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

NACompletedINTERVENTIONAL
Enrollment

146

Participants

Timeline

Start Date

March 28, 2022

Primary Completion Date

August 15, 2023

Study Completion Date

August 15, 2023

Conditions
Lower Back PainLumbar Radiculopathy
Interventions
DEVICE

Virtual reality

Subjects in the virtual reality group will be offered a variety of immersive environments to choose from (mountains, beach, rainforest and temperate forest) in addition to local anesthetic.

DRUG

Intravenous sedation

Sedation will be administered using low-dose midazolam and/ or fentanyl. We will use a wide range of dosing (1-5 mg for midazolam, up to 150 mcg for fentanyl) to maximize generalizability and account for widespread variability in clinical circumstances, medical practice and patient response (personalized medicine). Sedation will be titrated to effect by a board-certified or eligible anesthesiologist so that patients remain responsive to verbal stimuli.

OTHER

Standard care

Patients will receive superficial local anesthetic with 1% lidocaine. Local anesthetic will be administered by the physician performing the procedure titrated to patient comfort.

Trial Locations (1)

21205

Johns Hopkins Medical Institutions, Baltimore

All Listed Sponsors
collaborator

United States Department of Defense

FED

collaborator

The Geneva Foundation

OTHER

collaborator

Walter Reed National Military Medical Center

FED

collaborator

United States Naval Medical Center, San Diego

FED

collaborator

Brigham and Women's Hospital

OTHER

lead

Johns Hopkins University

OTHER