Can Distraction Substitute for Procedural Sedation and Improve Tolerance in Patients Receiving Epidural Steroid Injection for Pain? A Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Virtual reality
- Conditions
- Lower Back Pain
- Sponsor
- Johns Hopkins University
- Enrollment
- 146
- Locations
- 1
- Primary Endpoint
- Pain Score During Procedure
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
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)
Arms & Interventions
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.
Intervention: Virtual reality
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.
Intervention: Intravenous sedation
Standard care
Patients in this arm will be administered only 1% lidocaine as superficial anesthesia, similar to the other 2 arms.
Intervention: Standard care
Outcomes
Primary Outcomes
Pain Score During Procedure
Time Frame: Immediately after procedure
0-10 verbal rating scale (higher scores indicate greater pain)
Secondary Outcomes
- Amount of Local Anesthetic Required(At the start of the procedure)
- Subcutaneous Skin Wheal Pain Score(Immediately after skin wheal)
- Procedure Satisfaction(In postanesthetic care unit (within 1 hour))
- Ability to Communicate(In postanesthetic care unit (within 1 hour))
- Procedure-related Anxiety(In postanesthetic care unit (within 1 hour))
- Time to Discharge From Postanesthetic Care Unit(At discharge from postanesthetic care unit assessed up to 6 hours)
- Participants With Positive Categorical Outcome(4 weeks)
- Average Leg Pain Score(4 weeks)
- Worst Leg Pain Score(4 weeks)
- Average Back Pain Score(4 weeks)
- Worst Back Pain Score(4 weeks)
- Patient Global Impression of Change (PGIC)(4 weeks)
- Number of Participants With Analgesic Reduction(4 weeks)
- Oswestry Disability Index (ODI) Score(4 weeks)
- Hospital Anxiety and Depression Scale (HADS) Scores for Anxiety and Depressions(4 weeks)
- Number of Participants With Complications(4 weeks)
- Percentage Change of the Spectral Edge Frequency (SEF)(During the procedure for up to 20 minutes)
- Hospital Anxiety and Depression Scale (HADS) Scores for Depression and Anxiety(4 weeks)