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NCT Number: NCT06196619

The Relationship of Shear Wave Elastography Findings With Pain Threshold and Quality of Life in Patients With Lipedema

The aim of this study is to evaluate the relationship between disease severity and subcutaneous tissue shearwave elastography findings with pain threshold and quality of life in patients diagnosed with lipedema.

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

Female

Study type

Observational

Primary location

Gulcan Ozturk

Istanbul, 34752, Turkey (Türkiye)

About this study

Patients diagnosed with lipedema were divided into 3 stages according to disease severity. Pain level was evaluated with visual analogue scale, pain threshold with algometric measurement, and quality of life with EQ-5D general quality of life scale. All patients underwent measurements using B-mode ultrasound and subcutaneous elastic modulus with shear wave elastography (SWE) imaging of lower limbs at three anatomical levels.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Female patients diagnosed with lipedema

Exclusion criteria

  • under 18 years of age,
  • Patients with edema of cardiac or nephrogenic origin, diabetes mellitus, thyroid dysfunction, patients with lymphedema or chronic venous insufficiency, oncology patients,
  • individuals with polyneuropathy, radiculopathy, or advanced degenerative diseases affecting the extremities within the last 6 months, based on clinical findings and medical history.
  • patients using antiepileptics and antidepressants,
  • individuals unable to cognitively tolerate participation in the study were also excluded.

Treatment and study plan

SWE:B-mode ultrasound and subcutaneous elastic modulus with shear wave elastography at three level

Diagnostic Test

Visual analog scale(VAS):This scale measure in which individuals rate their pain from 0 to 10, with 0 indicating no pain at all and 10 representing the worst pain;pain threshold through algometric measurement; quality of life using the EQ-5D general quality of life scale.

Other names: visual analog scale(VAS), pain threshold through algometric measurement, EQ-5D general quality of life scale.

Primary outcomes

  1. Subcutaneous elastic modulus with shear wave elastography (SWE) imaging of lower limbs

    Time frame: 1 day

    Measurements using B-mode ultrasound and subcutaneous elastic modulus with shear wave elastography (SWE) imaging of lower limbs at three anatomical levels.

  2. Visual analog scale(VAS)

    Time frame: 1 day

    Pain levels were assessed using the visual analog scale(VAS)

  3. Algometric measurement

    Time frame: 1 day

    Pain threshold through algometric measurement

  4. EQ-5D general quality of life scale.

    Time frame: 1 day

    quality of life using the EQ-5D general quality of life scale.

Sponsors and collaborators

Lead sponsor

Fatih Sultan Mehmet Training and Research Hospital

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 9, 2024
Registry last updated
Jan 9, 2024

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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