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Extracorporeal Shock Wave Therapy in Patients With Lipedema

ConditionLipedema
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAtlas University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Pregnancy or breastfeeding

Active infection in the treatment area

Malignancy

Severe cardiovascular disease

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: ESWTExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
Baseline and 2 weeks

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Atlas University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: