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

NCT ID: NCT06196619

Last Updated: 2024-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-04-01

Study Completion Date

2023-11-01

Brief Summary

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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

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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.

Conditions

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Pain Lipedema

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Stage 1 lipedema patients

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

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

Intervention Type 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.

Stage 2 lipedema patients

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

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

Intervention Type 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.

Stage 3 lipedema patients

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

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

Intervention Type 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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Fatih Sultan Mehmet Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Gulcan Ozturk

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 35972618 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34764426 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31544340 (View on PubMed)

Other Identifiers

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gulcanozturkchatip

Identifier Type: -

Identifier Source: org_study_id

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