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CompletedNCT07240285Updated Nov 20, 2025

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

An observational study in Lipedema, sponsored by Istanbul Physical Medicine Rehabilitation Training and Research Hospital. Completed at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-11-20.

Sponsored by Istanbul Physical Medicine Rehabilitation Training and Research Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
60
Ages
18 Years to 75 Years
Sex
Female
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Study 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.

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Conditions studied

  • Lipedema

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
Female
Sampling method
Probability sample

Study population

-Patients with and without lipedema

Inclusion criteria

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

Exclusion criteria

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
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Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
60 participants (actual)
Target follow-up
1 Day
Patient registry
Yes

Groups and cohorts

  • Lipedema group

    Patients with lipedema

  • Control group

    Patients without lipedema

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What researchers measure

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.

    Time frame: Baseline

Secondary outcomes

  1. 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.

    Time frame: Baseline

  2. 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.

    Time frame: Baseline

  3. 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.

    Time frame: Baseline

  4. 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.

    Time frame: Baseline

  5. 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.

    Time frame: Baseline

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Study locations

1 site
  • Istanbul Physical Medicine Rehabilitation Training and Research Hospital
    Istanbul, Turkey (Türkiye)
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Registry details

Key details

Study ID
NCT07240285
Lead sponsor
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Responsible party
Sponsor
First posted
Nov 20, 2025
Start date
Oct 10, 2025
Primary completion
Nov 10, 2025
Completion
Nov 10, 2025
Last update
Nov 20, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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