- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07724483
Ultrasonographic Evaluation and Pedobarographic Correlation of Lower Extremity Muscles in Lipedema Patients (PODUSG)
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Canan Şanal, Assoc. Prof.
- Telefonnummer: +90 533 138 10 32
- E-mail: canansanal@hotmail.com
Undersøgelse Kontakt Backup
- Navn: M. Selim Eryılmaz, Res. Asst.
- Telefonnummer: +90 542 48 48 329
- E-mail: selimerylmz@gmail.com
Studiesteder
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Pendik
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Istanbul, Pendik, Tyrkiet (Türkiye), 34899
- Rekruttering
- Marmara University School of Medicine Pendik Research and Training Hospital
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Kontakt:
- Canan Sanal, Assoc. Prof.
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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).
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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Lipedema
Patients Diagnosed Lipedema
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Healthy Volunteer
Healthy Volunteers thoose age- and BMI-matched
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Lower Extremity Muscle and Tendon Thickness
Tidsramme: At baseline (Day 0)
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Measurement of thickness (mm) for M. Rectus Femoris, Gastrocnemius Medialis, Tibialis Posterior, and Gluteus Medius muscles, and the Patellar tendon via B-mode Ultrasonography (Esaote MyLab Seven).
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At baseline (Day 0)
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Tendon Cross-Sectional Area (CSA)
Tidsramme: At baseline (Day 0)
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Measurement of cross-sectional area (mm^2) for Patellar, Achilles, and Tibialis Posterior tendons using B-mode Ultrasonography (Esaote MyLab Seven).
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At baseline (Day 0)
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Static Pedobarographic Weight Distribution
Tidsramme: At baseline (Day 0)
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Evaluation of the percentage (%) of weight distribution between left and right feet and the forefoot/hindfoot pressure ratio during static standing
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At baseline (Day 0)
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Center of Pressure (COP) Sway Area
Tidsramme: At baseline (Day 0)
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Measurement of the area (mm^2) covered by the center of pressure during static standing to assess postural stability.
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At baseline (Day 0)
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Center of Pressure (COP) Sway Velocity
Tidsramme: At baseline (Day 0)
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Measurement of the movement speed (mm/s) of the center of pressure during static standing.
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At baseline (Day 0)
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Dynamic Peak Plantar Pressures
Tidsramme: At baseline (Day 0)
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Measurement of maximum peak pressures (N/cm^2) across 6 gait phases (Heel Strike, Foot Flat, Mid-stance, Heel Off, Toe Off) using the pedogram system.
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At baseline (Day 0)
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Clarke's Angle
Tidsramme: At baseline (Day 0).
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Measurement of Clarke's angle (in degrees) derived from the plantar pressure distribution to objectively evaluate the integrity of the medial longitudinal arch.
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At baseline (Day 0).
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Rapprich Lipedema Symptomatic Assessment Score
Tidsramme: At baseline (Day 0)
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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
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At baseline (Day 0)
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LYMPQOL-LEG (Lymphedema Quality of Life Questionnaire - Leg)
Tidsramme: At baseline (Day 0)
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A questionnaire evaluating the impact of the condition on daily activities, symptoms, social life, and clothing choices
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At baseline (Day 0)
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Foot Posture Index-6 (FPI-6) Score
Tidsramme: At baseline (Day 0)
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Assessment of foot posture (pronation, supination, or neutral) based on six clinical criteria, providing a total score for foot alignment
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At baseline (Day 0)
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6-Minute Walk Test (6MWT) Distance
Tidsramme: At baseline (Day 0)
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Evaluation of functional exercise capacity measured in meters
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At baseline (Day 0)
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Subcutaneous Fat Tissue Thickness
Tidsramme: At baseline (Day 0)
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Measurement of subcutaneous fat thickness (mm) at standardized regions (anterior thigh, medial thigh, lateral calf, arm, and forearm) via Ultrasonography (Esaote MyLab Seven).
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At baseline (Day 0)
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Canan Şanal, Assoc. Prof., Marmara University Faculty of Medicine
Publikationer og nyttige links
Generelle publikationer
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- MARPODUSG
- PODUSG (Anden identifikator: Marmara University)
Plan for individuelle deltagerdata (IPD)
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