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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06196619
• Other study ID #: gulcanozturkchatip
• Status: Completed
• Start date: April 1, 2023
• Est. completion date: November 1, 2023

Study information

• Verified date: November 2023
• Source: Fatih Sultan Mehmet Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: November 1, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lipedema
• Pain

Intervention

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

Locations

Country	Name	City	State
Turkey	Gulcan Ozturk	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Fatih Sultan Mehmet Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Visual analog scale(VAS)	Pain levels were assessed using the visual analog scale(VAS)	1 day
Primary	Algometric measurement	Pain threshold through algometric measurement	1 day
Primary	EQ-5D general quality of life scale.	quality of life using the EQ-5D general quality of life scale.	1 day