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NCT Number: NCT06454734

Shock Wave Therapy for Lower Limb Lymphedema

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital del Mar

Barcelona, 08003, Spain

Location status: Recruiting

Location contact

Ana V Lobato, PT

SUB_INVESTIGATOR

Esther Duarte, PhD

CONTACT

[email protected]

933674214

Marina Alvarez, MD

SUB_INVESTIGATOR

Mercedes Piqueras, PT

SUB_INVESTIGATOR

Roser Belmonte, PhD

CONTACT

[email protected]

933674214

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Extracorporeal shock wave therapy by radial device

Device

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

Other names: Radial ESWT, rESWT

Placebo extracorporeal shock wave therapy by radial device

Device

Patients will receive treatment sham extracorporeal shock waves.

Other names: Radial ESWT, rESWT

DLT

Other

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

Other names: Decongestive Lymphatic Therapy

Primary outcomes

  1. Limb volume change 1

    Time frame: 5 weeks

    The difference between limb volume previous of treatment and at the end of treatment

Secondary outcomes

  1. Limb volume change 2

    Time frame: 9 weeks

    The difference between limb volume from previous of treatment to 1 month after

  2. VAS Pain

    Time frame: 9 weeks

    Changes in pain at previous treatment, at the end of treatment and to 1 month after. Measured by a visual analogue scale (VAS) (from 0 not pain to 10 maximum imaginable)

  3. VAS Heaviness

    Time frame: 9 weeks

    Changes in heaviness from previous treatment, to the end of treatment and to 1 month after. Measured by a visual analogue scale (VAS) (from 0 not heaviness to 10 maximum imaginable)

  4. VAS Hardness

    Time frame: 9 weeks

    Changes in hardness from previous treatment, to the end of treatment and to 1 month after. Measured by a visual analogue scale (VAS) (from 0 not hardness to 10 maximum imaginable)

Other outcomes

  1. Water composition

    Time frame: 9 weeks

    Changes in water lower limb composition at previous treatment, to the end of treatment anto 1 month after.

Study contacts

Contact information is provided by the study sponsor or research team.

Esther Duarte, MD, PhD

CONTACT

[email protected]

+34 933674214

Roser Belmonte, MD, PhD

CONTACT

[email protected]

+34 933674214

Sponsors and collaborators

Lead sponsor

Parc de Salut Mar

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 12, 2024
Registry last updated
Jul 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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