Shock Wave Therapy for Lower Limb Lymphedema

NCT06454734 | Recruiting

• 1 other identifier: 2023/11201/I
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lymphedema, Lower Limb

Outcome Measures

Primary Outcomes (1)

• Limb volume change 1

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

  5 weeks

Secondary Outcomes (4)

• Limb volume change 2

  9 weeks

• VAS Pain

  9 weeks

• VAS Heaviness

  9 weeks

• VAS Hardness

  9 weeks

Other Outcomes (1)

• Water composition

  9 weeks

Study Arms (2)

DLT + ESWT

EXPERIMENTAL

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; Other: DLT

DLT + Sham ESWT

SHAM COMPARATOR

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

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

Interventions

Extracorporeal shock wave therapy by radial device DEVICE

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

Also known as: Radial ESWT, rESWT

DLT + ESWT

Placebo extracorporeal shock wave therapy by radial device DEVICE

Patients will receive treatment sham extracorporeal shock waves.

Also known as: Radial ESWT, rESWT

DLT + Sham ESWT

DLT OTHER

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

Also known as: Decongestive Lymphatic Therapy

DLT + ESWT; DLT + Sham ESWT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Parc de Salut Mar: lead

Study Sites (1)

Hospital del Mar

Barcelona, 08003, Spain

RECRUITING

Related Publications (4)

• Rankin J, Morris K, Reilly A. The All-Ireland Guidelines for the diagnosis, assessment and management of lymphoedema. Br J Community Nurs. 2022 Oct 1;27(Sup10):S22-S26. doi: 10.12968/bjcn.2022.27.Sup10.S22.

  PMID: 36205409 BACKGROUND

• Bae H, Kim HJ. Clinical outcomes of extracorporeal shock wave therapy in patients with secondary lymphedema: a pilot study. Ann Rehabil Med. 2013 Apr;37(2):229-34. doi: 10.5535/arm.2013.37.2.229. Epub 2013 Apr 30.

  PMID: 23705118 BACKGROUND

• Tsai YL, I TJ, Chuang YC, Cheng YY, Lee YC. Extracorporeal Shock Wave Therapy Combined with Complex Decongestive Therapy in Patients with Breast Cancer-Related Lymphedema: A Systemic Review and Meta-Analysis. J Clin Med. 2021 Dec 19;10(24):5970. doi: 10.3390/jcm10245970.

  PMID: 34945266 BACKGROUND

• Lee KW, Kim SB, Lee JH, Kim YS. Effects of Extracorporeal Shockwave Therapy on Improvements in Lymphedema, Quality of Life, and Fibrous Tissue in Breast Cancer-Related Lymphedema. Ann Rehabil Med. 2020 Oct;44(5):386-392. doi: 10.5535/arm.19213. Epub 2020 Sep 28.

  PMID: 32986941 BACKGROUND

MeSH Terms

Conditions

Lymphedema

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Roser Belmonte, MD, PhD

  Hospital del Mar

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roser Belmonte, MD, PhD

CONTACT

+34 933674214; rbelmonte@psmar.cat

Esther Duarte, MD, PhD

CONTACT

+34 933674214; eduarte@psmar.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Patients, outcome assessors and investigators will not know if received treatment was placebo or therapeutic. The physiotherapist will apply the treatment according to a list of random numbers generated to make 2 treatment groups
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Rehabilitation specialist, MD, PhD

Model Details: Double blind randomized clinical trial

Study Record Dates

• First Submitted: May 28, 2024
• First Posted: June 12, 2024
• Study Start: May 28, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)