Cervical PainNCT05176301
Cervical Cord to Canal Diameter Ratio
An observational study of Cervical Pain, run by Daegu Catholic University Medical Center at 1 site in South Korea.
Trial summary
Cervical epidural block could cause spinal cord injury if the epidural needle is over-inserted and punctures the spinal cord. Investigators retrospectively evaluated the imaging data of 100 patients (50 men and 50 women) who underwent both cervical computed tomography (CT) and cervical magnetic resonance imaging (MRI)… Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Cervical Pain
- What is being tested?
- computed tomography, Magnetic resonance image
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 8 Jun 2021to 12 Jul 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients who visited Daegu catholic university hospital
Who may be able to join
- 100 patients (50 men and 50 women aged 20 to 70 years old) who visited our hospital and underwent both cervical CT and MRI simultaneously
Who cannot join
- patients who had a history of cervical spine surgery or cervical cord edema, whose CT or MR images did not include all the cervical vertebrae from C3 to T1,
- patients who had at least one missing medical detail such as diagnosis, age, height, or weight.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between the Coronal Diameters of the Cervical Spinal Canal and Spinal Cord Measured Using Computed Tomography and Magnetic Resonance Imaging in Korean Patients
Cervical epidural block could cause spinal cord injury if the epidural needle is over-inserted and punctures the spinal cord. Investigators retrospectively evaluated the imaging data of 100 patients (50 men and 50 women) who underwent both cervical computed tomography (CT) and cervical magnetic resonance imaging (MRI) at our hospital. Investigators measured the diameters of the spinal canal and spinal cord from the 3rd cervical vertebra to the 1st thoracic vertebra (T1) at each level by using the patients' cervical CT and MR images. The spinal cord and spinal canal diameters were measured in the transverse plane of cervical MR and CT images, respectively.
Read the detailed description
The spinal canal diameter, i.e., the epidural transverse diameter, was measured as the distance between the innermost border of the left and right pedicles at each upper pedicular level from C3 to T1 on transverse CT images by using a picture archiving and communication system (PACS; INFINITT PACS G3, INFINITT Healthcare, Korea) The spinal cord diameter was measured between the left and right outermost distances of the cord at each upper pedicular level, which were almost the same locations used for measuring the spinal canal diameter, from C3 to T1 on transverse MR images by using the PACS.
- Conditions
- Cervical Pain
- Being tested
- computed tomography, Magnetic resonance image
- Keywords
- Coronal, Cervical canal diameter, Cervical cord diameter
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
computed tomography, Magnetic resonance imageRadiation
Investigators measured the cervical cord and canal diameter by using CT and MRI that were previously taken.
What is being measured
The primary outcome is the main question the study is designed to answer.
the cord to canal diameter ratio
the measurement of the cord to canal diameter ratio, i.e., the cord to epidural space diameter ratio of each cervical vertebral level from the 3rd cervical vertebra (C3) to the 1st thoracic vertebra (T1) in the coronal plane
Measured: from December 1, 2020 through study completion, an average of 2 years were investigated retrospectively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2022
- Study start8 Jun 2021
- Primary completion30 Jun 2021
- Study completion12 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical PainStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daegu Catholic University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin Yong Jung, Daegu Catholic University Medical Center
- Investigators
- Jin Y Jung, M.D., Study chair, Daegu Catholic University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05176301
- Sponsor's protocol ID
- DaeguCUMC
- Status last verified
- Mar 2022
- First submitted
- 3 Dec 2021
- Last updated
- 1 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between the Coronal Diameters of the Cervical Spinal Canal and Spinal Cord Measured Using Computed Tomography and Magnetic Resonance Imaging in Korean Patients
- ClinicalTrials.gov ID
- NCT05176301
- Acronym / sponsor ID
- DaeguCUMC
- Conditions
- Cervical Pain
- Keywords
- Coronal, Cervical canal diameter, Cervical cord diameter
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Daegu Catholic University Medical CenterUniversity, hospital or other
- Study start
- 8 Jun 2021 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 12 Jul 2021 (actual)
- First posted
- 4 Jan 2022 (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.
Cervical epidural block could cause spinal cord injury if the epidural needle is over-inserted and punctures the spinal cord. Investigators retrospectively evaluated the imaging data of 100 patients (50 men and 50 women) who underwent both cervical computed tomography (CT) and cervical magnetic resonance imaging (MRI) at our hospital. Investigators measured the diameters of the spinal canal and spinal cord from the 3rd cervical vertebra to the 1st thoracic vertebra (T1) at each level by using the patients' cervical CT and MR images. The spinal cord and spinal canal diameters were measured in the transverse plane of cervical MR and CT images, respectively.
Detailed description
The spinal canal diameter, i.e., the epidural transverse diameter, was measured as the distance between the innermost border of the left and right pedicles at each upper pedicular level from C3 to T1 on transverse CT images by using a picture archiving and communication system (PACS; INFINITT PACS G3, INFINITT Healthcare, Korea) The spinal cord diameter was measured between the left and right outermost distances of the cord at each upper pedicular level, which were almost the same locations used for measuring the spinal canal diameter, from C3 to T1 on transverse MR images by using the PACS.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients who visited Daegu catholic university hospital
Key inclusion criteria (1 listed)
- 100 patients (50 men and 50 women aged 20 to 70 years old) who visited our hospital and underwent both cervical CT and MRI simultaneously
Key exclusion criteria (2 listed)
- patients who had a history of cervical spine surgery or cervical cord edema, whose CT or MR images did not include all the cervical vertebrae from C3 to T1,
- patients who had at least one missing medical detail such as diagnosis, age, height, or weight.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| computed tomography, Magnetic resonance imageInvestigators measured the cervical cord and canal diameter by using CT and MRI that were previously taken. | Radiation | – |
Primary outcome
the cord to canal diameter ratio
Time frame: from December 1, 2020 through study completion, an average of 2 years were investigated retrospectively.
the measurement of the cord to canal diameter ratio, i.e., the cord to epidural space diameter ratio of each cervical vertebral level from the 3rd cervical vertebra (C3) to the 1st thoracic vertebra (T1) in the coronal plane
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 1 Apr 2022.
- Individual participant dataSharing planned: No
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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.
Jin Y Jung, M.D. study chair
Daegu Catholic University Medical Center
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 Cervical Pain, run by Daegu Catholic University Medical Center at 1 site in South Korea.
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 1 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: finished, as of the sponsor's last update on 1 Apr 2022. 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 South Korea. 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?
the cord to canal diameter ratio (time frame: from December 1, 2020 through study completion, an average of 2 years were investigated retrospectively.). 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 1 Apr 2022.