Pain Clinical Trial
Official title:
The Relationship of Shear Wave Elastography Findings With Pain Threshold and Quality of Life in Patients With Lipedema
Verified date | November 2023 |
Source | Fatih Sultan Mehmet Training and Research Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Turkey | Gulcan Ozturk | Istanbul |
Lead Sponsor | Collaborator |
---|---|
Fatih Sultan Mehmet Training and Research Hospital |
Turkey,
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
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 |
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