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)