Lumbar Spinal StenosisNCT07058350
Radiological Lumbar Spinal Stenosis Level and Patient Questionnaires
An observational study of Lumbar Spinal Stenosis and Low Back Pain, run by Sisli Hamidiye Etfal Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Lumbar Spinal Stenosis, Low Back Pain
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2025to 1 Sep 2025
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged 50 and over with low back pain
Who may be able to join
- Patients aged 50 and over with low back pain
- Those who have had a lumbar magnetic resonance imaging (MRI) scan within the last year
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Şişli Hamidiye Etfal Training and Research Hospital
Istanbul
About this study
Official title: Association Between Radiological Stenosis Level and Patient Questionnaires in Patients With Lumbar Spinal Stenosis: A Cross-Sectional Study
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.
Read the detailed description
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
- 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
- Medical subject headings
- Spinal Stenosis, Low Back Pain
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 |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Day 1
Secondary outcomes (1)
Visual Analog Scale
Using a ruler, the score is determined by measuring the distance (mm) on the 10 cm line between the "no pain" anchor and the patient's mark, providing a score range of 0-100. A higher score indicates greater pain intensity.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2025
- Study start1 Jun 2025
- Primary completion1 Sep 2025
- Study completion1 Sep 2025
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.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Selda Çiftci, Sisli Hamidiye Etfal Training and Research Hospital
- Investigators
- Banu Kuran, Professor, Medical Doctor, Study director, Şişli Hamidiye Etfal Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07058350
- Sponsor's protocol ID
- 04.08.2025/approval no:4828
- Status last verified
- Jun 2025
- First submitted
- 30 Jun 2025
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Radiological Stenosis Level and Patient Questionnaires in Patients With Lumbar Spinal Stenosis: A Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT07058350
- Acronym / sponsor ID
- 04.08.2025/approval no:4828
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 10 Jul 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.
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
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 50 and over with low back pain
Key inclusion criteria (2 listed)
- Patients aged 50 and over with low back pain
- Those who have had a lumbar magnetic resonance imaging (MRI) scan within the last year
Key exclusion criteria (5 listed)
- 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
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
Oswestry Disability Index
Time frame: Day 1
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.
İstanbul Low Back Pain Disability Questionnaire
Time frame: Day 1
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.
Swiss Spinal Stenosis Questionnaire
Time frame: Day 1
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.
1 secondary outcome
Visual Analog Scale
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Banu Kuran, Professor, Medical Doctor study director
Şişli Hamidiye Etfal Training and Research Hospital
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 Low Back Pain, run by Sisli Hamidiye Etfal Training and Research Hospital 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 2 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: finished, as of the sponsor's last update on 19 Nov 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oswestry Disability Index (time frame: Day 1). The study lists 3 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 19 Nov 2025.