechanism of dysfunctional fat clearance in patients with lipedema using traditional conservative therapy. By outlining internal mechanisms underlying lipedema etiology, and their response to CDT, this will provide objective markers elucidating the unique characteristics of lipedema compared with secondary lymphedema.

Study hypothesis: Therapeutic manipulation of lymphatic stasis over six weeks increases lymphatic pumping kinetics and reduces tissue sodium accumulation.

Biophysical measurements will also be acquired, including bioimpedance spectroscopy and perometry. Three cohorts will be studied: age-, gender-, and BMI-matched study controls, patients with lipedema, and patients with secondary unilateral leg lymphedema from cancer therapies. Only females will be recruited since lipedema primarily affects females. Only patients with leg lymphedema following cancer therapies will be recruited to control for the known reason for leg lymphedema. Subjects will be recruited from age 14 years and older since lipedema is triggered by hormonal changes occurring with menarche and pregnancy. Measurements will be repeated on a separate study date in a subset of volunteers. Reproducibility will be determined using an intraclass correlation coefficient; results will establish the normative range of these measures in healthy tissue. Significant differences in imaging metrics and biophysical measures between groups will be evaluated using a one-way ANOVA. This work will improve the investigators understanding of the physiology of lipedema compared to obesity and lymphedema. The results will determine the potential for these measures to serve as biomarkers of lipedema, as distinguished from obesity or on a spectrum of lymphedema. The results will also evaluate for changes in lymphatic pumping and tissue sodium accumulation following a commonly used physical therapy intervention over a course of 6 weeks in the two patient populations, lipedema (n=5) and secondary leg lymphedema (n=5).

Eligibility criteria: Inclusion Criteria:

* Females with a diagnosis of lipedema or a probable diagnosis of lipedema
* Females with a diagnosis of secondary limb lymphedema following cancer treatments

Exclusion Criteria:

* Subjects who have any type of non-MRI compatible bioimplant activated by mechanical, electronic, or magnetic means (e.g., cochlear implants, pacemakers, neurostimulators, biostimulators, electronic infusion pumps, etc.) or are not able to comfortably be able to tolerate the limited fit of the MRI
* Subjects who have any type of ferromagnetic bioimplant that could potentially be displaced.
* Subjects who may have shrapnel imbedded in their bodies (such as from war wounds), metal workers and machinists (potential for metallic fragments in or near the eyes).
* Pregnant women will be excluded from the MRI portion of the study only
* Subjects who have open wounds on either ankle or top of foot because of contraindications with placement of electrodes to obtain the L-DEX U400 readings.
* Persons with heart pacemakers.
* Persons with Dercum's disease, diabetes or high blood pressure (systolic great than 140 and diastolic great than 90).

Primary outcomes:
measure: Assessing a Change in Bioimpedance Spectroscopy (BIS) Following CDT with Graded Negative Pressure
timeFrame: At baseline and at 6-8 weeks following the completion of therapy
Secondary outcomes:
measure: Assessing a Change in Lymphatic stasis Following CDT with Graded Negative Pressure
timeFrame: At baseline and at 6-8 weeks following the completion of therapy
measure: Assessing a Change in Limb Volume Following CDT with Graded Negative Pressure
timeFrame: At baseline and at 6-8 weeks following the completion of therapy
measure: Assessing a Change in Sodium Levels in Regions of Interest Following CDT with Graded Negative Pressure
timeFrame: At baseline and at 6-8 weeks following the completion of therapy
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Manus J Donahue, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Crescenzi R, Marton A, Donahue PMC, Mahany HB, Lants SK, Wang P, Beckman JA, Donahue MJ, Titze J. Tissue Sodium Content is Elevated in the Skin and Subcutaneous Adipose Tissue in Women with Lipedema. Obesity (Silver Spring). 2018 Feb;26(2):310-317. doi: 10.1002/oby.22090. Epub 2017 Dec 27.