RecruitingNot ApplicableNCT06454734

Shock Wave Therapy for Lower Limb Lymphedema

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


Sponsor

Parc de Salut Mar

Enrollment

30 participants

Start Date

May 28, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • 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 Criteria11

  • 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

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Interventions

DEVICEExtracorporeal shock wave therapy by radial device

Patients will receive treatment by extracorporeal shock waves therapy (ESWT).

DEVICEPlacebo extracorporeal shock wave therapy by radial device

Patients will receive treatment sham extracorporeal shock waves.

OTHERDLT

Patients will receive treatment with decongestive lymphatic therapy (DLT: manual lymphatic drainage, compression)


Locations(1)

Hospital del Mar

Barcelona, Spain

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NCT06454734


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