Virtual Reality as a Substitute for Procedural Sedation During Epidural Steroid Injections
Condition: Lower Back Pain; Lumbar Radiculopathy
MeSH terms: Radiculopathy; Low Back Pain
Study type: Interventional

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.
    

Intervention name(s): Virtual reality; Intravenous sedation; Standard care
Intervention type(s): Device; Drug; Other
Intervention description(s): 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.; 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.; 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 intervention name(s): Local anesthetic only
Intervention MeSH terms: Anesthetics; Anesthetics, Local
Allocation: Randomized
Intervention model: Parallel Assignment
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.
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: epidural steroid injection; virtual reality; distraction; sedation; lumbar radiculopathy