Investigation of Central Sensitization and Associated Factors in Patients With Lipedema

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.

Conditions

• Lipedema
• Central Sensitisation

Interventions

OTHER

Pain-Pressure Threshold Measurement With an Algometer

The measurement will be performed 2 times with 3 min intervals for each region and the average of these applications will be recorded. Before the test, a trial test will be applied to the patient. With the pressure algometer, pressure will be applied to the selected points until it causes pain and the test will be terminated for that region when the patient feels pain. The measurement includes bilateral thigh, pretibial region and left forearm as remote site and Wagner manual pressure algometer (1 cm2 probe-10 kg/20 lb) will be used. The selected points will be: Bilateral thigh: Mid-thigh anterior surface Bilateral pretibial region: Anterior proximal 1/3 of the pretibial area Bilateral forearm volar side center as control point

OTHER

Central Sensitization Inventory

The central sensitization scale was developed primarily to detect central sensitization findings in patients with chronic pain and consists of two parts, A and B. In part A, 25 somatic and psychosocial symptoms frequently found in patients with central sensitization.

OTHER

Numeric Rating Scale

Leg pain, feeling of tension and heaviness on the affected arm will be evaluated separately by numerical scale.

OTHER

Lower Extremity Functional Scale

The lower extremity functional scale is a valid patient-rated outcome measure for the measurement of lower extremity function. The scale consist of 4 groups with 20 questions. The questions in these group focus on activities with increasing physical demands like questions from walking between rooms to running on uneven ground. The scoring of this scale varies from 0 (extreme difficulty/unable to perform activity) to 4 (no difficulty). The total score can be obtained by summing the scores of the individual items. The maximum score of 80 indicates no functional limitations and the minimum score of 0 indicates extreme limitations.

OTHER

Short form 12

The Short form 12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. It is often used as a quality of life measure.The scoring yields two summary measures: the Physical Component Summary (PCS) and the Mental Component Summary (MCS).Utilize the norm-based scoring system to interpret PCS and MCS scores, with a mean of 50 and a standard deviation of 10 in the general population.Scores above 50 indicate a better-than-average health-related quality of life, while scores below 50 suggest below-average health.

OTHER

lower extremity volumetric measurement

It is calculated by converting the circumference measurements taken at 4 cm intervals from the ankle to the proximal thigh into lower extremity volume with Excel.

OTHER

lower extremity circumference measurement

bilateral tuberosity tibia, 20 cm proximal tuberosity tibia, tuberosity tibia 10 cm distal and ankle level

OTHER

Bioelectrical Impedance Analysis

With Bioelectrical Impedance Analysis, fat, muscle and water ratio and lean mass are calculated in addition to the patient's body weight.

DIAGNOSTIC_TEST

Ultrasound

Measurement of subcutaneous fat tissue thickness from mid-thigh, pretibial, lateral leg and supramalleolar regions with ultrasound.The average of two measurements taken from the same area will be recorded.According to these measurements; 12-15 mm = mild lipedema or lipohyperplasia, 15-20 mm = moderate lipedema, \>20 mm = significant lipedema, \>30 mm = severe lipedema.

Sponsors & Collaborators

• Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

  lead OTHER

Principal Investigators

• Emre Ata, Assoc.Prof · Sultan Abdülhamid Han Research and Training Hospital

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-12-06

Primary Completion

2025-09-01

Completion

2025-12-30

Countries

• Turkey (Türkiye)

Study Locations