Clinical trial NCT04887285: Virtual Reality as a Substitute for Procedural Sedation During Epidural Steroid Injections
Official title: Can Distraction Substitute for Procedural Sedation and Improve Tolerance in Patients Receiving Epidural Steroid Injection for Pain? A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lower Back Pain
Lumbar Radiculopathy
Keywords: epidural steroid injection
virtual reality
distraction
sedation
lumbar radiculopathy
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
name: The Geneva Foundation
name: Walter Reed National Military Medical Center
name: United States Naval Medical Center, San Diego
name: Brigham and Women's Hospital
First posted: 2021-05-14
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Pain Score During Procedure
timeFrame: Immediately after procedure
Secondary outcomes:
measure: Amount of Local Anesthetic Required
timeFrame: At the start of the procedure
measure: Subcutaneous Skin Wheal Pain Score
timeFrame: Immediately after skin wheal
measure: Procedure Satisfaction
timeFrame: In postanesthetic care unit (within 1 hour)
measure: Ability to Communicate
timeFrame: In postanesthetic care unit (within 1 hour)
measure: Procedure-related Anxiety
timeFrame: In postanesthetic care unit (within 1 hour)
measure: Time to Discharge From Postanesthetic Care Unit
timeFrame: At discharge from postanesthetic care unit assessed up to 6 hours
measure: Participants With Positive Categorical Outcome
timeFrame: 4 weeks
measure: Average Leg Pain Score
timeFrame: 4 weeks
measure: Worst Leg Pain Score
timeFrame: 4 weeks
measure: Average Back Pain Score
timeFrame: 4 weeks
measure: Worst Back Pain Score
timeFrame: 4 weeks
measure: Patient Global Impression of Change (PGIC)
timeFrame: 4 weeks
measure: Number of Participants With Analgesic Reduction
timeFrame: 4 weeks
measure: Oswestry Disability Index (ODI) Score
timeFrame: 4 weeks
measure: Hospital Anxiety and Depression Scale (HADS) Scores for Anxiety and Depressions
timeFrame: 4 weeks
measure: Number of Participants With Complications
timeFrame: 4 weeks
measure: Percentage Change of the Spectral Edge Frequency (SEF)
timeFrame: During the procedure for up to 20 minutes
measure: Hospital Anxiety and Depression Scale (HADS) Scores for Depression and Anxiety
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Medical Institutions
state: Maryland
Study officials:
affiliation: Walter Reed National Military Medical Center
name: Whitley Lucio
role: STUDY_DIRECTOR
affiliation: Johns Hopkins Uinversity - SOM Ane Pain
name: Steven P Cohen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ramathibodi Hospital, Mahidol University
name: Nuj Tontisirin, MD
role: STUDY_DIRECTOR
affiliation: King Chulalongkorn Memorial Hospital, Chulalongkorn University
name: Pornpan Chalermkitpanit, MD
role: STUDY_DIRECTOR
affiliation: Siriraj Hospital
name: Pramote Euasobhon, MD
role: STUDY_DIRECTOR
affiliation: Phramongkutklao College of Medicine
name: Sithapan Munjupong, MD
role: STUDY_DIRECTOR
affiliation: NYU Langone Health
name: Qian Chen, MD
role: STUDY_DIRECTOR
References:
citation: 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/AJP.0000000000000599.
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.