Radiological Lumbar Spinal Stenosis Level and Patient Questionnaires

NCT07058350 | Completed

• 1 other identifier: 04.08.2025/approval no:4828
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lumbar Spinal Stenosis; Low Back Pain

Keywords

lumbar spinal stenosis; low back pain; İstanbul low back pain disability index; Oswestry Disability Index; Swiss Spinal Stenosis Questionnaire

Outcome Measures

Primary Outcomes (3)

• Oswestry Disability Index

  The Oswestry Disability Index (ODI) is used to measure the degree of functional limitations caused by pain in patients with low back pain. The questionnaire provides the user with detailed information about the general daily functioning of a patient with low back pain. Questions are included regarding pain intensity, self-care, lifting, moving, sitting or standing, sleeping, sexual life, social life, and travel/transportation. A score of 0 indicates no limitations due to pain, while a score of 5 indicates the greatest perceived limitation in an activity due to pain. It is calculated by dividing the total score by the score range and multiplying the result by 100 to obtain the percentage value of the index. 0% indicating no disability and 100% indicating the highest level of disability.

  Day 1

• İstanbul Low Back Pain Disability Questionnaire

  The Istanbul Low Back Pain Disability Index consists of 18 questions that evaluate the effects of low back pain on activities such as going up and down stairs, walking, bathing, brushing teeth, dressing, etc. If a person can do it "without any difficulty", 0 points, if "with little difficulty", 1 point, if "with some difficulty", 2 points, if "with great difficulty", 3 points, if "almost impossible", 4 points, and "impossible" (5 points) are used to obtain a total score of 0-90. A total score of 0 indicates no disability, while 90 indicates maximum disability.

  Day 1

• Swiss Spinal Stenosis Questionnaire

  The Swiss Spinal Stenosis Questionnaire consists of 18 questions. The first 7 questions concern the patient's symptoms. The first three questions concern pain (intensity, frequency and back pain) and the last four questions concern neuroischemic symptoms (numbness or tingling, weakness and balance disorders). Each question is scored from 1 to 5 (maximum 35 points). The next 5 questions concern the patients' physical activity and each question is scored from 1 to 4 (maximum 20 points). A higher score indicates a more severe disease. The last 6 questions concern the patients' satisfaction with surgical treatment and each is scored from 1 to 4. A higher score indicates less satisfaction with surgery.

  Day 1

Secondary Outcomes (1)

• Visual Analog Scale

  Day 1

Study Arms (2)

Those with radiological lumbar spinal stenosis

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

Those without radiological lumbar spinal stenosis

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

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients aged 50 and over with low back pain

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sisli Hamidiye Etfal Training and Research Hospital: lead

Study Sites (1)

Şişli Hamidiye Etfal Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Spinal Stenosis; Low Back Pain

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Banu Kuran, Professor, Medical Doctor

  Şişli Hamidiye Etfal Training and Research Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: June 30, 2025
• First Posted: July 10, 2025
• Study Start: June 1, 2025
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: November 19, 2025

Record last verified: 2025-06

Locations

TU (1)