Extracorporeal Shock Wave Therapy in Patients With Lipedema

NCT07683559 | Not Yet Recruiting

• 2 other identifiers: KSSEAH-LIPO-ESWT-2026Atlas-EC-2026-01-04
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Lipedema

Keywords

Extracorporeal Shock Wave Therapy; ESWT; Lipedema; Pain; Ultrasonography; Quality of Life; PROMIS; Patient-Reported Outcomes

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 2 weeks

Secondary Outcomes (5)

• 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

Study Arms (1)

ESWT

EXPERIMENTAL

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

Interventions

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.

ESWT

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Atlas University: lead

Study Sites (1)

Kanuni Sultan Suleyman Training and Research Hospital

Istanbul, Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Lipedema; Pain

Interventions

Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Elif Ozyigit, MD

  University of Health Sciences, Kanuni Sultan Suleyman Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elif Ozyigit, MD

CONTACT

+902124041500; dr.elifoz16@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: This is an open-label single-arm study without masking.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 23, 2026
• First Posted: July 6, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: July 6, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)