Shock Wave Therapy for Lower Limb Lymphedema

July 30, 2025 updated by: Roser Belmonte, Parc de Salut Mar

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
      • Barcelona, Spain, 08003
        • Recruiting
        • Hospital del Mar
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Marina Alvarez, MD
        • Sub-Investigator:
          • Mercedes Piqueras, PT
        • Sub-Investigator:
          • Ana V Lobato, PT

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DLT + ESWT
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.
Device: Extracorporeal shock wave therapy by radial device
Patients will receive treatment by extracorporeal shock waves therapy (ESWT).
Other Names:
  • rESWT
  • Radial ESWT
Other: DLT
Patients will receive treatment with decongestive lymphatic therapy (DLT: manual lymphatic drainage, compression)
Other Names:
  • Decongestive Lymphatic Therapy
Sham Comparator: DLT + Sham ESWT
To DLT + Sham ESWT group, decongestive lymphatic therapy plus sham radial extracorporeal wave treatment will be applied, at a placebo dose and intensity.
Other: DLT
Patients will receive treatment with decongestive lymphatic therapy (DLT: manual lymphatic drainage, compression)
Other Names:
  • Decongestive Lymphatic Therapy
Device: Placebo extracorporeal shock wave therapy by radial device
Patients will receive treatment sham extracorporeal shock waves.
Other Names:
  • rESWT
  • Radial ESWT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Limb volume change 1
Time Frame: 5 weeks
The difference between limb volume previous of treatment and at the end of treatment
5 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Limb volume change 2
Time Frame: 9 weeks
The difference between limb volume from previous of treatment to 1 month after
9 weeks
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)
9 weeks
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)
9 weeks
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)
9 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Water composition
Time Frame: 9 weeks
Changes in water lower limb composition at previous treatment, to the end of treatment anto 1 month after.
9 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Parc de Salut Mar

Investigators

  • Principal Investigator: Roser Belmonte, MD, PhD, Hospital del Mar

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 28, 2024

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

May 28, 2024

First Submitted That Met QC Criteria

June 11, 2024

First Posted (Actual)

June 12, 2024

Study Record Updates

Last Update Posted (Actual)

July 31, 2025

Last Update Submitted That Met QC Criteria

July 30, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023/11201/I

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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