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Completed

NCT Number: NCT04887285

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

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.

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Key information

Conditions

Lower Back Pain Back Pain Low Back Pain Lumbar Radiculopathy Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Radiculopathy Signs and Symptoms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins Medical Institutions

Baltimore, Maryland, 21205, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Virtual reality

Device

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.

Intravenous sedation

Drug

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.

Standard care

Other

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

Primary outcomes

  1. Pain Score During Procedure

    Time frame: Immediately after procedure

    0-10 verbal rating scale (higher scores indicate greater pain)

Secondary outcomes

  1. 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.

  2. Subcutaneous Skin Wheal Pain Score

    Time frame: Immediately after skin wheal

    0-10 verbal rating scale (higher scores indicate greater pain)

  3. 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.

  4. 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.

  5. 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.

  6. 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

  7. 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.

  8. 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)

  9. 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)

  10. 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)

  11. 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)

  12. 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)

  13. 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)

  14. 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)

  15. 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.

  16. Number of Participants With Complications

    Time frame: 4 weeks

    Number of Participants With Complications related to the procedure, sedation or use of virtual reality

  17. 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.

  18. 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.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • 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

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 14, 2021
Registry last updated
Dec 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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