Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2025-12-25 @ 9:57 PM
Study NCT ID:
NCT06041958
Status:
RECRUITING
Last Update Posted:
2025-09-03
First Post:
2023-08-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Extracorporeal Shock Wave Therapy and Pulse Electromagnetic Field Therapy on Lymphoedema
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008209', 'term': 'Lymphedema'}], 'ancestors': [{'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000074059', 'term': 'Extracorporeal Shockwave Therapy'}, {'id': 'D012046', 'term': 'Rehabilitation'}], 'ancestors': [{'id': 'D014464', 'term': 'Ultrasonic Therapy'}, {'id': 'D003972', 'term': 'Diathermy'}, {'id': 'D006979', 'term': 'Hyperthermia, Induced'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-10-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-26', 'studyFirstSubmitDate': '2023-08-31', 'studyFirstSubmitQcDate': '2023-09-11', 'lastUpdatePostDateStruct': {'date': '2025-09-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-09-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'circumference', 'timeFrame': 'every 1 week, through study completion, an average of 1 year', 'description': 'Limb circumference'}, {'measure': 'Thickness', 'timeFrame': 'every 1 week, through study completion, an average of 1 year', 'description': 'thickness of skin and Subcutaneous tissue'}, {'measure': 'Hardness', 'timeFrame': 'every 1 week, through study completion, an average of 1 year', 'description': 'Hardness by shearwave elastography'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lymphedema']}, 'descriptionModule': {'briefSummary': '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.\n\nCurrently, 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.\n\nThis 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.', 'detailedDescription': '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.\n\nAnother 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.\n\nThis study design to evaluate the effect of extracorporeal shock wave therapy on patients with lymphedema, and further explore its therapeutic effect.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n* 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).\n* 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.\n\nExclusion Criteria:\n\n* The affected limb has unhealed open wounds, acute infections, or other conditions unsuitable for contact-based treatment.\n* The affected limb has metastatic tumors.\n* The affected limb has untreated deep vein thrombosis.\n* Severe clotting abnormalities.'}, 'identificationModule': {'nctId': 'NCT06041958', 'briefTitle': 'Effects of Extracorporeal Shock Wave Therapy and Pulse Electromagnetic Field Therapy on Lymphoedema', 'organization': {'class': 'OTHER', 'fullName': 'Kaohsiung Veterans General Hospital.'}, 'officialTitle': 'Effects of Extracorporeal Shock Wave Therapy and Pulse Electromagnetic Field Therapy on Lymphoedema', 'orgStudyIdInfo': {'id': '21-CT12-01(210917-1)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'General rehabilitation therapy', 'description': 'Conducting a general rehabilitation program for lymphedema, three times a week, continuing until the end of the experiment.', 'interventionNames': ['Other: Rehabilitation']}, {'type': 'EXPERIMENTAL', 'label': 'ESWT therapy group', '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.', 'interventionNames': ['Device: Extracorporeal shock wave therapy']}, {'type': 'EXPERIMENTAL', 'label': 'PEMFT therapy group', '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.', 'interventionNames': ['Device: Pulse electromagnetic field therapy']}], 'interventions': [{'name': 'Extracorporeal shock wave therapy', 'type': 'DEVICE', 'description': '2 times/week for 12 weeks', 'armGroupLabels': ['ESWT therapy group']}, {'name': 'Pulse electromagnetic field therapy', 'type': 'DEVICE', 'description': '2 times/week for 12 weeks', 'armGroupLabels': ['PEMFT therapy group']}, {'name': 'Rehabilitation', 'type': 'OTHER', 'description': '2 times/week for 12 weeks', 'armGroupLabels': ['General rehabilitation therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '81362', 'city': 'Kaohsiung City', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Zheng-Yu Hoe', 'role': 'CONTACT', 'email': 'jhoe@vghks.gov.tw', 'phone': '+886975581721'}, {'name': 'Zheng-Yu Hoe', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kaohsiung Veterans General Hospital', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}], 'centralContacts': [{'name': 'Zheng Yu Hoe, MD.,PhD.', 'role': 'CONTACT', 'email': 'jhoe@vghks.gov.tw', 'phone': '+886935517631'}], 'overallOfficials': [{'name': 'Zheng Yu Hoe, MD.,PhD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kaohsiung Veterans General Hospital.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zheng-Yu Hoe, MD., PhD.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Zheng-Yu Hoe, MD., PhD.', 'investigatorAffiliation': 'Kaohsiung Veterans General Hospital.'}}}}