PainNCT06196619
The Relationship of Shear Wave Elastography Findings With Pain Threshold and Quality of Life in Patients With Lipedema
An observational study of Pain and Lipedema, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women onlyHealthy volunteers can take part
- What is being tested?
- SWE:B-mode ultrasound and subcutaneous elastic modulus with shear wave elastography at three level
- Type of treatment
- Injection or infusion
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2023to 1 Nov 2023
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study consist of female patients aged 18-70, diagnosed with lipedema
Who may be able to join
- Female patients diagnosed with lipedema
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- SWE:B-mode ultrasound and subcutaneous elastic modulus with shear wave elastography at three level
- Keywords
- Shear Wave Elastography, Pain, Lipedema
- Medical subject headings
- Pain, Lipedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SWE:B-mode ultrasound and subcutaneous elastic modulus with shear wave elastography at three levelDiagnostic test
Also called visual analog scale(VAS), pain threshold through algometric measurement, EQ-5D general quality of life scale.
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.
| Study group | Role | What they receive |
|---|---|---|
| Stage 1 lipedema patients | It is the stage where normal skin surface, enlarged subcutaneous fat tissue, and many small nodules are present upon palpation. Receives: Diagnostic Test: SWE:B-mode ultrasound and subcutaneous elastic modulus with shear wave elastography at three level | |
| Stage 2 lipedema patients | It is the stage with rough skin surface, large nodules of palpable subcutaneous fat tissue Receives: Diagnostic Test: SWE:B-mode ultrasound and subcutaneous elastic modulus with shear wave elastography at three level | |
| Stage 3 lipedema patients | It is the stage in which lobular deformation of the skin surface occurs with enlarged fatty tissue. Receives: Diagnostic Test: SWE:B-mode ultrasound and subcutaneous elastic modulus with shear wave elastography at three level |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Visual analog scale(VAS)
Pain levels were assessed using the visual analog scale(VAS)
Measured: 1 day
Algometric measurement
Pain threshold through algometric measurement
Measured: 1 day
EQ-5D general quality of life scale.
quality of life using the EQ-5D general quality of life scale.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2024
- Study start1 Apr 2023
- Primary completion1 Aug 2023
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 70 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Fatih Sultan Mehmet Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06196619
- Sponsor's protocol ID
- gulcanozturkchatip
- Status last verified
- Nov 2023
- First submitted
- 25 Dec 2023
- Last updated
- 9 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 35972618Ishaq 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.
PubMed 34764426Buso 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.
PubMed 31544340
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship of Shear Wave Elastography Findings With Pain Threshold and Quality of Life in Patients With Lipedema
- ClinicalTrials.gov ID
- NCT06196619
- Acronym / sponsor ID
- gulcanozturkchatip
- Keywords
- Shear Wave Elastography, Pain, Lipedema
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Fatih Sultan Mehmet Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 9 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Stage 1 lipedema patients | – | Diagnostic Test: SWE:B-mode ultrasound and subcutaneous elastic modulus with shear wave elastography at three levelIt is the stage where normal skin surface, enlarged subcutaneous fat tissue, and many small nodules are present upon palpation. |
| Stage 2 lipedema patients | – | Diagnostic Test: SWE:B-mode ultrasound and subcutaneous elastic modulus with shear wave elastography at three levelIt is the stage with rough skin surface, large nodules of palpable subcutaneous fat tissue |
| Stage 3 lipedema patients | – | Diagnostic Test: SWE:B-mode ultrasound and subcutaneous elastic modulus with shear wave elastography at three levelIt is the stage in which lobular deformation of the skin surface occurs with enlarged fatty tissue. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study consist of female patients aged 18-70, diagnosed with lipedema
Key inclusion criteria (1 listed)
- Female patients diagnosed with lipedema
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SWE:B-mode ultrasound and subcutaneous elastic modulus with shear wave elastography at three levelAlso: visual analog scale(VAS), pain threshold through algometric measurement, EQ-5D general quality of life scale.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. | Diagnostic test | Stage 1 lipedema patients, Stage 2 lipedema patients, Stage 3 lipedema patients |
Primary outcome
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.
Visual analog scale(VAS)
Time frame: 1 day
Pain levels were assessed using the visual analog scale(VAS)
Algometric measurement
Time frame: 1 day
Pain threshold through algometric measurement
EQ-5D general quality of life scale.
Time frame: 1 day
quality of life using the EQ-5D general quality of life scale.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2024.
- Background: PubMed 35972618Clarke 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.
- Background: PubMed 34764426Ishaq 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.
- Background: PubMed 31544340Buso 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.
- Individual participant dataSharing planned: Undecided
Related trials for Pain
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain and Lipedema, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subcutaneous elastic modulus with shear wave elastography (SWE) imaging of lower limbs (time frame: 1 day). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06196619, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2024.