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RecruitingNCT06041958Updated Mar 31, 2026

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

An interventional study of Extracorporeal shock wave therapy and Pulse electromagnetic field therapy in Lymphedema, sponsored by Zheng-Yu Hoe, MD., PhD.. Recruiting at 1 site in Taiwan. Open to participants aged 20 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-31.

Sponsored by Zheng-Yu Hoe, MD., PhD. · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 10 months after the study started (first participant enrolled Oct 2021, registered Aug 2023).
  • Started Oct 2021; still recruiting 5 years 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
20 Years to 80 Years
Sex
All
01

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.

Read the 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.

02

Conditions studied

  • Lymphedema

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03

In context

Lymphedema

529 studies on the registry are indexed under Lymphedema; 131 are open to participants now.

This study's planned enrollment of 90 is above the median of 50 across 369 interventional studies indexed under Lymphedema.

Browse Lymphedema studies →

Lead sponsor

This is the only study on the registry with Zheng-Yu Hoe, MD., PhD. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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

Exclusion Criteria:

  • The affected limb has unhealed open wounds, acute infections, or other conditions unsuitable for contact-based treatment.
  • The affected limb has tumors.
  • The affected limb has untreated deep vein thrombosis.
  • Severe clotting abnormalities.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
90 participants (estimated)

Study arms

  • 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

  • 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

  • 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

Interventions

  • DeviceExtracorporeal shock wave therapy

    2 times/week for 12 weeks

  • DevicePulse electromagnetic field therapy

    2 times/week for 12 weeks

  • OtherRehabilitation

    2 times/week for 12 weeks

06

What researchers measure

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

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 31, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06041958
Lead sponsor
Zheng-Yu Hoe, MD., PhD.
Responsible party
Zheng-Yu Hoe, MD., PhD. (Principal Investigator, Kaohsiung Veterans General Hospital.) — Sponsor-investigator
First posted
Sep 18, 2023
Start date
Oct 8, 2021
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Mar 31, 2026

Study contacts

Zheng Yu Hoe, MD.,PhD.
Contact
jhoe@vghks.gov.tw
+886935517631
Zheng Yu Hoe, MD.,PhD.
principal investigator · Kaohsiung Veterans General Hospital.

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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