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NCT Number: NCT06041958

Effects of Extracorporeal Shock Wave Therapy and Pulse Electromagnetic Field Therapy on Lymphoedema

Lymphedema occurs not only in patients with breast cancer and gynecological cancers but also in those where lymphatic drainage is obstructed. Accumulation of lymphatic fluid within tissues results in limb swelling. Additionally, proteins present in lymphatic fluid might lead to fibrosis within tissues, causing various challenges for patients. The changes in volume and weight can significantly impact daily life activities such as eating, brushing teeth, and other routine tasks. Furthermore, it can lead to clothing difficulties and provoke unwanted attention due to aesthetic concerns.

Currently, there is no definitive treatment for lymphedema. However, prospective research has shown promising results in applying extracorporeal shock wave therapy (ESWT), originally used for musculoskeletal disorders like plantar fasciitis, tennis elbow, frozen shoulder, and non-union fractures, to lymphedema patients. Similarly, Pulse Electromagnetic Field Therapy (PEMFT), widely used for pain management and muscle strengthening, has the potential for treating lymphedema as it can enhance blood circulation and stimulate muscle contractions.

This research project aims to explore the effectiveness and sustainability of using ESWT and PEMFT for lymphedema patients. By applying these therapies to lymphedema patients, this study aims to evaluate their treatment outcomes and long-term effects.

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Key information

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaohsiung Veterans General Hospital

Kaohsiung City, 81362, Taiwan

Location status: Recruiting

Location contact

Zheng-Yu Hoe

CONTACT

[email protected]

+886975581721

Zheng-Yu Hoe

PRINCIPAL_INVESTIGATOR

About this study

There is currently no cure for lymphedema. Literature review revealed extracorporeal shock wave therapy (previously applied to soft tissue diseases such as plantar fasciitis, tennis elbow, frozen shoulders, and poor fracture healing) showed positive therapeutic effect for patients with lymphedema.

Another widely used therapy for pain treatment and muscle strengthening is Pulse Electromagnetic Field Therapy (PEMFT), which has the potential to be used in the treatment of lymphedema due to its ability to increase blood circulation and stimulate muscle contractions.

This study design to evaluate the effect of extracorporeal shock wave therapy on patients with lymphedema, and further explore its therapeutic effect.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Participants must be at least 20 years old and have no significant cognitive, language comprehension, or communication issues, be able to understand and follow instructions, and sign the informed consent form.
  • Individuals with lymphedema after treatment for breast cancer or gynecologic cancer are eligible (lymphedema is defined as a circumference difference of >2 cm in the same location on both limbs).
  • You must be able to attend follow-up appointments at specific times during the 12 months of the trial, referred by a rehabilitation physician in the outpatient department.

Exclusion criteria

  • The affected limb has unhealed open wounds, acute infections, or other conditions unsuitable for contact-based treatment.
  • The affected limb has metastatic tumors.
  • The affected limb has untreated deep vein thrombosis.
  • Severe clotting abnormalities.

Treatment and study plan

Extracorporeal Shock Wave Therapy

Device

2 times/week for 12 weeks

Pulse electromagnetic field therapy

Device

2 times/week for 12 weeks

rehabilitation

Other

2 times/week for 12 weeks

Primary outcomes

  1. circumference

    Time frame: every 1 week, through study completion, an average of 1 year

    Limb circumference

  2. Thickness

    Time frame: every 1 week, through study completion, an average of 1 year

    thickness of skin and Subcutaneous tissue

  3. Hardness

    Time frame: every 1 week, through study completion, an average of 1 year

    Hardness by shearwave elastography

Study contacts

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

Zheng Yu Hoe, MD.,PhD.

CONTACT

[email protected]

+886935517631

Sponsors and collaborators

Lead sponsor

Zheng-Yu Hoe, MD., PhD.

Other

Registry information

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Sep 18, 2023
Registry last updated
Mar 31, 2026

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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