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

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.

Conditions

• Lower Back Pain
• Lumbar 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.

Sponsors & Collaborators

• United States Department of Defense

  collaborator FED

• The Geneva Foundation

  collaborator OTHER

• Walter Reed National Military Medical Center

  collaborator FED

• United States Naval Medical Center, San Diego

  collaborator FED

• Brigham and Women's Hospital

  collaborator OTHER

• Johns Hopkins University

  lead OTHER

Principal Investigators

• Whitley Lucio · Walter Reed National Military Medical Center

• Steven P Cohen, MD · Johns Hopkins Uinversity - SOM Ane Pain

• Nuj Tontisirin, MD · Ramathibodi Hospital, Mahidol University

• Pornpan Chalermkitpanit, MD · King Chulalongkorn Memorial Hospital, Chulalongkorn University

• Pramote Euasobhon, MD · Siriraj Hospital

• Sithapan Munjupong, MD · Phramongkutklao College of Medicine

• Qian Chen, MD · NYU Langone Health

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-03-28

Primary Completion

2023-08-15

Completion

2023-08-15

FDA Device

Yes

Countries

• United States

Study Locations