Presence of Dural Pulsation in Patients Diagnosed With Lumbar Spinal Stenosis
NCT ID: NCT07233798
Last Updated: 2025-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
84 participants
OBSERVATIONAL
2025-12-07
2026-12-30
Brief Summary
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Pressure fluctuations within the cerebral and spinal vascular systems lead to the formation of pulsations. The periodic occurrence of these pulsations in the dura mater is referred to as spinal dural pulsation.The vibratory movements of the dura mater have been interpreted as an indicator that the spinal cord is freely mobile within the subarachnoid space and not subjected to any external compression.This study aims to investigate whether the presence of dural pulsation is associated with clinical and radiological parameters in patients diagnosed with lumbar spinal stenosis
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Detailed Description
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Magnetic Resonance Imaging is the primary imaging modality for the diagnosis of LSS. It provides high sensitivity and specificity in identifying anatomical abnormalities such as disc herniation, facet joint degeneration, and hypertrophy of the ligamentum flavum. However, as MRI findings may be influenced by factors such as patient positioning and imaging protocols, the interpretation of MRI should always be correlated with clinical findings in the diagnosis of LSS.
Periodic oscillations within the central nervous system occur due to pressure changes in the cerebral and spinal vascular systems. The rhythmic occurrence of these oscillations at the level of the dura mater is referred to as spinal dural pulsation. In previous studies, the vibratory movements of the spinal cord, dura mater, and cerebrospinal fluid (CSF) have been observed intraoperatively and evaluated in detail using MRI. Surgeons have interpreted these rhythmic movements of the dura mater as an indication that the spinal cord is freely suspended within the subarachnoid space and not subjected to external compression. This has been considered in earlier studies as a finding correlated with the presence of spinal dural pulsation.In this study, patients will be placed in the prone position, and the presence of dural pulsation will be evaluated using ultrasound.
The aim of this study is to evaluate the relationship between the presence of spinal dural pulsation and the clinical and radiological findings in patients diagnosed with lumbar spinal stenosis.
This study has been approved by the Marmara University Faculty of Medicine Non-Pharmaceutical and Non-Medical Device Clinical Trials Ethics Committee with the ethics approval number 09.2025.25-0459.
Conditions
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Study Design
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OTHER
CROSS_SECTIONAL
Study Groups
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Positive for dural pulsation
No interventions assigned to this group
Negative for dural pulsation
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Patients experiencing low back and/or leg pain attributable to lumbar spinal stenosis
* Presence of lumbar spinal stenosis at least at one level consistent with clinical symptoms on lumbar MRI
Exclusion Criteria
* Patients with radiculopathy due to lumbar disc herniation
* Patients with axial low back pain caused by facet syndrome, sacroiliac dysfunction, or discogenic pain
* History of lumbar spine surgery
* Individuals with mental retardation
* Patients with major psychiatric comorbidities
* Patients with congenital spinal anomalies
* Inflammatory rheumatic diseases characterized by osteophyte formation and ligament calcification, such as ankylosing spondylitis and diffuse idiopathic skeletal hyperostosis (DISH)
* Pregnancy
* Patients with heart failure
18 Years
85 Years
ALL
No
Sponsors
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Marmara University
OTHER
Responsible Party
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Haner Direskeneli
Professor
Principal Investigators
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Fatma B Akdağ, Research Assistant
Role: PRINCIPAL_INVESTIGATOR
Marmara University Faculty of Medicine ,Marmara University, Department of Physical Medicine and Rehabilitation
Osman H Gündüz, Professor
Role: STUDY_DIRECTOR
Algology Division, Department of Physical Medicine and Rehabilitation, Marmara University Faculty of Medicine
Serdar Kokar, Associate Professor
Role: STUDY_DIRECTOR
Algology Division, Department of Physical Medicine and Rehabilitation, Marmara University Faculty of Medicine
Savaş Şencan, Associate Professor
Role: STUDY_DIRECTOR
Algology Division, Department of Physical Medicine and Rehabilitation, Marmara University Faculty of Medicine
Locations
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Marmara University Faculty of Medicine, Pendik Training and Research Hospital, Algology Department
Pendik, Istanbul, Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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MarmaraU-FTR-FBA-01
Identifier Type: -
Identifier Source: org_study_id
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