An interventional study of Extracorporeal Shock Wave Therapy (ESWT) and Sham Extracorporeal Shock Wave Therapy (Sham ESWT) in Lymphedema, Lower Limb, Extracorporeal Shock Wave Therapy and Edema Leg, sponsored by Gazi University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by Gazi University · Not applicable, Interventional, and Treatment
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.
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.
529 studies on the registry are indexed under Lymphedema; 131 are open to participants now.
This study's planned enrollment of 36 is below the median of 50 across 369 interventional studies indexed under Lymphedema.
Browse Lymphedema studies →Gazi University is the lead sponsor of 551 studies on the registry; 102 are open to participants now.
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Exclusion Criteria:
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
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)
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
Also known as: Extracorporeal Shock Wave Therapy, 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.
Also known as: Sham Extracorporeal Shock Wave Therapy, Sham ESWT
Change in Lower Extremity Limb Volume
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.
Time frame: Baseline, immediately after treatment (week 3), and 1-month follow-up
Change in Lower Extremity Circumferential Measurements
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.
Time frame: Baseline, immediately after treatment (week 3) and 1-month follow-up
Change in Skin and Subcutaneous Tissue Thickness Assessed by Ultrasonography
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.
Time frame: Baseline, immediately after treatment (week 3), and 1-month follow-up
Change in Lymphedema-Specific Quality of Life (LYMQOL-Leg)
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.
Time frame: Baseline, immediately after treatment (week 3), and 1-month follow-up
Change in Lower Extremity Functional Status (LEFS)
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.
Time frame: Baseline, immediately after treatment (week 3), and 1-month follow-up
Change in Pain Intensity Measured by Visual Analogue Scale (VAS)
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.
Time frame: Baseline, immediately after treatment (week 3), and 1-month follow-up
Plan to share: Undecided
Started Sep 2026 (actual). Primary completion is estimated for Feb 2027, 5 months after the start.
Of 175 non-industry interventional studies with no phase under Lymphedema, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 68. This study's planned 5 months is below that.
Counting every sponsor, half of 197 studies reached it within 25 months; a quarter within 9 and three quarters within 64.
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