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Extracorporeal Shock Wave Therapy in Patients With Lipedema (LIPO-ESWT)

1. juli 2026 opdateret af: Atlas University

Evaluation of the Effects of Extracorporeal Shock Wave Therapy on Pain, Quality of Life, and Ultrasonographic Findings 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

40

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Tyrkiet (Türkiye)
    • Istanbul
      • Istanbul, Istanbul, Tyrkiet (Türkiye)
        • Kanuni Sultan Suleyman Training and Research Hospital
        • Kontakt:
        • Ledende efterforsker:
          • Elif Ozyigit, MD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: ESWT
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.
Enhed: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Pain Intensity Assessed by Visual Analog Scale (VAS)
Tidsramme: Baseline and 2 weeks
Change in pain intensity measured using the Visual Analog Scale (VAS) from baseline to post-treatment assessment.
Baseline and 2 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Pressure Pain Threshold Measured by Pressure Algometry
Tidsramme: 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.
Baseline and 2 weeks
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Score
Tidsramme: 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.
Baseline and 2 weeks
Change in Pain Catastrophizing Scale (PCS) Score
Tidsramme: Baseline and 2 weeks
Change in pain catastrophizing assessed using the Pain Catastrophizing Scale (PCS) from baseline to the 2-week post-treatment assessment.
Baseline and 2 weeks
Change in Lower Extremity Circumference Measured Using a Flexible Measuring Tape
Tidsramme: 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.
Baseline and 2 weeks
Change in Ultrasonographic Characteristics of Skin and Subcutaneous Tissue
Tidsramme: 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.
Baseline and 2 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Atlas University

Efterforskere

  • Ledende efterforsker: Elif Ozyigit, MD, University of Health Sciences, Kanuni Sultan Suleyman Training and Research Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juli 2026

Primær færdiggørelse (Anslået)

1. december 2026

Studieafslutning (Anslået)

1. januar 2027

Datoer for studieregistrering

Først indsendt

23. juni 2026

Først indsendt, der opfyldte QC-kriterier

1. juli 2026

Først opslået (Faktiske)

6. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. juli 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • KSSEAH-LIPO-ESWT-2026
  • Atlas-EC-2026-01-04 (Anden identifikator: Istanbul Atlas University Clinical Research Ethics Committee)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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Kliniske forsøg med Extracorporeal Shock Wave Therapy

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Betingelser

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