NCT06454734

Shock Wave Therapy for Lower Limb Lymphedema

Lower Limb Lymphedema Treatment by Extracorporeal Shock Wave Therapy: Clinical Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Parc de Salut Mar · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Lymphedema, Lower Limb

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2024-05-28
• Primary completion: 2026-07-01
• Completion: 2026-12-01
• First posted: 2024-06-12
• Last updated: 2025-07-31

Locations

1 site across 1 country: Spain