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CompletedNCT06643572Updated Aug 13, 2026

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

An interventional study of Virtual reality simulator in Lumbar Radiculopathy, sponsored by Korea University Anam Hospital. Completed at 1 site in South Korea. Per ClinicalTrials.gov, last updated 2026-08-13.

Sponsored by Korea University Anam Hospital · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Lumbar Radiculopathy

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Keywords

  • lumbar radiculopathy
  • virtual reality
  • Transforaminal epidural steroid injection
  • virtual simulator
03

In context

Radiculopathy

488 studies on the registry are indexed under Radiculopathy; 141 are open to participants now.

This study's enrollment of 30 is below the median of 60 across 376 interventional studies indexed under Radiculopathy.

Browse Radiculopathy studies →

Lead sponsor

Korea University Anam Hospital is the lead sponsor of 110 studies on the registry; 29 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    VR simulation

    In this group, the practitioner will perform lumbar transforaminal epidural steroid injections after undergoing training using a 3D virtual simulator based on the patient's CT images.

    Device: Virtual reality simulator

  • No intervention
    Conventional

    In this group, the patients will undergo lumbar transforaminal epidural steroid injections without the practitioner receiving any additional training.

Interventions

  • DeviceVirtual reality simulator

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

06

What researchers measure

Primary outcomes

  1. Procedure time (seconds)

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

    Time frame: Immediately after the procedure

  2. Number of fluoroscopic image shots

    The number of fluoroscopic image shots taken will be measured.

    Time frame: Immediately after the procedure

Secondary outcomes

  1. Number of bone contacts

    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

  2. Patient satisfaction

    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

  3. Presence of vascular injection

    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

  4. Procedure success or failure

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

    Time frame: Immediately after the procedure

07

Study locations

1 site
  • Korea University Anam Hospital
    Seoul, 02841, South Korea
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06643572
Lead sponsor
Korea University Anam Hospital
Responsible party
Sunmin Kim (Clinical Assistant Professor, Korea University Anam Hospital) — Principal investigator
First posted
Oct 16, 2024
Start date
Dec 4, 2024
Primary completion
Mar 6, 2026
Completion
Mar 10, 2026
Last update
Aug 13, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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