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

NCT ID: NCT04887285

Last Updated: 2024-12-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 146 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-28
• Study Completion Date: 2023-08-15

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.

Detailed Description

All patients enrolled in the study will already be undergoing lumbar epidural steroid injections for lumbar radicular pain as part of their clinical care. The epidural approach will either be transforaminal or interlaminar depending on clinical judgment (i.e. transforaminal ESI for unilateral pain, interlaminar ESI for bilateral pain). The study will consist of 3 groups: virtual reality, sedation, and a control group which receives no intervention (i.e. standard of care). The virtual reality group will receive virtual reality via a headset containing a menu of 6 programs that the subject can choose; the sedation group will receive from 1-5 mg of midazolam and up to 150 mcg of fentanyl as clinically indicated, and the control group will not receive an intervention (standard of care). All subjects will also receive 1% lidocaine local anesthetic through a 25-gauge needle for superficial anesthesia, which is standard of care. Subjects will be randomized to each of these groups, with sub-allocation being done stratified by the type of ESI (transforaminal vs. interlaminar).

A secondary pilot study will evaluate whether a processed electroencephalogram (pEEG) and continuous colored density spectral array monitored via a four-channel Masimo SEDLine frontal EEG sensor can serve as a biomarker for painful stimulation and the effectiveness of distraction and sedation to reduce acute pain.

Conditions

Lower Back Pain; Lumbar Radiculopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Virtual reality (VR)

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.

Group Type: EXPERIMENTAL

Virtual reality

Intervention Type: 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.

Sedation

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.

Group Type: ACTIVE_COMPARATOR

Intravenous sedation

Intervention Type: 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.

Standard care

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

Group Type: OTHER

Standard care

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: DRUG

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.

Intervention Type: OTHER

Other Intervention Names

Local anesthetic only

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

United States Department of Defense

FED

Sponsor Role: collaborator

The Geneva Foundation

OTHER

Sponsor Role: collaborator

Walter Reed National Military Medical Center

FED

Sponsor Role: collaborator

United States Naval Medical Center, San Diego

FED

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Whitley Lucio

Role: STUDY_DIRECTOR

Walter Reed National Military Medical Center

Steven P Cohen, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins Uinversity - SOM Ane Pain

Nuj Tontisirin, MD

Role: STUDY_DIRECTOR

Ramathibodi Hospital, Mahidol University

Pornpan Chalermkitpanit, MD

Role: STUDY_DIRECTOR

King Chulalongkorn Memorial Hospital, Chulalongkorn University

Pramote Euasobhon, MD

Role: STUDY_DIRECTOR

Siriraj Hospital

Sithapan Munjupong, MD

Role: STUDY_DIRECTOR

Phramongkutklao College of Medicine

Qian Chen, MD

Role: STUDY_DIRECTOR

NYU Langone Health

Locations

Johns Hopkins Medical Institutions

Baltimore, Maryland, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 29485536 (View on PubMed)

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.

Reference Type: RESULT

PMID: 31308733 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

HU00011920011

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IRB00255275

Identifier Type: -

Identifier Source: org_study_id