What is this study trying to find out about lipedema?

This study aims to understand central sensitization and related factors in patients with lipedema, a condition that causes chronic pain and swelling in the lower limbs. Researchers want to compare pain sensitivity and ultrasound findings between people with lipedema and healthy volunteers to better diagnose and treat this condition. The study is sponsored by Sultan Abdulhamid Han Training and Research Hospital in Istanbul, Turkey.

Who may be eligible for this lipedema clinical trial?

Adults aged 18 to 65 years with a diagnosis of lipedema or healthy individuals without metabolic or internal conditions may be eligible. Participants must be literate and willing to take part. Those with other conditions like lymphedema, chronic venous insufficiency, or fibromyalgia are excluded. Please review eligibility criteria for more details.

Is there any cost to participate in this lipedema clinical trial?

Study-related care, including all assessments and procedures, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel or accommodation costs.

Actively Recruiting

Age: 18Years - 65Years

All Genders

Healthy Volunteers

ID06770634

Study of Central Sensitization and Its Related Factors in Adults With Lipedema Compared to Healthy Individuals

Led by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey · Updated on 2025-09-08

Participants Needed

Research Sites

17 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are investigating central sensitization and related factors in people with lipedema, a chronic and inherited condition mainly affecting womens lower limbs. Lipedema often causes pain, swelling, and tenderness linked to hormonal changes, and this study aims to better understand these symptoms by comparing affected individuals with healthy people. The goal is to improve diagnosis and treatment of lipedema by exploring the role of nervous system sensitivity in the experience of pain. The study involves two groups patients diagnosed with lipedema and healthy volunteers without metabolic or internal health issues. Various assessments will be conducted, including pain-pressure threshold measurements with an algometer, central sensitization inventories, ultrasound imaging of subcutaneous fat, and functional and quality of life scales. Measurements of limb circumference and volume, along with bioelectrical impedance analysis, will also be performed to gather detailed physical and physiological data. Participants will undergo evaluations at baseline and after three months, including questionnaires on pain, function, and health quality, as well as ultrasound and body composition tests. Researchers will monitor changes in central sensitization and pain sensitivity over this period. The study will record all findings related to pain thresholds and physical measurements to understand how lipedema affects the body and nervous system, contributing valuable information for future care approaches.

CONDITIONS

Brief Title

Investigation of Central Sensitization and Associated Factors in Patients With Lipedema

Who Can Participate

Age: 18Years - 65Years

All Genders

Healthy Volunteers

Eligibility Criteria

You may qualify if you...

Diagnosis of lipedema
Aged between 18 and 65 years
Literate
Willing to participate in the study
For control group: completely healthy without internal or metabolic issues such as diabetes, obesity, or hypothyroidism
Control group BMI must be 30 or less

You will not qualify if you...

Under 18 or over 65 years of age
Presence of other conditions such as lymphedema, chronic venous insufficiency, deep vein thrombosis, polyneuropathy, or fibromyalgia
For control group: systemic rheumatic diseases, active cancer, infections, or pregnancy
Illiterate
Not willing to participate in the study

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Up to 3 months

Participants undergo diagnostic assessments including ultrasound measurements of subcutaneous fat tissue thickness and other physical measurements such as lower extremity circumference and volumetric measurements, bioelectrical impedance analysis, and pain-pressure threshold measurements.

Initial measurements and assessments during baseline and follow-up visits within 3 months

Long-term Monitoring

Duration - 3 months

Participants complete patient-reported outcome measures including the Central Sensitization Inventory, Numeric Rating Scale for pain, Lower Extremity Functional Scale, and Short Form-12 to monitor symptoms, pain sensitivity, function, and quality of life over the study period.

Periodic assessments over 3 months