Radiological Lumbar Spinal Stenosis Level and Patient Questionnaires

NCT ID: NCT07058350

Last Updated: 2025-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-06-01

Study Completion Date

2025-09-01

Brief Summary

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One of the important causes of low back pain is lumbar spinal stenosis. With the increasing prevalence of magnetic resonance imaging (MRI), lumbar spinal stenosis grading systems have been developed. The Lee and Schizas lumbar spinal stenosis grading systems are widely used. Patient questionnaires are also used especially in treatment follow-ups. This study aimed to compare the compliance of patient questionnaires with the presence or absence of radiological stenosis and the degree of stenosis if present.

Detailed Description

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Patients who apply to our Physical Medicine and Rehabilitation out-patient clinic with complaints of low back pain and who have or do not have lumbar spinal stenosis on lumbar spinal MRI will be screened. Demographic values, accompanying diseases, radiological staging of lumbar spinal stenosis, Oswestry Disability Index, Istanbul Low Back Pain Disability Questionnaire, Swiss Spinal Stenosis Questionnaire will be evaluated. Pain levels will be evaluated with Visual Analog Scale (VAS). Radiological stenosis level will be determined with Lee radiological spinal stenosis classification system. Those with and without stenosis will be determined. In addition, subgroup analysis will be performed by creating subgroups with mild, moderate and severe stenosis in the stenosis group. Evaluations will be made at the L4-L5 vertebrae level, where degenerative spinal stenosis is most frequently seen. All questionnaires will be filled in both groups with and without stenosis.

Conditions

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Lumbar Spinal Stenosis Low Back Pain

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Those with radiological lumbar spinal stenosis

Those with Grade 1 or 2 or 3 according to the Lee radiological spinal stenosis staging system

No interventions assigned to this group

Those without radiological lumbar spinal stenosis

Those with Grade 0 according to the Lee radiological spinal stenosis staging system

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patients aged 50 and over with low back pain
* Those who have had a lumbar magnetic resonance imaging (MRI) scan within the last year

Exclusion Criteria

* Patients with congenital lumbar spinal stenosis
* Patients with traumatic lumbar spinal stenosis
* Patients with iatrogenic lumbar spinal stenosis
* Those with a history of lumbar vertebral surgery
* Those with cognitive impairment
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sisli Hamidiye Etfal Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Selda Çiftci

Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Banu Kuran, Professor, Medical Doctor

Role: STUDY_DIRECTOR

Şişli Hamidiye Etfal Training and Research Hospital

Locations

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Şişli Hamidiye Etfal Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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04.08.2025/approval no:4828

Identifier Type: -

Identifier Source: org_study_id

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