An interventional study of Extracorporeal Shock Wave Therapy in Lipedema, sponsored by Atlas University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-07-06.
Sponsored by Atlas University · Not applicable, Interventional, and Treatment
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.
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.
85 studies on the registry are indexed under Lipedema; 32 are open to participants now.
This study's planned enrollment of 40 is above the median of 35 across 42 interventional studies indexed under Lipedema.
Browse Lipedema studies →Atlas University is the lead sponsor of 96 studies on the registry; 25 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants with lipedema will receive extracorporeal shock wave therapy (ESWT) administered three times per week for two consecutive weeks, for a total of six treatment sessions.
Device: 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.
Change in Pain Intensity Assessed by Visual Analog Scale (VAS)
Change in pain intensity measured using the Visual Analog Scale (VAS) from baseline to post-treatment assessment.
Time frame: Baseline and 2 weeks
Change in Pressure Pain Threshold Measured by Pressure Algometry
Pressure pain threshold will be assessed using a digital pressure algometer. The change from baseline to the post-treatment assessment will be analyzed.
Time frame: Baseline and 2 weeks
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Score
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.
Time frame: Baseline and 2 weeks
Change in Pain Catastrophizing Scale (PCS) Score
Change in pain catastrophizing assessed using the Pain Catastrophizing Scale (PCS) from baseline to the 2-week post-treatment assessment.
Time frame: Baseline and 2 weeks
Change in Lower Extremity Circumference Measured Using a Flexible Measuring Tape
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.
Time frame: Baseline and 2 weeks
Change in Ultrasonographic Characteristics of Skin and Subcutaneous Tissue
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.
Time frame: Baseline and 2 weeks
Plan to share: No — Individual participant data will not be shared. The study involves locally collected clinical data and no plan has been established for public sharing of individual participant-level datasets.
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This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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