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

Last updated: September 19, 2023
Sponsor: Zheng-Yu Hoe, MD., PhD.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Lymphedema

Treatment

Pulse electromagnetic field therapy

Extracorporeal shock wave therapy

Rehabilitation

Clinical Study ID

NCT06041958
21-CT12-01(210917-1)
  • Ages 20-80
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants must be at least 20 years old and have no significant cognitive, languagecomprehension, 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 cancerare eligible (lymphedema is defined as a circumference difference of >2 cm in the samelocation on both limbs).
  • You must be able to attend follow-up appointments at specific times during the 12months of the trial, referred by a rehabilitation physician in the outpatientdepartment.

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 90
Treatment Group(s): 3
Primary Treatment: Pulse electromagnetic field therapy
Phase:
Study Start date:
October 08, 2021
Estimated Completion Date:
December 31, 2025

Study Description

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.

Connect with a study center

  • Kaohsiung Veterans General Hospital

    Kaohsiung, 81362
    Taiwan

    Active - Recruiting

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