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RECRUITING Not applicable ClinicalTrials.gov

Extracorporeal Shock Wave Therapy in Lower Extremity Lymphedema

Sponsor: Gazi University • ClinicalTrials.gov ID: NCT07626645

Registry updated: 2026-09-15
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Description

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.

Interventions

  • Extracorporeal Shock Wave Therapy (ESWT) (Device)
    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) (Device)
    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.

Eligibility criteria

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

Conditions

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

Locations

  • Gazi University Hospital, Department of Physical Medicine and Rehabilitation, Ankara, 06560 — Ankara, Yenimahalle, Turkey (Türkiye)
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record