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

Status: Recruiting
Location: See location...
Intervention Type: Device, Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Maximum Age: 80
Healthy Volunteers: t
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• 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.

Locations
Other Locations
Taiwan
Kaohsiung Veterans General Hospital
RECRUITING
Kaohsiung City
Contact Information
Primary
Zheng Yu Hoe, MD.,PhD.
jhoe@vghks.gov.tw
+886935517631
Time Frame
Start Date: 2021-10-08
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 90
Treatments
Active_comparator: General rehabilitation therapy
Conducting a general rehabilitation program for lymphedema, three times a week, continuing until the end of the experiment.
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.
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.
Sponsors
Leads: Zheng-Yu Hoe, MD., PhD.

This content was sourced from clinicaltrials.gov