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

NCT06196619 | Completed

• 1 other identifier: gulcanozturkchatip
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain; Lipedema

Keywords

Shear Wave Elastography; Pain; Lipedema

Outcome Measures

Primary Outcomes (4)

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

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

  1 day

• Visual analog scale(VAS)

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

  1 day

• Algometric measurement

  Pain threshold through algometric measurement

  1 day

• EQ-5D general quality of life scale.

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

  1 day

Study Arms (3)

Stage 1 lipedema patients

It is the stage where normal skin surface, enlarged subcutaneous fat tissue, and many small nodules are present upon palpation.

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

Stage 2 lipedema patients

It is the stage with rough skin surface, large nodules of palpable subcutaneous fat tissue

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

Stage 3 lipedema patients

It is the stage in which lobular deformation of the skin surface occurs with enlarged fatty tissue.

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

Interventions

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.

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

Stage 1 lipedema patients; Stage 2 lipedema patients; Stage 3 lipedema patients

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study consist of female patients aged 18-70, diagnosed with lipedema

You may qualify if:

• Female patients diagnosed with lipedema

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fatih Sultan Mehmet Training and Research Hospital: lead

Study Sites (1)

Gulcan Ozturk

Istanbul, 34752, Turkey (Türkiye)

Location

Related Publications (3)

• Clarke C, Kirby JN, Smidt T, Best T. Stages of lipoedema: experiences of physical and mental health and health care. Qual Life Res. 2023 Jan;32(1):127-137. doi: 10.1007/s11136-022-03216-w. Epub 2022 Aug 16.

  PMID: 35972618 BACKGROUND

• Ishaq M, Bandara N, Morgan S, Nowell C, Mehdi AM, Lyu R, McCarthy D, Anderson D, Creek DJ, Achen MG, Shayan R, Karnezis T. Key signaling networks are dysregulated in patients with the adipose tissue disorder, lipedema. Int J Obes (Lond). 2022 Mar;46(3):502-514. doi: 10.1038/s41366-021-01002-1. Epub 2021 Nov 11.

  PMID: 34764426 BACKGROUND

• Buso G, Depairon M, Tomson D, Raffoul W, Vettor R, Mazzolai L. Lipedema: A Call to Action! Obesity (Silver Spring). 2019 Oct;27(10):1567-1576. doi: 10.1002/oby.22597.

  PMID: 31544340 BACKGROUND

MeSH Terms

Conditions

Pain; Lipedema

Interventions

Visual Analog Scale

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 25, 2023
• First Posted: January 9, 2024
• Study Start: April 1, 2023
• Primary Completion: August 1, 2023
• Study Completion: November 1, 2023
• Last Updated: January 9, 2024

Record last verified: 2023-11

Locations

TU (1)