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

Lymphedema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06041958
• Other study ID #: 21-CT12-01(210917-1)
• Status: Recruiting
• Phase: N/A
• Start date: October 8, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: September 2023
• Source: Kaohsiung Veterans General Hospital.
• Contact: Zheng Yu Hoe, MD.,PhD.
• Phone: +886935517631
• Email: jhoe[@]vghks.gov.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lymphedema

Intervention

Device:
• Extracorporeal shock wave therapy
2 times/week for 12 weeks
• Pulse electromagnetic field therapy
2 times/week for 12 weeks

Other:
• Rehabilitation
2 times/week for 12 weeks

Locations

Country	Name	City	State
Taiwan	Kaohsiung Veterans General Hospital	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Zheng-Yu Hoe, MD., PhD.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	circumference	Limb circumference	every 1 week, through study completion, an average of 1 year
Primary	Thickness	thickness of skin and Subcutaneous tissue	every 1 week, through study completion, an average of 1 year
Primary	Hardness	Hardness by shearwave elastography	every 1 week, through study completion, an average of 1 year