Complete Decongestive Therapy With Negative Pressure for Lipedema and Lymphedema Therapy
Condition: Lipedema; Secondary Lymphedema
MeSH terms: Lymphedema; Lipedema
Study type: Interventional

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).
    

Intervention name(s): CDT with graded negative pressure
Intervention type(s): Other
Intervention description(s): Complete Decongestive Therapy (CDT)is a common conservative intervention involving stimulation of the lymphatic system, use of compression, skin care and exercise. The use of graded negative pressure in conjunction with CDT is another conservative therapy intervention used to help clear the lymphatic congestion.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects with lipedema or secondary leg lymphedema will receive standard manual lymphatic drainage therapy with negative pressure.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: lipedema; lymphedema; therapy; sodium; swelling