The Relationship Between Central Sensitization, Pain, and Psychosocial Factors in Individuals With Lipedema: A Cross-Sectional Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Central Sensitization Inventory (CSI)
研究概览
简要总结
This cross-sectional study will include women aged 18-75 with clinically diagnosed lipedema and healthy controls. Sociodemographic and clinical data will be collected, and participants will complete the Central Sensitization Inventory (CSI), Visual Analog Scale (VAS), Hospital Anxiety and Depression Scale (HADS), and Pain Catastrophizing Scale (PCS). Pain pressure thresholds (PPT) will be assessed using a digital algometer at the middle deltoid, lateral thigh, and medial knee, with three measurements taken at each site and the average recorded.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Clinically diagnosed with lipedema
- •Aged between 18 and 75 years
- •Provided voluntary informed consent
排除标准
- •History of systemic diseases such as diabetes, rheumatologic disorders, or malignancy
- •Presence of neurological disorders (e.g., polyneuropathy, multiple sclerosis, history of stroke)
- •Currently under active psychiatric treatment Pregnancy
- •History of lower extremity surgery or major trauma within the past 6 months
- •Received injection therapy or physical therapy for the lower extremities within the past 6 -months
- •History of infection or active dermatological disease affecting the lower extremities
结局指标
主要结局
Central Sensitization Inventory (CSI)
时间窗: Baseline
The CSI assesses symptoms related to central sensitization, such as widespread pain, fatigue, and sleep disturbance. Scores range from 0 to 100, with higher values indicating a greater degree of central sensitization.
次要结局
- Pain Intensity (Visual Analog Scale - VAS)(Baseline)
- Hospital Anxiety and Depression Scale - Depression Subscale (HADS-D)(Baseline)
- Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A):(Baseline)
- Pain Catastrophizing Scale (PCS):(Baseline)
- Pain Pressure Threshold (PPT):(Baseline)