[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100575311":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":68,"centralContacts":73,"locations":81,"responsibleParty":95,"collaborators":10,"id":97,"slug":98,"hasResults":99,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":10,"eligibilityCriteria":103,"healthyVolunteers":104,"sex":105,"minAge":106,"maxAge":107,"enrollmentInfo":108,"targetDuration":10,"studyType":111,"phases":10,"briefSummary":112,"conditions":113,"keywords":116,"overallStatus":84,"whyStopped":10,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":127},{"fullName":5,"class":6},"Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey","OTHER",[8,22],{"label":9,"type":10,"description":11,"interventionNames":12},"lipedema",null,"patients with lipedema",[13,14,15,16,17,18,19,20,21],"Other: Pain-Pressure Threshold Measurement With an Algometer","Other: Central Sensitization Inventory","Other: Numeric Rating Scale","Other: Lower Extremity Functional Scale","Other: Short form 12","Other: lower extremity volumetric measurement","Other: lower extremity circumference measurement","Other: Bioelectrical Impedance Analysis","Diagnostic Test: Ultrasound",{"label":23,"type":10,"description":24,"interventionNames":25},"Healthy control","Healthy volunteers",[13,14,16,17,19,20,21],[27,31,37,41,47,51,55,59,63],{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":10},"Pain-Pressure Threshold Measurement With an Algometer","The measurement will be performed 2 times with 3 min intervals for each region and the average of these applications will be recorded. Before the test, a trial test will be applied to the patient. With the pressure algometer, pressure will be applied to the selected points until it causes pain and the test will be terminated for that region when the patient feels pain.\n\nThe measurement includes bilateral thigh, pretibial region and left forearm as remote site and Wagner manual pressure algometer (1 cm2 probe-10 kg\u002F20 lb) will be used. The selected points will be:\n\nBilateral thigh: Mid-thigh anterior surface Bilateral pretibial region: Anterior proximal 1\u002F3 of the pretibial area Bilateral forearm volar side center as control point",[23,9],{"type":6,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"Central Sensitization Inventory","The central sensitization scale was developed primarily to detect central sensitization findings in patients with chronic pain and consists of two parts, A and B. In part A, 25 somatic and psychosocial symptoms frequently found in patients with central sensitization.",[23,9],[36],"CSI",{"type":6,"name":38,"description":39,"armGroupLabels":40,"otherNames":10},"Numeric Rating Scale","Leg pain, feeling of tension and heaviness on the affected arm will be evaluated separately by numerical scale.",[9],{"type":6,"name":42,"description":43,"armGroupLabels":44,"otherNames":45},"Lower Extremity Functional Scale","The lower extremity functional scale is a valid patient-rated outcome measure for the measurement of lower extremity function. The scale consist of 4 groups with 20 questions. The questions in these group focus on activities with increasing physical demands like questions from walking between rooms to running on uneven ground. The scoring of this scale varies from 0 (extreme difficulty\u002Funable to perform activity) to 4 (no difficulty). The total score can be obtained by summing the scores of the individual items. The maximum score of 80 indicates no functional limitations and the minimum score of 0 indicates extreme limitations.",[23,9],[46],"LEFS",{"type":6,"name":48,"description":49,"armGroupLabels":50,"otherNames":10},"Short form 12","The Short form 12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. It is often used as a quality of life measure.The scoring yields two summary measures: the Physical Component Summary (PCS) and the Mental Component Summary (MCS).Utilize the norm-based scoring system to interpret PCS and MCS scores, with a mean of 50 and a standard deviation of 10 in the general population.Scores above 50 indicate a better-than-average health-related quality of life, while scores below 50 suggest below-average health.",[23,9],{"type":6,"name":52,"description":53,"armGroupLabels":54,"otherNames":10},"lower extremity volumetric measurement","It is calculated by converting the circumference measurements taken at 4 cm intervals from the ankle to the proximal thigh into lower extremity volume with Excel.",[9],{"type":6,"name":56,"description":57,"armGroupLabels":58,"otherNames":10},"lower extremity circumference measurement","bilateral tuberosity tibia, 20 cm proximal tuberosity tibia, tuberosity tibia 10 cm distal and ankle level",[23,9],{"type":6,"name":60,"description":61,"armGroupLabels":62,"otherNames":10},"Bioelectrical Impedance Analysis","With Bioelectrical Impedance Analysis, fat, muscle and water ratio and lean mass are calculated in addition to the patient's body weight.",[23,9],{"type":64,"name":65,"description":66,"armGroupLabels":67,"otherNames":10},"DIAGNOSTIC_TEST","Ultrasound","Measurement of subcutaneous fat tissue thickness from mid-thigh, pretibial, lateral leg and supramalleolar regions with ultrasound.The average of two measurements taken from the same area will be recorded.According to these measurements; 12-15 mm = mild lipedema or lipohyperplasia, 15-20 mm = moderate lipedema, \\>20 mm = significant lipedema, \\>30 mm = severe lipedema.",[23,9],[69],{"name":70,"affiliation":71,"role":72},"Emre Ata, Assoc.Prof","Sultan Abdülhamid Han Research and Training Hospital","STUDY_CHAIR",[74,79],{"name":75,"role":76,"phone":77,"phoneExt":78,"email":77},"Zeynep Candan, MD","CONTACT","drzeynepcandan@gmail.com","05395955090",{"name":80,"role":76,"phone":10,"phoneExt":10,"email":10},"Feyza N Yucel, MD",[82],{"facility":83,"status":84,"city":85,"state":86,"zip":87,"country":88,"countryCode":10,"cosmosGeoPoint":89,"geoPoint":94,"contacts":10},"Sultan 2. Abdülhamid Han Eğitim ve Araştırma Hastanesi, İstanbul, Üsküdar 34000","RECRUITING","Istanbul","Üsküdar","34000","Turkey (Türkiye)",{"type":90,"coordinates":91},"Point",[92,93],28.94966,41.01384,{"lat":93,"lon":92},{"type":96,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100575311","investigation-of-central-sensitization-and-associated-factors-in-patients-with-lipedema-100575311",false,"NCT06770634","Investigation of Central Sensitization and Associated Factors in Patients With Lipedema","Investigation of the Prevalence of Central Sensitization and Associated Factors in Patients With Lipedema","Inclusion Criteria:\n\n1. Lipedema; Diagnosis of lipedema Aged between 18 and 65 years Literate Willing to participate in the study\n2. control group; Being completely healthy (no internal\u002Fmetabolic issues such as diabetes, obesity, or hypothyroidism, and no diagnosis of lipedema) BMI ≤ 30 Aged between 18 and 65 years Literate Willing to participate in the study\n\nExclusion Criteria:\n\n1. Lipedema group; Under 18 or over 65 years of age Presence of concurrent lymphedema, chronic venous insufficiency, deep vein thrombosis, polyneuropathy, or fibromyalgia Illiterate Not willing to participate in the study\n2. Control group; Under 18 or over 65 years of age Presence of concurrent lymphedema, chronic venous insufficiency, deep vein thrombosis, polyneuropathy, fibromyalgia, systemic rheumatic diseases, active cancer, infections, or pregnancy Illiterate Not willing to participate in the study",true,"ALL","18 Years","65 Years",{"count":109,"type":110},50,"ESTIMATED","OBSERVATIONAL","This study aims to investigate the presence of central sensitization and its associated parameters in patients with lipedema. Lipedema is a chronic and hereditary condition that primarily affects the lower extremities in women and is often associated with hormonal changes. Symptoms such as pain, swelling, and tenderness are common in lipedema, and these symptoms may be related to central sensitization. Additionally, the ultrasonographic findings and pain sensitivity in lipedema will be compared with those of healthy individuals. This study seeks to contribute to the diagnosis and treatment process of lipedema.",[114,115],"Lipedema","Central Sensitisation",[117,114],"central sensitization","2025-09-05",{"date":120,"type":121},"2025-09-08","ACTUAL",{"date":123,"type":121},"2024-12-06",{"date":125,"type":110},"2025-12-30",{"name":5,"class":6},1]