[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100638885":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":36,"centralContacts":37,"locations":44,"responsibleParty":70,"collaborators":36,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":36,"eligibilityCriteria":79,"healthyVolunteers":75,"sex":80,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":36,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":95,"overallStatus":102,"whyStopped":36,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"Gazi University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"ESWT + CDT Maintenance","EXPERIMENTAL","Participants in this group receive active Extracorporeal Shock Wave Therapy (ESWT) applied to fibrotic tissue regions of the affected lower extremity and periinguinal and peripopliteal lymph node areas, in addition to standard CDT maintenance therapy. ESWT will be administered twice weekly for a total of five sessions.",[13],"Device: Extracorporeal Shock Wave Therapy (ESWT)",{"label":15,"type":16,"description":17,"interventionNames":18},"Sham ESWT + CDT Maintenance","SHAM_COMPARATOR","Participants in this group receive sham ESWT applied to the same anatomical regions using identical device positioning and application procedures, but with only non-energized impulses delivered. Standard CDT maintenance therapy will be continued throughout the study.",[19],"Device: Sham Extracorporeal Shock Wave Therapy (Sham ESWT)",[21,29],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Extracorporeal Shock Wave Therapy (ESWT)","Radial shock wave therapy will be applied using the EMS Swiss DolorClast® device. Each session will consist of 3,000 impulses delivered at 20 Hz and 2 bar using a 40 mm applicator, targeting fibrotic tissue regions and periinguinal and peripopliteal lymph node areas. ESWT will be administered twice weekly for five sessions",[9],[27,28],"Extracorporeal Shock Wave Therapy","ESWT",{"type":22,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"Sham Extracorporeal Shock Wave Therapy (Sham ESWT)","Sham ESWT will be applied with identical positioning and session duration as the active ESWT group. Only non-energized impulses will be delivered, ensuring participant blinding. Sham ESWT will be administered twice weekly for five sessions.",[15],[34,35],"Sham Extracorporeal Shock Wave Therapy","Sham ESWT",null,[38],{"name":39,"role":40,"phone":41,"phoneExt":42,"email":43},"Ayca Utkan Karasu, M.D","CONTACT","+905365759757","+903122025219","ayca_utkan@yahoo.com",[45],{"facility":46,"status":36,"city":47,"state":48,"zip":49,"country":50,"countryCode":36,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Gazi University Hospital, Department of Physical Medicine and Rehabilitation, Ankara, 06560","Ankara","Yenimahalle","06560","Turkey (Türkiye)",{"type":52,"coordinates":53},"Point",[54,55],32.85427,39.91987,{"lat":55,"lon":54},[58,60,64,66,67],{"name":59,"role":40,"phone":41,"phoneExt":42,"email":43},"Ayca Utkan Karasu, MD",{"name":61,"role":40,"phone":62,"phoneExt":36,"email":63},"Turkan Gokcelik, MD","+905078492343","turkancanturk@gmail.com",{"name":59,"role":65,"phone":36,"phoneExt":36,"email":36},"PRINCIPAL_INVESTIGATOR",{"name":61,"role":65,"phone":36,"phoneExt":36,"email":36},{"name":68,"role":69,"phone":36,"phoneExt":36,"email":36},"Ilknur Onurlu, MD","SUB_INVESTIGATOR",{"type":65,"investigatorFullName":71,"investigatorTitle":72,"investigatorAffiliation":5,"oldNameTitle":36,"oldOrganization":36},"Ayça Utkan Karasu","MD, Principal Investigator","100638885","extracorporeal-shock-wave-therapy-in-lower-extremity-lymphedema-100638885",false,"NCT07626645","Extracorporeal Shock Wave Therapy in Lower Extremity Lymphedema","Efficacy of Extracorporeal Shock Wave Therapy (ESWT) in Lower Extremity Lymphedema: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Adults aged 18 to 80 years\n* Clinical diagnosis of lower extremity lymphedema established at least 6 months prior to enrollment\n* Completion of at least one cycle of CDT Phase 1 (intensive decongestive phase) within the preceding six months\n* Currently in CDT Phase 2 (maintenance phase) with active use of compression garments\n* Ability and willingness to provide written informed consent\n\nExclusion Criteria:\n\n* Active chemotherapy or radiotherapy\n* Active infection\n* Lower extremity vascular diseases including deep vein thrombosis or arterial insufficiency\n* Presence of a cardiac pacemaker\n* Pregnancy\n* Bleeding disorders","ALL","18 Years","80 Years",{"count":84,"type":85},36,"ESTIMATED","INTERVENTIONAL",[88],"NA","Lower extremity lymphedema is a chronic and progressive condition associated with significant functional impairment and reduced quality of life. The current gold-standard treatment is Complex Decongestive Therapy (CDT); however, a substantial proportion of patients continue to experience persistent symptoms during the maintenance phase. This prospective, randomized, double-blind, placebo-controlled clinical trial aims to evaluate the effectiveness of Extracorporeal Shock Wave Therapy (ESWT) as an adjunct to standard CDT maintenance therapy in patients with lower extremity lymphedema. Participants will be randomly allocated to either an active ESWT group or a sham ESWT group, with both groups continuing standard CDT maintenance throughout the study. ESWT will be administered twice weekly for five sessions. Changes in limb volume, skin thickness and subcutaneous tissue thickness assessed by ultrasonography, pain, functional status, and quality of life will be evaluated at baseline, after treatment, and at one-month follow-up.",[91,27,92,93,94],"Lymphedema, Lower Limb","Edema Leg","Sham-controlled","Placebo Control Design",[96,23,97,98,99,100,101],"Lower Extremity Lymphedema","Complex Decongestive Therapy (CDT)","Limb Volume","Ultrasonography","skin and subcutaneous tissue thickness","Quality of Life","NOT_YET_RECRUITING","2026-06-02",{"date":105,"type":106},"2026-06-04","ACTUAL",{"date":108,"type":85},"2026-06-22",{"date":110,"type":85},"2027-02-01",{"name":5,"class":6},1]