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

December 25, 2023 updated by: Fatih Sultan Mehmet Training and Research Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34752
        • Gulcan Ozturk

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The study consist of female patients aged 18-70, diagnosed with lipedema

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Stage 1 lipedema patients
It is the stage where normal skin surface, enlarged subcutaneous fat tissue, and many small nodules are present upon palpation.
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.
Other Names:
  • visual analog scale(VAS)
  • pain threshold through algometric measurement
  • 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
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.
Other Names:
  • visual analog scale(VAS)
  • pain threshold through algometric measurement
  • 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.
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.
Other Names:
  • visual analog scale(VAS)
  • pain threshold through algometric measurement
  • EQ-5D general quality of life scale.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fatih Sultan Mehmet Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2023

Primary Completion (Actual)

August 1, 2023

Study Completion (Actual)

November 1, 2023

Study Registration Dates

First Submitted

December 25, 2023

First Submitted That Met QC Criteria

December 25, 2023

First Posted (Actual)

January 9, 2024

Study Record Updates

Last Update Posted (Actual)

January 9, 2024

Last Update Submitted That Met QC Criteria

December 25, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • gulcanozturkchatip

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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