[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659026":3},{"organization":4,"outcomesModule":7,"designInfo":37,"detailedDescription":36,"studyPopulation":36,"armGroups":45,"interventions":60,"overallOfficials":36,"centralContacts":78,"locations":84,"responsibleParty":100,"collaborators":36,"id":104,"slug":105,"hasResults":106,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":110,"eligibilityCriteria":111,"healthyVolunteers":106,"sex":112,"minAge":113,"maxAge":114,"enrollmentInfo":115,"targetDuration":36,"studyType":118,"phases":119,"briefSummary":121,"conditions":122,"keywords":124,"overallStatus":87,"whyStopped":36,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":140},{"fullName":5,"class":6},"Istanbul University - Cerrahpasa","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":36},[9],{"measure":10,"description":11,"timeFrame":12},"Change in Pain Intensity","Pain intensity will be assessed using the Numerical Pain Rating Scale (NPRS), an 11-point self-reported scale ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity. Changes in NPRS scores from baseline to week 6 will be evaluated.","Baseline and week 6",[14,17,20,23,26,29,32],{"measure":15,"description":16,"timeFrame":12},"Change in Lower Extremity Volume","Lower extremity volume will be assessed bilaterally using circumferential measurements taken at standardized intervals with a non-elastic measuring tape. Total limb volume will be calculated using the truncated cone (frustum) formula. Changes in limb volume from baseline to week 6 will be evaluated. Results will be expressed in milliliters (mL).",{"measure":18,"description":19,"timeFrame":12},"Change in Body Composition","Body composition will be assessed using bioelectrical impedance analysis (BIA). Measurements will include fat mass, fat-free mass, total body water, and the leg-to-arm impedance ratio. Changes in these parameters from baseline to week 6 will be evaluated.",{"measure":21,"description":22,"timeFrame":12},"Change in Heart Rate Variability","Heart rate variability (HRV) will be assessed using a Polar H10 heart rate monitor, with data analyzed using the Elite HRV application. Time-domain and frequency-domain parameters, including mean RR interval, SDNN, RMSSD, ln(RMSSD), pNN50, LF power, HF power, LF\u002FHF ratio, LF peak, HF peak, and total power, will be evaluated. Changes from baseline to week 6 will be assessed.",{"measure":24,"description":25,"timeFrame":12},"Change in Lower Extremity Functional Status","Description: Lower extremity functional status will be assessed using the Lower Extremity Functional Scale (LEFS), a 20-item questionnaire evaluating difficulty in performing daily activities. Each item is scored from 0 to 4, yielding a total score ranging from 0 to 80. Higher scores indicate better lower extremity function. Changes from baseline to week 6 will be evaluated.",{"measure":27,"description":28,"timeFrame":12},"Change in Functional Capacity","Description: Functional capacity will be assessed using the Six-Minute Walk Test (6MWT), conducted along a 30-meter indoor corridor. The total distance walked in six minutes will be recorded in meters. Changes in walking distance from baseline to week 6 will be evaluated.",{"measure":30,"description":31,"timeFrame":12},"Change in Health-Related Quality of Life","Description: Health-related quality of life will be assessed using the 36-Item Short Form Health Survey (SF-36), which evaluates eight health domains: physical functioning, role limitations due to physical health, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health. Each domain is scored from 0 to 100, with higher scores indicating better health status. Changes from baseline to week 6 will be evaluated.",{"measure":33,"description":34,"timeFrame":35},"Patient-Perceived Global Change","Description: Patient-perceived change will be assessed using the Global Rating of Change (GRC) Scale, a five-point Likert-type scale ranging from -2 (much worse) to +2 (much better), with 0 indicating no change. Participants will rate their perceived change compared with their pretreatment status.","Week 6 (to be confirmed)",null,{"allocation":38,"interventionModel":39,"interventionModelDescription":36,"primaryPurpose":40,"observationalModel":36,"timePerspective":36,"maskingInfo":41},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":42,"maskingDescription":36,"whoMasked":43},"SINGLE",[44],"OUTCOMES_ASSESSOR",[46,54],{"label":47,"type":48,"description":49,"interventionNames":50},"Arm 1 - Experimental","EXPERIMENTAL","taVNS + Aerobic Exercise + Complex Decongestive Therapy (CDT)",[51,52,53],"Device: Active taVNS","Other: Aerobic Exercise","Other: Complex Decongestive Therapy (CDT)",{"label":55,"type":56,"description":57,"interventionNames":58},"Arm 2 - Sham Comparator","SHAM_COMPARATOR","Sham taVNS + Aerobic Exercise + Complex Decongestive Therapy (CDT)",[59,52,53],"Device: Sham taVNS",[61,66,70,74],{"type":62,"name":63,"description":64,"armGroupLabels":65,"otherNames":36},"DEVICE","Active taVNS","Active taVNS will be administered concurrently with aerobic exercise for 30 minutes per session, twice weekly for six weeks. Electrical stimulation will be delivered to the auricular region using a transcutaneous vagus nerve stimulation device.",[47],{"type":62,"name":67,"description":68,"armGroupLabels":69,"otherNames":36},"Sham taVNS","Sham taVNS will be administered concurrently with aerobic exercise for 30 minutes per session, twice weekly for six weeks. The sham procedure will be performed using the auricular stimulation device without sustained therapeutic electrical stimulation.",[55],{"type":6,"name":71,"description":72,"armGroupLabels":73,"otherNames":36},"Aerobic Exercise","Participants in both groups will receive supervised moderate-intensity treadmill-based aerobic exercise concurrently with active or sham taVNS. Aerobic exercise will be administered for 30 minutes per session, twice weekly for six weeks.",[47,55],{"type":6,"name":75,"description":76,"armGroupLabels":77,"otherNames":36},"Complex Decongestive Therapy (CDT)","Participants in both groups will receive complex decongestive therapy for 30 minutes per session, twice weekly for six weeks, following the concurrent aerobic exercise and active or sham taVNS intervention.",[47,55],[79],{"name":80,"role":81,"phone":82,"phoneExt":36,"email":83},"merve sevinç gündüz, MSc","CONTACT","05312991841","mrvsevinccc@gmail.com",[85],{"facility":86,"status":87,"city":88,"state":89,"zip":90,"country":91,"countryCode":36,"cosmosGeoPoint":92,"geoPoint":97,"contacts":98},"Bezmialem Vakif University","RECRUITING","Istanbul","Eyupsultan","34250","Turkey (Türkiye)",{"type":93,"coordinates":94},"Point",[95,96],28.94966,41.01384,{"lat":96,"lon":95},[99],{"name":80,"role":81,"phone":82,"phoneExt":36,"email":83},{"type":101,"investigatorFullName":102,"investigatorTitle":103,"investigatorAffiliation":5,"oldNameTitle":36,"oldOrganization":36},"PRINCIPAL_INVESTIGATOR","Merve SEVINC GUNDUZ","research assistant","100659026","transcutaneous-auricular-vagus-nerve-stimulation-enriched-rehabilitation-in-individuals-with-lipedema-100659026",false,"NCT07857499","Transcutaneous Auricular Vagus Nerve Stimulation-Enriched Rehabilitation in Individuals With Lipedema","Effects of Rehabilitation Enriched With Transcutaneous Auricular Vagus Nerve Stimulation on Lower Extremity Function, Pain, and Quality of Life in Individuals With Lipedema","LipoVNS","Inclusion Criteria:\n\n* Female participants aged 18-65 years.\n* Clinical diagnosis of lipedema confirmed by a specialist physician.\n* Bilateral and symmetrical disproportionate adipose tissue accumulation in the lower extremities.\n* Pain or tenderness on pressure in the affected areas.\n* Negative Stemmer's sign.\n* Willingness to participate in the study and provision of written informed consent.\n\nExclusion Criteria:\n\n* Secondary or iatrogenic obesity due to endocrine disorders or medication use.\n* Body weight change greater than 10% within the previous six months.\n* Initiation or modification of estrogen-progestin therapy within the previous two months.","FEMALE","18 Years","65 Years",{"count":116,"type":117},30,"ESTIMATED","INTERVENTIONAL",[120],"NA","Lipedema is a chronic inflammatory disorder of adipose tissue that predominantly affects women and is associated with estrogen-mediated mechanisms. \\[1\\] Conservative physiotherapy approaches, including exercise, compression therapy, complex decongestive therapy (CDT), and behavioral interventions, are recommended for the management of lipedema. \\[2,3\\] Transcutaneous auricular vagus nerve stimulation (taVNS) is a neuromodulation method that may reduce pro-inflammatory cytokines through the cholinergic anti-inflammatory pathway and exert metabolic and autonomic regulatory effects. \\[4\\] These effects suggest that taVNS may serve as a complementary intervention to exercise and conservative physiotherapy approaches in the management of chronic low-grade inflammation, one of the pathophysiological components of lipedema. In light of this evidence, the aim of this study is to comparatively investigate the effects of taVNS-enhanced rehabilitation versus conventional rehabilitation on lower extremity function, pain, and quality of life in individuals with lipedema.",[123],"Lipedema",[125,126,127,71,128,129,130],"Transcutaneous Auricular Vagus Nerve Stimulation","taVNS","Complex Decongestive Therapy","Pain","Lower Extremity Function","Quality of Life","2026-09-30",{"date":133,"type":134},"2026-10-05","ACTUAL",{"date":136,"type":134},"2026-09-18",{"date":138,"type":117},"2028-02-28",{"name":5,"class":6},1]