Lipedema
Conditions
Keywords
Extracorporeal Shock Wave Therapy, ESWT, Lipedema, Pain, Ultrasonography, Quality of Life, PROMIS, Patient-Reported Outcomes
Brief summary
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.
Detailed description
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.
Interventions
DEVICEExtracorporeal 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.
Sponsors
Atlas University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
This is an open-label single-arm study without masking.
Intervention model description
All enrolled participants will receive extracorporeal shock wave therapy (ESWT). Clinical and ultrasonographic assessments will be performed before and after treatment in a single-group pre-post intervention design.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Intensity Assessed by Visual Analog Scale (VAS) | Baseline and 2 weeks | Change in pain intensity measured using the Visual Analog Scale (VAS) from baseline to post-treatment assessment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pressure Pain Threshold Measured by Pressure Algometry | Baseline and 2 weeks | Pressure pain threshold will be assessed using a digital pressure algometer. The change from baseline to the post-treatment assessment will be analyzed. |
| Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Score | Baseline and 2 weeks | Change in patient-reported global health assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health questionnaire from baseline to the 2-week post-treatment assessment. |
| Change in Pain Catastrophizing Scale (PCS) Score | Baseline and 2 weeks | Change in pain catastrophizing assessed using the Pain Catastrophizing Scale (PCS) from baseline to the 2-week post-treatment assessment. |
| Change in Lower Extremity Circumference Measured Using a Flexible Measuring Tape | Baseline and 2 weeks | Lower extremity circumference will be measured using a flexible measuring tape at standardized anatomical landmarks. The change from baseline to the 2-week post-treatment assessment will be analyzed. |
| Change in Ultrasonographic Characteristics of Skin and Subcutaneous Tissue | Baseline and 2 weeks | Change in ultrasonographic characteristics of the affected skin and subcutaneous tissue assessed by B-mode ultrasonography from baseline to the 2-week post-treatment assessment. |
Countries
Turkey (Türkiye)
Contacts
CONTACTElif Ozyigit, MD
PRINCIPAL_INVESTIGATORElif Ozyigit, MD
University of Health Sciences, Kanuni Sultan Suleyman Training and Research Hospital
Outcome results
None listed