Extracorporeal Shock Wave Therapy in Lower Extremity Lymphedema
11 de setembro de 2026 atualizado 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.
Visão geral do estudo
Status
Recrutamento
Condições
Descrição detalhada
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 estudo
Intervencional
Inscrição (Estimado)
36
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Ayca Utkan Karasu, M.D
- Número de telefone: +903122025219 +905365759757
- E-mail: ayca_utkan@yahoo.com
Locais de estudo
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Yenimahalle
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Ankara, Yenimahalle, Turquia (Türkiye), 06560
- Recrutamento
- 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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Contato:
- Ayca Utkan Karasu, MD
- Número de telefone: +903122025219 +905365759757
- E-mail: ayca_utkan@yahoo.com
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Contato:
- Turkan Gokcelik, MD
- Número de telefone: +905078492343
- E-mail: turkancanturk@gmail.com
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Investigador principal:
- Turkan Gokcelik, MD
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Subinvestigador:
- Ilknur Onurlu, MD
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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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
Outros nomes:
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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.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in Lower Extremity Limb Volume
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in Lower Extremity Circumferential Measurements
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Publicações e links úteis
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Publicações Gerais
- 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.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
1 de setembro de 2026
Conclusão Primária (Estimado)
1 de fevereiro de 2027
Conclusão do estudo (Estimado)
1 de fevereiro de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
21 de maio de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
2 de junho de 2026
Primeira postagem (Real)
4 de junho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
15 de setembro de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
11 de setembro de 2026
Última verificação
1 de setembro de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- GUFTR-LELymphedemaESWT-2026
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