Correlation of the Presence of Dural Pulsation With Clinical and Radiological Parameters in Patients Diagnosed With Lumbar Spinal Stenosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The Numeric Rating Scale (NRS)
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Positive for dural pulsation
Negative for dural pulsation
结局指标
主要结局
The Numeric Rating Scale (NRS)
时间窗: At the time of data collection
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.
Oswestry Disability Index
时间窗: At the time of data collection
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).
Walking Distance Capacity
时间窗: At the time of data collection
SHORT FORM-12
时间窗: At the time of data collection
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.
次要结局
- Schizas classification of the stenotic level on MRI(At the time of data collection)
- 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)