- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07629466
Association Between Trendelenburg Sign and Lumbar MRI Abnormalities
Association of the Trendelenburg Sign With Spinopelvic Biomechanics and Lumbar MRI Abnormalities"
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
The Trendelenburg sign is a clinical indicator of hip abductor muscle dysfunction and altered pelvic stability. Changes in hip abductor function may affect spinopelvic biomechanics and contribute to lumbar degenerative changes. This prospective observational study aims to investigate the association between Trendelenburg sign positivity and lumbar MRI abnormalities in adults with chronic low back pain.
Participants will be classified as Trendelenburg-positive or Trendelenburg-negative based on clinical examination. Hip abductor muscle strength and lumbar MRI findings will be evaluated. MRI parameters will include the presence and severity of facet joint arthropathy, ligamentum flavum thickness, multifidus muscle thickness, and psoas muscle characteristics.
The primary objective is to determine whether a positive Trendelenburg sign is associated with lumbar facet arthropathy. Secondary objectives include evaluating the relationships between the Trendelenburg sign, hip abductor strength, and other lumbar MRI parameters. The findings may improve understanding of the biomechanical relationship between hip function and lumbar degeneration in patients with chronic low back pain.
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: zeynep Iyigun, Prof. MD
- Telefonnummer: +905056987368
- E-mail: zeynep.iyigun@bau.edu.tr
Studiesteder
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Istanbul, Tyrkiet (Türkiye)
- Bahçeşehir University
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:Age between 18 and 65 years. Patients who have previously presented to the clinic with a complaint of low back pain.
Willingness and ability to provide written informed consent for participation in the study.
Availability of lumbar MRI images obtained within the previous 12 months and accessible for evaluation.
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Exclusion Criteria:Presence of red flag conditions associated with low back pain, including malignancy, infection, acute trauma, or significant neurological deficits.
History of lumbar spine surgery. Structural spinal anomalies such as sacralization or lumbarization. Spinal deformities, including scoliosis. Rheumatologic diseases affecting the spine (e.g., axial spondyloarthritis). Significant radiculopathy or advanced neurological deficits, and the presence of extruded or sequestrated lumbar disc herniation.
Clinically significant lumbar spinal stenosis. Spondylolysis and/or spondylolisthesis. Acute vertebral fracture, compression fracture, or recent fracture associated with severe osteoporosis.
Hip or pelvic conditions that may directly influence the Trendelenburg sign, including:
History of hip arthroplasty or hip surgery, Advanced hip osteoarthritis, Residual deformity following lower-extremity fracture, Significant leg length discrepancy (>2 cm). Systemic or neuromuscular disorders, including multiple sclerosis, myopathies, amyotrophic lateral sclerosis (ALS), stroke, or peripheral neuropathies.
Pregnancy. Severe knee or ankle pathology or other conditions causing substantial gait impairment.
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Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Presence and Severity of Lumbar Facet Joint Arthropathy
Tidsramme: Baseline
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Assessment of the presence and severity of lumbar facet joint arthropathy on magnetic resonance imaging (MRI) and its association with Trendelenburg sign positivity.
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Baseline
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
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
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- BAU-FTR-2026-07/04
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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