Korea University Anam Hospital
Seoul, 02841, South Korea
NCT Number: NCT06643572
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.
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Notify Me20 year and older
All sexes
Interventional
Not applicable
Seoul, 02841, South Korea
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
This virtual reality simulator allows for the simulation of a lumbar transforaminal epidural steroid injection using the patient's 3D lumbar images.
Time frame: Immediately after the procedure
The time taken to perform each procedure will be measured in seconds.
Time frame: Immediately after the procedure
The number of fluoroscopic image shots taken will be measured.
Time frame: Immediately after the procedure
The number of times the needle tip contacts the bone will be measured based on the practitioner's tactile feedback.
Time frame: Immediately after the procedure
After the procedure, patient satisfaction will be assessed using a questionnaire consisting of four items, with responses measured on a 5-point Likert scale ranging from "strongly agree" to "strongly disagree."
Time frame: Immediately after the procedure
The procedure image will be analyzed to determine whether contrast dye was visualized in the blood vessels, confirming the presence or absence of intravascular injection.
Time frame: Immediately after the procedure
The success or failure of the procedure, as determined by the practitioner, will be recorded.
Korea University Anam Hospital
Other
Comparing the Effectiveness of Using Patient Imaging and Virtual Reality-based Simulation Prior to Challenging Lumbar Transforaminal Epidural Steroid Injections: a Randomized Controlled Trial
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