Lumbar Spinal Canal MeasurementNCT05782998
Normal Range of Measurement of Lumbar Spinal Canal in MSCT
An observational study of Lumbar Spinal Canal Measurement, run by Assiut University.
Trial summary
The present study aims to establish a normal range of measurements of lumbar spinal canal. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Lumbar Spinal Canal Measurement
- How many people
- 170 participants
- Where
- No sites listed yet
- Study dates
- Aug 2023to Jun 2024
- 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 20 to 60 years
- All sexes
- Adult
Study population: Normal population without any known vertebral column pathology or complaints in both sex \& different age groups and fit for CT examination.
Who may be able to join
- Normal population without any known vertebral column pathology or complaints in both sex \& different age groups.
- Patient fit for CT examination.
Who cannot join
- Pregnancy.
- Patients having sciatic pain with or without pain in the back.
- Patient having past history of back surgery.
- Patients with osteophytes or developmental anomalies, trauma vertebral fracture and known case of lordosis, scoliosis or kyphosis or other abnormalities in lumbar vertebrae.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: MSCT Measurements of the Lumbar Spinal Canal Regarding Age and Sex.
The present study aims to establish a normal range of measurements of lumbar spinal canal.
Read the detailed description
The knowledge of normal diameter of lumbar spinal canal is very important for diagnosing lumbar spinal canal stenosis and also for performing spinal surgeries at the lumbar level by Neurosurgeons and Orthopedicians. However, it varies widely among ethnic groups and between sexes in the same ethnic group . Spinal canal stenosis (defined as the narrowing of central spinal canal) is a condition in which the anteroposterior (AP) and lateral dimensions of the bony spinal canal are less than normal for corresponding age and sex. Back pain is the commonest manifestation of lumbar canal stenosis which usually results from lumbar spondylosis. Lumber lordosis is a problem of adults, but is now being increasingly seen in youth, probably due to lifestyle changes. Multiple factors play a role in spondylosis, but if it is associated with spinal canal stenosis, its management differs. Radiological evaluation forms an important part in the evaluation and management of lumbar spondylosis. But it requires clear understanding of the normal dimensions of lumbar vertebrae for particular age \& sex . Multislice computed tomography (MSCT) scans provides a noninvasive, non-operator dependent method of direct imaging of the spinal canal without injection of intra thecal contrast and is better than MRI for bony detail as in osteophytes. Though there is a wide variation in the capacity of spinal canal in patients who are clinically and radiologically normal. It is said that those with smaller canals are more likely to have symptoms from nerve root compression . By determining normal ranges of spinal canal diameter investigators can make early diagnosis in individuals who have lower diameters of spinal canal. These individuals are predisposed to spinal canal stenosis, which is a major cause of spinal radiculopathies. The recent use of CT for the measurements of the vertebral dimensions such as canal diameter and vertebral dimension has led to better evaluation of vertebral morphometry as compared with x-ray and cadaveric studies . CT scan measurement of lumbar spine demonstrated a mean AP canal diameter between 12 mm and 14 mm with a measurement of 11.5 mm considered small. On CT scan, electronic measurement of the sagittal diameter of the normal bony canal is 11.5 mm . These differences in dimension of the spinal canal across studies demands necessity of study of dimension of the spinal canal in every ethnic group.
- Conditions
- Lumbar Spinal Canal Measurement
What is being measured
The primary outcome is the main question the study is designed to answer.
MSCT Measurements of the Lumbar Spinal Canal
Establish a normal range of measurements of lumbar spinal canal regarding age and sex in Egyptian population.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2023
- Study startAug 2023 (estimated)
- Primary completionApr 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Spinal Canal MeasurementStudies 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
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yomna Gamal Abozeid, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05782998
- Sponsor's protocol ID
- Measurement of spinal canal
- Status last verified
- Aug 2023
- First submitted
- 13 Mar 2023
- Last updated
- 4 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MSCT Measurements of the Lumbar Spinal Canal Regarding Age and Sex.
- ClinicalTrials.gov ID
- NCT05782998
- Acronym / sponsor ID
- Measurement of spinal canal
- Conditions
- Lumbar Spinal Canal Measurement
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Aug 2023 (estimated)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 24 Mar 2023 (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.
The present study aims to establish a normal range of measurements of lumbar spinal canal.
Detailed description
The knowledge of normal diameter of lumbar spinal canal is very important for diagnosing lumbar spinal canal stenosis and also for performing spinal surgeries at the lumbar level by Neurosurgeons and Orthopedicians. However, it varies widely among ethnic groups and between sexes in the same ethnic group . Spinal canal stenosis (defined as the narrowing of central spinal canal) is a condition in which the anteroposterior (AP) and lateral dimensions of the bony spinal canal are less than normal for corresponding age and sex. Back pain is the commonest manifestation of lumbar canal stenosis which usually results from lumbar spondylosis. Lumber lordosis is a problem of adults, but is now being increasingly seen in youth, probably due to lifestyle changes. Multiple factors play a role in spondylosis, but if it is associated with spinal canal stenosis, its management differs. Radiological evaluation forms an important part in the evaluation and management of lumbar spondylosis. But it requires clear understanding of the normal dimensions of lumbar vertebrae for particular age \& sex . Multislice computed tomography (MSCT) scans provides a noninvasive, non-operator dependent method of direct imaging of the spinal canal without injection of intra thecal contrast and is better than MRI for bony detail as in osteophytes. Though there is a wide variation in the capacity of spinal canal in patients who are clinically and radiologically normal. It is said that those with smaller canals are more likely to have symptoms from nerve root compression . By determining normal ranges of spinal canal diameter investigators can make early diagnosis in individuals who have lower diameters of spinal canal. These individuals are predisposed to spinal canal stenosis, which is a major cause of spinal radiculopathies. The recent use of CT for the measurements of the vertebral dimensions such as canal diameter and vertebral dimension has led to better evaluation of vertebral morphometry as compared with x-ray and cadaveric studies . CT scan measurement of lumbar spine demonstrated a mean AP canal diameter between 12 mm and 14 mm with a measurement of 11.5 mm considered small. On CT scan, electronic measurement of the sagittal diameter of the normal bony canal is 11.5 mm . These differences in dimension of the spinal canal across studies demands necessity of study of dimension of the spinal canal in every ethnic group.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Age groups
- Adult
- Study population
- Normal population without any known vertebral column pathology or complaints in both sex \& different age groups and fit for CT examination.
Key inclusion criteria (2 listed)
- Normal population without any known vertebral column pathology or complaints in both sex \& different age groups.
- Patient fit for CT examination.
Key exclusion criteria (4 listed)
- Pregnancy.
- Patients having sciatic pain with or without pain in the back.
- Patient having past history of back surgery.
- Patients with osteophytes or developmental anomalies, trauma vertebral fracture and known case of lordosis, scoliosis or kyphosis or other abnormalities in lumbar vertebrae.
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
MSCT Measurements of the Lumbar Spinal Canal
Time frame: baseline
Establish a normal range of measurements of lumbar spinal canal regarding age and sex in Egyptian population.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2023.
- 1.Spinal Canal measurement at the level of lower three lumbar vertebrae by 128- Slice CT Scanner in Bangladeshi population .Siraj N,Ghafoor N,Parven JP,Deepa KP,Haque MZ.Ibrahim Card Med J 2021 :11 (1):8-13.Link provided by the sponsor.
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Lumbar Spinal Canal Measurement, 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 4 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 4 Aug 2023. 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 Yomna Gamal, Resident doctor (01094092006, dryomna96@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MSCT Measurements of the Lumbar Spinal Canal (time frame: baseline). 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 4 Aug 2023.