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

Not Applicable

Completed

Conditions: Lumbar Radiculopathy
Lower Back Pain

Interventions: Device: Virtual reality
Drug: Intravenous sedation
Other: Standard care

Registration Number: NCT04887285

Lead Sponsor: Johns Hopkins University

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 146

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)

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Virtual reality (VR)	Virtual reality	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.
Sedation	Intravenous 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.
Standard care	Standard care	Patients in this arm will be administered only 1% lidocaine as superficial anesthesia, similar to the other 2 arms.

Primary Outcome Measures

Name	Time	Method
Pain Score During Procedure	Immediately after procedure	0-10 verbal rating scale (higher scores indicate greater pain)

Secondary Outcome Measures

Name	Time	Method
Amount of Local Anesthetic Required	At the start of the procedure	Volume of 1% lidocaine used to complete the skin wheel prior to the procedure.
Subcutaneous Skin Wheal Pain Score	Immediately after skin wheal	0-10 verbal rating scale (higher scores indicate greater pain)
Procedure Satisfaction	In postanesthetic care unit (within 1 hour)	This outcome was measured using a standalone question using the 1-5 Likert scale (1= very unsatisfied, 3= neither satisfied nor dissatisfied, 5= very satisfied). A mean of the participant selection is reported.
Ability to Communicate	In postanesthetic care unit (within 1 hour)	This outcome was measured using a standalone question using the 1-5 Likert scale (1= complete inability to communicate, 2= markedly decreased ability to communicate, 3= slightly decreased ability to communicate, 4= no change in ability to communicate, 5= improved ability to communicate). A mean of the participant selection is reported.
Procedure-related Anxiety	In postanesthetic care unit (within 1 hour)	This outcome was measured using a standalone question using the 1-5 Likert scale (1=extreme anxiety, 2=high anxiety, 3=average or expected anxiety, 4=minimal or mild anxiety, 5=no anxiety. A mean of the participant selection is reported.
Time to Discharge From Postanesthetic Care Unit	At discharge from postanesthetic care unit assessed up to 6 hours	Time to discharge from postanesthetic care unit, in minutes
Participants With Positive Categorical Outcome	4 weeks	This outcome measure is either positive or negative. A positive outcome is measured by participants with a 2-point or greater reduction in average leg pain score coupled with participants with a score of 5 or greater score on the Patient Global Impression of Change (PGIC), or negative is measure by a 1 or no point reduction in the average leg pain score couple with a 4 or less score on the Patient Global Impression of Change (PGIC). The average leg pain score on 0-10 numerical rating scale over the last week (higher pain scores indicate greater pain). The Patient global impression of change on 7-point Likert scale (from 1= no change, 3= a little better 5= moderately better, a slight but noticeable change, to 7=a great deal better, a considerable improvement that has made all the difference). Participants with positive outcome are reported.
Average Leg Pain Score	4 weeks	Average leg pain score on 0-10 numerical rating scale over the last week (higher pain scores indicate greater pain)
Worst Leg Pain Score	4 weeks	Worst leg pain score on 0-10 numerical rating scale over the last week (higher pain scores indicate greater pain)
Average Back Pain Score	4 weeks	Average back pain score on 0-10 numerical rating scale over the last week (higher pain scores indicate greater pain)
Worst Back Pain Score	4 weeks	Worst back pain score on 0-10 numerical rating scale over the last week (higher pain scores indicate greater pain)
Patient Global Impression of Change (PGIC)	4 weeks	Patient global impression of change on 7-point Likert scale (from 1= no change, 3= a little better 5= moderately better, a slight but noticeable change, to 7=a great deal better, a considerable improvement that has made all the difference)
Number of Participants With Analgesic Reduction	4 weeks	Categorical reduction in analgesic usage (cessation of non-opioid analgesic and/ or \> 20% reduction in opioid use)
Oswestry Disability Index (ODI) Score	4 weeks	Functional measurement of back and leg pain disability on 0-100% scale (higher levels indicate greater disability)
Hospital Anxiety and Depression Scale (HADS) Scores for Anxiety and Depressions	4 weeks	The Hospital anxiety and depression scale (HADS) is an instrument used to measure depression and anxiety. Anxiety and depression are scored separately, each on a subscale. The score on each subscale ranges from 0 to 21 score on a scale. A score of 0 indicates the absence of depression or anxiety. A score of 21 indicated severe depression or anxiety. The subscales are not combined for a total score. Anxiety score is reported.
Number of Participants With Complications	4 weeks	Number of Participants With Complications related to the procedure, sedation or use of virtual reality
Percentage Change of the Spectral Edge Frequency (SEF)	During the procedure for up to 20 minutes	Frontal EEG sensor will be placed with electrode positions corresponding to Fp1, Fp2, F7, and F8 in the international 10-20 system. The spectral edge frequency (SEF) on the Sedline monitor ranges in frequency from 0 to 30 Hz.
Hospital Anxiety and Depression Scale (HADS) Scores for Depression and Anxiety	4 weeks	The Hospital anxiety and depression scale (HADS) is an instrument used to measure depression and anxiety. Anxiety and depression are scored separately, each on a subscale. The score on each subscale ranges from 0 to 21 score on a scale. A score of 0 indicates the absence of depression or anxiety. A score of 21 indicated severe depression or anxiety. The subscales are not combined for a total score. Depression score is reported.