Ignite Creation Date:
2024-10-25 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06643572
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-10
Brief Title:
Comparing of Using Patient Imaging and Virtual Reality-based Simulation Prior to Lumbar Transforaminal Injections
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Comparing the Effectiveness of Using Patient Imaging and Virtual Reality-based Simulation Prior to Challenging Lumbar Transforaminal Epidural Steroid Injections a Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to evaluate the impact of pre-procedure training using a 3D simulator based on lumbar CT images on the success rate and efficiency of lumbar transforaminal steroid injections in patients who are expected to be difficult to treat The training is provided to practitioners prior to performing the procedure on these patients
Detailed Description:
This study aims to evaluate the impact of pre-procedure training using a 3D simulator based on lumbar CT images on the success rate and efficiency of lumbar transforaminal steroid injections in patients who are expected to be difficult to treat The training is provided to practitioners prior to performing the procedure on these patients
The lumbar transforaminal epidural steroid injection TFESI is a widely used non-surgical treatment for chronic lower back pain and sciatica TFESI is effective in reducing inflammation and alleviating pain but the procedure can be challenging due to anatomical structures and individual variations In particular when chronic degenerative changes in the lower back such as reduced disc height hypertrophy of the facet joints foraminal stenosis lateral recess hypertrophy and the formation of osteophytes complicate the needle insertion path or increase the likelihood of the needle contacting bone a high level of skill and experience is required
Recently advancements in virtual reality VR technology have enabled highly realistic 3D simulations which have spurred a growing body of research on VR-based simulations in healthcare These simulations range from complex surgeries to disaster preparedness training in hospital settings VR-based simulations offer an environment similar to real procedures allowing practitioners to improve their skills and providing opportunities to rehearse complex or difficult cases in advance
However despite the growing interest in VR simulations across various fields research on their application to precise procedures like TFESI remains scarce To the best of our knowledge no studies have utilized real patient imaging to create 3D models in a virtual environment for this purpose
This study against this background aims to evaluate the impact of 3D virtual reality simulations using lumbar CT images of actual patients on the outcomes of transforaminal epidural steroid injections through a randomized controlled trial The study will clarify how VR simulations can alleviate procedural difficulties and improve success rates and patient satisfaction compared to conventional image assessment methods Moreover it will contribute to establishing the foundation for incorporating VR-based simulations into standard protocols for complex procedures in the future
The lumbar transforaminal epidural steroid injection TFESI is a widely used non-surgical treatment for chronic lower back pain and sciatica TFESI is effective in reducing inflammation and alleviating pain but the procedure can be challenging due to anatomical structures and individual variations In particular when chronic degenerative changes in the lower back such as reduced disc height hypertrophy of the facet joints foraminal stenosis lateral recess hypertrophy and the formation of osteophytes complicate the needle insertion path or increase the likelihood of the needle contacting bone a high level of skill and experience is required
Recently advancements in virtual reality VR technology have enabled highly realistic 3D simulations which have spurred a growing body of research on VR-based simulations in healthcare These simulations range from complex surgeries to disaster preparedness training in hospital settings VR-based simulations offer an environment similar to real procedures allowing practitioners to improve their skills and providing opportunities to rehearse complex or difficult cases in advance
However despite the growing interest in VR simulations across various fields research on their application to precise procedures like TFESI remains scarce To the best of our knowledge no studies have utilized real patient imaging to create 3D models in a virtual environment for this purpose
This study against this background aims to evaluate the impact of 3D virtual reality simulations using lumbar CT images of actual patients on the outcomes of transforaminal epidural steroid injections through a randomized controlled trial The study will clarify how VR simulations can alleviate procedural difficulties and improve success rates and patient satisfaction compared to conventional image assessment methods Moreover it will contribute to establishing the foundation for incorporating VR-based simulations into standard protocols for complex procedures in the future
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None