An observational study in Lumbar Spinal Stenosis, Numerical Rating Scale and Disability Physical, sponsored by Marmara University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-03-11.
Sponsored by Marmara University · Observational
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
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.
458 studies on the registry are indexed under Spinal Stenosis; 105 are open to participants now.
This study's planned enrollment of 100 is below the median of 120 across 154 observational studies indexed under Spinal Stenosis.
Browse Spinal Stenosis studies →Marmara University is the lead sponsor of 599 studies on the registry; 138 are open to participants now.
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Patients aged between 18 and 85 years diagnosed with lumbar spinal stenosis based on physical examination, clinical evaluation, and lumbar magnetic resonance imaging.
Inclusion criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Time frame: 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).
Time frame: 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.
Time frame: At the time of data collection
Walking Distance Capacity
Time frame: At the time of data collection
Dural anteroposterior diameter measured by MRI at the stenotic level
Time frame: At the time of data collection
Dural cross-sectional area measured by MRI at the stenotic level
Time frame: 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.
Time frame: At the time of data collection
Plan to share: No
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