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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07240285
Enrollment
60
Registered
2025-11-20
Start date
2025-10-10
Completion date
2025-11-10
Last updated
2025-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lipedema

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.

Interventions

None listed

Sponsors

Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Lead SponsorOTHER_GOV

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 75 Years

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

Design outcomes

Primary

MeasureTime frameDescription
Central Sensitization Inventory (CSI)BaselineThe 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

MeasureTime frameDescription
Pain Intensity (Visual Analog Scale - VAS)BaselinePain 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.
Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A):BaselineThe HADS-A assesses anxiety symptoms in non-psychiatric populations. Scores range from 0 to 21; higher scores indicate greater anxiety severity.
Hospital Anxiety and Depression Scale - Depression Subscale (HADS-D)BaselineThe HADS-D evaluates depressive symptoms, with scores ranging from 0 to 21. Higher scores indicate more severe depressive symptoms.
Pain Catastrophizing Scale (PCS):Baselinehe PCS measures negative cognitive and emotional responses to pain. Scores range from 0 to 52, with higher scores indicating greater pain catastrophizing.
Pain Pressure Threshold (PPT):BaselinePPT will be measured using a digital algometer at the middle deltoid, lateral thigh, and medial knee. Lower values indicate greater pain sensitivity.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026