Clinical trial NCT06196619: The Relationship of Shear Wave Elastography Findings With Pain Threshold and Quality of Life in Patients With Lipedema
Official title: The Relationship of Shear Wave Elastography Findings With Pain Threshold and Quality of Life in Patients With Lipedema
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain
Lipedema
Keywords: Shear Wave Elastography
Pain
Lipedema
Lead sponsor: Fatih Sultan Mehmet Training and Research Hospital
Sponsor class: OTHER
First posted: 2024-01-09
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study consist of female patients aged 18-70, diagnosed with lipedema

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Subcutaneous elastic modulus with shear wave elastography (SWE) imaging of lower limbs
timeFrame: 1 day
measure: Visual analog scale(VAS)
timeFrame: 1 day
measure: Algometric measurement
timeFrame: 1 day
measure: EQ-5D general quality of life scale.
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Gulcan Ozturk
Study officials:
References:
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.
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.
citation: 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.