Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03634462
Study type Interventional
Source Vanderbilt University Medical Center
Contact
Status Completed
Phase N/A
Start date January 15, 2019
Completion date February 28, 2020

See also
  Status Clinical Trial Phase
Completed NCT04643392 - Physiotherapy Applications in Upper Extremity Lipedema
Completed NCT04492046 - Complex Decongestive Applications in Patients With Lipedema
Recruiting NCT05464927 - Visualizing Vascular Mechanisms of Lipedema
Completed NCT02907411 - Quadrivas Therapy® to Reduce Lipedema Subcutaneous Adipose Tissue (QUADRIVAS) N/A
Completed NCT06238791 - Plantar Pressure Analysis and Foot Biomechanics in Lipedema and Chronic Venous Disease
Completed NCT03758651 - Williams Syndrome Strength, Hormones, Activity & Adiposity, DNA Programming, Eating Study
Completed NCT03710798 - Effect of an Low Carbon High Fat Diet on Pain- and Quality of Life in Patients With Lipedema N/A
Not yet recruiting NCT04166084 - Trunk Stabilization Exercises at Lipoedema Patients N/A
Recruiting NCT05628948 - Vascular Lab Resource (VLR) Biorepository
Not yet recruiting NCT05944796 - Diathermy Effectiveness in Reducing Subcutaneous Adipose Tissue Affected by Lipedema N/A
Completed NCT05616962 - Collected Data of Medical Food, Vasculera or Diosmiplex, in Clinic Patients 20 to 70 Years Old Diagnosed With Lipedema N/A
Active, not recruiting NCT04632810 - Effect of Ketosis on Pain and Quality of Life in Patients With Lipedema N/A
Recruiting NCT05284266 - The National Lipedema Study N/A
Active, not recruiting NCT06338059 - Relationship Between Vitamin D and Vitamin B12 Levels and Neuropathic Pain in Lipedema
Completed NCT03492840 - Treatment of Women With Lipedema Involving Substantial Fat Knee of Women and Men With Nodular Dercum's Disease Phase 2
Completed NCT04076891 - Treatment of Women With Lipedema Involving Substantial Fat Above the Knee or of Women and Men With Nodular Dercum's Disease Phase 2
Recruiting NCT02838277 - Insight Into Subcutaneous Adipose Tissue Disorders N/A
Completed NCT05966779 - Physical Therapy in Lipedema Surgery
Recruiting NCT05488977 - The Effects of Endurance Training on Lipedema N/A
Completed NCT04213989 - Intermittent Pneumatic Compression in Women With Lipo-lymphedema (Lipedema With Swelling) N/A