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

NCT04887285 | Completed Results FDA Device

• 2 other identifiers: IRB00255275HU00011920011
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

epidural steroid injection; virtual reality; distraction; sedation; lumbar radiculopathy

Outcome Measures

Primary Outcomes (1)

• Pain Score During Procedure

  0-10 verbal rating scale (higher scores indicate greater pain)

  Immediately after procedure

Secondary Outcomes (18)

• Amount of Local Anesthetic Required

  At the start of the procedure

• Subcutaneous Skin Wheal Pain Score

  Immediately after skin wheal

• Procedure Satisfaction

  In postanesthetic care unit (within 1 hour)

• Ability to Communicate

  In postanesthetic care unit (within 1 hour)

• Procedure-related Anxiety

  In postanesthetic care unit (within 1 hour)

Study Arms (3)

Virtual reality (VR)

EXPERIMENTAL

Subjects in the VR group will be fitted with an HTC headset and headphones with disposable ear covers. They will choose from a menu of 6 different programs. They will also receive 1% superficial anesthesia.

Device: Virtual reality

Sedation

ACTIVE COMPARATOR

Conscious sedation will be accomplished by the use of 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). All medications will be titrated to conscious sedation by a board-certified anesthesiologist. Subjects will also receive 1% superficial anesthesia.

Drug: Intravenous sedation

Standard care

OTHER

Patients in this arm will be administered only 1% lidocaine as superficial anesthesia, similar to the other 2 arms.

Other: Standard care

Interventions

Virtual reality DEVICE

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.

Virtual reality (VR)

Intravenous sedation DRUG

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.

Sedation

Standard care OTHER

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

Also known as: Local anesthetic only

Standard care

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Sponsors & Collaborators

• Johns Hopkins University: lead
• United States Department of Defense: collaborator
• The Geneva Foundation: collaborator
• Walter Reed National Military Medical Center: collaborator
• United States Naval Medical Center, San Diego: collaborator
• Brigham and Women's Hospital: collaborator

Study Sites (1)

Johns Hopkins Medical Institutions

Baltimore, Maryland, 21205, United States

Location

Related Publications (2)

• Indovina P, Barone D, Gallo L, Chirico A, De Pietro G, Giordano A. Virtual Reality as a Distraction Intervention to Relieve Pain and Distress During Medical Procedures: A Comprehensive Literature Review. Clin J Pain. 2018 Sep;34(9):858-877. doi: 10.1097/AJP.0000000000000599.

  PMID: 29485536 RESULT

• Mallari B, Spaeth EK, Goh H, Boyd BS. Virtual reality as an analgesic for acute and chronic pain in adults: a systematic review and meta-analysis. J Pain Res. 2019 Jul 3;12:2053-2085. doi: 10.2147/JPR.S200498. eCollection 2019.

  PMID: 31308733 RESULT

MeSH Terms

Conditions

Low Back Pain; Radiculopathy

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Steven P. Cohen
• Organization: Northwestern University

steven.cohen@northwestern.edu

312-695-2500

Study Officials

• Whitley Lucio

  Walter Reed National Military Medical Center

  STUDY DIRECTOR

• Steven P Cohen, MD

  Johns Hopkins Uinversity - SOM Ane Pain

  PRINCIPAL INVESTIGATOR

• Nuj Tontisirin, MD

  Ramathibodi Hospital, Mahidol University

  STUDY DIRECTOR

• Pornpan Chalermkitpanit, MD

  King Chulalongkorn Memorial Hospital, Chulalongkorn University

  STUDY DIRECTOR

• Pramote Euasobhon, MD

  Siriraj Hospital

  STUDY DIRECTOR

• Sithapan Munjupong, MD

  Phramongkutklao College of Medicine

  STUDY DIRECTOR

• Qian Chen, MD

  NYU Langone Health

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessor will be unaware of treatment allocation but the patient and provider cannot be.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel study comparing virtual reality to sedation to standard care (no sedation or virtual reality) for procedure-related pain in patients undergoing lumbar epidural steroid injections.

Study Record Dates

• First Submitted: May 7, 2021
• First Posted: May 14, 2021
• Study Start: March 28, 2022
• Primary Completion: August 15, 2023
• Study Completion: August 15, 2023
• Last Updated: December 2, 2024
• Results First Posted: August 26, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 6 months after publication until 3 years
• Access Criteria: By e-mail request, upon approval by Dept. of Defense

Locations

US (1)