RecruitingNot ApplicableNCT07626645

Extracorporeal Shock Wave Therapy in Lower Extremity Lymphedema

Efficacy of Extracorporeal Shock Wave Therapy (ESWT) in Lower Extremity Lymphedema: A Randomized Controlled Trial


Sponsor

Gazi University

Enrollment

36 participants

Start Date

Sep 1, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Extracorporeal Shock Wave Therapy (ESWT) and a medical device called Sham Extracorporeal Shock Wave Therapy (Sham ESWT) for people with edema leg, extracorporeal shock wave therapy, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 80 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEExtracorporeal 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

DEVICESham 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)

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NCT07626645


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