Pain, Central Sensitization, and Misophonia in Lipedema
ConditionLipedema
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-65
SponsorGaziantep City Hospital
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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.
Trial design
Design model
Case-control
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
70 Participants
are grouped into 2 trial groupsGroup A: Women With Lipedema
Group B: Women Without Lipedema
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline, at the time of clinical assessmentSecondary outcomes
1
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.
Time frame
Baseline, at the time of clinical assessment2
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.
Time frame
Baseline, at the time of clinical assessment3
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.
Time frame
Baseline, at the time of clinical assessment4
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.
Time frame
Baseline, at the time of clinical assessmentLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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