Degenerative Lumbar DiseaseNCT04130035
Decision Making in Degenerative Lumbar Spine : CT vs. MRI
An observational study of Degenerative Lumbar Disease, run by Assiut University.
Trial summary
To identify the optimal imaging modality involved in decision making in patients with degenerative lumbar spine using CT vs. MRI. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Degenerative Lumbar Disease
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2019to 1 Dec 2021
- 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 18 to 75 years
- All sexes
- Adult, Older adult
Study population: patients more than 18 years old have degenerative lumbar disease with contraindication of MRI and have spinal implant at lumbar region.
Who may be able to join
- degenerative lumbar spine diseases.
- age more than 18.
Who cannot join
- Patients with contraindications for MRI.
- Patients with spinal implants in the target region.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Decision Making in Degenerative Lumbar Spine: CT vs. MRI
To identify the optimal imaging modality involved in decision making in patients with degenerative lumbar spine using CT vs. MRI.
Read the detailed description
- There is 266 million individuals (3.63%) worldwide have DSD and LBP each year; the highest and lowest estimated incidences were found in Europe (5.7%) and Africa (2.4%), respectively. Based on population sizes, low- and middle-income countries have 4 times as many cases as high-income countries. Thirty-nine million individuals (0.53%) worldwide were found to have Spondylolisthesis, 403 million (5.5%) individuals worldwide with symptomatic disc degeneration, and 103 million (1.41%) individuals worldwide with spinal stenosis annually.
- Degenerative disease of the lumbar spine is a significant cause of disability in the world; it encompasses conditions such as Spondylolisthesis, disc degeneration, and lumbar spinal stenosis. Associated with a variety of clinical symptoms, including lower extremity pain, weakness, and low back pain (LBP) of varying levels of severity.
- Imaging plays an important role in the evaluation of degenerative spine.
- Plain films still play an important role in evaluation of the spine, because the examination is inexpensive and available and gives a wide panoramic view of the spine. Direct information about bony structures can be obtained, and functional information about misalignment and vertebral stability can be obtained with upright dynamic films in flexion-extension and lateral bending.
- Computerized axial tomography (CAT) scan: CT scan shows soft tissues such as ligaments and muscles more clearly than traditional X-rays do, so it is more useful for diagnosing certain problems, such as ruptured or degenerated discs and spinal stenosis.
- Magnetic resonance imaging (MRI): The advantage of MRI scans over X-rays and CT scans is that MRI provides clear, detailed images of the soft-tissue structures, such as the muscles, cartilage, ligaments, discs, tendons and blood vessels, in addition to the bones.
- Conditions
- Degenerative Lumbar Disease
- Keywords
- decision making, degenerative lumbar disease, CT, MRI
What is being measured
The primary outcome is the main question the study is designed to answer.
comparison between CT vs. MRI in decision making in degenerative lumbar spine.
Differences in decision making in patients of lumbar degenerative spine based on CT vs. MRI.
Measured: baseline
Secondary outcomes (1)
The correlation between the image finding and intraoperative finding.
The correlation between the image finding and intraoperative finding.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2019
- Study start1 Nov 2019 (estimated)
- Primary completion1 Nov 2021 (estimated)
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Degenerative Lumbar DiseaseStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Aamer, Assiut University
- Investigators
- essam Elsherief, prof., Study chair, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04130035
- Sponsor's protocol ID
- degenerative lumbar spine
- Status last verified
- Oct 2019
- First submitted
- 15 Oct 2019
- Last updated
- 17 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Maravilla KR, Lesh P, Weinreb JC, Selby DK, Mooney V. Magnetic resonance imaging of the lumbar spine with CT correlation. AJNR Am J Neuroradiol. 1985 Mar-Apr;6(2):237-45.
PubMed 3920882Modic MT, Ross JS. Magnetic resonance imaging in the evaluation of low back pain. Orthop Clin North Am. 1991 Apr;22(2):283-301.
PubMed 1826552Jarvik JG, Deyo RA. Diagnostic evaluation of low back pain with emphasis on imaging. Ann Intern Med. 2002 Oct 1;137(7):586-97. doi: 10.7326/0003-4819-137-7-200210010-00010.
PubMed 12353946Ravindra VM, Senglaub SS, Rattani A, Dewan MC, Hartl R, Bisson E, Park KB, Shrime MG. Degenerative Lumbar Spine Disease: Estimating Global Incidence and Worldwide Volume. Global Spine J. 2018 Dec;8(8):784-794. doi: 10.1177/2192568218770769. Epub 2018 Apr 24.
PubMed 30560029
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decision Making in Degenerative Lumbar Spine: CT vs. MRI
- ClinicalTrials.gov ID
- NCT04130035
- Acronym / sponsor ID
- degenerative lumbar spine
- Conditions
- Degenerative Lumbar Disease
- Keywords
- decision making, degenerative lumbar disease, CT, MRI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Nov 2019 (estimated)
- Primary completion
- 1 Nov 2021 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 17 Oct 2019 (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.
To identify the optimal imaging modality involved in decision making in patients with degenerative lumbar spine using CT vs. MRI.
Detailed description
- There is 266 million individuals (3.63%) worldwide have DSD and LBP each year; the highest and lowest estimated incidences were found in Europe (5.7%) and Africa (2.4%), respectively. Based on population sizes, low- and middle-income countries have 4 times as many cases as high-income countries. Thirty-nine million individuals (0.53%) worldwide were found to have Spondylolisthesis, 403 million (5.5%) individuals worldwide with symptomatic disc degeneration, and 103 million (1.41%) individuals worldwide with spinal stenosis annually.
- Degenerative disease of the lumbar spine is a significant cause of disability in the world; it encompasses conditions such as Spondylolisthesis, disc degeneration, and lumbar spinal stenosis. Associated with a variety of clinical symptoms, including lower extremity pain, weakness, and low back pain (LBP) of varying levels of severity.
- Imaging plays an important role in the evaluation of degenerative spine.
- Plain films still play an important role in evaluation of the spine, because the examination is inexpensive and available and gives a wide panoramic view of the spine. Direct information about bony structures can be obtained, and functional information about misalignment and vertebral stability can be obtained with upright dynamic films in flexion-extension and lateral bending.
- Computerized axial tomography (CAT) scan: CT scan shows soft tissues such as ligaments and muscles more clearly than traditional X-rays do, so it is more useful for diagnosing certain problems, such as ruptured or degenerated discs and spinal stenosis.
- Magnetic resonance imaging (MRI): The advantage of MRI scans over X-rays and CT scans is that MRI provides clear, detailed images of the soft-tissue structures, such as the muscles, cartilage, ligaments, discs, tendons and blood vessels, in addition to the bones.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients more than 18 years old have degenerative lumbar disease with contraindication of MRI and have spinal implant at lumbar region.
Key inclusion criteria (2 listed)
- degenerative lumbar spine diseases.
- age more than 18.
Key exclusion criteria (2 listed)
- Patients with contraindications for MRI.
- Patients with spinal implants in the target region.
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
comparison between CT vs. MRI in decision making in degenerative lumbar spine.
Time frame: baseline
Differences in decision making in patients of lumbar degenerative spine based on CT vs. MRI.
1 secondary outcome
The correlation between the image finding and intraoperative finding.
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2019.
- Background: PubMed 3920882Maravilla KR, Lesh P, Weinreb JC, Selby DK, Mooney V. Magnetic resonance imaging of the lumbar spine with CT correlation. AJNR Am J Neuroradiol. 1985 Mar-Apr;6(2):237-45.
- Background: PubMed 1826552Modic MT, Ross JS. Magnetic resonance imaging in the evaluation of low back pain. Orthop Clin North Am. 1991 Apr;22(2):283-301.
- Background: PubMed 12353946Jarvik JG, Deyo RA. Diagnostic evaluation of low back pain with emphasis on imaging. Ann Intern Med. 2002 Oct 1;137(7):586-97. doi: 10.7326/0003-4819-137-7-200210010-00010.
- Background: PubMed 30560029Ravindra VM, Senglaub SS, Rattani A, Dewan MC, Hartl R, Bisson E, Park KB, Shrime MG. Degenerative Lumbar Spine Disease: Estimating Global Incidence and Worldwide Volume. Global Spine J. 2018 Dec;8(8):784-794. doi: 10.1177/2192568218770769. Epub 2018 Apr 24.
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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.
essam Elsherief, prof. study chair
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Degenerative Lumbar Disease, run by Assiut University.
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 2 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: status not confirmed, as of the sponsor's last update on 17 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmad Aamer, physician (01011452722, a.aamer2020@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
comparison between CT vs. MRI in decision making in degenerative lumbar spine. (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04130035, which also lists 4 linked publications.
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 17 Oct 2019.