[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658207":3},{"organization":4,"outcomesModule":7,"designInfo":39,"detailedDescription":42,"studyPopulation":43,"armGroups":44,"interventions":38,"overallOfficials":38,"centralContacts":51,"locations":38,"responsibleParty":58,"collaborators":38,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":38,"eligibilityCriteria":68,"healthyVolunteers":69,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":38,"studyType":76,"phases":38,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":86,"whyStopped":38,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":38},{"fullName":5,"class":6},"Gaziantep City Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":38},[9],{"measure":10,"description":11,"timeFrame":12},"Central Sensitization Inventory (CSI)","The CSI consists of 25 items. Each item is scored on a five-point scale: never (0), rarely (1), sometimes (2), often (3), and always (4). Total scores range from 0 to 100, with higher scores indicating greater symptom severity. A score of 40 is used as the cutoff.","Baseline, at the time of clinical assessment",[14,17,20,23,26,29,32,35],{"measure":15,"description":16,"timeFrame":12},"Visual Analog Scale (VAS)","Pain intensity will be assessed using a 10-cm horizontal line anchored by \"no pain\" at one end and \"worst imaginable pain\" at the other. Participants will mark the point that best represents their pain intensity. The distance from the left end of the line to the mark will be recorded in centimeters; higher values indicate greater pain intensity.",{"measure":18,"description":19,"timeFrame":12},"Pain Catastrophizing Scale (PCS)","The PCS is a 13-item self-report questionnaire used to assess catastrophic thoughts and feelings related to pain in clinical and nonclinical populations. Its items cover three dimensions: rumination, magnification, and helplessness. Each item is scored from 0 to 4 on a five-point scale, yielding a total score of 0-52. Higher scores indicate greater pain catastrophizing.",{"measure":21,"description":22,"timeFrame":12},"Pressure Pain Threshold Measurement by Algometry","Pressure pain threshold (PPT) is the minimum applied pressure at which a participant first perceives pain. A pressure algometer with a 1 cm² probe tip will be applied perpendicular to the skin, and pressure will be increased at a rate of approximately 1 kg\u002Fcm² per second. Participants will be instructed to indicate when the pressure first becomes painful. PPT will be measured bilaterally at the deltoid regions, lateral thighs, and medial aspects of the knees. Higher PPT values indicate lower sensitivity to pressure-induced pain.",{"measure":24,"description":25,"timeFrame":12},"Beck Depression Inventory (BDI)","The BDI is a standardized self-report instrument developed by Aaron T. Beck to assess the severity of depressive symptoms. The validity and reliability of its Turkish version were established by Nihal Hisli. Higher scores indicate more severe depressive symptoms.",{"measure":27,"description":28,"timeFrame":12},"Beck Anxiety Inventory (BAI)","The BAI is a 21-item self-report questionnaire used to assess the severity of anxiety symptoms experienced during the past week. It places particular emphasis on somatic symptoms of anxiety. Each item is scored from 0 to 3, yielding a total score of 0-63; higher scores indicate more severe anxiety symptoms.",{"measure":30,"description":31,"timeFrame":12},"Pittsburgh Sleep Quality Index (PSQI)","The PSQI is a self-report questionnaire developed by Buysse and colleagues in 1989 to assess sleep quality and sleep disturbances over the past month. The validity and reliability of its Turkish version were evaluated by Ağargün and colleagues in 1996. The global score ranges from 0 to 21, with higher scores indicating poorer sleep quality.",{"measure":33,"description":34,"timeFrame":12},"Misophonia Scale","The scale assesses sensitivity to specific sounds, such as eating sounds, repetitive tapping, rustling, and breathing sounds. Participants first rate their sensitivity to these sounds from 0 (\"not at all true\") to 4 (\"always true\"). Those reporting any sound sensitivity then rate how often the sounds lead to avoidance, emotional distress, anger, or aggressive responses, using a scale from 0 (\"never\") to 4 (\"always\"). Finally, participants rate the overall severity of their sound sensitivity on a separate 1-15 scale, taking into account its intensity and impact on daily life.",{"measure":36,"description":37,"timeFrame":12},"Body Image Scale (BIS)","The BIS, developed by Saylan and Soyyiğit, is a 21-item instrument used to assess body image. It comprises four subscales: Sensitivity to Evaluation, Negative Body Perception, Positive Body Perception, and Body Modification. Item scores are summed to obtain a total score ranging from 21 to 105. Higher total scores indicate a more negative body image.",null,{"allocation":38,"interventionModel":38,"interventionModelDescription":38,"primaryPurpose":38,"observationalModel":40,"timePerspective":41,"maskingInfo":38},"CASE_CONTROL","CROSS_SECTIONAL","Lipedema is a chronic condition characterized by a disproportionate, usually symmetrical accumulation of subcutaneous adipose tissue, predominantly in the hips, thighs, and legs. The arms may also be affected. It occurs almost exclusively in women and can substantially affect daily functioning, quality of life, and psychosocial well-being. Commonly reported symptoms include pain, tenderness, easy bruising, and a sensation of swelling. Fatigue, walking difficulties, sleep problems, and symptoms of depression or anxiety may also occur. Misophonia involves intense negative reactions to specific sounds, such as chewing, breathing, or pen clicking. Given the symptom burden associated with lipedema, investigating misophonia symptoms in this population may provide insight into their relationship with pain, central sensitization, and psychological well-being.\n\nThis observational case-control study will investigate central sensitization and its relationship with misophonia and other clinical symptoms in women with lipedema. Women aged 18-65 years who provide written informed consent will be eligible for assessment. Participants with a Lipedema Screening Questionnaire score of ≥9 and a clinical diagnosis of lipedema will be included in the case group. Women with a score of \\\u003C9 will be included in the control group. The screening questionnaire will support group allocation but will not serve as the sole basis for a clinical diagnosis.\n\nDemographic and clinical data will include age, marital status, education, occupation, menopausal status, parity, smoking and alcohol use, body mass index, systemic diseases, medications, family history, and exercise habits. For participants with lipedema, the duration of diagnosis, disease stage and type, affected body regions, age at pain onset, and clinical features-including pain, tenderness, easy bruising, perceived swelling, and symmetric or asymmetric involvement-will be recorded. Previous treatments, including dietary interventions, compression garments, liposuction, complex decongestive therapy, and other reported interventions, will also be documented.\n\nThe primary outcome will be central sensitization severity, assessed using the Central Sensitization Inventory. Secondary outcomes will include pain intensity measured with a visual analog scale; pressure pain thresholds measured by algometry at the bilateral deltoid regions, lateral thighs, and medial aspects of the knees; pain catastrophizing assessed with the Pain Catastrophizing Scale; sleep quality assessed with the Pittsburgh Sleep Quality Index; depressive symptoms assessed with the Beck Depression Inventory; anxiety symptoms assessed with the Beck Anxiety Inventory; and body image assessed with the Body Image Scale. Misophonia symptoms will be assessed using a Misophonia Scale.\n\nThe study will compare these measures between the lipedema and control groups and examine associations between misophonia symptoms, central sensitization, pain, and psychological measures.","The study population will consist of women aged 18-65 years recruited for an observational case-control study. The case group will comprise women with a clinical diagnosis of lipedema based on medical history and physical examination and a Lipedema Screening Questionnaire score of ≥9. The control group will comprise women without clinical evidence of lipedema and with a questionnaire score of \\\u003C9. Eligible participants will provide written informed consent and complete assessments of misophonia, central sensitization, pain, sleep, psychological symptoms, and body image, as well as pressure pain threshold measurements.",[45,48],{"label":46,"type":38,"description":47,"interventionNames":38},"Women With Lipedema","Women aged 18-65 years with a clinical diagnosis of lipedema and a Lipedema Screening Questionnaire score of ≥9. Participants will complete questionnaires and undergo pressure pain threshold measurements. No intervention will be administered.",{"label":49,"type":38,"description":50,"interventionNames":38},"Women Without Lipedema","Women aged 18-65 years without a clinical diagnosis of lipedema and with a Lipedema Screening Questionnaire score of \\\u003C9. Participants will complete the same questionnaires and undergo the same pressure pain threshold measurements. No intervention will be administered.",[52],{"name":53,"role":54,"phone":55,"phoneExt":56,"email":57},"Merve ÖNOĞUL ÖZMEN, Medıcal Doctor","CONTACT","05398981401","+(0312)7970000","drmerveonogul@gmail.com",{"type":59,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":38,"oldOrganization":38},"PRINCIPAL_INVESTIGATOR","Merve Önoğul Özmen","Consultant","100658207","pain-central-sensitization-and-misophonia-in-lipedema-100658207",false,"NCT07849634","Pain, Central Sensitization, and Misophonia in Lipedema","Assessment of the Relationships Among Pain, Central Sensitization, Psychological Factors, and Misophonia in Women With Lipedema: A Cross-Sectional Controlled Study","Inclusion Criteria:\n\n* Female sex.\n* Age 18-65 years.\n* Case group: Clinical diagnosis of lipedema based on medical history and physical examination, and a Lipedema Screening Questionnaire score of ≥9.\n* Control group: No clinical diagnosis of lipedema based on medical history and physical examination, and a Lipedema Screening Questionnaire score of \\\u003C9.\n* Willingness to participate and provision of written informed consent.\n\nExclusion Criteria:\n\n* Primary or secondary lymphedema.\n* Active malignancy or infection.\n* Severe immobility or advanced venous insufficiency.\n* A history of major surgery, trauma, or serious systemic illness within the past six months.\n* Pregnancy or breastfeeding.\n* A diagnosed neuropsychiatric disorder, such as schizophrenia, schizoaffective disorder, or bipolar disorder.\n* A history of ear or hearing disorders.\n* A diagnosed neurological disorder, such as epilepsy, multiple sclerosis, stroke, or dementia.\n* Current substance use disorder or use of psychotropic medication within the past 30 days.\n* Inability to understand or complete the study procedures because of language, cognitive, or sensory limitations.",true,"FEMALE","18 Years","65 Years",{"count":74,"type":75},70,"ESTIMATED","OBSERVATIONAL","Lipedema is a chronic condition that predominantly affects women and is characterized by disproportionate, usually symmetrical accumulation of subcutaneous fat, particularly in the hips and legs. Pain, tenderness, easy bruising, fatigue, and psychological symptoms may substantially affect daily functioning and quality of life. Misophonia involves intense negative reactions to specific sounds, but its relationship with lipedema remains unclear.\n\nThis observational case-control study aims to investigate misophonia symptoms in women with lipedema compared with women without lipedema and to explore their associations with pain and psychosocial factors. The prespecified primary outcome measure is central sensitization severity, assessed using the Central Sensitization Inventory. Secondary outcome measures include misophonia symptom severity, pain intensity, pressure pain thresholds, pain catastrophizing, sleep quality, depressive and anxiety symptoms, and body image. The study will compare these outcomes between groups and examine their associations with misophonia symptoms.",[79],"Lipedema",[79,81,82,83,84,85],"Central Sensitization","Misophonia","Pain","Psychological Factors","Pressure Pain Threshold","NOT_YET_RECRUITING","2026-09-24",{"date":89,"type":90},"2026-09-30","ACTUAL",{"date":92,"type":75},"2026-09-28",{"date":94,"type":75},"2026-12-07",{"name":5,"class":6}]