Central Sensitization, HOMA-IR, Lipedema, Pain
Conditions
Keywords
Triglyceride, HOMA-IR, Pain, Fasting Blood Glucose, Fasting Insulin, Lipedema
Brief summary
The aim of this study is to evaluate the effect of metabolic markers (HOMA-IR, triglyceride/HDL ratio, HbA1c, waist and hip circumference measurements, BMI, etc.) on pain and central sensitization in patients diagnosed with lipedema. The primary objective is to investigate the association between metabolic markers and central sensitization. The secondary objective is to assess the relationship between metabolic markers and pain intensity, pain phenotype, and functional status.
Detailed description
Lipedema is a chronic disorder observed in women, characterized by symmetrical accumulation of adipose tissue in the lower extremities, easy bruising, and marked tenderness or pain. In lipedema, pain is often spontaneous, increases with pressure, and does not always correlate with the amount of adipose tissue. This suggests that lipedema-related pain cannot be explained solely by peripheral mechanical factors. Previous studies in patients with lipedema have demonstrated reduced pressure pain thresholds, bilateral and symmetrical hyperalgesia, and increased pain sensitivity extending beyond the areas of local adipose tissue involvement. These findings suggest that alterations in central pain processing mechanisms may occur in lipedema and that central sensitization may play a role. However, systematic studies specifically evaluating central sensitization in lipedema remain limited. Although lipedema has long been considered a "metabolically protected" condition, recent studies have reported that insulin resistance, dyslipidemia, and components of metabolic syndrome are more frequently observed, particularly in lipedema cases accompanied by obesity. HOMA-IR, which is used to evaluate insulin resistance; the triglyceride/HDL ratio (TG/HDL), a marker of atherogenic dyslipidemia; and HbA1c, reflecting long-term glycemic load, are closely associated with chronic inflammation and metabolic dysfunction. In the chronic pain literature, metabolic dysfunction has been shown to play an important role in the development of central sensitization and nociplastic pain, with obesity, insulin resistance, and dyslipidemia being associated with central pain amplification. However, to the best of our knowledge, no studies in lipedema have simultaneously evaluated the relationship between metabolic parameters, pain phenotype, and central sensitization. The aim of this study is to evaluate the effects of metabolic markers (HOMA-IR, triglyceride/HDL ratio, HbA1c, waist and hip circumference measurements, BMI, etc.) on pain and central sensitization in patients diagnosed with lipedema. The primary objective is to investigate the association between metabolic markers and central sensitization. The secondary objective is to assess the relationship between metabolic markers and pain intensity, pain phenotype, and functional status.
Interventions
None listed
Sponsors
Marmara University
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Being female and aged 18 years or older * Having chronic pain persisting for at least 3 months * Having sufficient cognitive ability to understand and respond to the assessment scales used in the study * Voluntarily agreeing to participate in the study and providing written informed consent
Exclusion criteria
* Presence of a history of malignancy, active infection, inflammatory rheumatic disease, or severe systemic disease * History of known neurological disorders (e.g., stroke, multiple sclerosis, epilepsy) * Diagnosis of severe psychiatric disorders (e.g., psychotic disorders, bipolar disorder) * Pregnancy or breastfeeding * Presence of cognitive impairment or communication difficulties that could affect the study results * Diagnosed diabetes mellitus * Active thyroid disease (uncontrolled hypothyroidism or hyperthyroidism) * Cushing's syndrome or other significant endocrine disorders * Use of antidiabetic medications * Use of lipid-lowering therapy (e.g., statins, fibrates) * Systemic glucocorticoid use within the past 3 months * Use of medications that may significantly affect central pain mechanisms (e.g., high-dose opioids, antipsychotic drugs) * History of major surgery or invasive treatment for pain within the past 3 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Central Sensitization Inventory (CSI) | At baseline | The Central Sensitization Inventory is a self-report screening tool developed to assess the presence and severity of symptoms associated with central sensitization. The inventory evaluates symptoms reflecting sensitization in central nervous system pain-processing mechanisms, including widespread pain, fatigue, sleep disturbances, and cognitive complaints. The CSI consists of 25 items, each scored on a scale from 0 to 4, with a total score ranging from 0 to 100. A total score of 40 or higher is considered to be associated with a high likelihood of central sensitization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Numeric Rating Scale (NRS) | At baseline | The Numeric Rating Scale (NRS) is used to measure and monitor pain intensity. A score of "0" represents no pain, while "10" indicates the worst pain imaginable. Patients are asked to rate their pain on a scale from 0 to 10. Due to its simplicity and ease of understanding, this scale is frequently used in clinical research. |
| Fatigue Severity Scale (FSS) | At baseline | The Fatigue Severity Scale is a self-report measure used to evaluate the impact of fatigue on daily life and functional activities. The scale consists of 9 items, each scored on a scale from 1 to 7. Higher average scores indicate greater fatigue severity. |
| Neuropathic Pain Diagnostic Questionnaire (DN4) | At baseline | The DN4 questionnaire was developed to assess the presence of neuropathic pain. It consists of 10 items derived from symptom-based questions and clinical examination findings. The total score ranges from 0 to 10, and a score of 4 or higher is considered indicative of neuropathic pain. |
| Short Form-12 (SF-12) | At baseline | The Short Form-12 is a questionnaire used to assess general health status and health-related quality of life. It consists of 12 items. Scores range from 0 to 100, with higher scores indicating better quality of life. |
| Jenkins Sleep Scale (JSS) | At baseline | The Jenkins Sleep Scale is a self-report measure consisting of four items that evaluates the frequency of sleep problems experienced over the past month. Higher scores indicate a greater frequency of sleep disturbance symptoms, such as difficulty falling asleep, nocturnal awakenings, and early morning awakening. |
| Lower Extremity Functional Scale (LEFS) | At baseline | The Lower Extremity Functional Scale is a self-report measure consisting of 20 items that evaluates lower extremity functional status during activities of daily living. Lower total scores indicate greater functional limitation, whereas higher scores reflect better lower extremity function. |
| International Physical Activity Questionnaire (IPAQ) | At baseline | The International Physical Activity Questionnaire is a measure consisting of seven items that assess the time spent walking, performing moderate-intensity and vigorous-intensity activities, and sitting. The total score is calculated by considering the duration (minutes) and frequency (days) of walking, moderate-intensity activity, and vigorous-intensity activity. Energy expenditure for these activities is expressed in MET-minutes. Standard MET values have been established for each activity: sitting 1.5 MET, walking 3.3 MET, moderate-intensity physical activity 4 MET, and vigorous-intensity physical activity 8 MET. Using these values, daily and weekly physical activity levels can be calculated. |
Countries
Turkey (Türkiye)
Contacts
CONTACTFatma B Akdağ
CONTACTYeliz Özdemir
Outcome results
None listed