- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07629466
Association Between Trendelenburg Sign and Lumbar MRI Abnormalities
Association of the Trendelenburg Sign With Spinopelvic Biomechanics and Lumbar MRI Abnormalities"
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: zeynep Iyigun, Prof. MD
- Phone Number: +905056987368
- Email: zeynep.iyigun@bau.edu.tr
Study Locations
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Istanbul, Turkey (Türkiye)
- Bahcesehir university
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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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Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Presence and Severity of Lumbar Facet Joint Arthropathy
Time Frame: 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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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BAU-FTR-2026-07/04
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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