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Completed

NCT Number: NCT06643572

Comparing of Using Patient Imaging and Virtual Reality-based Simulation Prior to Lumbar Transforaminal Injections

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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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Korea University Anam Hospital

Seoul, 02841, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with lumbar lateral recess or foraminal stenosis who are scheduled to undergo lumbar transforaminal epidural steroid injection.
  • Patients with lumbar CT images, where all four pain specialists in anesthesiology and pain medicine have determined that needle insertion through the transforaminal approach would be difficult.

Exclusion criteria

  • Patients who have previously undergone transforaminal epidural steroid injections at this center.
  • Patients with abnormal lumbar anatomical structures or a history of lumbar surgery.
  • Patients who do not consent to participate in the study.

Treatment and study plan

Virtual reality simulator

Device

This virtual reality simulator allows for the simulation of a lumbar transforaminal epidural steroid injection using the patient's 3D lumbar images.

Primary outcomes

  1. Procedure time (seconds)

    Time frame: Immediately after the procedure

    The time taken to perform each procedure will be measured in seconds.

  2. Number of fluoroscopic image shots

    Time frame: Immediately after the procedure

    The number of fluoroscopic image shots taken will be measured.

Secondary outcomes

  1. Number of bone contacts

    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.

  2. Patient satisfaction

    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."

  3. Presence of vascular injection

    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.

  4. Procedure success or failure

    Time frame: Immediately after the procedure

    The success or failure of the procedure, as determined by the practitioner, will be recorded.

Sponsors and collaborators

Lead sponsor

Korea University Anam Hospital

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 16, 2024
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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