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

Johns Hopkins University

Status: Completed

Conditions: Lower Back Pain; Lumbar Radiculopathy

Treatments: Other: Standard care; Drug: Intravenous sedation; Device: Virtual reality

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT04887285

IRB00255275

HU00011920011 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 146 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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146 participants in 3 patient groups

Virtual reality (VR)

Experimental group

Description:

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.

Treatment:

Device: Virtual reality

Sedation

Active Comparator group

Description:

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.

Treatment:

Drug: Intravenous sedation

Standard care

Other group

Description:

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

Treatment:

Other: Standard care