The Relationship Between Central Sensitization, Pain, and Psychosocial Factors in Individuals With Lipedema

NCT07240285 | Completed

• 1 other identifier: Istftreah
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This cross-sectional study will include women aged 18-75 with clinically diagnosed lipedema and healthy controls. Sociodemographic and clinical data will be collected, and participants will complete the Central Sensitization Inventory (CSI), Visual Analog Scale (VAS), Hospital Anxiety and Depression Scale (HADS), and Pain Catastrophizing Scale (PCS). Pain pressure thresholds (PPT) will be assessed using a digital algometer at the middle deltoid, lateral thigh, and medial knee, with three measurements taken at each site and the average recorded.

Conditions

Lipedema

Outcome Measures

Primary Outcomes (1)

• Central Sensitization Inventory (CSI)

  The CSI assesses symptoms related to central sensitization, such as widespread pain, fatigue, and sleep disturbance. Scores range from 0 to 100, with higher values indicating a greater degree of central sensitization.

  Baseline

Secondary Outcomes (5)

• Pain Intensity (Visual Analog Scale - VAS)

  Baseline

• Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A):

  Baseline

• Hospital Anxiety and Depression Scale - Depression Subscale (HADS-D)

  Baseline

• Pain Catastrophizing Scale (PCS):

  Baseline

• Pain Pressure Threshold (PPT):

  Baseline

Study Arms (2)

Lipedema group

Patients with lipedema

Control group

Patients without lipedema

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

-Patients with and without lipedema

You may qualify if:

• Clinically diagnosed with lipedema
• Aged between 18 and 75 years
• Provided voluntary informed consent

You may not qualify if:

• History of systemic diseases such as diabetes, rheumatologic disorders, or malignancy
• Presence of neurological disorders (e.g., polyneuropathy, multiple sclerosis, history of stroke)
• Currently under active psychiatric treatment Pregnancy
• History of lower extremity surgery or major trauma within the past 6 months
• Received injection therapy or physical therapy for the lower extremities within the past 6 -months
• History of infection or active dermatological disease affecting the lower extremities

Sponsors & Collaborators

• Istanbul Physical Medicine Rehabilitation Training and Research Hospital: lead

Study Sites (1)

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Lipedema

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2025
• First Posted: November 20, 2025
• Study Start: October 10, 2025
• Primary Completion: November 10, 2025
• Study Completion: November 10, 2025
• Last Updated: November 20, 2025

Record last verified: 2025-11

Locations

TU (1)