Status:
COMPLETED
Virtual Reality as a Substitute for Procedural Sedation During Epidural Steroid Injections
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
United States Department of Defense
The Geneva Foundation
Conditions:
Lower Back Pain
Lumbar Radiculopathy
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
This study examines the impact of virtual reality compared to sedation (midazolam and/or fentanyl) and no intervention on pain experienced from an epidural steroid injection (ESI). The intervention gr...
Detailed Description
All patients enrolled in the study will already be undergoing lumbar epidural steroid injections for lumbar radicular pain as part of their clinical care. The epidural approach will either be transfor...
Eligibility Criteria
Inclusion
- Males and females; ages 18-90 years
- Lumbosacral radicular pain with a baseline average of leg pain score of \> 4/10, MRI findings (if available) consistent with symptoms, duration of pain \> 6 weeks, and no previous lumbar spine surgery.
- Documented diagnosis of radicular pain caused by herniated disc, central stenosis, foraminal stenosis, degenerative disk disease
- Willingness to adhere to undergo ESI with either sedation (midazolam and or fentanyl) or with virtual reality
- Able to appear for a follow up visit between 24-40 days following the intervention
Exclusion
- MRI findings discordant with symptoms (absence of herniated disc, spinal stenosis or severe disc degeneration without nerve root impingement (e.g. annular tears) that could explain symptoms)
- Previous lumbosacral spine surgery at the area affected
- Prior ESI within the past 6 months
- Allergy to contrast dye
- Poorly controlled psychiatric conditions that could affect outcomes (e.g. active substance abuse) or impose a barrier to participation (e.g. anxiety disorder requiring procedural sedation)
- Morbid obesity (BMI \>40)
Key Trial Info
Start Date :
March 28 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 15 2023
Estimated Enrollment :
146 Patients enrolled
Trial Details
Trial ID
NCT04887285
Start Date
March 28 2022
End Date
August 15 2023
Last Update
December 2 2024
Active Locations (1)
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1
Johns Hopkins Medical Institutions
Baltimore, Maryland, United States, 21205