Lumbar RadiculopathyNCT06643572
Comparing of Using Patient Imaging and Virtual Reality-based Simulation Prior to Lumbar Transforaminal Injections
A study testing Virtual reality simulator in people with Lumbar Radiculopathy, run by Korea University Anam Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lumbar Radiculopathy
- What is being tested?
- Virtual reality simulator
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 4 Dec 2024to 10 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Lumbar Radiculopathy
- Being tested
- Virtual reality simulator
- Keywords
- lumbar radiculopathy, virtual reality, Transforaminal epidural steroid injection, virtual simulator
- Medical subject headings
- Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality simulatorDevice
This virtual reality simulator allows for the simulation of a lumbar transforaminal epidural steroid injection using the patient's 3D lumbar images.
| Study group | Role | What they receive |
|---|---|---|
| VR simulation | Experimental | 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. Receives: Device: Virtual reality simulator |
| Conventional | No intervention | In this group, the patients will undergo lumbar transforaminal epidural steroid injections without the practitioner receiving any additional training. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedure time (seconds)
The time taken to perform each procedure will be measured in seconds.
Measured: Immediately after the procedure
Number of fluoroscopic image shots
The number of fluoroscopic image shots taken will be measured.
Measured: Immediately after the procedure
Secondary outcomes (4)
Number of bone contacts
The number of times the needle tip contacts the bone will be measured based on the practitioner's tactile feedback.
Measured: Immediately after the procedure
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."
Measured: Immediately after the procedure
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.
Measured: Immediately after the procedure
Procedure success or failure
The success or failure of the procedure, as determined by the practitioner, will be recorded.
Measured: Immediately after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2024
- Study start4 Dec 2024
- Primary completion6 Mar 2026
- Study completion10 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar RadiculopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea University Anam Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sunmin Kim, Korea University Anam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06643572
- Sponsor's protocol ID
- VRTF
- Status last verified
- Aug 2026
- First submitted
- 10 Oct 2024
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06643572
- Acronym / sponsor ID
- VRTF
- Conditions
- Lumbar Radiculopathy
- Keywords
- lumbar radiculopathy, virtual reality, Transforaminal epidural steroid injection, virtual simulator
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Korea University Anam HospitalUniversity, hospital or other
- Study start
- 4 Dec 2024 (actual)
- Primary completion
- 6 Mar 2026 (actual)
- Study completion
- 10 Mar 2026 (actual)
- First posted
- 16 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VR simulation | Experimental | Device: Virtual reality simulatorIn 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. |
| Conventional | No intervention | –In this group, the patients will undergo lumbar transforaminal epidural steroid injections without the practitioner receiving any additional training. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual reality simulatorThis virtual reality simulator allows for the simulation of a lumbar transforaminal epidural steroid injection using the patient's 3D lumbar images. | Device | VR simulation |
Primary outcome
Procedure time (seconds)
Time frame: Immediately after the procedure
The time taken to perform each procedure will be measured in seconds.
Number of fluoroscopic image shots
Time frame: Immediately after the procedure
The number of fluoroscopic image shots taken will be measured.
4 secondary outcomes
Number of bone contacts
Time frame: Immediately after the procedure
Patient satisfaction
Time frame: Immediately after the procedure
Presence of vascular injection
Time frame: Immediately after the procedure
Procedure success or failure
Time frame: Immediately after the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality simulator in people with Lumbar Radiculopathy, run by Korea University Anam Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedure time (seconds) (time frame: Immediately after the procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.