Ultrasonographic Evaluation and Pedobarographic Correlation of Lower Extremity Muscles in Lipedema Patients (PODUSG)
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
Status
Bedingungen
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
Studientyp
Einschreibung (Tatsächlich)
Einschreibung
Kontakte und Standorte
Studienorte
-
-
Pendik
-
Istanbul, Pendik, Türkei (türkiye), 34899
- Marmara University School of Medicine Pendik Research and Training Hospital
-
-
Teilnahmekriterien
Zulassungskriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
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
Wie ist die Studie aufgebaut?
Designdetails
- Beobachtungsmodelle: CASE_CONTROL
- Zeitperspektiven: CROSS_SECTIONAL
Anzahl der Gruppen / Kohorten
Kohorten und Interventionen
Gruppe / KohorteGruppe / Kohorte |
|---|
|
Lipedema
Patients Diagnosed Lipedema |
|
Healthy Volunteer
Healthy Volunteers thoose age- and BMI-matched |
Was misst die Studie?
Primäre Ergebnismessungen
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
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
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
Sponsor
Sponsor
Ermittler
Ermittler
- Hauptermittler: Canan Şanal, Assoc. Prof., Marmara University Faculty of Medicine
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- Whittaker JL, Emery CA. Sonographic measures of the gluteus medius, gluteus minimus, and vastus medialis muscles. J Orthop Sports Phys Ther. 2014 Aug;44(8):627-32. doi: 10.2519/jospt.2014.5315. Epub 2014 Jul 16.
- Kara M, Kaymak B, Ata AM, Ozkal O, Kara O, Baki A, Sengul Aycicek G, Topuz S, Karahan S, Soylu AR, Cakir B, Halil M, Ozcakar L. STAR-Sonographic Thigh Adjustment Ratio: A Golden Formula for the Diagnosis of Sarcopenia. Am J Phys Med Rehabil. 2020 Oct;99(10):902-908. doi: 10.1097/PHM.0000000000001439.
- WOLD LE, HINES EA Jr, ALLEN EV. Lipedema of the legs; a syndrome characterized by fat legs and edema. Ann Intern Med. 1951 May;34(5):1243-50. doi: 10.7326/0003-4819-34-5-1243. No abstract available.
- Nijholt W, Scafoglieri A, Jager-Wittenaar H, Hobbelen JSM, van der Schans CP. The reliability and validity of ultrasound to quantify muscles in older adults: a systematic review. J Cachexia Sarcopenia Muscle. 2017 Oct;8(5):702-712. doi: 10.1002/jcsm.12210. Epub 2017 Jul 12.
- Buso G, Depairon M, Tomson D, Raffoul W, Vettor R, Mazzolai L. Lipedema: A Call to Action! Obesity (Silver Spring). 2019 Oct;27(10):1567-1576. doi: 10.1002/oby.22597.
- Yalfani A, Ahmadi M, Asgarpoor A. The effect of kinetic factors of dynamic knee valgus on patellofemoral pain: A systematic review and meta-analysis. J Bodyw Mov Ther. 2024 Jan;37:246-253. doi: 10.1016/j.jbmt.2023.11.001. Epub 2023 Nov 14.
- Faerber G, Cornely M, Daubert C, Erbacher G, Fink J, Hirsch T, Mendoza E, Miller A, Rabe E, Rapprich S, Reich-Schupke S, Stucker M, Brenner E. S2k guideline lipedema. J Dtsch Dermatol Ges. 2024 Sep;22(9):1303-1315. doi: 10.1111/ddg.15513. Epub 2024 Aug 27.
- Mortada H, Alhithlool AW, AlBattal NZ, Shetty RK, Al-Mekhlafi GA, Hong JP, Alshomer F. Lipedema: Clinical Features, Diagnosis, and Management. Arch Plast Surg. 2025 May 15;52(3):185-196. doi: 10.1055/a-2530-5875. eCollection 2025 May.
- van la Parra RFD, Deconinck C, Pirson G, Servaes M, Fosseprez P. Lipedema: What we don't know. J Plast Reconstr Aesthet Surg. 2023 Sep;84:302-312. doi: 10.1016/j.bjps.2023.05.056. Epub 2023 May 30.
- Rapprich S, Dingler A, Podda M. Liposuction is an effective treatment for lipedema-results of a study with 25 patients. J Dtsch Dermatol Ges. 2011 Jan;9(1):33-40. doi: 10.1111/j.1610-0387.2010.07504.x. Epub 2010 Sep 7. English, German.
- Linsmayer D, Neidlinger PK, Braus DF. [Rheumatism and the mind-A mini review]. Orthopade. 2019 Nov;48(11):957-962. doi: 10.1007/s00132-019-03812-8. German.
- Volkan-Yazici M, Yazici G, Esmer M. The Effects of Complex Decongestive Physiotherapy Applications on Lower Extremity Circumference and Volume in Patients with Lipedema. Lymphat Res Biol. 2021 Feb;19(1):111-114. doi: 10.1089/lrb.2020.0080. Epub 2020 Oct 30.
- Amato AC. Chondromalacia in Lipedema: The Sarcopenic-Valgus Cascade That Keeps Getting Missed. Cureus. 2025 Oct 24;17(10):e95299. doi: 10.7759/cureus.95299. eCollection 2025 Oct.
- Guven M, Kocadal O, Akman B, Poyanli OS, Kemah B, Atay EF. Proximal femoral nail shows better concordance of gait analysis between operated and uninjured limbs compared to hemiarthroplasty in intertrochanteric femoral fractures. Injury. 2016 Jun;47(6):1325-31. doi: 10.1016/j.injury.2016.03.009. Epub 2016 Mar 12.
- Lorkowski J, Zarzycki D. [Clinical use of pedobarographic examination--own experience and review of literature]. Przegl Lek. 2006;63 Suppl 5:28-32. Polish.
- Lorkowski J, Gawronska K. Pedobarography in Physiotherapy: A Narrative Review on Current Knowledge. Adv Exp Med Biol. 2022;1375:13-22. doi: 10.1007/5584_2021_636.
- Neville C, Meyers K, Hojnowski L. Ultrasound assessment of the tibialis posterior tendon. J Orthop Sports Phys Ther. 2010 Oct;40(10):667. doi: 10.2519/jospt.2010.0417. No abstract available.
- Johnson AW, Bruening DA, Violette VA, Perkins KV, Thompson CL, Ridge ST. Ultrasound Imaging Is Reliable for Tibialis Posterior Size Measurements. J Ultrasound Med. 2020 Dec;39(12):2305-2312. doi: 10.1002/jum.15340. Epub 2020 May 15.
- Sheptulina AF, Yafarova AA, Mamutova EM, Drapkina OM. Sonographic Features of Rectus Femoris Muscle in Patients with Metabolic Dysfunction-Associated Fatty Liver Disease and Their Correlation with Body Composition Parameters and Muscle Strength: Results of a Single-Center Cross-Sectional Study. Biomedicines. 2024 Jul 28;12(8):1684. doi: 10.3390/biomedicines12081684.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Studienbeginn
Primärer Abschluss (Tatsächlich)
Primärer Abschluss
Studienabschluss (Tatsächlich)
Studienabschluss
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Zuerst gepostet
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes Update gepostet
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
Andere Studien-ID-Nummern
- MARPODUSG
- PODUSG (Andere Kennung: Marmara University)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .