Extracorporeal shock wave therapy by radial devicePlacebo extracorporeal shock wave therapy by radial deviceDLT
Extracorporeal shock wave therapy by radial device: Patients will receive treatment by extracorporeal shock waves therapy (ESWT).
Placebo extracorporeal shock wave therapy by radial device: Patients will receive treatment sham extracorporeal shock waves.
DLT: Patients will receive treatment with decongestive lymphatic therapy (DLT: manual lymphatic drainage, compression)
Study summary
This is a double-blind randomized clinical trial to compare the effect of shock wave therapy on lower limb lymphedema. There are two arms: A) complex decongestive therapy + extracorporeal shock waves therapy; B) complex decongestive therapy plus placebo extracorporeal shock waves.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion criteria
* Patients with lower limb lymphedema
* Lymphedema of at least 6 months of evolution
* The lymphedema must affect at least the knee to the foot
* Moderate or severe lymphedema (grades 2 or 3)
* Sign the informed consent
Exclusion criteria
* Under 18 years of age
* Coagulation disorders (hemophilia, treatment with acenocoumarol, etc.)
* Current or previous deep vein thrombosis of the lower extremity
* Pregnancy
* Electronic implantable medical devices as pacemaker implants, medication pumps, etc
* Having received treatment with complex decongestive therapy or shock waves during the last 6 months
* Treatment with corticosteroids or radiotherapy in the area to be treated in the last 6 weeks
* Active oncological disease in the area to be treated
* Active infectious-inflammatory process in the area to be treated
* Cognitive or sensory deficits that prevent collaboration
* Inability to walk independently or inability to attend therapy
Primary outcome measure(s)
Limb volume change 1 — 5 weeks The difference between limb volume previous of treatment and at the end of treatment
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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