Extracorporeal Shock Wave Therapy in Lower Extremity Lymphedema

Lower extremity lymphedema results from impairment of the lymphatic system and is characterized by progressive tissue fibrosis, chronic limb swelling, recurrent infections, and reduced quality of life. Complex Decongestive Therapy (CDT), recommended by the International Society of Lymphology, remains the gold-standard treatment. Despite adherence to CDT, many patients continue to experience persistent symptoms and functional decline, underscoring the need for effective adjunctive interventions. Extracorporeal Shock Wave Therapy (ESWT) is a non-invasive modality that has shown potential benefits in reducing fibrosis and improving lymphatic function. While its efficacy has been reported in upper extremity lymphedema, evidence in lower extremity lymphedema remains limited. This single-center, prospective, randomized, double-blind, placebo-controlled trial will be conducted at the Department of Physical Medicine and Rehabilitation, Gazi University Faculty of Medicine. Patients currently in CDT Phase 2 (maintenance phase) will be randomly assigned in a 1:1 ratio to receive either active ESWT or sham ESWT, using stratified randomization by lymphedema stage. All participants will continue standard maintenance therapy - compression garments, skin care, and exercise - throughout the study. ESWT will be applied to fibrotic tissue regions and periinguinal and peripopliteal lymph node areas using the EMS Swiss DolorClast® device, with 3,000 impulses per session at 20 Hz and 2 bar. The primary outcome is change in lower extremity circumferential measurements and limb volume. Secondary outcomes include skin and subcutaneous tissue thickness assessed by ultrasonography, pain intensity measured by the Visual Analogue Scale (VAS), lymphedema-specific quality of life evaluated by the LYMQOL-Leg, and functional status assessed by the Lower Extremity Functional Scale (LEFS). All outcomes will be assessed at baseline, immediately after treatment, and at one-month follow-up.