NCT06643572

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 10, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 16, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2025

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 6, 2026

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2026

Completed
Last Updated

March 31, 2026

Status Verified

March 1, 2026

Enrollment Period

1.2 years

First QC Date

October 10, 2024

Last Update Submit

March 30, 2026

Conditions

Lumbar Radiculopathy

Keywords

lumbar radiculopathyvirtual realityTransforaminal epidural steroid injectionvirtual simulator

Outcome Measures

Primary Outcomes (2)

  • Procedure time (seconds)

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

    Immediately after the procedure

  • Number of fluoroscopic image shots

    The number of fluoroscopic image shots taken will be measured.

    Immediately after the procedure

Secondary Outcomes (4)

  • Number of bone contacts

    Immediately after the procedure

  • Patient satisfaction

    Immediately after the procedure

  • Presence of vascular injection

    Immediately after the procedure

  • Procedure success or failure

    Immediately after the procedure

Study Arms (2)

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.

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.

Interventions

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.

VR simulation

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Korea University Anam Hospital

Seoul, 02841, South Korea

Location

MeSH Terms

Conditions

Radiculopathy

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

October 10, 2024

First Posted

October 16, 2024

Study Start

January 1, 2025

Primary Completion

March 6, 2026

Study Completion

March 10, 2026

Last Updated

March 31, 2026

Record last verified: 2026-03

Locations

KR(1)