Presence of Dural Pulsation in Patients Diagnosed With Lumbar Spinal Stenosis

NCT07233798 | Recruiting

• 1 other identifier: MarmaraU-FTR-FBA-01
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Lumbar Spinal Stenosis; Claudication; Numerical Rating Scale; Disability Physical; Magnetic Resonance

Keywords

Dural Pulsation; oswestry disability index

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• 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

  At the time of data collection

Study Arms (2)

Positive for dural pulsation

Negative for dural pulsation

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University Faculty of Medicine, Pendik Training and Research Hospital, Algology Department

Pendik, Istanbul, 34890, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Spinal Stenosis; Intermittent Claudication

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Peripheral Arterial Disease; Peripheral Vascular Diseases; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Fatma B Akdağ, Research Assistant

  Marmara University Faculty of Medicine ,Marmara University, Department of Physical Medicine and Rehabilitation

  PRINCIPAL INVESTIGATOR

• 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 DIRECTOR

Central Study Contacts

Fatma B Akdağ, Research Assistant

CONTACT

+90 537 452 96 60; fatma.betul820@gmail.com

Savaş Şencan, Associate Professor

CONTACT

+90 537 066 57 13; savas-44@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2025
• First Posted: November 18, 2025
• Study Start: December 7, 2025
• Primary Completion (Estimated): December 20, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)