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

NCT06041958 | Recruiting

• 1 other identifier: 21-CT12-01(210917-1)
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lymphedema

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (3)

General rehabilitation therapy

ACTIVE COMPARATOR

Conducting a general rehabilitation program for lymphedema, three times a week, continuing until the end of the experiment.

Other: Rehabilitation

ESWT therapy group

EXPERIMENTAL

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

PEMFT therapy group

EXPERIMENTAL

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

Interventions

Pulse electromagnetic field therapy DEVICE

2 times/week for 12 weeks

PEMFT therapy group

Rehabilitation OTHER

2 times/week for 12 weeks

General rehabilitation therapy

Extracorporeal shock wave therapy DEVICE

2 times/week for 12 weeks

ESWT therapy group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zheng-Yu Hoe, MD., PhD.: lead

Study Sites (1)

Kaohsiung Veterans General Hospital

Kaohsiung City, 81362, Taiwan

RECRUITING

MeSH Terms

Conditions

Lymphedema

Interventions

Extracorporeal Shockwave Therapy; Rehabilitation

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Aftercare; Continuity of Patient Care; Patient Care; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Zheng Yu Hoe, MD.,PhD.

  Kaohsiung Veterans General Hospital.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zheng Yu Hoe, MD.,PhD.

CONTACT

+886935517631; jhoe@vghks.gov.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 31, 2023
• First Posted: September 18, 2023
• Study Start: October 8, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 31, 2026

Record last verified: 2026-03

Locations

TW (1)