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Extracorporeal Shock Wave Therapy in Lower Extremity Lymphedema

NCT07626645 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2026-06-04

No results posted yet for this study

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.

Conditions

  • Lymphedema, Lower Limb
  • Extracorporeal Shock Wave Therapy
  • Edema Leg
  • Sham-controlled
  • Placebo Control Design

Interventions

DEVICE

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

DEVICE

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.

Sponsors & Collaborators

  • Gazi University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-22
Primary Completion
2027-02-01
Completion
2027-02-01

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07626645 on ClinicalTrials.gov