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.

Study Overview

• Status: Recruiting
• Conditions: Lymphedema
• Intervention / Treatment: Other: Rehabilitation; Device: Extracorporeal shock wave therapy; Device: Pulse electromagnetic field therapy

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zheng Yu Hoe, MD.,PhD.; Phone Number: +886935517631; Email: jhoe@vghks.gov.tw

Study Locations

• Taiwan
  • Kaohsiung City, Taiwan, 81362
    • Recruiting
    • Kaohsiung Veterans General Hospital
    • Contact: Zheng-Yu Hoe; Phone Number: +886975581721; Email: jhoe@vghks.gov.tw
    • Principal Investigator: Zheng-Yu Hoe

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: General rehabilitation therapy; Conducting a general rehabilitation program for lymphedema, three times a week, continuing until the end of the experiment.	Other: Rehabilitation; 2 times/week for 12 weeks
Experimental: ESWT therapy group; Participants are randomly assigned to receive either shockwave therapy or electromagnetic pulse therapy. Once assigned, the treatment method is fixed and continues for 12 weeks. From week 1 to week 12, participants receive either extracorporeal shockwave therapy or electromagnetic pulse therapy three times a week, totaling 36 sessions. After the completion of the 12-week treatment, the general rehabilitation program for lymphedema continues, conducted three times a week.	Device: Extracorporeal shock wave therapy; 2 times/week for 12 weeks
Experimental: PEMFT therapy group; Participants are randomly assigned to receive either shockwave therapy or electromagnetic pulse therapy. Once assigned, the treatment method is fixed and continues for 12 weeks. From week 1 to week 12, participants receive either extracorporeal shockwave therapy or electromagnetic pulse therapy three times a week, totaling 36 sessions. After the completion of the 12-week treatment, the general rehabilitation program for lymphedema continues, conducted three times a week.	Device: Pulse electromagnetic field therapy; 2 times/week for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
circumference	Limb circumference	every 1 week, through study completion, an average of 1 year
Thickness	thickness of skin and Subcutaneous tissue	every 1 week, through study completion, an average of 1 year
Hardness	Hardness by shearwave elastography	every 1 week, through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Zheng-Yu Hoe, MD., PhD.
• Investigators: Principal Investigator: Zheng Yu Hoe, MD.,PhD., Kaohsiung Veterans General Hospital.

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: August 31, 2023
• First Submitted That Met QC Criteria: September 11, 2023
• First Posted (Actual): September 18, 2023

Study Record Updates

• Last Update Posted (Actual): March 31, 2026
• Last Update Submitted That Met QC Criteria: March 26, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lymphatic Diseases; Hemic and Lymphatic Diseases; Lymphedema; Therapeutics; Physical Therapy Modalities; Patient Care; Health Services; Health Care Facilities Workforce and Services; Aftercare; Continuity of Patient Care; Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Rehabilitation; Extracorporeal Shockwave Therapy
• Other Study ID Numbers: 21-CT12-01(210917-1)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No