Extracorporeal Shock Wave Therapy in Patients With Lipedema
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Extracorporeal Shock Wave Therapy.
- Кому может быть актуально
- Состояния в реестре: Lipedema. Базовые параметры: 18 лет — 75 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Turkey (Türkiye)
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Официальное название
Evaluation of the Effects of Extracorporeal Shock Wave Therapy on Pain, Quality of Life, and Ultrasonographic Findings in Patients With Lipedema
Обзор
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.
Подробное описание
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.
The findings of this study may provide evidence regarding the effectiveness of ESWT as a non-invasive treatment option for patients with lipedema.
Вмешательства
- Устройство Extracorporeal Shock Wave Therapy
Extracorporeal shock wave therapy (ESWT) will be applied to affected lower-extremity regions using a CE-marked shock wave device. Participants will receive six treatment sessions administered three times per week for two consecutive weeks. Clinical and ultrasonographic assessments will be performed before and after treatment.
Первичные конечные точки
- Change in Pain Intensity Assessed by Visual Analog Scale (VAS) [Срок оценки: Baseline and 2 weeks]
Вторичные конечные точки (5)
- Change in Pressure Pain Threshold Measured by Pressure Algometry [Срок оценки: Baseline and 2 weeks]
- Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Score [Срок оценки: Baseline and 2 weeks]
- Change in Pain Catastrophizing Scale (PCS) Score [Срок оценки: Baseline and 2 weeks]
- Change in Lower Extremity Circumference Measured Using a Flexible Measuring Tape [Срок оценки: Baseline and 2 weeks]
- Change in Ultrasonographic Characteristics of Skin and Subcutaneous Tissue [Срок оценки: Baseline and 2 weeks]
Критерии участия
Критерии включения
- 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
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Не применимо
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
Turkey (Türkiye) · 1 центр
- Kanuni Sultan Suleyman Training and Research Hospital — Istanbul
Идентификаторы
NCT: NCT07683559 · KSSEAH-LIPO-ESWT-2026 · Atlas-EC-2026-01-04