Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04887285
Study type Interventional
Source Johns Hopkins University
Contact
Status Completed
Phase N/A
Start date March 28, 2022
Completion date August 15, 2023

See also
  Status Clinical Trial Phase
Terminated NCT05047679 - The Effectiveness of Pain Neuroscience Education in At-risk Patients Following Surgery for Lumbar Radiculopathy N/A
Withdrawn NCT03543033 - Preoperative Corticosteroid Epidural Injection and Lumbar Decompression Surgery Outcomes N/A
Recruiting NCT06076408 - Effects of SNAGS With and Without Pilates in Lumbar Disc Bulge Patients N/A
Completed NCT03133845 - Shaping Anesthetic Techniques to Reduce Post-operative Delirium N/A
Completed NCT06087107 - Comparative Effects Of High Intensity Spinal Decompression Exercises And Eldoa In Patients Of Lumbar Radiculopathy N/A
Completed NCT04852900 - Different Dosage of Decompression Therapy on Symptoms of Lumbar Radiculopathy N/A
Terminated NCT05022251 - Identifying Pain Generators and Potentiators of Residual Complaints Following Lumbar Discectomy
Recruiting NCT04212949 - The Effect of Transcranial Magnetic Stimulation Therapy in Patients With Lumbar Radiculopathy N/A
Terminated NCT03952377 - Safety and Efficacy of SX600 Administered by Lumbosacral Transforaminal Epidural Injection for Radicular Pain Phase 1/Phase 2
Recruiting NCT06339931 - Lumber Spine Mobilization and Spinal Traction on Lumber Radiculopathy. N/A
Recruiting NCT04540068 - Prediction of TEI Success in Sciatica
Recruiting NCT05922228 - Effects of Neural Flossing and PNF on Lumbar Radiculopathy N/A
Recruiting NCT05953727 - Low Level LASER Therapy With and Without Proprioceptive Stimulation Among Discogenic Lumbar Radiculopathy Patients N/A
Completed NCT05449288 - Urdu Version Of Modified Oswestry Low Back Pain Scale; A Reliability And Validity Study
Completed NCT05874427 - Comparison Between the Imaging Consent Form and the Existing Narrative Consent Form N/A
Terminated NCT01443819 - Lumbar Transforaminal Epidural Corticosteroid Injection(s) Versus Defined Physical Therapy Phase 3
Recruiting NCT05535010 - The Effect of the Presence of Active Trigger Points in the Muscles Innervated by the Affected Nerve Roots on the Treatment Results of Transforaminal Epidural Steroid Injection in Patients With Lumbar Radiculopathy. N/A
Recruiting NCT06154005 - OsteoAdapt SP Advanced Bone Graft Feasibility Study - Transforaminal Interbody Lumbar Fusion Phase 1/Phase 2
Completed NCT04674917 - Effects of Decompression in Patient With Acute vs Chronic Lumbar Radiculopathy N/A
Not yet recruiting NCT06296303 - Effect of Pulsed Magnetic Therapy Versus Phonophoresis in Discogenic Lumbar Radiculopathy Patients N/A