Extracorporeal Shock Wave Therapy in Lower Extremity Lymphedema
11 de septiembre de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
36
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Ayca Utkan Karasu, M.D
- Número de teléfono: +903122025219 +905365759757
- Correo electrónico: ayca_utkan@yahoo.com
Ubicaciones de estudio
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Yenimahalle
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Ankara, Yenimahalle, Turquía (Türkiye), 06560
- Reclutamiento
- Gazi University Hospital, Department of Physical Medicine and Rehabilitation, Ankara, 06560
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Investigador principal:
- Ayca Utkan Karasu, MD
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Contacto:
- Ayca Utkan Karasu, MD
- Número de teléfono: +903122025219 +905365759757
- Correo electrónico: ayca_utkan@yahoo.com
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Contacto:
- Turkan Gokcelik, MD
- Número de teléfono: +905078492343
- Correo electrónico: turkancanturk@gmail.com
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Investigador principal:
- Turkan Gokcelik, MD
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Sub-Investigador:
- Ilknur Onurlu, MD
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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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.
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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
Otros nombres:
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Comparador falso: 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.
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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.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Lower Extremity Limb Volume
Periodo de tiempo: Baseline, immediately after treatment (week 3), and 1-month follow-up
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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.
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Baseline, immediately after treatment (week 3), and 1-month follow-up
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Lower Extremity Circumferential Measurements
Periodo de tiempo: Baseline, immediately after treatment (week 3) and 1-month follow-up
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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.
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Baseline, immediately after treatment (week 3) and 1-month follow-up
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Change in Skin and Subcutaneous Tissue Thickness Assessed by Ultrasonography
Periodo de tiempo: Baseline, immediately after treatment (week 3), and 1-month follow-up
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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.
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Baseline, immediately after treatment (week 3), and 1-month follow-up
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Change in Lymphedema-Specific Quality of Life (LYMQOL-Leg)
Periodo de tiempo: Baseline, immediately after treatment (week 3), and 1-month follow-up
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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.
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Baseline, immediately after treatment (week 3), and 1-month follow-up
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Change in Lower Extremity Functional Status (LEFS)
Periodo de tiempo: Baseline, immediately after treatment (week 3), and 1-month follow-up
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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.
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Baseline, immediately after treatment (week 3), and 1-month follow-up
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Change in Pain Intensity Measured by Visual Analogue Scale (VAS)
Periodo de tiempo: Baseline, immediately after treatment (week 3), and 1-month follow-up
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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.
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Baseline, immediately after treatment (week 3), and 1-month follow-up
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
- 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.
- 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.
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de septiembre de 2026
Finalización primaria (Estimado)
1 de febrero de 2027
Finalización del estudio (Estimado)
1 de febrero de 2027
Fechas de registro del estudio
Enviado por primera vez
21 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
2 de junio de 2026
Publicado por primera vez (Actual)
4 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
15 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
11 de septiembre de 2026
Última verificación
1 de septiembre de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- GUFTR-LELymphedemaESWT-2026
Plan de datos de participantes individuales (IPD)
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INDECISO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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