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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Can Distraction Substitute for Procedural Sedation and Improve Tolerance in Patients Receiving Epidural Steroid Injection for Pain? A Randomized Controlled Trial

Conditions
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Lower Back Pain, Lumbar Radiculopathy

Intervention / Treatment
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* Device: Virtual reality
* Drug: Intravenous sedation
* Other: Standard care


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual reality (VR)<br>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<br>* 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.<br>|
| Active Comparator: Sedation<br>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<br>* 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.<br>|
| Other: Standard care<br>Patients in this arm will be administered only 1% lidocaine as superficial anesthesia, similar to the other 2 arms. | Other: Standard care<br>* Patients will receive superficial local anesthetic with 1% lidocaine. Local anesthetic will be administered by the physician performing the procedure titrated to patient comfort.<br>* Other names: Local anesthetic only;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score during procedure | 0-10 verbal rating scale (higher scores indicate greater pain) | Immediately after procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of local anesthetic required | Volume of 1% lidocaine used to complete procedure | Immediately after procedure | 
| Subcutaneous skin wheal pain score | 0-10 verbal rating scale (higher scores indicate greater pain) | Immediately after skin wheal | 
| Procedure satisfaction | 1-5 Likert scale (1= very unsatisfied, 3= neither satisfied nor dissatisfied, 5= very satisfied) | In postanesthetic care unit (within 1 hour) | 
| Ability to communicate | 1-5 Likert scale (1= complete inability to communicate with physician, 2= markedly decreased ability to communicate, 3= slightly decreased ability to communicate, 4= no change in ability to communicate, 5= improved ability to communicate) | In postanesthetic care unit (within 1 hour) | 
| Procedure-related anxiety | 1-5 Likert scale (1=extreme anxiety, 2=high anxiety, 3=average or expected anxiety, 2=minimal or mild anxiety, 5=no anxiety | In postanesthetic care unit (within 1 hour) | 
| Time to discharge from postanesthetic care unit | Time to discharge from postanesthetic care unit, in minutes | At discharge from postanesthetic care unit assessed up to 6 hours | 
| Categorical outcome | Positive (2-point or greater reduction in average leg pain score coupled with score of 5 or greater on PGIC) or negative | 1-month | 
| Average leg pain score | Average leg pain score on 0-10 numerical rating scale over the last week (higher pain scores indicate greater pain) | 1-month | 
| Worst leg pain score | Worst leg pain score on 0-10 numerical rating scale over the last week (higher pain scores indicate greater pain) | 1-month | 
| Average back pain score | Average back pain score on 0-10 numerical rating scale over the last week (higher pain scores indicate greater pain) | 1-month | 
| Worst back pain score | Worst back pain score on 0-10 numerical rating scale over the last week (higher pain scores indicate greater pain) | 1-month | 
| Patient global impression of change (PGIC) | 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) | 1-month | 
| Analgesic reduction | Categorical reduction in analgesic usage (cessation of non-opioid analgesic and/ or > 20% reduction in opioid use) | 1-month | 
| Oswestry disability index (ODI) score | Functional measurement of back and leg pain disability on 0-100% scale (higher levels indicate greater disability) | 1-month | 
| Hospital anxiety and depression scale (HADS) scores | Instrument to measure depression and anxiety, each on 21-point scale (higher levels indicate greater anxiety and depression) | 1-month | 
| Complications | Complications related to the procedure, sedation or use of virtual reality | 1-month | 
| Processed electroencephalogram (pEEG) and continuous colored density spectral array | Frontal EEG sensor will be placed with electrode positions corresponding to Fp1, Fp2, F7, and F8 in the international 10-20 system. The median power across channels is computed across different wave forms (delta through beta). Power spectral analysis and spectral edge frequency calculations will be performed. | During the procedure for up to 20 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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epidural steroid injection, virtual reality, distraction, sedation, lumbar radiculopathy