Dokuz Eylul University Faculty of Medicine Hospital
Izmir, 35330, Turkey (Türkiye)
NCT Number: NCT07808242
The aim of this observational study is to determine the prevalence of joint hypermobility in female patients with lipedema compared to healthy volunteers. Additionally, the study investigates how the presence of hypermobility in lipedema patients relates to the clinical and ultrasonographic stage of the disease, regional pain severity, pain sensitivity, postural status (such as genu valgum and foot overpronation), quality of life, and physical activity levels. The study includes 65 female patients clinically diagnosed with lipedema and 65 healthy female volunteers matched for age and body mass index.
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Notify Me18 year–65 year
Female
Observational
Izmir, 35330, Turkey (Türkiye)
Study Overview and Design This research is designed as a cross-sectional, case-control observational study to investigate the prevalence of joint hypermobility in female patients with lipedema. The study cohort is divided into two matched groups: female patients clinically diagnosed with lipedema and a control group of healthy female volunteers strictly matched for age and Body Mass Index (BMI).
Primary and Secondary Objectives The primary objective of this study is to evaluate and compare the prevalence of generalized joint hypermobility (GJH) between the lipedema group and the healthy control group using the validated Beighton Scoring System.
The secondary objective focuses exclusively on the lipedema cohort to analyze the potential biomechanical and clinical impacts of hypermobility. It aims to determine the relationship between hypermobility status and various clinical parameters, including regional pain severity, pressure pain thresholds, lower extremity postural deviations, subcutaneous tissue thickness, and overall health-related quality of life.
Clinical Evaluations and Outcome Measures:
Statistical Analysis:
Data analysis will be performed using IBM SPSS Statistics. Group comparisons for continuous variables will utilize independent samples t-tests or Mann-Whitney U tests, depending on data normality. Categorical variables will be analyzed using Chi-Square or Fisher's Exact tests. Correlation analyses will be conducted using Pearson or Spearman tests, and logistic regression models may be applied to evaluate independent factors associated with hypermobility.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Aged between 18-65 years. Diagnosed with lipedema. Willing to participate in the study. Having a socio-cultural level suitable for study participation.
Aged between 18-65 years. Willing to participate in the study. Having a socio-cultural level suitable for study participation.
Exclusion criteria
Uncontrolled thyroid dysfunction. Chronic venous insufficiency and/or lymphedema (Stage 4 lipedema). Acute or chronic renal failure. Heart failure. Active cancer or ongoing cancer treatment. Presence of neurological disease. Presence of rheumatological disease. History of liposuction or major surgery for lipedema within the last 6 months. Visual or hearing impairment severe enough to affect study compliance. Illiteracy or cognitive impairment preventing the ability to give written informed consent.
Previous diagnosis of lipedema, lymphedema, chronic venous insufficiency. History of rheumatologic, neurologic, endocrinologic, or cardiovascular diseases.
Uncontrolled thyroid dysfunction. History of acute or chronic renal failure, heart failure, active cancer, or ongoing cancer treatment.
Orthopedic problems affecting lower extremities, trauma, or history of liposuction/major surgery within the last 6 months.
Regular use of medications that may affect pain threshold (e.g., systemic corticosteroids, antidepressants, anticonvulsants, etc.).
Physical barriers affecting pain assessment (algometry, VAS) or postural observation (e.g., severe vision/hearing loss, local skin lesions, amputation, etc.).
Cognitive impairment or lack of literacy preventing written informed consent. Psychiatric illness preventing compliance with the study process or communication problems affecting cooperation.
Time frame: Baseline (measured at the time of enrollment)
The Beighton Scoring System is used to assess generalized joint hypermobility. Total scores range from a minimum of 0 to a maximum of 9. A higher score indicates a greater degree of joint hypermobility (a worse outcome). A score of 5 or higher is considered positive for generalized joint hypermobility.
Time frame: Baseline
A self-reported visual analog scale to measure pain intensity. Scores range from 0 (no pain) to 10 (worst possible pain). (Assessed in the Lipedema Group only)
Time frame: Baseline
Pressure pain threshold measured using a digital algometer (kg/cm²) on the lower extremities. Lower values indicate higher pain sensitivity. (Assessed in the Lipedema Group only)
Time frame: Baseline
Measured bilaterally in millimeters (mm) using ultrasonography at 6-8 cm proximal to the medial malleolus. The average thickness is used for ultrasonographic staging of lipedema (Stage 1 to 4). (Assessed in the Lipedema Group only).
Time frame: Baseline
The NHP is a questionnaire used to assess health-related quality of life, consisting of 38 questions across 6 domains (energy, pain, emotional reactions, sleep, social isolation, and physical mobility). Each domain is scored from 0 to 100, yielding a total profile score ranging from a minimum of 0 to a maximum of 600. Higher scores indicate worse health-related quality of life (a worse outcome). (Assessed in the Lipedema Group only).
Time frame: Baseline
The IPAQ-SF is used to assess physical activity levels. Results are calculated as a continuous score in MET-minutes/week. The minimum possible score is 0 MET-minutes/week, with no theoretical maximum limit. Higher scores indicate higher levels of physical activity (a better outcome). (Assessed in the Lipedema Group only).
Time frame: Baseline
Presence of foot deformities (specifically pes planus / overpronation) and knee deformities (specifically genu valgum) will be evaluated observationally in a standing position. Findings will be recorded as "Present" or "Absent". (Assessed in the Lipedema Group only)
Dokuz Eylul University
Other
Joint Hypermobility and Associated Factors in Patients With Lipedema: Turkish Population Data
Acronym: LIP-HYP
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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