Lumbar Spinal StenosisNCT07233798
Presence of Dural Pulsation in Patients Diagnosed With Lumbar Spinal Stenosis
An observational study of Lumbar Spinal Stenosis and Numerical Rating Scale, run by Marmara University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Lumbar Spinal Stenosis, Numerical Rating Scale, Disability Physical
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Dec 2025to 30 Dec 2026
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Show all 14Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Marmara University Faculty of Medicine, Pendik Training and Research Hospital, Algology Department
Pendik, Istanbul, 34890
Fatma B Akdağ, Research Assistant, +905374529660, fatma.betul820@gmail.com
About this study
Official title: 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
Read the 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.
- Conditions
- Lumbar Spinal Stenosis, Numerical Rating Scale, Disability Physical, Magnetic Resonance, Claudication
- Keywords
- Dural Pulsation, oswestry disability index
- Medical subject headings
- Spinal Stenosis, Intermittent Claudication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Positive for dural pulsation | Not described | |
| Negative for dural pulsation | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: At the time of data collection
Walking Distance Capacity
Measured: At the time of data collection
Secondary outcomes (3)
Dural anteroposterior diameter measured by MRI at the stenotic level
Measured: At the time of data collection
Dural cross-sectional area measured by MRI at the stenotic level
Measured: 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.
Measured: At the time of data collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start7 Dec 2025
- Primary completion20 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Spinal StenosisStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fatma B Akdağ, Research Assistant, Principal investigator, Marmara University Faculty of Medicine ,Marmara University, Department of Physical Medicine and RehabilitationOsman H Gündüz, Professor, Study director, Algology Division, Department of Physical Medicine and Rehabilitation, Marmara University Faculty of MedicineSerdar Kokar, Associate Professor, Study director, Algology Division, Department of Physical Medicine and Rehabilitation, Marmara University Faculty of MedicineSavaş Şencan, Associate Professor, Study director, Algology Division, Department of Physical Medicine and Rehabilitation, Marmara University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07233798
- Sponsor's protocol ID
- MarmaraU-FTR-FBA-01
- Status last verified
- Mar 2026
- First submitted
- 1 Jul 2025
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of the Presence of Dural Pulsation With Clinical and Radiological Parameters in Patients Diagnosed With Lumbar Spinal Stenosis
- ClinicalTrials.gov ID
- NCT07233798
- Acronym / sponsor ID
- MarmaraU-FTR-FBA-01
- Conditions
- Lumbar Spinal Stenosis, Numerical Rating Scale, Disability Physical, Magnetic Resonance, Claudication
- Keywords
- Dural Pulsation, oswestry disability index
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 7 Dec 2025 (actual)
- Primary completion
- 20 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 18 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Positive for dural pulsation | – | – |
| Negative for dural pulsation | – | – |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The Numeric Rating Scale (NRS)
Time frame: 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
Time frame: 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).
SHORT FORM-12
Time frame: 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.
Walking Distance Capacity
Time frame: At the time of data collection
3 secondary outcomes
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
Time frame: At the time of data collection
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fatma B Akdağ, Research Assistant principal investigator
Marmara University Faculty of Medicine ,Marmara University, Department of Physical Medicine and Rehabilitation
Osman H Gündüz, Professor study director
Algology Division, Department of Physical Medicine and Rehabilitation, Marmara University Faculty of Medicine
Serdar Kokar, Associate Professor study director
Algology Division, Department of Physical Medicine and Rehabilitation, Marmara University Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lumbar Spinal Stenosis and Numerical Rating Scale, run by Marmara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fatma B Akdağ, Research Assistant (+90 537 452 96 60, fatma.betul820@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Numeric Rating Scale (NRS) (time frame: At the time of data collection). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.