Extracorporeal Shock Wave Therapy in Lower Extremity Lymphedema

June 2, 2026 updated by: Ayça Utkan Karasu, Gazi University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Ayca Utkan Karasu, M.D
  • Phone Number: +903122025219 +905365759757
  • Email: ayca_utkan@yahoo.com

Study Locations

  • Turkey (Türkiye)
    • Yenimahalle
      • Ankara, Yenimahalle, Turkey (Türkiye), 06560
        • Gazi University Hospital, Department of Physical Medicine and Rehabilitation, Ankara, 06560
        • Principal Investigator:
          • Ayca Utkan Karasu, MD
        • Contact:
        • Contact:
        • Principal Investigator:
          • Turkan Gokcelik, MD
        • Sub-Investigator:
          • Ilknur Onurlu, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults aged 18 to 80 years
  • Clinical diagnosis of lower extremity lymphedema established at least 6 months prior to enrollment
  • Completion of at least one cycle of CDT Phase 1 (intensive decongestive phase) within the preceding six months
  • Currently in CDT Phase 2 (maintenance phase) with active use of compression garments
  • Ability and willingness to provide written informed consent

Exclusion Criteria:

  • Active chemotherapy or radiotherapy
  • Active infection
  • Lower extremity vascular diseases including deep vein thrombosis or arterial insufficiency
  • Presence of a cardiac pacemaker
  • Pregnancy
  • Bleeding disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ESWT + CDT Maintenance
Participants in this group receive active Extracorporeal Shock Wave Therapy (ESWT) applied to fibrotic tissue regions of the affected lower extremity and periinguinal and peripopliteal lymph node areas, in addition to standard CDT maintenance therapy. ESWT will be administered twice weekly for a total of five sessions.
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
Other Names:
  • ESWT
  • Extracorporeal Shock Wave Therapy
Sham Comparator: Sham ESWT + CDT Maintenance
Participants in this group receive sham ESWT applied to the same anatomical regions using identical device positioning and application procedures, but with only non-energized impulses delivered. Standard CDT maintenance therapy will be continued throughout the study.
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.
Other Names:
  • Sham Extracorporeal Shock Wave Therapy
  • Sham ESWT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Lower Extremity Limb Volume
Time Frame: Baseline, immediately after treatment (week 3), and 1-month follow-up
Change in lower extremity limb volume calculated using the truncated cone formula. Volume will be estimated from circumferential measurements taken at 4 cm intervals from approximately 2 cm proximal to the medial malleolus to the inguinal region, with the patient in the supine position.
Baseline, immediately after treatment (week 3), and 1-month follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Lower Extremity Circumferential Measurements
Time Frame: Baseline, immediately after treatment (week 3) and 1-month follow-up
Change in lower extremity circumferential measurements taken at 4 cm intervals from approximately 2 cm proximal to the medial malleolus to the inguinal region, with the patient in the supine position using a non-elastic tape measure. The difference between baseline and post-treatment values will be compared between groups.
Baseline, immediately after treatment (week 3) and 1-month follow-up
Change in Skin and Subcutaneous Tissue Thickness Assessed by Ultrasonography
Time Frame: Baseline, immediately after treatment (week 3), and 1-month follow-up
Change in skin and subcutaneous tissue thickness measured by B-mode linear ultrasonography at standardized anatomical sites on the affected lower extremity. Three measurements will be obtained at each site and averaged.
Baseline, immediately after treatment (week 3), and 1-month follow-up
Change in Lymphedema-Specific Quality of Life (LYMQOL-Leg)
Time Frame: Baseline, immediately after treatment (week 3), and 1-month follow-up
Lymphedema-specific quality of life will be assessed using the LYMQOL-Leg questionnaire, a patient-reported outcome measure consisting of 22 items evaluating function, body image, symptoms, and emotional well-being. Each item is scored from 1 to 4, and an overall quality of life score is rated separately on a scale from 0 to 10, with higher scores indicating better quality of life.
Baseline, immediately after treatment (week 3), and 1-month follow-up
Change in Lower Extremity Functional Status (LEFS)
Time Frame: Baseline, immediately after treatment (week 3), and 1-month follow-up
Lower extremity functional status will be assessed using the Lower Extremity Functional Scale (LEFS). The LEFS consists of 20 items, each scored from 0 to 4, yielding a total score ranging from 0 (extreme difficulty or inability to perform all activities) to 80 (no difficulty), with higher scores indicating better functional status.
Baseline, immediately after treatment (week 3), and 1-month follow-up
Change in Pain Intensity Measured by Visual Analogue Scale (VAS)
Time Frame: Baseline, immediately after treatment (week 3), and 1-month follow-up
Pain intensity will be assessed using a 10 cm Visual Analogue Scale (VAS). Scores range from 0 (no pain) to 10 (worst imaginable pain), with lower scores indicating less pain.
Baseline, immediately after treatment (week 3), and 1-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gazi University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 22, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

May 21, 2026

First Submitted That Met QC Criteria

June 2, 2026

First Posted (Actual)

June 4, 2026

Study Record Updates

Last Update Posted (Actual)

June 4, 2026

Last Update Submitted That Met QC Criteria

June 2, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GUFTR-LELymphedemaESWT-2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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