Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-26 @ 5:50 PM
Study NCT ID:
NCT06454734
Status:
RECRUITING
Last Update Posted:
2025-07-31
First Post:
2024-05-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Shock Wave Therapy for Lower Limb Lymphedema
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Patients, outcome assessors and investigators will not know if received treatment was placebo or therapeutic. The physiotherapist will apply the treatment according to a list of random numbers generated to make 2 treatment groups'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Double blind randomized clinical trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-30', 'studyFirstSubmitDate': '2024-05-28', 'studyFirstSubmitQcDate': '2024-06-11', 'lastUpdatePostDateStruct': {'date': '2025-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Water composition', 'timeFrame': '9 weeks', 'description': 'Changes in water lower limb composition at previous treatment, to the end of treatment anto 1 month after.'}], 'primaryOutcomes': [{'measure': 'Limb volume change 1', 'timeFrame': '5 weeks', 'description': 'The difference between limb volume previous of treatment and at the end of treatment'}], 'secondaryOutcomes': [{'measure': 'Limb volume change 2', 'timeFrame': '9 weeks', 'description': 'The difference between limb volume from previous of treatment to 1 month after'}, {'measure': 'VAS Pain', 'timeFrame': '9 weeks', 'description': 'Changes in pain at previous treatment, at the end of treatment and to 1 month after. Measured by a visual analogue scale (VAS) (from 0 not pain to 10 maximum imaginable)'}, {'measure': 'VAS Heaviness', 'timeFrame': '9 weeks', 'description': 'Changes in heaviness from previous treatment, to the end of treatment and to 1 month after. Measured by a visual analogue scale (VAS) (from 0 not heaviness to 10 maximum imaginable)'}, {'measure': 'VAS Hardness', 'timeFrame': '9 weeks', 'description': 'Changes in hardness from previous treatment, to the end of treatment and to 1 month after. Measured by a visual analogue scale (VAS) (from 0 not hardness to 10 maximum imaginable)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lymphedema, Lower Limb']}, 'referencesModule': {'references': [{'pmid': '36205409', 'type': 'BACKGROUND', 'citation': 'Rankin J, Morris K, Reilly A. The All-Ireland Guidelines for the diagnosis, assessment and management of lymphoedema. Br J Community Nurs. 2022 Oct 1;27(Sup10):S22-S26. doi: 10.12968/bjcn.2022.27.Sup10.S22.'}, {'pmid': '23705118', 'type': 'BACKGROUND', 'citation': 'Bae H, Kim HJ. Clinical outcomes of extracorporeal shock wave therapy in patients with secondary lymphedema: a pilot study. Ann Rehabil Med. 2013 Apr;37(2):229-34. doi: 10.5535/arm.2013.37.2.229. Epub 2013 Apr 30.'}, {'pmid': '34945266', 'type': 'BACKGROUND', 'citation': 'Tsai YL, I TJ, Chuang YC, Cheng YY, Lee YC. Extracorporeal Shock Wave Therapy Combined with Complex Decongestive Therapy in Patients with Breast Cancer-Related Lymphedema: A Systemic Review and Meta-Analysis. J Clin Med. 2021 Dec 19;10(24):5970. doi: 10.3390/jcm10245970.'}, {'pmid': '32986941', 'type': 'BACKGROUND', 'citation': 'Lee KW, Kim SB, Lee JH, Kim YS. Effects of Extracorporeal Shockwave Therapy on Improvements in Lymphedema, Quality of Life, and Fibrous Tissue in Breast Cancer-Related Lymphedema. Ann Rehabil Med. 2020 Oct;44(5):386-392. doi: 10.5535/arm.19213. Epub 2020 Sep 28.'}]}, 'descriptionModule': {'briefSummary': 'This is a double-blind randomized clinical trial to compare the effect of shock wave therapy on lower limb lymphedema. There are two arms: A) complex decongestive therapy + extracorporeal shock waves therapy; B) complex decongestive therapy plus placebo extracorporeal shock waves.', 'detailedDescription': 'This is a double blind, randomized, clinical trial. 30 patients with lower limb lymphedema will be randomized in 2 groups. One group will receive the habitual complex decongestive therapy (lymphatic manual drainage and compression) plus extracorporeal shock waves therapy. The other group will receive complex decongestive therapy (lymphatic manual drainage and compression) plus placebo extracorporeal shock waves.\n\nPatients in the 2 groups will be instructed on skin care measures and kinesitherapy. The usual manual lymphatic drainage and compression will be applied to the 2 groups. The 2 groups will receive 10 treatment sessions, 2 weekly for 5 weeks.\n\nGroup complex decongestive therapy + shock waves. Patients will receive treatment with manual lymphatic drainage, compression, and shock waves.\n\nGroup complex decongestant therapy + placebo. Patients will receive treatment with manual lymphatic drainage, compression, and placebo shock waves.\n\nTolerance and possible adverse effects will be recorded by physiotherapist. Any adverse effect detected will be evaluated by the rehabilitation medical doctor.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria\n\n* Patients with lower limb lymphedema\n* Lymphedema of at least 6 months of evolution\n* The lymphedema must affect at least the knee to the foot\n* Moderate or severe lymphedema (grades 2 or 3)\n* Sign the informed consent\n\nExclusion criteria\n\n* Under 18 years of age\n* Coagulation disorders (hemophilia, treatment with acenocoumarol, etc.)\n* Current or previous deep vein thrombosis of the lower extremity\n* Pregnancy\n* Electronic implantable medical devices as pacemaker implants, medication pumps, etc\n* Having received treatment with complex decongestive therapy or shock waves during the last 6 months\n* Treatment with corticosteroids or radiotherapy in the area to be treated in the last 6 weeks\n* Active oncological disease in the area to be treated\n* Active infectious-inflammatory process in the area to be treated\n* Cognitive or sensory deficits that prevent collaboration\n* Inability to walk independently or inability to attend therapy'}, 'identificationModule': {'nctId': 'NCT06454734', 'briefTitle': 'Shock Wave Therapy for Lower Limb Lymphedema', 'organization': {'class': 'OTHER', 'fullName': 'Parc de Salut Mar'}, 'officialTitle': 'Lower Limb Lymphedema Treatment by Extracorporeal Shock Wave Therapy: Clinical Trial', 'orgStudyIdInfo': {'id': '2023/11201/I'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DLT + ESWT', 'description': 'To DLT + ESWT group, decongestive lymphatic therapy (DLT) plus radial extracorporeal wave treatment (ESWT) will be applied, at a dose and intensity probed to be useful to diminish volume in upper limb lymphedema.', 'interventionNames': ['Device: Extracorporeal shock wave therapy by radial device', 'Other: DLT']}, {'type': 'SHAM_COMPARATOR', 'label': 'DLT + Sham ESWT', 'description': 'To DLT + Sham ESWT group, decongestive lymphatic therapy plus sham radial extracorporeal wave treatment will be applied, at a placebo dose and intensity.', 'interventionNames': ['Device: Placebo extracorporeal shock wave therapy by radial device', 'Other: DLT']}], 'interventions': [{'name': 'Extracorporeal shock wave therapy by radial device', 'type': 'DEVICE', 'otherNames': ['Radial ESWT', 'rESWT'], 'description': 'Patients will receive treatment by extracorporeal shock waves therapy (ESWT).', 'armGroupLabels': ['DLT + ESWT']}, {'name': 'Placebo extracorporeal shock wave therapy by radial device', 'type': 'DEVICE', 'otherNames': ['Radial ESWT', 'rESWT'], 'description': 'Patients will receive treatment sham extracorporeal shock waves.', 'armGroupLabels': ['DLT + Sham ESWT']}, {'name': 'DLT', 'type': 'OTHER', 'otherNames': ['Decongestive Lymphatic Therapy'], 'description': 'Patients will receive treatment with decongestive lymphatic therapy (DLT: manual lymphatic drainage, compression)', 'armGroupLabels': ['DLT + ESWT', 'DLT + Sham ESWT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08003', 'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Esther Duarte, PhD', 'role': 'CONTACT', 'email': 'eduarte@psmar.cat', 'phone': '933674214'}, {'name': 'Roser Belmonte, PhD', 'role': 'CONTACT', 'email': 'rbelmonte@psmar.cat', 'phone': '933674214'}, {'name': 'Marina Alvarez, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Mercedes Piqueras, PT', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ana V Lobato, PT', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hospital del Mar', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'centralContacts': [{'name': 'Roser Belmonte, MD, PhD', 'role': 'CONTACT', 'email': 'rbelmonte@psmar.cat', 'phone': '+34 933674214'}, {'name': 'Esther Duarte, MD, PhD', 'role': 'CONTACT', 'email': 'eduarte@psmar.cat', 'phone': '+34 933674214'}], 'overallOfficials': [{'name': 'Roser Belmonte, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital del Mar'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Parc de Salut Mar', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Rehabilitation specialist, MD, PhD', 'investigatorFullName': 'Roser Belmonte', 'investigatorAffiliation': 'Parc de Salut Mar'}}}}