Evaluation of the Effects of Extracorporeal Shock Wave Therapy on Pain, Quality of Life, and Ultrasonographic Findings in Patients With Lipedema
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in Pain Intensity Assessed by Visual Analog Scale (VAS)
研究概览
简要总结
Lipedema is a chronic adipose tissue disorder characterized by pain, tenderness, disproportionate fat accumulation, and impaired quality of life. Extracorporeal shock wave therapy (ESWT) has been proposed as a non-invasive treatment option that may improve pain and tissue characteristics in patients with lipedema.
The aim of this prospective interventional study is to evaluate the effects of ESWT on pain intensity, quality of life, functional outcomes, and ultrasonographic findings in patients diagnosed with lipedema. Participants will receive a standardized ESWT protocol consisting of six treatment sessions over a two-week period. Clinical assessments and ultrasonographic examinations will be performed before and after treatment.
详细描述
Lipedema is a chronic progressive disorder of adipose tissue that predominantly affects women and is characterized by symmetrical enlargement of the extremities, pain, tenderness, easy bruising, and reduced quality of life. Despite increasing recognition of the disease, effective treatment options remain limited.
Extracorporeal shock wave therapy (ESWT) has demonstrated beneficial effects in several musculoskeletal and soft tissue disorders through mechanisms including pain modulation, improvement of microcirculation, stimulation of tissue remodeling, and reduction of fibrosis. However, evidence regarding its effectiveness in patients with lipedema remains limited.
This prospective single-arm interventional study aims to investigate the clinical and ultrasonographic effects of ESWT in patients with lipedema. Eligible adult participants diagnosed with lipedema will undergo six ESWT sessions administered three times per week for two consecutive weeks.
Outcome assessments will include pain intensity measured by the Visual Analog Scale (VAS), pressure pain threshold measured by algometry, patient-reported outcomes assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS), Patient Global Impression of Change (PGIC), limb circumference measurements, and ultrasonographic evaluation of tissue characteristics.
Assessments will be performed at baseline and after completion of treatment. The primary objective is to evaluate changes in pain and patient-reported outcomes following ESWT. Secondary objectives include assessment of changes in ultrasonographic findings and limb measurements.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
This is an open-label single-arm study without masking.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female participants aged 18 to 75 years
- •Clinical diagnosis of lipedema
- •Willingness to participate and provide written informed consent
- •Ability to comply with study procedures and follow-up assessments
排除标准
- •Pregnancy or breastfeeding
- •Active infection in the treatment area
- •Malignancy
- •Severe cardiovascular disease
- •Coagulation disorders or current anticoagulant therapy
- •Previous ESWT treatment within the last 6 months
- •Severe psychiatric or cognitive disorders interfering with study participation
- •Any condition deemed by the investigator to make participation unsafe
结局指标
主要结局
Change in Pain Intensity Assessed by Visual Analog Scale (VAS)
时间窗: Baseline and 2 weeks
Change in pain intensity measured using the Visual Analog Scale (VAS) from baseline to post-treatment assessment.
次要结局
- Change in Pressure Pain Threshold Measured by Pressure Algometry(Baseline and 2 weeks)
- Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Score(Baseline and 2 weeks)
- Change in Pain Catastrophizing Scale (PCS) Score(Baseline and 2 weeks)
- Change in Lower Extremity Circumference Measured Using a Flexible Measuring Tape(Baseline and 2 weeks)
- Change in Ultrasonographic Characteristics of Skin and Subcutaneous Tissue(Baseline and 2 weeks)