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Ultrasonographic Evaluation and Pedobarographic Correlation of Lower Extremity Muscles in Lipedema Patients (PODUSG)

3. Oktober 2026 aktualisiert von: Marmara University

The primary aim of this study is to evaluate the lower extremity muscle structure, lower extremity alignment, and foot posture in lipedema; secondly, to reveal the chain relationship and biomechanical problems that may be observed in lipedema patients. Lipedema is a condition characterized by abnormal fat accumulation that can lead to walking difficulties and joint problems. We will use ultrasonography to measure muscle thickness and tendon structures, and a pedobarography system to analyze foot pressure distribution during standing and walking. By comparing 50 women diagnosed lipedema with 50 healthy volunteers, we aim to identify the musculoskeletal causes of gait disorders in lipedema to help develop better prevention and treatment strategies

Studienübersicht

Status

Abgeschlossen

Bedingungen

Detaillierte Beschreibung

Lipedema is a disease affecting fat tissues. Fat accumulates abnormally, especially in the hips and lower extremities. It was first described by Worl et al. The cause of the disease is unknown at the current level of scientific knowledge. Lipedema usually occurs in women during adolescence and the third decade. Although there is usually no lymphatic flow dysfunction in these patients, they are often misdiagnosed with lymphedema, but lipedema can cause secondary lymphatic dysfunction, leading to the development of lipolymphedema.

Lipedema is a clinical diagnosis. It is evaluated with appropriate history taking and physical examination. It can be detected by symptoms such as easy bruising, difficulty in losing weight from the legs while losing weight from the trunk, the presence of women with similar conditions in the family, pain on pressure, disproportion between the upper and lower body, pearl-sized nodules on the thighs, and decreased tissue and fascia elasticity on physical examination.

Ultrasonography (USG) muscle thickness measurement is a reliable method for determining regional muscle mass. Previous studies in the literature have evaluated the rectus femoris, gastrocnemius, gluteus medius and posterior tibialis muscles with USG and appropriate measurement techniques have been determined in these studies.

Pedobarography is a technology that evaluates a person's gait, balance, and consequently their locomotor system by examining the pressure distributions on the sole of the foot. It can be used diagnostically in the evaluation of lower extremity pathologies. Pedobarographic examination can provide static, postural, and dynamic evaluation. Static evaluation assesses the plantar pressure distribution during a certain standing time, while postural evaluation examines the pressure distributions in different standing positions. Dynamic evaluation assesses the load distribution on the sole of the foot during walking.

It is known that foot mechanics are affected in patients with lipedema. Considering that the load on the foot is increased in this patient group and that the majority of this load is caused by atypically stored fat, impairment of foot function is inevitable, especially in advanced stages. This is attributed to the valgus position of the knee and the disruption of the medial arch of the foot due to weakness of the knee extensors and hip abductors, and it has also been stated that these alignment problems may be due to gait disorders. Furthermore, it is known that obesity, which may occur simultaneously with lipedema, can lead to additional problems in mobility, and this limited mobility also increases the risk of depression. In addition, predominant sarcopenia in the thigh can be observed in these patients. In this case, weakness of the gluteus medius and quadriceps femoris that may develop contributes to the development of dynamic valgus in the knee. With the development of dynamic valgus, patellar displacement may occur, and as a result, chondromalacia may develop.

Considering the walking problems frequently observed in lipedema patients, it is crucial to address the root causes of these problems, preventing them where possible and detecting them when intervention is required. To achieve this, an assessment of potential problems and identification of related muscle and tendon dysfunctions are necessary to determine their causes. The aim of this study is to evaluate musculoskeletal problems in the lower extremities of lipedema patients, particularly those related to gait and posture, and their functional implications, and to determine the relationship between these functional problems and measurements of muscles and tendons using ultrasonography.

Study Methodology:

Design: Cross-sectional case-control study. Participants: 45 female patients with lipedema and 45 healthy controls. Clinical Evaluation: BMI, waist-hip ratio, leg volume calculation, and Foot Posture Index-6.

Functional Assessment: 6-Minute Walk Test. Questionnaires: Rapprich Lipedema Symptomatic Assessment, LYMPQOL-LEG and Short Form-36 USG Protocol: Measurement of M. Rectus Femoris, Gastrocnemius, Tibialis Posterior, and Gluteus Medius thickness using Esaote MyLab Seven lineer probe [SL1543].

Pedobarography: Static and dynamic 6-phase gait analysis using ACK Medical pedogram system.

Statistical Analysis: Group comparisons and Pearson/Spearman correlation analysis will be performed using SPSS.

Studientyp

Beobachtungs

Einschreibung (Tatsächlich)

100

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

    • Pendik
      • Istanbul, Pendik, Türkei (türkiye), 34899
        • Marmara University School of Medicine Pendik Research and Training Hospital

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 65 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Weiblich

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

Female patients aged 18-65 years diagnosed with lipedema by a clinician and their age- and BMI-matched healthy volunteers

Beschreibung

Inclusion Criteria:

  • Female patients aged 18-65 years and diagnosed with lipedema by a clinician.
  • To agree to participate in the research.

Exclusion Criteria:

  • Positivity of Stemmer's sign (inability to compress the skin between the proximal phalanges of the 2nd and 3rd fingers)
  • Patients with Heart Failure
  • Patients with Chronic Kidney Disease
  • Motor neuron diseases or myositis
  • Diseases causing myositis
  • Patients diagnosed with polyneuropathy
  • Patients with motor-involved L3, L4, L5, or S1 radiculopathy
  • Those unable to ambulate independently
  • Those who cannot tolerate the assessments
  • Pregnant women
  • Congenital or traumatic lower extremity disorders (e.g., developmental hip dysplasia, previous lower extremity fractures with orthopaedic implants).

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Beobachtungsmodelle: CASE_CONTROL
  • Zeitperspektiven: CROSS_SECTIONAL

Kohorten und Interventionen

Gruppe / Kohorte
Lipedema

Patients Diagnosed Lipedema

Healthy Volunteer

Healthy Volunteers thoose age- and BMI-matched

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
M. Rectus Femoris Muscle Thickness
Zeitfenster: At baseline (Day 0)

Measurement of thickness (mm) for M. Rectus Femoris with B-mode Ultrasonography (Esaote MyLab Seven). With the participant's knee fully extended and in a supine position, the transverse section of the image obtained from the midpoint of the distance between the SIAS and the upper edge of the patella was used to measure the RF thickness, excluding the fascial boundaries.

At baseline (Day 0)
M. Gastrocnemius Medialis Muscle Thickness
Zeitfenster: At baseline (Day 0)

Measurement of thickness (mm) for Gastrocnemius Medialis via B-mode Ultrasonography (Esaote MyLab Seven). With the participant in the prone position, muscle thickness (distance between superficial and deep fascia) was measured in a longitudinal section at the proximal 1/3 of the muscle, where it is widest.

At baseline (Day 0)
M. Tibialis Posterior Muscle Thickness
Zeitfenster: At Baseline (Day 0)

Measurement of thickness (mm) for M. Tibialis Posterior via B-mode Ultrasonography (Esaote MyLab Seven). With the participant in the supine position, the muscle running deep within the tibialis anterior, at approximately 30% of the lateral malleolus and between the lateral knee joint space, was identified. The thickness of the muscle was assessed at the midline in the transverse section.

At Baseline (Day 0)
M. Gluteus Medius Muscle Thickness
Zeitfenster: At Baseline (Day 0)

Measurement of thickness (mm) for M. Gluteus Medius via B-mode Ultrasonography (Esaote MyLab Seven). The participant was positioned in the LD position, with both legs crossed and hips and knees flexed at 30°. The midpoint between the major trochanter and the crista iliaca was located and measured longitudinally. The thickness of the muscle located in the deep compartment was evaluated in the longitudinal section.

At Baseline (Day 0)
Clarke's Angle
Zeitfenster: At baseline (Day 0).

Measurement of Clarke's angle (in degrees) derived from the plantar pressure distribution to objectively evaluate the integrity of the medial longitudinal arch.

At baseline (Day 0).
Foot Posture Index-6 (FPI-6) Score
Zeitfenster: At baseline (Day 0)

Assessment of foot posture (pronation, supination, or neutral) based on six clinical criteria, providing a total score for foot alignment

At baseline (Day 0)
Genu Valgum
Zeitfenster: At baseline (Day 0)

In genu valgum examination, the intermalleolar distance was measured while the participant had both knees together, and values greater than 8 cm were considered positive. In participants with an increase in intermalleolar distance, the tibiofemoral angle was measured, and values above 5° were considered genu valgum.

At baseline (Day 0)
Genu Recurvatum
Zeitfenster: At Baseline (Day 0)

In the genu recurvatum assessment, participants were placed in a supine position with a cushion under their heels, the goniometer was placed on the lateral femoral condyle, the tips of the goniometer were aligned with the greater trochanter and the lateral malleolus, and goniometric knee hyperextension was measured; values above 5° were considered positive.

At Baseline (Day 0)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Static Pedobarographic Weight Distribution Left& Right
Zeitfenster: At baseline (Day 0)

Evaluation of the percentage (%) of weight distribution between left and right feet during static standing.

At baseline (Day 0)
Static Pedobarographic Weight Distribution Forefoot& Hindfoot
Zeitfenster: At Baseline (Day 0)

Evaluation of the percentage (%) of weight distribution between forefoot and hindfoot pressure ratio during static standing.

At Baseline (Day 0)
Center of Pressure (COP) Sway Area
Zeitfenster: At baseline (Day 0)

Measurement of the area (mm^2) covered by the center of pressure during static standing to assess postural stability.

At baseline (Day 0)
Center of Pressure (COP) Sway Velocity
Zeitfenster: At baseline (Day 0)

Measurement of the movement speed (mm/s) of the center of pressure during static standing.

At baseline (Day 0)
Dynamic Peak Plantar Pressures
Zeitfenster: At baseline (Day 0)

Measurement of maximum peak pressure (N/cm^2) during 6 gait phases (Heel Strike, Foot Flat, Mid-stance, Heel Off, Toe Off) using the pedogram system.

At baseline (Day 0)
Patellar Tendon Cross-Sectional Area (CSA)
Zeitfenster: At baseline (Day 0)

Measurement of cross-sectional area (mm^2) for Patellar tendon using B-mode Ultrasonography (Esaote MyLab Seven). For the patellar tendon, a cross-sectional area (CSA, mm²) was drawn in a transverse section between the lower end of the patella and the midpoint of the tibial tuberosity with the knee flexed at 30°; the tendon thickness was measured in millimeters in a longitudinal section.

At baseline (Day 0)
Achilles Tendon Cross-Sectional Area (CSA)
Zeitfenster: At Baseline (Day 0)

Measurement of cross-sectional area (mm^2) for Achilles tendon using B-mode Ultrasonography (Esaote MyLab Seven). With the ankle in a 90° neutral position, and the participant in the prone position, CSA (mm²) measurement was performed in a transverse section with the probe positioned at a perfect right angle to the tendon at the level of the medial malleolus, with a dense gel layer underneath.

At Baseline (Day 0)
Tibialis Posterior Tendon Cross-Sectional Area (CSA)
Zeitfenster: At Baseline (Day 0)

Measurement of cross-sectional area (mm^2) for tibialis posterior tendon using B-mode Ultrasonography (Esaote MyLab Seven). For the tendon, the participant was positioned in the lateral decubitus position, with the side to be evaluated close to the operator and medial to the anterior aspect. Images were acquired through the retromalleolar canal immediately behind the Medial Malleolus. A transverse section was obtained and measured at the point where the tendon wraps around the MM.

At Baseline (Day 0)

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Rapprich Lipedema Symptomatic Assessment Score
Zeitfenster: At baseline (Day 0)

A 15-item scale (0-10 points each) assessing the severity of symptoms such as pain, tension, sensitivity, and easy bruising in the legs. Total score ranges from 0 to 150

At baseline (Day 0)
LYMPQOL-LEG (Lymphedema Quality of Life Questionnaire - Leg)
Zeitfenster: At baseline (Day 0)

A questionnaire evaluating the impact of the condition on daily activities, symptoms, social life, and clothing choices

At baseline (Day 0)
6-Minute Walk Test (6MWT) Distance
Zeitfenster: At baseline (Day 0)

Evaluation of functional exercise capacity measured in meters. The test was administered in a 30-meter straight corridor, following standard verbal instructions, in accordance with the American Thoracic Society guidelines.

At baseline (Day 0)
Subcutaneous Fat Tissue Thickness
Zeitfenster: At baseline (Day 0)

Measurement of subcutaneous fat thickness (mm) at standardized regions (anterior thigh, medial thigh, lateral calf, arm, and forearm) via Ultrasonography (Esaote MyLab Seven).

At baseline (Day 0)
Waist to Hip Ratio
Zeitfenster: At Baselin (Day 0)

Waist circumference was measured at the midpoint between the lower edge of the costal margin and the iliac crest; hip circumference was measured at the widest point of the gluteal region, with the participant standing and at the end of normal expiration, using a non-stretching measuring tape according to the World Health Organization protocol.

At Baselin (Day 0)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Ermittler

  • Hauptermittler: Canan Şanal, Assoc. Prof., Marmara University Faculty of Medicine

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

15. Juli 2026

Primärer Abschluss (Tatsächlich)

31. August 2026

Studienabschluss (Tatsächlich)

15. September 2026

Studienanmeldedaten

Zuerst eingereicht

17. Juli 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

21. Juli 2026

Zuerst gepostet (Tatsächlich)

24. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

7. Oktober 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

3. Oktober 2026

Zuletzt verifiziert

1. Oktober 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

  • MARPODUSG
  • PODUSG (Andere Kennung: Marmara University)

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