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Extracorporeal Shock Wave Therapy in Lower Extremity Lymphedema
Sponsor: Gazi University
Summary
Lower extremity lymphedema is a chronic and progressive condition associated with significant functional impairment and reduced quality of life. The current gold-standard treatment is Complex Decongestive Therapy (CDT); however, a substantial proportion of patients continue to experience persistent symptoms during the maintenance phase. This prospective, randomized, double-blind, placebo-controlled clinical trial aims to evaluate the effectiveness of Extracorporeal Shock Wave Therapy (ESWT) as an adjunct to standard CDT maintenance therapy in patients with lower extremity lymphedema. Participants will be randomly allocated to either an active ESWT group or a sham ESWT group, with both groups continuing standard CDT maintenance throughout the study. ESWT will be administered twice weekly for five sessions. Changes in limb volume, skin thickness and subcutaneous tissue thickness assessed by ultrasonography, pain, functional status, and quality of life will be evaluated at baseline, after treatment, and at one-month follow-up.
Official title: Efficacy of Extracorporeal Shock Wave Therapy (ESWT) in Lower Extremity Lymphedema: A Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
36
Start Date
2026-06-22
Completion Date
2027-02-01
Last Updated
2026-06-04
Healthy Volunteers
No
Conditions
Interventions
Extracorporeal Shock Wave Therapy (ESWT)
Radial shock wave therapy will be applied using the EMS Swiss DolorClast® device. Each session will consist of 3,000 impulses delivered at 20 Hz and 2 bar using a 40 mm applicator, targeting fibrotic tissue regions and periinguinal and peripopliteal lymph node areas. ESWT will be administered twice weekly for five sessions
Sham Extracorporeal Shock Wave Therapy (Sham ESWT)
Sham ESWT will be applied with identical positioning and session duration as the active ESWT group. Only non-energized impulses will be delivered, ensuring participant blinding. Sham ESWT will be administered twice weekly for five sessions.
Locations (1)
Gazi University Hospital, Department of Physical Medicine and Rehabilitation, Ankara, 06560
Ankara, Yenimahalle, Turkey (Türkiye)