Virtual Reality as a Substitute for Procedural Sedation During Epidural Steroid Injections
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Lower Back Pain
- Lumbar Radiculopathy
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention 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.Masking: Single (Outcomes Assessor)Masking Description: Outcome assessor will be unaware of treatment allocation but the patient and provider cannot be.Primary Purpose: Supportive Care
Participation Requirements
- Age
- Between 18 years and 90 years
- Gender
- Both males and females
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, ...
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).
Tracking Information
- NCT #
- NCT04887285
- Collaborators
- United States Department of Defense
- The Geneva Foundation
- Walter Reed National Military Medical Center
- United States Naval Medical Center, San Diego
- Brigham and Women's Hospital
- Investigators
- Study Director: Jason Ross, MD Brigham and Women's Hospital Study Director: Whitley Lucio Walter Reed National Military Medical Center Study Director: Christopher R Phillips, MD United States Naval Medical Center, San Diego
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