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Corticosteroid
Virtual reality for Lumbar Radiculopathy
N/A
Waitlist Available
Led By Steven P Cohen, MD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during the procedure for up to 20 minutes
Awards & highlights
No Placebo-Only Group
Summary
This trial looks at whether virtual reality can help ease pain during an epidural steroid injection, compared to no intervention or sedation.
Eligible Conditions
- Lumbar Radiculopathy
- Lower Back Pain
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ immediately after procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediately after procedure
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Pain Score During Procedure
Secondary study objectives
Ability to Communicate
Amount of Local Anesthetic Required
Average Back Pain Score
+15 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Virtual reality (VR)Experimental Treatment1 Intervention
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.
Group II: Standard careExperimental Treatment1 Intervention
Patients in this arm will be administered only 1% lidocaine as superficial anesthesia, similar to the other 2 arms.
Group III: SedationActive Control1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Virtual reality
2020
N/A
~1850
Find a Location
Who is running the clinical trial?
United States Department of DefenseFED
904 Previous Clinical Trials
333,083 Total Patients Enrolled
Johns Hopkins UniversityLead Sponsor
2,317 Previous Clinical Trials
14,871,673 Total Patients Enrolled
Brigham and Women's HospitalOTHER
1,660 Previous Clinical Trials
11,699,876 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- People between the ages of 18 and 90 of any gender can participate.You have had surgery on your lower back that affects the area being studied.You have been diagnosed with back pain caused by certain spinal conditions, such as herniated disc or degenerative disk disease.You agree to either receive sedation (using midazolam and/or fentanyl) or virtual reality during a certain procedure.You have had severe pain in your leg or lower back for more than 6 weeks and have not had any previous surgery on your lower back. MRI scans show that the pain is consistent with your symptoms.You have a mental health condition, such as substance abuse or severe anxiety, that could interfere with the study or make it difficult for you to participate.
Research Study Groups:
This trial has the following groups:- Group 1: Virtual reality (VR)
- Group 2: Sedation
- Group 3: Standard care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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