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

Primary Purpose

Lymphedema

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Extracorporeal shock wave therapy
Pulse electromagnetic field therapy
Rehabilitation
Sponsored by
Zheng-Yu Hoe, MD., PhD.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphedema

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Kaohsiung Veterans General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

General rehabilitation therapy

ESWT therapy group

PEMFT therapy group

Arm Description

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

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.

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.

Outcomes

Primary Outcome Measures

circumference
Limb circumference
Thickness
thickness of skin and Subcutaneous tissue
Hardness
Hardness by shearwave elastography

Secondary Outcome Measures

Full Information

First Posted
August 31, 2023
Last Updated
September 19, 2023
Sponsor
Zheng-Yu Hoe, MD., PhD.
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1. Study Identification

Unique Protocol Identification Number
NCT06041958
Brief Title
Effects of Extracorporeal Shock Wave Therapy and Pulse Electromagnetic Field Therapy on Lymphoedema
Official Title
Effects of Extracorporeal Shock Wave Therapy and Pulse Electromagnetic Field Therapy on Lymphoedema
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 8, 2021 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Zheng-Yu Hoe, MD., PhD.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphedema

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
General rehabilitation therapy
Arm Type
Active Comparator
Arm Description
Conducting a general rehabilitation program for lymphedema, three times a week, continuing until the end of the experiment.
Arm Title
ESWT therapy group
Arm Type
Experimental
Arm Description
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.
Arm Title
PEMFT therapy group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Extracorporeal shock wave therapy
Intervention Description
2 times/week for 12 weeks
Intervention Type
Device
Intervention Name(s)
Pulse electromagnetic field therapy
Intervention Description
2 times/week for 12 weeks
Intervention Type
Other
Intervention Name(s)
Rehabilitation
Intervention Description
2 times/week for 12 weeks
Primary Outcome Measure Information:
Title
circumference
Description
Limb circumference
Time Frame
every 1 week, through study completion, an average of 1 year
Title
Thickness
Description
thickness of skin and Subcutaneous tissue
Time Frame
every 1 week, through study completion, an average of 1 year
Title
Hardness
Description
Hardness by shearwave elastography
Time Frame
every 1 week, through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zheng Yu Hoe, MD.,PhD.
Phone
+886935517631
Email
jhoe@vghks.gov.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zheng Yu Hoe, MD.,PhD.
Organizational Affiliation
Kaohsiung Veterans General Hospital.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaohsiung Veterans General Hospital
City
Kaohsiung
ZIP/Postal Code
81362
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zheng-Yu Hoe
Phone
+886975581721
Email
jhoe@vghks.gov.tw
First Name & Middle Initial & Last Name & Degree
Zheng-Yu Hoe

12. IPD Sharing Statement

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

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