Investigation of Central Sensitization and Associated Factors in Patients With Lipedema

NCT06770634 | Recruiting

• 1 other identifier: 2024/14/14/10
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Lipedema; Central Sensitisation

Keywords

central sensitization; Lipedema

Outcome Measures

Primary Outcomes (2)

• Central Sensitization Inventory

  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.

  3 months

• Pressure Pain Threshold

  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.

  3 months

Secondary Outcomes (6)

• 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

Study Arms (2)

lipedema

patients with lipedema

Other: Pain-Pressure Threshold Measurement With an Algometer; Other: Central Sensitization Inventory; Other: Numeric Rating Scale; Other: Lower Extremity Functional Scale; Other: Short form 12; Other: lower extremity volumetric measurement; Other: lower extremity circumference measurement; Other: Bioelectrical Impedance Analysis; Diagnostic Test: Ultrasound

Healthy control

Healthy volunteers

Other: Pain-Pressure Threshold Measurement With an Algometer; Other: Central Sensitization Inventory; Other: Lower Extremity Functional Scale; Other: Short form 12; Other: lower extremity circumference measurement; Other: Bioelectrical Impedance Analysis; Diagnostic Test: Ultrasound

Interventions

Pain-Pressure Threshold Measurement With an Algometer OTHER

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

Healthy control; lipedema

Central Sensitization Inventory OTHER

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.

Also known as: CSI

Healthy control; lipedema

Numeric Rating Scale OTHER

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

lipedema

Lower Extremity Functional Scale OTHER

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.

Also known as: LEFS

Healthy control; lipedema

Short form 12 OTHER

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.

Healthy control; lipedema

lower extremity volumetric measurement OTHER

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.

lipedema

lower extremity circumference measurement OTHER

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

Healthy control; lipedema

Bioelectrical Impedance Analysis OTHER

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

Healthy control; lipedema

Ultrasound DIAGNOSTIC_TEST

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.

Healthy control; lipedema

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Our study will be conducted as a cross-sectional, single-center study with lipedema-diagnosed patients and healthy volunteers who apply to the Physical Medicine and Rehabilitation outpatient clinic of Sultan 2nd Abdülhamid Han Hospital, Health Sciences University. Participants who meet the inclusion and exclusion criteria will be asked to complete the specified scales. In addition to clinical parameters, ultrasonographic evaluation and pressure pain threshold measurement using an algometer will be performed.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

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

Istanbul, Üsküdar, 34000, Turkey (Türkiye)

RECRUITING

Related Publications (7)

• Chakraborty A, Crescenzi R, Usman TA, Reyna AJ, Garza ME, Al-Ghadban S, Herbst KL, Donahue PMC, Rutkowski JM. Indications of Peripheral Pain, Dermal Hypersensitivity, and Neurogenic Inflammation in Patients with Lipedema. Int J Mol Sci. 2022 Sep 7;23(18):10313. doi: 10.3390/ijms231810313.

  PMID: 36142221 RESULT

• Dinnendahl R, Tschimmel D, Low V, Cornely M, Hucho T. Non-obese lipedema patients show a distinctly altered quantitative sensory testing profile with high diagnostic potential. Pain Rep. 2024 Apr 11;9(3):e1155. doi: 10.1097/PR9.0000000000001155. eCollection 2024 Jun.

  PMID: 38617100 RESULT

• Soylu C, Kutuk B. Reliability and Validity of the Turkish Version of SF-12 Health Survey. Turk Psikiyatri Derg. 2022 Summer;33(2):108-117. doi: 10.5080/u25700. English, Turkish.

  PMID: 35730511 RESULT

• Jebb SA, Cole TJ, Doman D, Murgatroyd PR, Prentice AM. Evaluation of the novel Tanita body-fat analyser to measure body composition by comparison with a four-compartment model. Br J Nutr. 2000 Feb;83(2):115-22. doi: 10.1017/s0007114500000155.

  PMID: 10743490 RESULT

• Duzce Keles E, Birtane M, Ekuklu G, Kilincer C, Caliyurt O, Tastekin N, Is EE, Ketenci A, Neblett R. Validity and reliability of the Turkish version of the central sensitization inventory. Arch Rheumatol. 2021 Oct 18;36(4):518-526. doi: 10.46497/ArchRheumatol.2022.8665. eCollection 2021 Dec.

  PMID: 35382371 RESULT

• Binkley JM, Stratford PW, Lott SA, Riddle DL. The Lower Extremity Functional Scale (LEFS): scale development, measurement properties, and clinical application. North American Orthopaedic Rehabilitation Research Network. Phys Ther. 1999 Apr;79(4):371-83.

  PMID: 10201543 RESULT

• Amato ACM, Saucedo DZ, Santos KDS, Benitti DA. Ultrasound criteria for lipedema diagnosis. Phlebology. 2021 Sep;36(8):651-658. doi: 10.1177/02683555211002340. Epub 2021 Apr 15.

  PMID: 33853452 RESULT

MeSH Terms

Conditions

Lipedema

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Emre Ata, Assoc.Prof

  Sultan Abdülhamid Han Research and Training Hospital

  STUDY CHAIR

Central Study Contacts

Zeynep Candan, MD

CONTACT

drzeynepcandan@gmail.com; drzeynepcandan@gmail.com

Feyza N Yucel, MD

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 1, 2025
• First Posted: January 13, 2025
• Study Start: December 6, 2024
• Primary Completion: September 1, 2025
• Study Completion: December 30, 2025
• Last Updated: September 8, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)