Neuropathic Pain Severity and Its Association With Radiological Findings in Lumbar Spinal Stenosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMarmara University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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.
Trial design
Design model
Other
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
100 Participants
are grouped into 1 trial groupGroup A: Patients with Lumbar Spinal Stenosis
Trial outcomes
Primary outcomes
1
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.
Time frame
Single assessment at baselineSecondary outcomes
1
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.
Time frame
Single assessment at baseline2
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.
Time frame
Single assessment at baseline3
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.
Time frame
Single assessment at baselineSponsors and contacts
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Source ClinicalTrials.gov