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

Lumbar Radiculopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04887285
• Other study ID #: IRB00255275
• Secondary ID: HU00011920011
• Status: Completed
• Phase: N/A
• Start date: March 28, 2022
• Est. completion date: August 15, 2023

Study information

• Verified date: October 2023
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: August 15, 2023
• Est. primary completion date: August 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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)

Related Conditions & MeSH terms

• Low Back Pain
• Lower Back Pain
• Lumbar Radiculopathy
• Radiculopathy

Intervention

Device:
• 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.

Drug:
• 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.

Other:
• 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.

Locations

Country	Name	City	State
United States	Johns Hopkins Medical Institutions	Baltimore	Maryland

Sponsors (6)

Lead Sponsor	Collaborator
Johns Hopkins University	Brigham and Women's Hospital, The Geneva Foundation, United States Department of Defense, United States Naval Medical Center, San Diego, Walter Reed National Military Medical Center

Country where clinical trial is conducted

United States, 

References & 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/A — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain score during procedure	0-10 verbal rating scale (higher scores indicate greater pain)	Immediately after procedure
Secondary	Amount of local anesthetic required	Volume of 1% lidocaine used to complete procedure	Immediately after procedure
Secondary	Subcutaneous skin wheal pain score	0-10 verbal rating scale (higher scores indicate greater pain)	Immediately after skin wheal
Secondary	Procedure satisfaction	1-5 Likert scale (1= very unsatisfied, 3= neither satisfied nor dissatisfied, 5= very satisfied)	In postanesthetic care unit (within 1 hour)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Analgesic reduction	Categorical reduction in analgesic usage (cessation of non-opioid analgesic and/ or > 20% reduction in opioid use)	1-month
Secondary	Oswestry disability index (ODI) score	Functional measurement of back and leg pain disability on 0-100% scale (higher levels indicate greater disability)	1-month
Secondary	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
Secondary	Complications	Complications related to the procedure, sedation or use of virtual reality	1-month
Secondary	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