Pain, Central Sensitization, and Misophonia in Lipedema

NCT07849634 | Not Yet Recruiting

• 1 other identifier: 654/2026
• Study Type: observational
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Lipedema

Keywords

Lipedema; Central Sensitization; Misophonia; Pain; Psychological Factors; Pressure Pain Threshold

Outcome Measures

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.

  Baseline, at the time of clinical assessment

Secondary Outcomes (8)

• Visual Analog Scale (VAS)

  Baseline, at the time of clinical assessment

• Pain Catastrophizing Scale (PCS)

  Baseline, at the time of clinical assessment

• Pressure Pain Threshold Measurement by Algometry

  Baseline, at the time of clinical assessment

• Beck Depression Inventory (BDI)

  Baseline, at the time of clinical assessment

• Beck Anxiety Inventory (BAI)

  Baseline, at the time of clinical assessment

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Gaziantep City Hospital: lead

MeSH Terms

Conditions

Lipedema; misophonia; Pain

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Merve ÖNOĞUL ÖZMEN, Medıcal Doctor

CONTACT

05398981401; drmerveonogul@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant

Study Record Dates

• First Submitted: September 24, 2026
• First Posted: September 30, 2026
• Study Start: September 28, 2026
• Primary Completion (Estimated): November 23, 2026
• Study Completion (Estimated): December 7, 2026
• Last Updated: September 30, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data will be available after publication of the study results.
• Access Criteria: De-identified individual participant data and supporting documents will be available to qualified researchers upon reasonable request to the principal investigator. Access will be granted for scientific research purposes after approval of the research proposal. Data will be shared through secure electronic transfer.