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Completed

NCT Number: NCT07240285

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

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.

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Key information

Conditions

Lipedema Connective Tissue Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

Female

Study type

Observational

Primary location

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Istanbul, Turkey (Türkiye)

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Central Sensitization Inventory (CSI)

    Time frame: Baseline

    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.

Secondary outcomes

  1. Pain Intensity (Visual Analog Scale - VAS)

    Time frame: Baseline

    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.

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

    Time frame: Baseline

    The HADS-A assesses anxiety symptoms in non-psychiatric populations. Scores range from 0 to 21; higher scores indicate greater anxiety severity.

  3. Hospital Anxiety and Depression Scale - Depression Subscale (HADS-D)

    Time frame: Baseline

    The HADS-D evaluates depressive symptoms, with scores ranging from 0 to 21. Higher scores indicate more severe depressive symptoms.

  4. Pain Catastrophizing Scale (PCS):

    Time frame: Baseline

    he PCS measures negative cognitive and emotional responses to pain. Scores range from 0 to 52, with higher scores indicating greater pain catastrophizing.

  5. Pain Pressure Threshold (PPT):

    Time frame: Baseline

    PPT will be measured using a digital algometer at the middle deltoid, lateral thigh, and medial knee. Lower values indicate greater pain sensitivity.

Sponsors and collaborators

Lead sponsor

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Nov 20, 2025
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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