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NCT Number: NCT07683559

Extracorporeal Shock Wave Therapy in Patients With Lipedema

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.

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Key information

Conditions

Lipedema Connective Tissue Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kanuni Sultan Suleyman Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location contact

Elif Ozyigit, MD

CONTACT

[email protected]

+902124041500

Elif Ozyigit, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Extracorporeal Shock Wave Therapy

Device

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.

Primary outcomes

  1. Change in Pain Intensity Assessed by Visual Analog Scale (VAS)

    Time frame: Baseline and 2 weeks

    Change in pain intensity measured using the Visual Analog Scale (VAS) from baseline to post-treatment assessment.

Secondary outcomes

  1. Change in Pressure Pain Threshold Measured by Pressure Algometry

    Time frame: 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.

  2. Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Score

    Time frame: 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.

  3. Change in Pain Catastrophizing Scale (PCS) Score

    Time frame: Baseline and 2 weeks

    Change in pain catastrophizing assessed using the Pain Catastrophizing Scale (PCS) from baseline to the 2-week post-treatment assessment.

  4. Change in Lower Extremity Circumference Measured Using a Flexible Measuring Tape

    Time frame: 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.

  5. Change in Ultrasonographic Characteristics of Skin and Subcutaneous Tissue

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Elif Ozyigit, MD

CONTACT

[email protected]

+902124041500

Sponsors and collaborators

Lead sponsor

Atlas University

Other

Registry information

Official study title

Evaluation of the Effects of Extracorporeal Shock Wave Therapy on Pain, Quality of Life, and Ultrasonographic Findings in Patients With Lipedema

Acronym: LIPO-ESWT

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jul 6, 2026
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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