Overview

Virtual Reality as a Substitute for Procedural Sedation During Epidural Steroid Injections

Status:
Not yet recruiting
Trial end date:
2023-09-14
Target enrollment:
0
Participant gender:
All
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 group (who receive virtual reality as a distraction modality) is compared to a sedation group and a control group.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Johns Hopkins University
Collaborators:
Brigham and Women's Hospital
The Geneva Foundation
United States Department of Defense
United States Naval Medical Center, San Diego
Walter Reed National Military Medical Center
Treatments:
Anesthetics
Anesthetics, Local
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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)