Presence of Dural Pulsation in Patients Diagnosed With Lumbar Spinal Stenosis

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-85
SponsorMarmara University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

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

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

100 Participants
are grouped into 2 trial groups
Group A: Positive for dural pulsation
Group B: Negative for dural pulsation

Trial outcomes

Primary outcomes

1

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
2

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
3

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
4

Walking Distance Capacity

Time frame
At the time of data collection

Secondary outcomes

1

Dural anteroposterior diameter measured by MRI at the stenotic level

Time frame
At the time of data collection
2

Dural cross-sectional area measured by MRI at the stenotic level

Time frame
At the time of data collection
3

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

Other outcomes

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