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

The Relationship Between Central Sensitization, Pain, and Psychosocial Factors in Individuals With Lipedema: A Cross-Sectional Study

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.

Study Overview

• Status: Completed
• Conditions: Lipedema

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Istanbul, Turkey (Türkiye)
    • Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

-Patients with and without lipedema

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Lipedema group; Patients with lipedema
Control group; Patients without lipedema

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Intensity (Visual Analog Scale - VAS)	Pain intensity will be rated on a 10-cm scale ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores reflect greater perceived pain severity.	Baseline
Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A):	The HADS-A assesses anxiety symptoms in non-psychiatric populations. Scores range from 0 to 21; higher scores indicate greater anxiety severity.	Baseline
Hospital Anxiety and Depression Scale - Depression Subscale (HADS-D)	The HADS-D evaluates depressive symptoms, with scores ranging from 0 to 21. Higher scores indicate more severe depressive symptoms.	Baseline
Pain Catastrophizing Scale (PCS):	he PCS measures negative cognitive and emotional responses to pain. Scores range from 0 to 52, with higher scores indicating greater pain catastrophizing.	Baseline
Pain Pressure Threshold (PPT):	PPT will be measured using a digital algometer at the middle deltoid, lateral thigh, and medial knee. Lower values indicate greater pain sensitivity.	Baseline

Collaborators and Investigators

• Sponsor: Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2025
• Primary Completion (Actual): November 10, 2025
• Study Completion (Actual): November 10, 2025

Study Registration Dates

• First Submitted: November 16, 2025
• First Submitted That Met QC Criteria: November 16, 2025
• First Posted (Actual): November 20, 2025

Study Record Updates

• Last Update Posted (Actual): November 20, 2025
• Last Update Submitted That Met QC Criteria: November 16, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Connective Tissue Diseases; Skin and Connective Tissue Diseases; Lipedema
• Other Study ID Numbers: Istftreah

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No