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

November 25, 2024 updated by: Johns Hopkins University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
146

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Mirinda Anderson-White, RN
  • Phone Number: 410-955-6488
  • Email: mander47@jhmi.edu

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins Medical Institutions

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
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.
Active Comparator: 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.
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 in this arm will be administered only 1% lidocaine as superficial anesthesia, similar to the other 2 arms.
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.
Other Names:
  • Local anesthetic only

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pain Score During Procedure
Time Frame: Immediately after procedure
0-10 verbal rating scale (higher scores indicate greater pain)
Immediately after procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Amount of Local Anesthetic Required
Time Frame: At the start of the procedure
Volume of 1% lidocaine used to complete the skin wheel prior to the procedure.
At the start of the procedure
Subcutaneous Skin Wheal Pain Score
Time Frame: Immediately after skin wheal
0-10 verbal rating scale (higher scores indicate greater pain)
Immediately after skin wheal
Procedure Satisfaction
Time Frame: 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.
In postanesthetic care unit (within 1 hour)
Ability to Communicate
Time Frame: 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.
In postanesthetic care unit (within 1 hour)
Procedure-related Anxiety
Time Frame: 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.
In postanesthetic care unit (within 1 hour)
Time to Discharge From Postanesthetic Care Unit
Time Frame: At discharge from postanesthetic care unit assessed up to 6 hours
Time to discharge from postanesthetic care unit, in minutes
At discharge from postanesthetic care unit assessed up to 6 hours
Participants With Positive Categorical Outcome
Time Frame: 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.
4 weeks
Average Leg Pain Score
Time Frame: 4 weeks
Average leg pain score on 0-10 numerical rating scale over the last week (higher pain scores indicate greater pain)
4 weeks
Worst Leg Pain Score
Time Frame: 4 weeks
Worst leg pain score on 0-10 numerical rating scale over the last week (higher pain scores indicate greater pain)
4 weeks
Average Back Pain Score
Time Frame: 4 weeks
Average back pain score on 0-10 numerical rating scale over the last week (higher pain scores indicate greater pain)
4 weeks
Worst Back Pain Score
Time Frame: 4 weeks
Worst back pain score on 0-10 numerical rating scale over the last week (higher pain scores indicate greater pain)
4 weeks
Patient Global Impression of Change (PGIC)
Time Frame: 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)
4 weeks
Number of Participants With Analgesic Reduction
Time Frame: 4 weeks
Categorical reduction in analgesic usage (cessation of non-opioid analgesic and/ or > 20% reduction in opioid use)
4 weeks
Oswestry Disability Index (ODI) Score
Time Frame: 4 weeks
Functional measurement of back and leg pain disability on 0-100% scale (higher levels indicate greater disability)
4 weeks
Hospital Anxiety and Depression Scale (HADS) Scores for Anxiety and Depressions
Time Frame: 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.
4 weeks
Number of Participants With Complications
Time Frame: 4 weeks
Number of Participants With Complications related to the procedure, sedation or use of virtual reality
4 weeks
Hospital Anxiety and Depression Scale (HADS) Scores for Depression and Anxiety
Time Frame: 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.
4 weeks
Percentage Change of the Spectral Edge Frequency (SEF)
Time Frame: 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.
During the procedure for up to 20 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Johns Hopkins University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
United States Department of Defense
Brigham and Women's Hospital
United States Naval Medical Center, San Diego
Walter Reed National Military Medical Center
The Geneva Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Whitley Lucio, Walter Reed National Military Medical Center
  • Principal Investigator: Steven P Cohen, MD, Johns Hopkins Uinversity - SOM Ane Pain
  • Study Director: Nuj Tontisirin, MD, Ramathibodi Hospital, Mahidol University
  • Study Director: Pornpan Chalermkitpanit, MD, King Chulalongkorn Memorial Hospital, Chulalongkorn University
  • Study Director: Pramote Euasobhon, MD, Siriraj Hospital
  • Study Director: Sithapan Munjupong, MD, Phramongkutklao College of Medicine
  • Study Director: Qian Chen, MD, NYU Langone Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 28, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 15, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 15, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 7, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 12, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 14, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 2, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 25, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB00255275
  • HU00011920011 (Other Grant/Funding Number: Geneva Foundation)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Protocol, Informed Consent Form, deidentified data and statistical code.

IPD Sharing Time Frame

6 months after publication until 3 years

IPD Sharing Access Criteria

By e-mail request, upon approval by Dept. of Defense

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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Drug Interventions

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