ClinicalTrials.gg
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
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 41 studies in Lipedema with a site in Turkey — 18 open to participants now, 19 under way, none of them phase 3. Lipedema · Turkey.

Enrollment
17th of 27
60 · median 76
Started
2025
with 8 others
Observational
27 of 41
9 open now
Registered
17th of 41
by date
Lead sponsor
3 of 41
Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Among the 41 studies in Lipedema with a site in Turkey, this one is the 17th largest by enrollment of the 27 observational ones that give a count, is one of 9 that started in 2025, is one of 27 observational ones, and was the 17th registered.

Lipedema

85 studies on the registry are indexed under Lipedema; 32 are open to participants now.

This study's enrollment of 60 is below the median of 90 across 42 observational studies indexed under Lipedema.

Browse Lipedema studies →

Open to participants now

18 of the 41 studies in Lipedema with a site in Turkey are open now, in 1 country. Each count lists the studies.

All 18 open studies →

Where they have run

Who these studies take

Of the 19 Lipedema studies recruiting now, 3 (16%) set no upper age limit and 16 (84%) stop at 75 or younger; 0 take children under 18; 4 take healthy volunteers.

This study: 18 Years to 75 Years · female.

The full table on the hub →
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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 41 studies in Lipedema with a site in Turkey, or all of them as a file.
02

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.

03

Conditions studied

  • Lipedema

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04

Who can participate

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

Study population

-Patients with and without lipedema

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • History of systemic diseases such as diabetes, rheumatologic disorders, or
  • 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

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

06

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

07

Study locations

1 site
  • Istanbul Physical Medicine Rehabilitation Training and Research Hospital
    Istanbul, Turkey (Türkiye)
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Oct 2025 to primary completion in Nov 2025, 1 month.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 16, 2025
First posted
Nov 20, 2025
StartActual
Oct 10, 2025
Primary completionActual
Nov 10, 2025
CompletionActual
Nov 10, 2025
Last update
Nov 20, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 20, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07240285
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 ↗

Not currently enrolling

This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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