Presence of Dural Pulsation in Patients Diagnosed With Lumbar Spinal Stenosis

Correlation of the Presence of Dural Pulsation With Clinical and Radiological Parameters in Patients Diagnosed With Lumbar Spinal Stenosis

Lumbar spinal stenosis is defined as the narrowing of the spinal canal resulting from degenerative changes in the spinal joints, intervertebral discs, and the ligamentum flavum.

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

Study Overview

• Status: Recruiting
• Conditions: Lumbar Spinal Stenosis; Claudication; Disability Physical; Magnetic Resonance; Numerical Rating Scale

Detailed Description

Lomber spinal stenosis is defined as a narrowing of the spinal canal resulting from degenerative changes in the spinal joints, intervertebral discs, and the ligamentum flavum. The reduction in the space surrounding the neurovascular structures may lead to significant clinical symptoms such as neurogenic claudication, radiating pain in the lower extremities, low back pain, and urinary or fecal incontinence. Symptoms often improve when patients sit down or lean forward. However, if the pain induced by standing or walking postures becomes severe, it may impair the ability to perform daily and independent activities.

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.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Fatma B Akdağ, Research Assistant; Phone Number: +90 537 452 96 60; Email: fatma.betul820@gmail.com
• Study Contact Backup: Name: Savaş Şencan, Associate Professor; Phone Number: +90 537 066 57 13; Email: savas-44@hotmail.com

Study Locations

• Turkey (Türkiye)
  • Istanbul
    • Pendik, Istanbul, Turkey (Türkiye), 34890
      • Recruiting
      • Marmara University Faculty of Medicine, Pendik Training and Research Hospital, Algology Department
      • Contact: Fatma B Akdağ, Research Assistant; Phone Number: +905374529660; Email: fatma.betul820@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients aged between 18 and 85 years diagnosed with lumbar spinal stenosis based on physical examination, clinical evaluation, and lumbar magnetic resonance imaging.

Description

Inclusion criteria

• Aged between 18 and 85 years
• 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
• Willingness to participate in the study Exclusion criteria
• Body Mass Index (BMI) ≥ 35 kg/m²
• 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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Positive for dural pulsation
Negative for dural pulsation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Numeric Rating Scale (NRS)	The Numeric Rating Scale (NRS) is a unidimensional, self-reported measure of pain intensity that is widely used in both clinical practice and research, including studies involving patients with chronic pain. On this scale, patients rate their current level of pain on an 11-point numeric range from 0 to 10, where 0 represents "no pain" and 10 represents "the worst pain imaginable." Higher scores indicate greater pain intensity.	At the time of data collection
Oswestry Disability Index	The Oswestry Disability Index (ODI) is a widely used and validated questionnaire designed to assess the degree of disability and functional impairment in patients with low back pain. It evaluates the impact of pain on various aspects of daily living and physical function through ten sections, each scored from 0 to 5, with higher scores indicating greater disability. The total score is converted into a percentage by dividing the obtained score by the maximum possible score and multiplying by 100, yielding a final score ranging from 0% (no disability) to 100% (maximum disability).	At the time of data collection
SHORT FORM-12	The Short Form-12 (SF-12) is a health-related quality of life assessment tool that summarizes an individual's physical and mental health status through 12 items. It is a shortened version of the SF-36 questionnaire and measures eight health domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The SF-12 produces two composite scores - the Physical Component Summary (PCS) and the Mental Component Summary (MCS) - which are standardized to a mean of 50 and a standard deviation of 10 in the general population. Higher scores indicate better health status and quality of life.	At the time of data collection
Walking Distance Capacity		At the time of data collection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dural anteroposterior diameter measured by MRI at the stenotic level		At the time of data collection
Dural cross-sectional area measured by MRI at the stenotic level		At the time of data collection
Schizas classification of the stenotic level on MRI	The Schizas classification is a qualitative grading system used to assess the severity of lumbar spinal canal stenosis on axial T2-weighted magnetic resonance imaging (MRI). It is based on the morphology of the dural sac and the distribution of cerebrospinal fluid (CSF) and nerve rootlets within the canal. The classification includes five grades (A-E): Grade A: Clearly visible CSF surrounding all cauda equina rootlets (no stenosis). Grade B: Some aggregation of rootlets, but CSF still visible (mild stenosis). Grade C: Rootlets form a dense bundle with minimal CSF signal (moderate stenosis). Grade D: No visible CSF, rootlets fill the dural sac (severe stenosis). Grade E: Dural sac completely obliterated or replaced by epidural fat or fibrosis (extreme stenosis). Higher grades correspond to more severe central canal stenosis.	At the time of data collection

Collaborators and Investigators

• Sponsor: Marmara University
• Investigators: Principal Investigator: Fatma B Akdağ, Research Assistant, Marmara University Faculty of Medicine ,Marmara University, Department of Physical Medicine and Rehabilitation; Study Director: Osman H Gündüz, Professor, Algology Division, Department of Physical Medicine and Rehabilitation, Marmara University Faculty of Medicine; Study Director: Serdar Kokar, Associate Professor, Algology Division, Department of Physical Medicine and Rehabilitation, Marmara University Faculty of Medicine; Study Director: Savaş Şencan, Associate Professor, Algology Division, Department of Physical Medicine and Rehabilitation, Marmara University Faculty of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2025
• Primary Completion (Estimated): December 20, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: July 1, 2025
• First Submitted That Met QC Criteria: November 16, 2025
• First Posted (Actual): November 18, 2025

Study Record Updates

• Last Update Posted (Actual): March 11, 2026
• Last Update Submitted That Met QC Criteria: March 9, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: oswestry disability index; Dural Pulsation
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Vascular Diseases; Cardiovascular Diseases; Spinal Diseases; Peripheral Vascular Diseases; Peripheral Arterial Disease; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Spinal Stenosis; Intermittent Claudication
• Other Study ID Numbers: MarmaraU-FTR-FBA-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No