LipedemaNCT07849634
Pain, Central Sensitization, and Misophonia in Lipedema
An observational study of Lipedema, run by Gaziantep City Hospital.
Trial summary
Lipedema is a chronic condition that predominantly affects women and is characterized by disproportionate, usually symmetrical accumulation of subcutaneous fat, particularly in the hips and legs. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Lipedema
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 28 Sep 2026to 7 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will consist of women aged 18-65 years recruited for an observational case-control study. The case group will comprise women with a clinical diagnosis of lipedema based on medical history and physical examination and a Lipedema Screening Questionnaire score of ≥9. The control group will comprise women without clinical evidence of lipedema and with a questionnaire score of <9. Eligible participants will provide written informed consent and complete assessments of misophonia, central sensitization, pain, sleep, psychological symptoms, and body image, as well as pressure pain threshold measurements.
Who may be able to join
- Female sex.
- Age 18-65 years.
- Case group: Clinical diagnosis of lipedema based on medical history and physical examination, and a Lipedema Screening Questionnaire score of ≥9.
- Control group: No clinical diagnosis of lipedema based on medical history and physical examination, and a Lipedema Screening Questionnaire score of <9.
- Willingness to participate and provision of written informed consent.
Who cannot join
- Primary or secondary lymphedema.
- Active malignancy or infection.
- Severe immobility or advanced venous insufficiency.
- A history of major surgery, trauma, or serious systemic illness within the past six months.
- Pregnancy or breastfeeding.
- A diagnosed neuropsychiatric disorder, such as schizophrenia, schizoaffective disorder, or bipolar disorder.
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- A history of ear or hearing disorders.
- A diagnosed neurological disorder, such as epilepsy, multiple sclerosis, stroke, or dementia.
- Current substance use disorder or use of psychotropic medication within the past 30 days.
- Inability to understand or complete the study procedures because of language, cognitive, or sensory limitations.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Assessment of the Relationships Among Pain, Central Sensitization, Psychological Factors, and Misophonia in Women With Lipedema: A Cross-Sectional Controlled Study
Lipedema is a chronic condition that predominantly affects women and is characterized by disproportionate, usually symmetrical accumulation of subcutaneous fat, particularly in the hips and legs. Pain, tenderness, easy bruising, fatigue, and psychological symptoms may substantially affect daily functioning and quality of life. Misophonia involves intense negative reactions to specific sounds, but its relationship with lipedema remains unclear.
This observational case-control study aims to investigate misophonia symptoms in women with lipedema compared with women without lipedema and to explore their associations with pain and psychosocial factors. The prespecified primary outcome measure is central sensitization severity, assessed using the Central Sensitization Inventory. Secondary outcome measures include misophonia symptom severity, pain intensity, pressure pain thresholds, pain catastrophizing, sleep quality, depressive and anxiety symptoms, and body image. The study will compare these outcomes between groups and examine their associations with misophonia symptoms.
Read the detailed description
Lipedema is a chronic condition characterized by a disproportionate, usually symmetrical accumulation of subcutaneous adipose tissue, predominantly in the hips, thighs, and legs. The arms may also be affected. It occurs almost exclusively in women and can substantially affect daily functioning, quality of life, and psychosocial well-being. Commonly reported symptoms include pain, tenderness, easy bruising, and a sensation of swelling. Fatigue, walking difficulties, sleep problems, and symptoms of depression or anxiety may also occur. Misophonia involves intense negative reactions to specific sounds, such as chewing, breathing, or pen clicking. Given the symptom burden associated with lipedema, investigating misophonia symptoms in this population may provide insight into their relationship with pain, central sensitization, and psychological well-being.
This observational case-control study will investigate central sensitization and its relationship with misophonia and other clinical symptoms in women with lipedema. Women aged 18-65 years who provide written informed consent will be eligible for assessment. Participants with a Lipedema Screening Questionnaire score of ≥9 and a clinical diagnosis of lipedema will be included in the case group. Women with a score of <9 will be included in the control group. The screening questionnaire will support group allocation but will not serve as the sole basis for a clinical diagnosis.
Demographic and clinical data will include age, marital status, education, occupation, menopausal status, parity, smoking and alcohol use, body mass index, systemic diseases, medications, family history, and exercise habits. For participants with lipedema, the duration of diagnosis, disease stage and type, affected body regions, age at pain onset, and clinical features-including pain, tenderness, easy bruising, perceived swelling, and symmetric or asymmetric involvement-will be recorded. Previous treatments, including dietary interventions, compression garments, liposuction, complex decongestive therapy, and other reported interventions, will also be documented.
The primary outcome will be central sensitization severity, assessed using the Central Sensitization Inventory. Secondary outcomes will include pain intensity measured with a visual analog scale; pressure pain thresholds measured by algometry at the bilateral deltoid regions, lateral thighs, and medial aspects of the knees; pain catastrophizing assessed with the Pain Catastrophizing Scale; sleep quality assessed with the Pittsburgh Sleep Quality Index; depressive symptoms assessed with the Beck Depression Inventory; anxiety symptoms assessed with the Beck Anxiety Inventory; and body image assessed with the Body Image Scale. Misophonia symptoms will be assessed using a Misophonia Scale.
The study will compare these measures between the lipedema and control groups and examine associations between misophonia symptoms, central sensitization, pain, and psychological measures.
- Conditions
- Lipedema
- Keywords
- Lipedema, Central Sensitization, Misophonia, Pain, Psychological Factors, Pressure Pain Threshold
- Medical subject headings
- Lipedema, misophonia, Pain
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 |
|---|---|---|
| Women With Lipedema | Women aged 18-65 years with a clinical diagnosis of lipedema and a Lipedema Screening Questionnaire score of ≥9. Participants will complete questionnaires and undergo pressure pain threshold measurements. No intervention will be administered. | |
| Women Without Lipedema | Women aged 18-65 years without a clinical diagnosis of lipedema and with a Lipedema Screening Questionnaire score of <9. Participants will complete the same questionnaires and undergo the same pressure pain threshold measurements. No intervention will be administered. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Central Sensitization Inventory (CSI)
The CSI consists of 25 items. Each item is scored on a five-point scale: never (0), rarely (1), sometimes (2), often (3), and always (4). Total scores range from 0 to 100, with higher scores indicating greater symptom severity. A score of 40 is used as the cutoff.
Measured: Baseline, at the time of clinical assessment
Secondary outcomes (8)
Visual Analog Scale (VAS)
Pain intensity will be assessed using a 10-cm horizontal line anchored by "no pain" at one end and "worst imaginable pain" at the other. Participants will mark the point that best represents their pain intensity. The distance from the left end of the line to the mark will be recorded in centimeters; higher values indicate greater pain intensity.
Measured: Baseline, at the time of clinical assessment
Pain Catastrophizing Scale (PCS)
The PCS is a 13-item self-report questionnaire used to assess catastrophic thoughts and feelings related to pain in clinical and nonclinical populations. Its items cover three dimensions: rumination, magnification, and helplessness. Each item is scored from 0 to 4 on a five-point scale, yielding a total score of 0-52. Higher scores indicate greater pain catastrophizing.
Measured: Baseline, at the time of clinical assessment
Pressure Pain Threshold Measurement by Algometry
Pressure pain threshold (PPT) is the minimum applied pressure at which a participant first perceives pain. A pressure algometer with a 1 cm² probe tip will be applied perpendicular to the skin, and pressure will be increased at a rate of approximately 1 kg/cm² per second. Participants will be instructed to indicate when the pressure first becomes painful. PPT will be measured bilaterally at the deltoid regions, lateral thighs, and medial aspects of the knees. Higher PPT values indicate lower sensitivity to pressure-induced pain.
Measured: Baseline, at the time of clinical assessment
Beck Depression Inventory (BDI)
The BDI is a standardized self-report instrument developed by Aaron T. Beck to assess the severity of depressive symptoms. The validity and reliability of its Turkish version were established by Nihal Hisli. Higher scores indicate more severe depressive symptoms.
Measured: Baseline, at the time of clinical assessment
Beck Anxiety Inventory (BAI)
The BAI is a 21-item self-report questionnaire used to assess the severity of anxiety symptoms experienced during the past week. It places particular emphasis on somatic symptoms of anxiety. Each item is scored from 0 to 3, yielding a total score of 0-63; higher scores indicate more severe anxiety symptoms.
Measured: Baseline, at the time of clinical assessment
Pittsburgh Sleep Quality Index (PSQI)
The PSQI is a self-report questionnaire developed by Buysse and colleagues in 1989 to assess sleep quality and sleep disturbances over the past month. The validity and reliability of its Turkish version were evaluated by Ağargün and colleagues in 1996. The global score ranges from 0 to 21, with higher scores indicating poorer sleep quality.
Measured: Baseline, at the time of clinical assessment
Misophonia Scale
The scale assesses sensitivity to specific sounds, such as eating sounds, repetitive tapping, rustling, and breathing sounds. Participants first rate their sensitivity to these sounds from 0 ("not at all true") to 4 ("always true"). Those reporting any sound sensitivity then rate how often the sounds lead to avoidance, emotional distress, anger, or aggressive responses, using a scale from 0 ("never") to 4 ("always"). Finally, participants rate the overall severity of their sound sensitivity on a separate 1-15 scale, taking into account its intensity and impact on daily life.
Measured: Baseline, at the time of clinical assessment
Body Image Scale (BIS)
The BIS, developed by Saylan and Soyyiğit, is a 21-item instrument used to assess body image. It comprises four subscales: Sensitivity to Evaluation, Negative Body Perception, Positive Body Perception, and Body Modification. Item scores are summed to obtain a total score ranging from 21 to 105. Higher total scores indicate a more negative body image.
Measured: Baseline, at the time of clinical assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study start28 Sep 2026 (estimated)
- Primary completion23 Nov 2026 (estimated)
- Study completion7 Dec 2026 (estimated)
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
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gaziantep City Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Önoğul Özmen, Gaziantep City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07849634
- Sponsor's protocol ID
- 654/2026
- Status last verified
- Sep 2026
- First submitted
- 24 Sep 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data will be available from the corresponding author upon reasonable request. These data may include age, body mass index, study group, questionnaire scores, pressure pain threshold measurements, and relevant lipedema-related clinical characteristics. Direct personal identifiers will be removed before any data are shared to protect participant confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Relationships Among Pain, Central Sensitization, Psychological Factors, and Misophonia in Women With Lipedema: A Cross-Sectional Controlled Study
- ClinicalTrials.gov ID
- NCT07849634
- Acronym / sponsor ID
- 654/2026
- Conditions
- Lipedema
- Keywords
- Lipedema, Central Sensitization, Misophonia, Pain, Psychological Factors, Pressure Pain Threshold
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Gaziantep City HospitalUniversity, hospital or other
- Study start
- 28 Sep 2026 (estimated)
- Primary completion
- 23 Nov 2026 (estimated)
- Study completion
- 7 Dec 2026 (estimated)
- First posted
- 30 Sep 2026 (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.
Lipedema is a chronic condition that predominantly affects women and is characterized by disproportionate, usually symmetrical accumulation of subcutaneous fat, particularly in the hips and legs. Pain, tenderness, easy bruising, fatigue, and psychological symptoms may substantially affect daily functioning and quality of life. Misophonia involves intense negative reactions to specific sounds, but its relationship with lipedema remains unclear.
This observational case-control study aims to investigate misophonia symptoms in women with lipedema compared with women without lipedema and to explore their associations with pain and psychosocial factors. The prespecified primary outcome measure is central sensitization severity, assessed using the Central Sensitization Inventory. Secondary outcome measures include misophonia symptom severity, pain intensity, pressure pain thresholds, pain catastrophizing, sleep quality, depressive and anxiety symptoms, and body image. The study will compare these outcomes between groups and examine their associations with misophonia symptoms.
Detailed description
Lipedema is a chronic condition characterized by a disproportionate, usually symmetrical accumulation of subcutaneous adipose tissue, predominantly in the hips, thighs, and legs. The arms may also be affected. It occurs almost exclusively in women and can substantially affect daily functioning, quality of life, and psychosocial well-being. Commonly reported symptoms include pain, tenderness, easy bruising, and a sensation of swelling. Fatigue, walking difficulties, sleep problems, and symptoms of depression or anxiety may also occur. Misophonia involves intense negative reactions to specific sounds, such as chewing, breathing, or pen clicking. Given the symptom burden associated with lipedema, investigating misophonia symptoms in this population may provide insight into their relationship with pain, central sensitization, and psychological well-being.
This observational case-control study will investigate central sensitization and its relationship with misophonia and other clinical symptoms in women with lipedema. Women aged 18-65 years who provide written informed consent will be eligible for assessment. Participants with a Lipedema Screening Questionnaire score of ≥9 and a clinical diagnosis of lipedema will be included in the case group. Women with a score of <9 will be included in the control group. The screening questionnaire will support group allocation but will not serve as the sole basis for a clinical diagnosis.
Demographic and clinical data will include age, marital status, education, occupation, menopausal status, parity, smoking and alcohol use, body mass index, systemic diseases, medications, family history, and exercise habits. For participants with lipedema, the duration of diagnosis, disease stage and type, affected body regions, age at pain onset, and clinical features-including pain, tenderness, easy bruising, perceived swelling, and symmetric or asymmetric involvement-will be recorded. Previous treatments, including dietary interventions, compression garments, liposuction, complex decongestive therapy, and other reported interventions, will also be documented.
The primary outcome will be central sensitization severity, assessed using the Central Sensitization Inventory. Secondary outcomes will include pain intensity measured with a visual analog scale; pressure pain thresholds measured by algometry at the bilateral deltoid regions, lateral thighs, and medial aspects of the knees; pain catastrophizing assessed with the Pain Catastrophizing Scale; sleep quality assessed with the Pittsburgh Sleep Quality Index; depressive symptoms assessed with the Beck Depression Inventory; anxiety symptoms assessed with the Beck Anxiety Inventory; and body image assessed with the Body Image Scale. Misophonia symptoms will be assessed using a Misophonia Scale.
The study will compare these measures between the lipedema and control groups and examine associations between misophonia symptoms, central sensitization, pain, and psychological measures.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Women With Lipedema | – | –Women aged 18-65 years with a clinical diagnosis of lipedema and a Lipedema Screening Questionnaire score of ≥9. Participants will complete questionnaires and undergo pressure pain threshold measurements. No intervention will be administered. |
| Women Without Lipedema | – | –Women aged 18-65 years without a clinical diagnosis of lipedema and with a Lipedema Screening Questionnaire score of <9. Participants will complete the same questionnaires and undergo the same pressure pain threshold measurements. No intervention will be administered. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of women aged 18-65 years recruited for an observational case-control study. The case group will comprise women with a clinical diagnosis of lipedema based on medical history and physical examination and a Lipedema Screening Questionnaire score of ≥9. The control group will comprise women without clinical evidence of lipedema and with a questionnaire score of <9. Eligible participants will provide written informed consent and complete assessments of misophonia, central sensitization, pain, sleep, psychological symptoms, and body image, as well as pressure pain threshold measurements.
Key inclusion criteria (5 listed)
- Female sex.
- Age 18-65 years.
- Case group: Clinical diagnosis of lipedema based on medical history and physical examination, and a Lipedema Screening Questionnaire score of ≥9.
- Control group: No clinical diagnosis of lipedema based on medical history and physical examination, and a Lipedema Screening Questionnaire score of <9.
- Willingness to participate and provision of written informed consent.
Key exclusion criteria (10 listed)
- Primary or secondary lymphedema.
- Active malignancy or infection.
- Severe immobility or advanced venous insufficiency.
- A history of major surgery, trauma, or serious systemic illness within the past six months.
- Pregnancy or breastfeeding.
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, at the time of clinical assessment
The CSI consists of 25 items. Each item is scored on a five-point scale: never (0), rarely (1), sometimes (2), often (3), and always (4). Total scores range from 0 to 100, with higher scores indicating greater symptom severity. A score of 40 is used as the cutoff.
8 secondary outcomes
Visual Analog Scale (VAS)
Time frame: Baseline, at the time of clinical assessment
Pain Catastrophizing Scale (PCS)
Time frame: Baseline, at the time of clinical assessment
Pressure Pain Threshold Measurement by Algometry
Time frame: Baseline, at the time of clinical assessment
Beck Depression Inventory (BDI)
Time frame: Baseline, at the time of clinical assessment
Beck Anxiety Inventory (BAI)
Time frame: Baseline, at the time of clinical assessment
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline, at the time of clinical assessment
Misophonia Scale
Time frame: Baseline, at the time of clinical assessment
Body Image Scale (BIS)
Time frame: Baseline, at the time of clinical assessment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data will be available from the corresponding author upon reasonable request. These data may include age, body mass index, study group, questionnaire scores, pressure pain threshold measurements, and relevant lipedema-related clinical characteristics. Direct personal identifiers will be removed before any data are shared to protect participant confidentiality.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Lipedema, run by Gaziantep City Hospital.
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 5 inclusion and 10 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: opening soon, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Merve ÖNOĞUL ÖZMEN, Medıcal Doctor (05398981401 ext. +(0312)7970000, drmerveonogul@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Central Sensitization Inventory (CSI) (time frame: Baseline, at the time of clinical assessment). 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 30 Sep 2026.