Virtual Reality as a Substitute for Procedural Sedation During Epidural Steroid Injections
Completed · Not applicable
Conditions studied: Lower Back Pain, Lumbar Radiculopathy
In brief
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 group (who receive virtual reality as a distraction modality) is compared to a sedation group and a control group.
Key facts
- Study ID
- NCT04887285
- Run by
- Johns Hopkins University
- People needed
- 146
- Starts
- 2022-03-28
- Expected to finish
- 2023-08-15
- Last updated by the study team
- 2024-12-02
Who can join
Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- Johns Hopkins Medical Institutions — Baltimore, Maryland, United States
Full record on ClinicalTrials.gov
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