Extracorporeal Shock Wave Therapy in Lower Extremity Lymphedema

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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
• Устройство 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.

Первичные конечные точки

• Change in Lower Extremity Limb Volume [Срок оценки: Baseline, immediately after treatment (week 3), and 1-month follow-up]

Вторичные конечные точки (5)

• Change in Lower Extremity Circumferential Measurements [Срок оценки: Baseline, immediately after treatment (week 3) and 1-month follow-up]
• Change in Skin and Subcutaneous Tissue Thickness Assessed by Ultrasonography [Срок оценки: Baseline, immediately after treatment (week 3), and 1-month follow-up]
• Change in Lymphedema-Specific Quality of Life (LYMQOL-Leg) [Срок оценки: Baseline, immediately after treatment (week 3), and 1-month follow-up]
• Change in Lower Extremity Functional Status (LEFS) [Срок оценки: Baseline, immediately after treatment (week 3), and 1-month follow-up]
• Change in Pain Intensity Measured by Visual Analogue Scale (VAS) [Срок оценки: Baseline, immediately after treatment (week 3), and 1-month follow-up]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Turkey (Türkiye) · 1 центр

• Gazi University Hospital, Department of Physical Medicine and Rehabilitation, Ankara, 0656 — Ankara

Публикации

• Cebicci MA, Sutbeyaz ST, Goksu SS, Hocaoglu S, Oguz A, Atilabey A. Extracorporeal Shock Wave Therapy for Breast Cancer-Related Lymphedema: A Pilot Study. Arch Phys Med Rehabil. 2016 Sep;97(9):1520-1525. doi: 10.1016/j.apmr.2016.02.019. Epub 2016 Mar 15. PMID 26987620
• Zhou JP, Lin YY, Zhu MF, Situ XX, Wang J. [Clinical effects of extracorporeal shock wave combined with complex decongestive therapy in the treatment of lower limb lymphedema after cervical cancer surgery]. Zhonghua Shao Shang Yu Chuang Mian Xiu Fu Za Zhi. 2025 Jun 20;41(6):543-551. doi: 10.3760/cma.j.cn501225-20250205-00051. Chinese. PMID 40588402
• Tsai YL, I TJ, Chuang YC, Cheng YY, Lee YC. Extracorporeal Shock Wave Therapy Combined with Complex Decongestive Therapy in Patients with Breast Cancer-Related Lymphedema: A Systemic Review and Meta-Analysis. J Clin Med. 2021 Dec 19;10(24):5970. doi: 10.3390/jcm10245970. PMID 34945266
• Lee KW, Kim SB, Lee JH, Kim YS. Effects of Extracorporeal Shockwave Therapy on Improvements in Lymphedema, Quality of Life, and Fibrous Tissue in Breast Cancer-Related Lymphedema. Ann Rehabil Med. 2020 Oct;44(5):386-392. doi: 10.5535/arm.19213. Epub 2020 Sep 28. PMID 32986941

Идентификаторы

NCT: NCT07626645 · GUFTR-LELymphedemaESWT-2026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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