LipedemaNCT07240285
The Relationship Between Central Sensitization, Pain, and Psychosocial Factors in Individuals With Lipedema
An observational study of Lipedema, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Lipedema
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Oct 2025to 10 Nov 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- Adult, Older adult
Study population: -Patients with and without lipedema
Who may be able to join
- Clinically diagnosed with lipedema
- Aged between 18 and 75 years
- Provided voluntary informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Istanbul
About this study
Official title: 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.
- Conditions
- Lipedema
- Medical subject headings
- Lipedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Lipedema group | Patients with lipedema | |
| Control group | Patients without lipedema |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study start10 Oct 2025
- Primary completion10 Nov 2025
- Study completion10 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LipedemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07240285
- Sponsor's protocol ID
- Istftreah
- Status last verified
- Nov 2025
- First submitted
- 16 Nov 2025
- Last updated
- 20 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Central Sensitization, Pain, and Psychosocial Factors in Individuals With Lipedema: A Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT07240285
- Acronym / sponsor ID
- Istftreah
- Conditions
- Lipedema
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research HospitalOther government
- Study start
- 10 Oct 2025 (actual)
- Primary completion
- 10 Nov 2025 (actual)
- Study completion
- 10 Nov 2025 (actual)
- First posted
- 20 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lipedema group | – | –Patients with lipedema |
| Control group | – | –Patients without lipedema |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- -Patients with and without lipedema
Key inclusion criteria (3 listed)
- Clinically diagnosed with lipedema
- Aged between 18 and 75 years
- Provided voluntary informed consent
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
5 secondary outcomes
Pain Intensity (Visual Analog Scale - VAS)
Time frame: Baseline
Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A):
Time frame: Baseline
Hospital Anxiety and Depression Scale - Depression Subscale (HADS-D)
Time frame: Baseline
Pain Catastrophizing Scale (PCS):
Time frame: Baseline
Pain Pressure Threshold (PPT):
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lipedema, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Central Sensitization Inventory (CSI) (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.