- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04130035
Decision Making in Degenerative Lumbar Spine : CT vs. MRI
October 16, 2019 updated by: Ahmed Aamer, Assiut University
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.
Study Overview
Status
Unknown
Conditions
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 Type
Observational
Enrollment (Anticipated)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ahmad Aamer, physician
- Phone Number: 01011452722
- Email: a.aamer2020@gmail.com
Study Contact Backup
- Name: Ahmad Shawqi, Ass. prof
- Phone Number: 01010212222
- Email: ahsh313@yahoo.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
patients more than 18 years old have degenerative lumbar disease with contraindication of MRI and have spinal implant at lumbar region.
Description
Inclusion Criteria:
- degenerative lumbar spine diseases.
- age more than 18.
Exclusion Criteria:
- Patients with contraindications for MRI.
- Patients with spinal implants in the target region.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The correlation between the image finding and intraoperative finding.
Time Frame: baseline
|
The correlation between the image finding and intraoperative finding.
|
baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: essam Elsherief, prof., Assiut University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Jarvik 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.
- Ravindra 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.
- 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.
- Modic MT, Ross JS. Magnetic resonance imaging in the evaluation of low back pain. Orthop Clin North Am. 1991 Apr;22(2):283-301.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
November 1, 2019
Primary Completion (Anticipated)
November 1, 2021
Study Completion (Anticipated)
December 1, 2021
Study Registration Dates
First Submitted
October 15, 2019
First Submitted That Met QC Criteria
October 16, 2019
First Posted (Actual)
October 17, 2019
Study Record Updates
Last Update Posted (Actual)
October 17, 2019
Last Update Submitted That Met QC Criteria
October 16, 2019
Last Verified
October 1, 2019
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- degenerative lumbar spine
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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