An observational study in Lipedema and Hypermobility, Joint, sponsored by Dokuz Eylul University. Completed at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-08.
Sponsored by Dokuz Eylul University · Observational
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.
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.
85 studies on the registry are indexed under Lipedema; 32 are open to participants now.
This study's enrollment of 130 is above the median of 90 across 42 observational studies indexed under Lipedema.
Browse Lipedema studies →Dokuz Eylul University is the lead sponsor of 261 studies on the registry; 35 are open to participants now.
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Lipedema Group: Female patients, aged between 18 and 65 years, who were clinically diagnosed with lipedema based on detailed physical examination and clinical assessments. The participants were evaluated and recruited at the Dokuz Eylul University Faculty of Medicine, Department of Physical Medicine and Rehabilitation Outpatient Clinic.
Control Group: Healthy female volunteers, aged between 18 and 65 years, who were strictly matched to the lipedema group in terms of age and Body Mass Index (BMI).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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 .
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 , 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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Women diagnosed with lipedema according to clinical criteria.
Healthy female volunteers matched for age and BMI, without lipedema diagnosis.
Beighton Score
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 (measured at the time of enrollment)
Pain Intensity
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
Algometric Assessment
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
Subcutaneous Adipose Tissue Thickness
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
Nottingham Health Profile (NHP)
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
International Physical Activity Questionnaire - Short Form (IPAQ-SF)
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
Observational Postural Analysis
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)
Time frame: Baseline
Plan to share: No — Individual participant data will not be shared to protect participant privacy and maintain data confidentiality. The informed consent forms approved by the local Ethics Committee explicitly state that personal clinical data will be kept confidential and will not be shared with third-party researchers. Therefore, only aggregated data will be reported in publications.
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This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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