Ignite Creation Date:
2024-05-06 @ 6:50 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05793528
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-03-31
First Post:
2023-03-20
Brief Title:
The Effect of Ultrasound Guidance on Radiation Dose and Procedure Time in Lumbar Transforaminal Epidural Injection
Sponsor:
Marmara University
Organization:
Marmara University
Study Overview
Official Title:
The Effect of Ultrasound Guidance on Radiation Dose and Procedure Time in Lumbar Transforaminal Epidural Injection
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Low back pain is one of the leading causes of disability and its social burden and economic cost are quite high Although there are many causes that can lead to low back pain radicular pain which develops mostly secondary to lumbar disc hernias is one of the most common pathologies Epidural corticosteroid and local anesthetic injections are an important treatment option in the treatment of lumbar radicular pain that does not respond to conservative methods
For fluoroscopy-guided epidural injections transforaminal interlaminar and caudal approaches may be preferred It is accepted as the superiority of the transforaminal approach that it allows access to the area of pathology thus to the anterior epidural area where inflammatory mediators are more concentrated and that it can spread to the target specifically around the inflamed nerve roots
In transforaminal epidural injections the use of ultrasound as the sole imaging tool throughout the entire procedure is still not appropriate as subbony structures cannot be visualized However ultrasound can be integrated at any stage of the process Thus the relatively inexpensive cost portability and ability to show non-osseous tissues of ultrasonography are utilized particularly in terms of reducing radiation exposure
Gofeld et al claimed that ultrasound-guided transforaminal epidural injection could be performed by targeting the posterior part of the vertebral body However in cases where the lamina is wide and covers the posterior of the vertebral body it may not be possible to sonographically view the vertebral body In addition although the intervertebral disc is differentiated from the corpus loss of fluid content in the elderly can cause acoustic shadowing in the disc This may result in accidental intra-disc injections Finally even if the target point is reached it is not possible to show intravascular spread at this level ultrasonographically Therefore in our opinion this method is unreliable for transforaminal epidural injections Another study used ultrasound and fluoroscopy together for transforaminal epidural injections After imaging the lamina of the relevant vertebral level sonographically the needle is directed to the lateral edge of the lamina then fluoroscopic imaging is performed after it passes under the lamina with the loss of resistance technique However it should be known that the loss of resistance technique is not a suitable and reliable method in transforaminal injections In addition since it is not known how far the lamina has progressed after it has passed under the bone in other words imaging guidance is disabled in this part of the process
In our clinic we use ultrasonography and fluoroscopy methods in an integrated way hybrid method for transforaminal epidural injections For this purpose we proceed to fluoroscopic imaging immediately after the spinal needle is advanced to the lateral edge of the lamina at the vertebral level where there is pathology with ultrasound We think that with this method we continue to stay in the safe window and reduce the radiation dose and procedure time Based on this we determined the aim of this study as the effect of including ultrasonography guidance in transforaminal epidural injections on radiation dose and procedure time
For fluoroscopy-guided epidural injections transforaminal interlaminar and caudal approaches may be preferred It is accepted as the superiority of the transforaminal approach that it allows access to the area of pathology thus to the anterior epidural area where inflammatory mediators are more concentrated and that it can spread to the target specifically around the inflamed nerve roots
In transforaminal epidural injections the use of ultrasound as the sole imaging tool throughout the entire procedure is still not appropriate as subbony structures cannot be visualized However ultrasound can be integrated at any stage of the process Thus the relatively inexpensive cost portability and ability to show non-osseous tissues of ultrasonography are utilized particularly in terms of reducing radiation exposure
Gofeld et al claimed that ultrasound-guided transforaminal epidural injection could be performed by targeting the posterior part of the vertebral body However in cases where the lamina is wide and covers the posterior of the vertebral body it may not be possible to sonographically view the vertebral body In addition although the intervertebral disc is differentiated from the corpus loss of fluid content in the elderly can cause acoustic shadowing in the disc This may result in accidental intra-disc injections Finally even if the target point is reached it is not possible to show intravascular spread at this level ultrasonographically Therefore in our opinion this method is unreliable for transforaminal epidural injections Another study used ultrasound and fluoroscopy together for transforaminal epidural injections After imaging the lamina of the relevant vertebral level sonographically the needle is directed to the lateral edge of the lamina then fluoroscopic imaging is performed after it passes under the lamina with the loss of resistance technique However it should be known that the loss of resistance technique is not a suitable and reliable method in transforaminal injections In addition since it is not known how far the lamina has progressed after it has passed under the bone in other words imaging guidance is disabled in this part of the process
In our clinic we use ultrasonography and fluoroscopy methods in an integrated way hybrid method for transforaminal epidural injections For this purpose we proceed to fluoroscopic imaging immediately after the spinal needle is advanced to the lateral edge of the lamina at the vertebral level where there is pathology with ultrasound We think that with this method we continue to stay in the safe window and reduce the radiation dose and procedure time Based on this we determined the aim of this study as the effect of including ultrasonography guidance in transforaminal epidural injections on radiation dose and procedure time
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None