Shock Wave Therapy for Lower Limb Lymphedema

Parc de Salut Mar

Status: Enrolling

Conditions: Lymphedema, Lower Limb

Treatments: Device: Placebo extracorporeal shock wave therapy by radial device; Device: Extracorporeal shock wave therapy by radial device; Other: DLT

Study type: Interventional

Funder types: Other

Identifiers

NCT06454734

2023/11201/I

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 2 patient groups

DLT + ESWT

Experimental group

Description:

To DLT + ESWT group, decongestive lymphatic therapy (DLT) plus radial extracorporeal wave treatment (ESWT) will be applied, at a dose and intensity probed to be useful to diminish volume in upper limb lymphedema.

Treatment:

Other: DLT

Device: Extracorporeal shock wave therapy by radial device

DLT + Sham ESWT

Sham Comparator group

Description:

To DLT + Sham ESWT group, decongestive lymphatic therapy plus sham radial extracorporeal wave treatment will be applied, at a placebo dose and intensity.

Treatment:

Other: DLT

Device: Placebo extracorporeal shock wave therapy by radial device