Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04130035
Other study ID # degenerative lumbar spine
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date November 1, 2019
Est. completion date December 1, 2021

Study information

Verified date October 2019
Source Assiut University
Contact Ahmad Aamer, physician
Phone 01011452722
Email a.aamer2020@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To identify the optimal imaging modality involved in decision making in patients with degenerative lumbar spine using CT vs. MRI.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date December 1, 2021
Est. primary completion date November 1, 2021
Accepts healthy volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (4)

Jarvik JG, Deyo RA. Diagnostic evaluation of low back pain with emphasis on imaging. Ann Intern Med. 2002 Oct 1;137(7):586-97. Review. — View Citation

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. — View Citation

Modic MT, Ross JS. Magnetic resonance imaging in the evaluation of low back pain. Orthop Clin North Am. 1991 Apr;22(2):283-301. Review. — View Citation

Ravindra VM, Senglaub SS, Rattani A, Dewan MC, Härtl 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. baseline
Secondary The correlation between the image finding and intraoperative finding. The correlation between the image finding and intraoperative finding. baseline
See also
  Status Clinical Trial Phase
Completed NCT01195584 - Minimal Access Surgical Technique (MAST) in Obese Patients in Degenerative Lumbar Disease N/A
Completed NCT01259960 - Minimal Access Surgical Technique (MAST) in Obese Patients in Degenerative Lumbar Disease. A Prospective Long-term Evaluation N/A
Enrolling by invitation NCT05981222 - Osteo Match Cages Versus PEEK Cages in Osteoporotic Patients