LipedemaLSQNCT07061808
The Reliability and Validity of the Turkish Version of the LSQ
An observational study of Lipedema and Women, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
Abstract Background/ Aim: The aim of this study was to investigate the reliability and validity of the Turkish version of the Lipedema Screening Questionnaire (T-LSQ). Method: The study involved 59 female volunteers diagnosed with lipedema by a cardiovascular surgeon. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- What is being tested?
- Lipedema Screening Questionnaire
- How many people
- 59 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Oct 2022to 25 Oct 2023
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Information provided about the study and informed consent was obtained from voluntary participants. Participants who came to University hospital physiotherapy department for treatment or control purposes with the diagnoses of lipoedema, lipolymphoedema were included in the study.
Who may be able to join
- 18 years of age or older
- had no communication cognitive and mental problem
- participant in Turkish
Who cannot join
- Patients with diagnoses of renal and heart failure
- individuals with history of lower extremity surgery
- individuals with severe arterial venous disease involving the lower extremity
- individuals with active cancer disease or metastasis
- individuals with severe acute infective disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
aDepartment of Physiotherapy and Rehabilitation, Health Science Faculty, Gazi University, Ankara, Turkey
Ankara, 06000
About this study
Official title: The Reliability and Validity of the Turkish Version of the Lipedema Screening Questionnaire
Abstract Background/ Aim: The aim of this study was to investigate the reliability and validity of the Turkish version of the Lipedema Screening Questionnaire (T-LSQ). Method: The study involved 59 female volunteers diagnosed with lipedema by a cardiovascular surgeon. Key demographics such as age, onset age, lipedema types and stages, clinical features, and BMI were recorded. The Turkish adaptation of the LSQ was performed in accordance with the protocol of Beaton. Confirmatory factor analysis was performed for structural validity. For concurrent validity, T- LSQ, the Lower Extremity Functional Scale (LEFS), the Lymphedema Life Impact Scale (LLIS), and the Lymphoedema Functioning, Disability and Health Quastionnaire for Lower Extremity Lymphedema (Lymph-ICF-LL) were applied and the correlation between the scale responses was analyzed. Test-retest and internal consistency reliability were performed.
- Being tested
- Lipedema Screening Questionnaire
- Keywords
- lipedema, validity, reliability, Turkish adaptation
- Medical subject headings
- Lipedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lipedema Screening QuestionnaireDiagnostic test
The Lipoedema screening questionnaire (LSQ) is a practical tool that can be applied quickly and easily and is used to identify patients with lipoedema during history taking and physical examination.
| Study group | Role | What they receive |
|---|---|---|
| women diagnosed with lipoedema | women diagnosed with lipoedema Receives: Diagnostic Test: Lipedema Screening Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Validity and Reliability of Turkish version of the Lipedema Screening Questionnaire
The Validity and Reliability of Turkish version of the Lipedema Screening Questionnaire: For validity, T-LSQ, Lower Extremity Functional Scale (LEFS), Lymphedema Life Impact Scale (LLIS) and Lymphedema Function, Disability and Health Questionnaire for Lower Extremity Lymphedema (Lymph-ICF-LL) were applied and correlation analysis between scale responses will be done. The LSQ questionnaire, whose reliability we measured, was applied at the beginning of the study and again after 10 days.
Measured: at 10-day intervals.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2025
- Study start20 Oct 2022
- Primary completion20 Jun 2023
- Study completion25 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (29)Papers the sponsor has linked to this study.
- Other trials for LipedemaStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- 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
- Other
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ilke Keser, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07061808
- Sponsor's protocol ID
- Canan Lipedema Screening Q.
- Acronym
- LSQ
- Status last verified
- Jun 2025
- First submitted
- 14 Jun 2025
- Last updated
- 11 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: I don't feel the need to.
Publications
Devoogdt N, Van Kampen M, Geraerts I, Coremans T, Christiaens MR. Lymphoedema Functioning, Disability and Health questionnaire (Lymph-ICF): reliability and validity. Phys Ther. 2011 Jun;91(6):944-57. doi: 10.2522/ptj.20100087. Epub 2011 Apr 14.
PubMed 21493748Terwee CB, Bot SD, de Boer MR, van der Windt DA, Knol DL, Dekker J, Bouter LM, de Vet HC. Quality criteria were proposed for measurement properties of health status questionnaires. J Clin Epidemiol. 2007 Jan;60(1):34-42. doi: 10.1016/j.jclinepi.2006.03.012. Epub 2006 Aug 24.
PubMed 17161752Herbst KL, Kahn LA, Iker E, Ehrlich C, Wright T, McHutchison L, Schwartz J, Sleigh M, Donahue PM, Lisson KH, Faris T, Miller J, Lontok E, Schwartz MS, Dean SM, Bartholomew JR, Armour P, Correa-Perez M, Pennings N, Wallace EL, Larson E. Standard of care for lipedema in the United States. Phlebology. 2021 Dec;36(10):779-796. doi: 10.1177/02683555211015887. Epub 2021 May 28.
PubMed 34049453Mishra, Manit. (2016). Confirmatory Factor Analysis (CFA) as an Analytical Technique to Assess Measurement Error in Survey Research: A Review. Paradigm. 20. 97-112. 10.1177/0971890716672933.
Zinbarg, R.E., Revelle, W., Yovel, I. et al. Cronbach's α, Revelle's β, and Mcdonald's ω H : their relations with each other and two alternative conceptualizations of reliability. Psychometrika 70, 123-133 (2005). https://doi.org/10.1007/s11336-003-0974-7
Feise RJ, Michael Menke J. Functional rating index: a new valid and reliable instrument to measure the magnitude of clinical change in spinal conditions. Spine (Phila Pa 1976). 2001 Jan 1;26(1):78-86; discussion 87. doi: 10.1097/00007632-200101010-00015.
PubMed 11148650Beaton DE, Bombardier C, Guillemin F, Ferraz MB. Guidelines for the process of cross-cultural adaptation of self-report measures. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3186-91. doi: 10.1097/00007632-200012150-00014. No abstract available.
PubMed 11124735Citaker S, Kafa N, Hazar Kanik Z, Ugurlu M, Kafa B, Tuna Z. Translation, cross-cultural adaptation and validation of the Turkish version of the Lower Extremity Functional Scale on patients with knee injuries. Arch Orthop Trauma Surg. 2016 Mar;136(3):389-95. doi: 10.1007/s00402-015-2384-6. Epub 2016 Jan 4.
PubMed 26728274Degirmenci B, Tuzun S, Of NS, Oral A, Sindel D. Reliability and validity of Turkish version of Lymphedema Life Impact Scale. Turk J Phys Med Rehabil. 2019 May 3;65(2):147-153. doi: 10.5606/tftrd.2019.3041. eCollection 2019 Jun.
PubMed 31453555Kostanoglu A, Hosbay Z, Tarakci E. Lymphoedema functioning, disability and health questionnaire Turkish version: translation, cross-cultural adaptation and validation. J Phys Ther Sci. 2016 Jun;28(6):1728-32. doi: 10.1589/jpts.28.1728. Epub 2016 Jun 28.
PubMed 27390404Begum, M. R. (2019). Validity and Reliability of Visual Analogue Scale (Vas) for Pain Measurement.
Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.
PubMed 1593914Weiss J, Daniel T. VALIDATION OF THE LYMPHEDEMA LIFE IMPACT SCALE (LLIS): A CONDITION-SPECIFIC MEASUREMENT TOOL FOR PERSONS WITH LYMPHEDEMA. Lymphology. 2015 Sep;48(3):128-38.
PubMed 26939160Devoogdt N, De Groef A, Hendrickx A, Damstra R, Christiaansen A, Geraerts I, Vervloesem N, Vergote I, Van Kampen M. Lymphoedema Functioning, Disability and Health Questionnaire for Lower Limb Lymphoedema (Lymph-ICF-LL): reliability and validity. Phys Ther. 2014 May;94(5):705-21. doi: 10.2522/ptj.20130285. Epub 2014 Jan 10.
PubMed 24415775Binkley JM, Stratford PW, Lott SA, Riddle DL. The Lower Extremity Functional Scale (LEFS): scale development, measurement properties, and clinical application. North American Orthopaedic Rehabilitation Research Network. Phys Ther. 1999 Apr;79(4):371-83.
PubMed 10201543
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Reliability and Validity of the Turkish Version of the Lipedema Screening Questionnaire
- ClinicalTrials.gov ID
- NCT07061808
- Acronym / sponsor ID
- LSQ / Canan Lipedema Screening Q.
- Keywords
- lipedema, validity, reliability, Turkish adaptation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 20 Oct 2022 (actual)
- Primary completion
- 20 Jun 2023 (actual)
- Study completion
- 25 Oct 2023 (actual)
- First posted
- 11 Jul 2025 (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.
Abstract Background/ Aim: The aim of this study was to investigate the reliability and validity of the Turkish version of the Lipedema Screening Questionnaire (T-LSQ). Method: The study involved 59 female volunteers diagnosed with lipedema by a cardiovascular surgeon. Key demographics such as age, onset age, lipedema types and stages, clinical features, and BMI were recorded. The Turkish adaptation of the LSQ was performed in accordance with the protocol of Beaton. Confirmatory factor analysis was performed for structural validity. For concurrent validity, T- LSQ, the Lower Extremity Functional Scale (LEFS), the Lymphedema Life Impact Scale (LLIS), and the Lymphoedema Functioning, Disability and Health Quastionnaire for Lower Extremity Lymphedema (Lymph-ICF-LL) were applied and the correlation between the scale responses was analyzed. Test-retest and internal consistency reliability were performed.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| women diagnosed with lipoedema | – | Diagnostic Test: Lipedema Screening Questionnairewomen diagnosed with lipoedema |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Information provided about the study and informed consent was obtained from voluntary participants. Participants who came to University hospital physiotherapy department for treatment or control purposes with the diagnoses of lipoedema, lipolymphoedema were included in the study.
Key inclusion criteria (3 listed)
- 18 years of age or older
- had no communication cognitive and mental problem
- participant in Turkish
Key exclusion criteria (5 listed)
- Patients with diagnoses of renal and heart failure
- individuals with history of lower extremity surgery
- individuals with severe arterial venous disease involving the lower extremity
- individuals with active cancer disease or metastasis
- individuals with severe acute infective disease
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 |
|---|---|---|
| Lipedema Screening QuestionnaireThe Lipoedema screening questionnaire (LSQ) is a practical tool that can be applied quickly and easily and is used to identify patients with lipoedema during history taking and physical examination. | Diagnostic test | women diagnosed with lipoedema |
Primary outcome
The Validity and Reliability of Turkish version of the Lipedema Screening Questionnaire
Time frame: at 10-day intervals.
The Validity and Reliability of Turkish version of the Lipedema Screening Questionnaire: For validity, T-LSQ, Lower Extremity Functional Scale (LEFS), Lymphedema Life Impact Scale (LLIS) and Lymphedema Function, Disability and Health Questionnaire for Lower Extremity Lymphedema (Lymph-ICF-LL) were applied and correlation analysis between scale responses will be done. The LSQ questionnaire, whose reliability we measured, was applied at the beginning of the study and again after 10 days.
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 11 Jul 2025.
- Results publication: PubMed 21493748Devoogdt N, Van Kampen M, Geraerts I, Coremans T, Christiaens MR. Lymphoedema Functioning, Disability and Health questionnaire (Lymph-ICF): reliability and validity. Phys Ther. 2011 Jun;91(6):944-57. doi: 10.2522/ptj.20100087. Epub 2011 Apr 14.
- Results publication: PubMed 17161752Terwee CB, Bot SD, de Boer MR, van der Windt DA, Knol DL, Dekker J, Bouter LM, de Vet HC. Quality criteria were proposed for measurement properties of health status questionnaires. J Clin Epidemiol. 2007 Jan;60(1):34-42. doi: 10.1016/j.jclinepi.2006.03.012. Epub 2006 Aug 24.
- Results publication: PubMed 34049453Herbst KL, Kahn LA, Iker E, Ehrlich C, Wright T, McHutchison L, Schwartz J, Sleigh M, Donahue PM, Lisson KH, Faris T, Miller J, Lontok E, Schwartz MS, Dean SM, Bartholomew JR, Armour P, Correa-Perez M, Pennings N, Wallace EL, Larson E. Standard of care for lipedema in the United States. Phlebology. 2021 Dec;36(10):779-796. doi: 10.1177/02683555211015887. Epub 2021 May 28.
- Results publicationMishra, Manit. (2016). Confirmatory Factor Analysis (CFA) as an Analytical Technique to Assess Measurement Error in Survey Research: A Review. Paradigm. 20. 97-112. 10.1177/0971890716672933.
- Results publicationZinbarg, R.E., Revelle, W., Yovel, I. et al. Cronbach's α, Revelle's β, and Mcdonald's ω H : their relations with each other and two alternative conceptualizations of reliability. Psychometrika 70, 123-133 (2005). https://doi.org/10.1007/s11336-003-0974-7
- Results publication: PubMed 11148650Feise RJ, Michael Menke J. Functional rating index: a new valid and reliable instrument to measure the magnitude of clinical change in spinal conditions. Spine (Phila Pa 1976). 2001 Jan 1;26(1):78-86; discussion 87. doi: 10.1097/00007632-200101010-00015.
- Results publication: PubMed 11124735Beaton DE, Bombardier C, Guillemin F, Ferraz MB. Guidelines for the process of cross-cultural adaptation of self-report measures. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3186-91. doi: 10.1097/00007632-200012150-00014. No abstract available.
- Results publication: PubMed 26728274Citaker S, Kafa N, Hazar Kanik Z, Ugurlu M, Kafa B, Tuna Z. Translation, cross-cultural adaptation and validation of the Turkish version of the Lower Extremity Functional Scale on patients with knee injuries. Arch Orthop Trauma Surg. 2016 Mar;136(3):389-95. doi: 10.1007/s00402-015-2384-6. Epub 2016 Jan 4.
- Results publication: PubMed 31453555Degirmenci B, Tuzun S, Of NS, Oral A, Sindel D. Reliability and validity of Turkish version of Lymphedema Life Impact Scale. Turk J Phys Med Rehabil. 2019 May 3;65(2):147-153. doi: 10.5606/tftrd.2019.3041. eCollection 2019 Jun.
- Results publication: PubMed 27390404Kostanoglu A, Hosbay Z, Tarakci E. Lymphoedema functioning, disability and health questionnaire Turkish version: translation, cross-cultural adaptation and validation. J Phys Ther Sci. 2016 Jun;28(6):1728-32. doi: 10.1589/jpts.28.1728. Epub 2016 Jun 28.
- Results publicationBegum, M. R. (2019). Validity and Reliability of Visual Analogue Scale (Vas) for Pain Measurement.
- Results publication: PubMed 1593914Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. I don't feel the need to.
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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 Lipedema and Women, run by Gazi University 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 3 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 11 Jul 2025. 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?
The Validity and Reliability of Turkish version of the Lipedema Screening Questionnaire (time frame: at 10-day intervals.). 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 NCT07061808, which also lists 29 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 11 Jul 2025.