Investigation of Central Sensitization and Associated Factors in Patients With Lipedema

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorSultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

About this trial

This study aims to investigate the presence of central sensitization and its associated parameters in patients with lipedema. Lipedema is a chronic and hereditary condition that primarily affects the lower extremities in women and is often associated with hormonal changes. Symptoms such as pain, swelling, and tenderness are common in lipedema, and these symptoms may be related to central sensitization. Additionally, the ultrasonographic findings and pain sensitivity in lipedema will be compared with those of healthy individuals. This study seeks to contribute to the diagnosis and treatment process of lipedema.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Lipedema; Diagnosis of lipedema Aged between 18 and 65 years Literate Willing to participate in the study

control group; Being completely healthy (no internal/metabolic issues such as diabetes, obesity, or hypothyroidism, and no diagnosis of lipedema) BMI ≤ 30 Aged between 18 and 65 years Literate Willing to participate in the study

Disqualifiers

Lipedema group; Under 18 or over 65 years of age Presence of concurrent lymphedema, chronic venous insufficiency, deep vein thrombosis, polyneuropathy, or fibromyalgia Illiterate Not willing to participate in the study

Control group; Under 18 or over 65 years of age Presence of concurrent lymphedema, chronic venous insufficiency, deep vein thrombosis, polyneuropathy, fibromyalgia, systemic rheumatic diseases, active cancer, infections, or pregnancy Illiterate Not willing to participate in the study

Trial population

Our study will be conducted as a cross-sectional, single-center study with lipedema-diagnosed patients and healthy volunteers who apply to the Physical Medicine and Rehabilitation outpatient clinic of Sultan 2nd Abdülhamid Han Hospital, Health Sciences University. Participants who meet the inclusion and exclusion criteria will be asked to complete the specified scales. In addition to clinical parameters, ultrasonographic evaluation and pressure pain threshold measurement using an algometer will be performed.

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

  • Pain-Pressure Threshold Measurement With an Algometer

    Other intervention

    The measurement will be performed 2 times with 3 min intervals for each region and the average of these applications will be recorded. Before the test, a trial test will be applied to the patient. With the pressure algometer, pressure will be applied to the selected points until it causes pain and the test will be terminated for that region when the patient feels pain. The measurement includes bilateral thigh, pretibial region and left forearm as remote site and Wagner manual pressure algometer (1 cm2 probe-10 kg/20 lb) will be used. The selected points will be: Bilateral thigh: Mid-thigh anterior surface Bilateral pretibial region: Anterior proximal 1/3 of the pretibial area Bilateral forearm volar side center as control point

  • Central Sensitization Inventory

    Other intervention

    The central sensitization scale was developed primarily to detect central sensitization findings in patients with chronic pain and consists of two parts, A and B. In part A, 25 somatic and psychosocial symptoms frequently found in patients with central sensitization.

  • Numeric Rating Scale

    Other intervention

    Leg pain, feeling of tension and heaviness on the affected arm will be evaluated separately by numerical scale.

  • Lower Extremity Functional Scale

    Other intervention

    The lower extremity functional scale is a valid patient-rated outcome measure for the measurement of lower extremity function. The scale consist of 4 groups with 20 questions. The questions in these group focus on activities with increasing physical demands like questions from walking between rooms to running on uneven ground. The scoring of this scale varies from 0 (extreme difficulty/unable to perform activity) to 4 (no difficulty). The total score can be obtained by summing the scores of the individual items. The maximum score of 80 indicates no functional limitations and the minimum score of 0 indicates extreme limitations.

  • Short form 12

    Other intervention

    The Short form 12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. It is often used as a quality of life measure.The scoring yields two summary measures: the Physical Component Summary (PCS) and the Mental Component Summary (MCS).Utilize the norm-based scoring system to interpret PCS and MCS scores, with a mean of 50 and a standard deviation of 10 in the general population.Scores above 50 indicate a better-than-average health-related quality of life, while scores below 50 suggest below-average health.

  • lower extremity volumetric measurement

    Other intervention

    It is calculated by converting the circumference measurements taken at 4 cm intervals from the ankle to the proximal thigh into lower extremity volume with Excel.

  • lower extremity circumference measurement

    Other intervention

    bilateral tuberosity tibia, 20 cm proximal tuberosity tibia, tuberosity tibia 10 cm distal and ankle level

  • Bioelectrical Impedance Analysis

    Other intervention

    With Bioelectrical Impedance Analysis, fat, muscle and water ratio and lean mass are calculated in addition to the patient's body weight.

  • Ultrasound

    Diagnostic test

    Measurement of subcutaneous fat tissue thickness from mid-thigh, pretibial, lateral leg and supramalleolar regions with ultrasound.The average of two measurements taken from the same area will be recorded.According to these measurements; 12-15 mm = mild lipedema or lipohyperplasia, 15-20 mm = moderate lipedema, \>20 mm = significant lipedema, \>30 mm = severe lipedema.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: lipedema9 interventions
Group B: Healthy control7 interventions

Trial outcomes

Primary outcomes

1

Central Sensitization Inventory

The Central Sensitization Inventory (CSI) is a tool used to assess the heightened sensitivity of the central nervous system. This scale is designed to identify the effects of central sensitization commonly seen in chronic pain conditions by examining an individual's pain perception, sensory changes (such as sensitivity to heat, cold, or pressure), the impact of persistent pain on daily activities, and the emotional effects of pain (such as anxiety, depression, etc.). It plays a crucial role in both clinical practice and research for diagnosing chronic pain syndromes and monitoring treatment responses.

Time frame
3 months
2

Pressure Pain Threshold

The purpose of this test is to measure the pressure pain threshold, defined as the minimal pressure level that causes pain. The test will be performed twice for each region with a 3-minute interval, and the average of these measurements will be recorded. Before the test, a trial run will be conducted for the patient. Using a pressure algometer, pressure will be applied to selected points until the patient experiences pain, at which point the test for that region will be terminated. The measurements will include bilateral thighs, the middle points of the pretibial region, and the control region (left forearm's volar surface). A Wagner manual pressure algometer (1 cm² probe - 10 kg/20 lb) will be used.

Time frame
3 months

Secondary outcomes

1

Short Form-12

The Short Form-12 is a short questionnaire used to assess individuals' physical and mental health. It is a shortened version of the Short form-36 and covers 8 health dimensions: physical function, social function, physical role limitations, emotional role limitations, mental health, general health, pain, and energy. The results are summarized into physical and mental health components, providing a quick and practical overview of general health status. A Turkish validity and reliability study has been conducted.

Time frame
3 months
2

Lower Extremity Functional Scale, LEFS

The Lower Extremity Functional Scale (LEFS) is a tool used to assess the function of the lower extremities (legs, knees, hips, and feet). It measures the limitations in daily activities related to lower extremity function. It is used to monitor functional status after injury or illness, evaluate treatment response, and set treatment goals. The scale consists of 20 physical activities, rated from 0 (unable to perform) to 4 (no difficulty performing). A total score of 80 indicates a high functional level. A Turkish validity and reliability study has been conducted.

Time frame
3 months
3

Bioelectrical Impedance Analysis

Bioelectrical Impedance Analysis is used to assess body composition, measuring parameters such as body fat percentage, muscle mass, water content, and metabolic age. It uses bioelectrical impedance analysis technology, sending a low-level electrical current through the body. Since different body components conduct this current in various ways, the resistance data obtained is used to determine fat, muscle, and water levels. Easy to use, these devices are typically in the form of a scale, and users can get results within seconds by stepping on the device. Widely preferred by athletes, dietitians, and individuals, these devices are considered reliable tools for monitoring health and achieving fitness goals.

Time frame
3 months
4

Evaluation with ultrasonography

Subcutaneous fat thickness measurements for diagnosing lipedema are recommended at specific sites, including the mid-thigh, pretibial, lateral calf, and supramalleolar regions. Subcutaneous thickness, including the skin, is measured 6-8 cm above the medial malleolus. Even in cases of proximal lipedema, this measurement serves as a reliable reference. Based on these measurements: 12-15 mm indicates mild lipedema or lipohypertrophy, 15-20 mm indicates moderate lipedema, \>20 mm indicates prominent lipedema, and \>30 mm indicates severe lipedema.

Time frame
3 months

Other outcomes

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