Shock Wave Therapy for Lower Limb Lymphedema
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Extracorporeal shock wave therapy by radial device, Placebo extracorporeal shock wave therapy by radial device, DLT.
- Who it may be relevant to
- Registry conditions: Lymphedema, Lower Limb. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Lower Limb Lymphedema Treatment by Extracorporeal Shock Wave Therapy: Clinical Trial
Overview
This is a double-blind randomized clinical trial to compare the effect of shock wave therapy on lower limb lymphedema. There are two arms: A) complex decongestive therapy + extracorporeal shock waves therapy; B) complex decongestive therapy plus placebo extracorporeal shock waves.
Detailed description
This is a double blind, randomized, clinical trial. 30 patients with lower limb lymphedema will be randomized in 2 groups. One group will receive the habitual complex decongestive therapy (lymphatic manual drainage and compression) plus extracorporeal shock waves therapy. The other group will receive complex decongestive therapy (lymphatic manual drainage and compression) plus placebo extracorporeal shock waves.
Patients in the 2 groups will be instructed on skin care measures and kinesitherapy. The usual manual lymphatic drainage and compression will be applied to the 2 groups. The 2 groups will receive 10 treatment sessions, 2 weekly for 5 weeks.
Group complex decongestive therapy + shock waves. Patients will receive treatment with manual lymphatic drainage, compression, and shock waves.
Group complex decongestant therapy + placebo. Patients will receive treatment with manual lymphatic drainage, compression, and placebo shock waves.
Tolerance and possible adverse effects will be recorded by physiotherapist. Any adverse effect detected will be evaluated by the rehabilitation medical doctor.
Interventions
- Device Extracorporeal shock wave therapy by radial device
Patients will receive treatment by extracorporeal shock waves therapy (ESWT). - Device Placebo extracorporeal shock wave therapy by radial device
Patients will receive treatment sham extracorporeal shock waves. - Other DLT
Patients will receive treatment with decongestive lymphatic therapy (DLT: manual lymphatic drainage, compression)
Primary outcome measures
- Limb volume change 1 [Time frame: 5 weeks]
Secondary outcome measures (4)
- Limb volume change 2 [Time frame: 9 weeks]
- VAS Pain [Time frame: 9 weeks]
- VAS Heaviness [Time frame: 9 weeks]
- VAS Hardness [Time frame: 9 weeks]
Eligibility criteria
Inclusion criteria
- Patients with lower limb lymphedema
- Lymphedema of at least 6 months of evolution
- The lymphedema must affect at least the knee to the foot
- Moderate or severe lymphedema (grades 2 or 3)
- Sign the informed consent
Exclusion criteria
- Under 18 years of age
- Coagulation disorders (hemophilia, treatment with acenocoumarol, etc.)
- Current or previous deep vein thrombosis of the lower extremity
- Pregnancy
- Electronic implantable medical devices as pacemaker implants, medication pumps, etc
- Having received treatment with complex decongestive therapy or shock waves during the last 6 months
- Treatment with corticosteroids or radiotherapy in the area to be treated in the last 6 weeks
- Active oncological disease in the area to be treated
- Active infectious-inflammatory process in the area to be treated
- Cognitive or sensory deficits that prevent collaboration
- Inability to walk independently or inability to attend therapy
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Spain · 1 center
- Hospital del Mar — Barcelona
Publications
- Rankin J, Morris K, Reilly A. The All-Ireland Guidelines for the diagnosis, assessment and management of lymphoedema. Br J Community Nurs. 2022 Oct 1;27(Sup10):S22-S26. doi: 10.12968/bjcn.2022.27.Sup10.S22. PMID 36205409
- Bae H, Kim HJ. Clinical outcomes of extracorporeal shock wave therapy in patients with secondary lymphedema: a pilot study. Ann Rehabil Med. 2013 Apr;37(2):229-34. doi: 10.5535/arm.2013.37.2.229. Epub 2013 Apr 30. PMID 23705118
- 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
Identifiers
NCT: NCT06454734 · 2023/11201/I