Actively Recruiting

Age: 18Years - 65Years
All Genders
Healthy Volunteers
ID06770634

Investigation of the Prevalence of Central Sensitization and Associated Factors in Patients With Lipedema

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

50

Participants Needed

1

Research Sites

17 weeks

Total Duration

On this page

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 women's 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

Eligible

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
Not Eligible

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

AI-Screening

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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

Trial Site Locations

Total: 1 location

1

Sultan 2. Abdülhamid Han Eğitim ve Araştırma Hastanesi, İstanbul, Üsküdar 34000

Istanbul, Üsküdar, Turkey (Türkiye), 34000

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Research Team

Z

Zeynep Candan, MD

F

Feyza N Yucel, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Published Research Related To This Trial

Indications of Peripheral Pain, Dermal Hypersensitivity, and Neurogenic Inflammation in Patients with Lipedema.

Adri Chakraborty, Rachelle Crescenzi, Timaj A Usman...

https://pubmed.ncbi.nlm.nih.gov/36142221

Non-obese lipedema patients show a distinctly altered quantitative sensory testing profile with high diagnostic potential.

Rebecca Dinnendahl, Dominik Tschimmel, Vanessa Löw...

https://pubmed.ncbi.nlm.nih.gov/38617100

The Lower Extremity Functional Scale (LEFS): scale development, measurement properties, and clinical application. North American Orthopaedic Rehabilitation Research Network.

J M Binkley, P W Stratford, S A Lott...

https://pubmed.ncbi.nlm.nih.gov/10201543