Spinal Stenosis LumbarNCT07855445
Neuropathic Pain Severity and Its Association With Radiological Findings in Lumbar Spinal Stenosis
An observational study of Spinal Stenosis Lumbar and Neuropathic Pain, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
This cross-sectional observational study aims to evaluate neuropathic pain severity in patients with lumbar spinal stenosis (LSS) and to investigate its association with radiological findings. Neuropathic pain will be evaluated using the Neuropathic Pain Symptom Inventory (NPSI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Stenosis Lumbar, Neuropathic Pain
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Oct 2026to Mar 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with clinically and radiologically confirmed lumbar spinal stenosis who present with low back and/or leg pain or symptoms of neurogenic claudication.
Who may be able to join
- Age ≥18 years.
- Diagnosis of lumbar spinal stenosis based on clinical evaluation and lumbar magnetic resonance imaging findings.
- Presence of low back and/or leg pain or symptoms of neurogenic claudication.
- Sufficient cognitive ability to understand and complete the study questionnaires.
Who cannot join
- Presence of diabetic neuropathy, polyneuropathy, peripheral nerve entrapment neuropathy, or other causes of neuropathic pain.
- Acute symptomatic lumbar disc herniation considered to be the primary cause of radicular symptoms.
- Active malignancy or a history of spinal metastasis.
- History of major lumbar spine surgery, such as lumbar fusion.
- Severe psychiatric disorder or cognitive impairment that prevents reliable completion of the study questionnaires.
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 Pendik Training and Research Hospital
Istanbul, Istanbul, 34899
Nurbanu Hindioglu Dogan, +90 216 625 45 45, nurbanuhindioglu@gmail.com
About this study
This cross-sectional observational study aims to evaluate neuropathic pain severity in patients with lumbar spinal stenosis (LSS) and to investigate its association with radiological findings. Neuropathic pain will be evaluated using the Neuropathic Pain Symptom Inventory (NPSI). Pain intensity, neuropathic pain characteristics, functional status, walking capacity, and psychological symptoms will also be assessed. The relationships between NPSI scores and clinical, functional, psychological, and radiological parameters will be investigated.
- Conditions
- Spinal Stenosis Lumbar, Neuropathic Pain
- Keywords
- Neuropathic pain, Spinal stenosis
- Medical subject headings
- Neuralgia, Spinal Stenosis
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 |
|---|---|---|
| Patients with Lumbar Spinal Stenosis | Patients diagnosed with lumbar spinal stenosis based on clinical and magnetic resonance imaging (MRI) findings. Participants will undergo a single cross-sectional assessment including neuropathic pain symptoms, pain intensity, functional status, walking capacity, psychological symptoms, and radiological severity. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuropathic Pain Symptom Inventory Total Intensity Score
Neuropathic pain symptom intensity will be assessed using the Neuropathic Pain Symptom Inventory (NPSI). The total intensity score is calculated as the sum of 10 symptom descriptor scores and ranges from 0 to 100, with higher scores indicating greater neuropathic pain symptom intensity.
Measured: Single assessment at baseline
Secondary outcomes (3)
Correlation Between Neuropathic Pain Symptom Inventory Total Intensity Score and Radiological Severity of Lumbar Spinal Stenosis
The correlation between the Neuropathic Pain Symptom Inventory (NPSI) total intensity score (range, 0-100; higher scores indicate greater neuropathic pain symptom intensity) and radiological severity of lumbar spinal stenosis assessed on lumbar magnetic resonance imaging using the Schizas grading system will be evaluated.
Measured: Single assessment at baseline
Correlation Between Neuropathic Pain Symptom Inventory Total Intensity Score and Leg Pain Intensity
The correlation between the NPSI total intensity score (range, 0-100; higher scores indicate greater neuropathic pain symptom intensity) and leg pain intensity assessed using the 11-point Numeric Rating Scale (NRS; 0 = no pain and 10 = worst imaginable pain) will be evaluated.
Measured: Single assessment at baseline
Correlation Between Neuropathic Pain Symptom Inventory Total Intensity Score and Functional Disability
The correlation between the NPSI total intensity score (range, 0-100; higher scores indicate greater neuropathic pain symptom intensity) and functional disability assessed using the Oswestry Disability Index (ODI) will be evaluated. Higher ODI scores indicate greater disability.
Measured: Single assessment at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study start2 Oct 2026
- Primary completionFeb 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Stenosis LumbarStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07855445
- Sponsor's protocol ID
- 09.2026.26.0532
- Status last verified
- Oct 2026
- First submitted
- 28 Sep 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data are not planned to be shared publicly due to participant confidentiality and data protection considerations.
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuropathic Pain Severity and Its Association With Radiological Findings in Lumbar Spinal Stenosis
- ClinicalTrials.gov ID
- NCT07855445
- Acronym / sponsor ID
- 09.2026.26.0532
- Conditions
- Spinal Stenosis Lumbar, Neuropathic Pain
- Keywords
- Neuropathic pain, Spinal stenosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 2 Oct 2026 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 2 Oct 2026 (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.
This cross-sectional observational study aims to evaluate neuropathic pain severity in patients with lumbar spinal stenosis (LSS) and to investigate its association with radiological findings. Neuropathic pain will be evaluated using the Neuropathic Pain Symptom Inventory (NPSI). Pain intensity, neuropathic pain characteristics, functional status, walking capacity, and psychological symptoms will also be assessed. The relationships between NPSI scores and clinical, functional, psychological, and radiological parameters will be investigated.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Lumbar Spinal Stenosis | – | –Patients diagnosed with lumbar spinal stenosis based on clinical and magnetic resonance imaging (MRI) findings. Participants will undergo a single cross-sectional assessment including neuropathic pain symptoms, pain intensity, functional status, walking capacity, psychological symptoms, and radiological severity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with clinically and radiologically confirmed lumbar spinal stenosis who present with low back and/or leg pain or symptoms of neurogenic claudication.
Key inclusion criteria (4 listed)
- Age ≥18 years.
- Diagnosis of lumbar spinal stenosis based on clinical evaluation and lumbar magnetic resonance imaging findings.
- Presence of low back and/or leg pain or symptoms of neurogenic claudication.
- Sufficient cognitive ability to understand and complete the study questionnaires.
Key exclusion criteria (5 listed)
- Presence of diabetic neuropathy, polyneuropathy, peripheral nerve entrapment neuropathy, or other causes of neuropathic pain.
- Acute symptomatic lumbar disc herniation considered to be the primary cause of radicular symptoms.
- Active malignancy or a history of spinal metastasis.
- History of major lumbar spine surgery, such as lumbar fusion.
- Severe psychiatric disorder or cognitive impairment that prevents reliable completion of the study questionnaires.
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
Neuropathic Pain Symptom Inventory Total Intensity Score
Time frame: Single assessment at baseline
Neuropathic pain symptom intensity will be assessed using the Neuropathic Pain Symptom Inventory (NPSI). The total intensity score is calculated as the sum of 10 symptom descriptor scores and ranges from 0 to 100, with higher scores indicating greater neuropathic pain symptom intensity.
3 secondary outcomes
Correlation Between Neuropathic Pain Symptom Inventory Total Intensity Score and Radiological Severity of Lumbar Spinal Stenosis
Time frame: Single assessment at baseline
Correlation Between Neuropathic Pain Symptom Inventory Total Intensity Score and Leg Pain Intensity
Time frame: Single assessment at baseline
Correlation Between Neuropathic Pain Symptom Inventory Total Intensity Score and Functional Disability
Time frame: Single assessment at baseline
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 7 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data are not planned to be shared publicly due to participant confidentiality and data protection considerations.
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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.
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 Spinal Stenosis Lumbar and Neuropathic Pain, 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 4 inclusion and 5 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 7 Oct 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 Nurbanu Hindioglu Dogan (+90 216 625 45 45, nurbanuhindioglu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuropathic Pain Symptom Inventory Total Intensity Score (time frame: Single assessment at baseline). 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 7 Oct 2026.