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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| General rehabilitation therapy | Active Comparator | Conducting a general rehabilitation program for lymphedema, three times a week, continuing until the end of the experiment. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Extracorporeal shock wave therapy | Device | 2 times/week for 12 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zheng Yu Hoe, MD.,PhD. | Contact | +886935517631 | jhoe@vghks.gov.tw |
| Name | Affiliation | Role |
|---|---|---|
| Zheng Yu Hoe, MD.,PhD. | Kaohsiung Veterans General Hospital. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaohsiung Veterans General Hospital | Recruiting | Kaohsiung City | 81362 | Taiwan |
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| ID | Term |
|---|---|
| D008209 | Lymphedema |
| ID | Term |
|---|---|
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D000074059 | Extracorporeal Shockwave Therapy |
| D012046 | Rehabilitation |
| ID | Term |
|---|---|
| D014464 | Ultrasonic Therapy |
| D003972 | Diathermy |
| D006979 | Hyperthermia, Induced |
| D013812 | Therapeutics |
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| Pulse electromagnetic field therapy |
| Device |
2 times/week for 12 weeks |
|
| Rehabilitation | Other | 2 times/week for 12 weeks |
|
| D026741 |
| Physical Therapy Modalities |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |