Skip to main content
Clinical Trials/NCT06770634
NCT06770634
Recruiting
Not Applicable

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

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey1 site in 1 country50 target enrollmentDecember 6, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Lipedema
Sponsor
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Enrollment
50
Locations
1
Primary Endpoint
Central Sensitization Inventory
Status
Recruiting
Last Updated
7 months ago

Overview

Brief Summary

This study aims to investigate the presence of central sensitization and its associated parameters in patients with lipedema. Lipedema is a chronic and hereditary condition that primarily affects the lower extremities in women and is often associated with hormonal changes. Symptoms such as pain, swelling, and tenderness are common in lipedema, and these symptoms may be related to central sensitization. Additionally, the ultrasonographic findings and pain sensitivity in lipedema will be compared with those of healthy individuals. This study seeks to contribute to the diagnosis and treatment process of lipedema.

Detailed Description

Lipedema is a chronic and hereditary condition that affects the subcutaneous fat tissue, particularly in the lower extremities of women. Although its prevalence is not clearly known, it is estimated to be common in the general population. It typically begins during periods of weight gain associated with hormonal changes such as puberty, pregnancy, and menopause. It is characterized by persistent swelling in the lower extremities, especially in the upper thighs, which does not improve with elevation, and is painful to touch. Patients often report easy bruising even with minor trauma or touch. The hips and gluteal region are the most commonly affected areas, and the hands and feet are typically spared. On examination, the affected extremities feel soft and doughy due to fat hypertrophy, and there is an increased sensitivity across the area. During follow-up, patients' weight and body mass index (BMI) should be monitored, and the circumferences and volumes of the affected extremities should be measured and recorded. The diagnosis is usually made clinically after ruling out other differential diagnoses. Among the auxiliary imaging methods, ultrasound (US), computed tomography (CT), and magnetic resonance imaging (MRI) can be used to evaluate the skin and subcutaneous fat tissue. US is frequently preferred in the diagnosis of lipedema as it allows differentiation from lymphedema. Common ultrasonographic findings of lipedema include normal skin thickness, increased thickness of the subcutaneous layer, homogeneous expansion of this layer, and a decrease in echogenicity. A key issue in the diagnosis of lipedema is its confusion with obesity, a prevalent health issue in the general population. Pain is a significant symptom in patients with lipedema. Studies have shown that pain and increased sensitivity in the swollen extremities of lipedema patients negatively affect their quality of life. Patients frequently complain of nonspecific pain and tenderness, thought to be transmitted by A beta and C fibers, a phenomenon known as allodynia. These complaints are believed to be associated with an increase in pain sensitivity. Central sensitization is the increased sensitivity of the central nervous system to pain. This condition is associated with exaggerated pain responses to stimuli from specific areas of the body, especially in patients with chronic pain. The pain experienced in lipedema, which worsens even with mild stimuli like touch, raises the possibility of central sensitization. These findings suggest that pain in lipedema is not merely a localized fat tissue issue, but rather a complex process that also affects the nervous system. Therefore, although the presence of central sensitization in lipedema has not been conclusively proven, it is believed that central sensitization may occur in lipedema, considering the role of chronic pain and neurogenic mechanisms. This study aims to investigate the presence of central sensitization and its associated parameters in patients with lipedema. Additionally, the study will examine the differences and similarities in ultrasonographic and pain sensitivity findings between individuals with lipedema and healthy controls.

Registry
clinicaltrials.gov
Start Date
December 6, 2024
End Date
December 30, 2025
Last Updated
7 months ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Lipedema; Diagnosis of lipedema Aged between 18 and 65 years Literate Willing to participate in the study
  • control group; Being completely healthy (no internal/metabolic issues such as diabetes, obesity, or hypothyroidism, and no diagnosis of lipedema) BMI ≤ 30 Aged between 18 and 65 years Literate Willing to participate in the study

Exclusion Criteria

  • Lipedema group; Under 18 or over 65 years of age Presence of concurrent lymphedema, chronic venous insufficiency, deep vein thrombosis, polyneuropathy, or fibromyalgia Illiterate Not willing to participate in the study
  • Control group; Under 18 or over 65 years of age Presence of concurrent lymphedema, chronic venous insufficiency, deep vein thrombosis, polyneuropathy, fibromyalgia, systemic rheumatic diseases, active cancer, infections, or pregnancy Illiterate Not willing to participate in the study

Outcomes

Primary Outcomes

Central Sensitization Inventory

Time Frame: 3 months

The Central Sensitization Inventory (CSI) is a tool used to assess the heightened sensitivity of the central nervous system. This scale is designed to identify the effects of central sensitization commonly seen in chronic pain conditions by examining an individual's pain perception, sensory changes (such as sensitivity to heat, cold, or pressure), the impact of persistent pain on daily activities, and the emotional effects of pain (such as anxiety, depression, etc.). It plays a crucial role in both clinical practice and research for diagnosing chronic pain syndromes and monitoring treatment responses.

Pressure Pain Threshold

Time Frame: 3 months

The purpose of this test is to measure the pressure pain threshold, defined as the minimal pressure level that causes pain. The test will be performed twice for each region with a 3-minute interval, and the average of these measurements will be recorded. Before the test, a trial run will be conducted for the patient. Using a pressure algometer, pressure will be applied to selected points until the patient experiences pain, at which point the test for that region will be terminated. The measurements will include bilateral thighs, the middle points of the pretibial region, and the control region (left forearm's volar surface). A Wagner manual pressure algometer (1 cm² probe - 10 kg/20 lb) will be used.

Secondary Outcomes

  • Short Form-12(3 months)
  • Lower Extremity Functional Scale, LEFS(3 months)
  • Bioelectrical Impedance Analysis(3 months)
  • Evaluation with ultrasonography(3 months)
  • Lower extremity measurements(3 months)
  • Lower extremity volumetric measurements(3 months)

Study Sites (1)

Loading locations...

Similar Trials