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

ConditionLymphedema
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-80
SponsorZheng-Yu Hoe, MD., PhD.

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Extracorporeal shock wave therapy

    Device

    2 times/week for 12 weeks

  • Pulse electromagnetic field therapy

    Device

    2 times/week for 12 weeks

  • Rehabilitation

    Other intervention

    2 times/week for 12 weeks

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: General rehabilitation therapyActive comparator 1 intervention
Group B: ESWT therapy groupExperimental treatment 1 intervention
Group C: PEMFT therapy groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

circumference

Limb circumference

Time frame
every 1 week, through study completion, an average of 1 year
2

Thickness

thickness of skin and Subcutaneous tissue

Time frame
every 1 week, through study completion, an average of 1 year
3

Hardness

Hardness by shearwave elastography

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zheng-Yu Hoe, MD., PhD.

Lead sponsor

Kaohsiung Veterans General Hospital.

Sponsor institution