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

Completed

• Conditions: Lipedema; Pain

• Registration Number: NCT06196619
• Lead Sponsor: Fatih Sultan Mehmet Training and Research Hospital

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.

Detailed Description

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.

Study Timeline

• Study Start: 2023-04-01
• Primary Completion: 2023-08-01
• Status Verified: 2023-11
• Study Completion: 2023-11-01
• Study First Submitted: 2023-12-25
• Study First Submitted QC: 2023-12-25
• Last Update Submitted: 2023-12-25
• Study First Posted: 2024-01-09
• Last Update Posted: 2024-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 70

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Subcutaneous elastic modulus with shear wave elastography (SWE) imaging of lower limbs	1 day	Measurements using B-mode ultrasound and subcutaneous elastic modulus with shear wave elastography (SWE) imaging of lower limbs at three anatomical levels.
Visual analog scale(VAS)	1 day	Pain levels were assessed using the visual analog scale(VAS)
Algometric measurement	1 day	Pain threshold through algometric measurement
EQ-5D general quality of life scale.	1 day	quality of life using the EQ-5D general quality of life scale.

Trial Locations

Locations (1)

Gulcan Ozturk; 🇹🇷 Istanbul, Turkey