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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 1-month

Awards & highlights

Study 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 ~ 1-month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1-month

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Pain score during procedure

Secondary outcome measures

Ability to communicate

Amount of local anesthetic required

Analgesic reduction

+14 more

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

~1890

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

United States Department of DefenseFED

861 Previous Clinical Trials

227,048 Total Patients Enrolled

Johns Hopkins UniversityLead Sponsor

2,256 Previous Clinical Trials

14,819,925 Total Patients Enrolled

Brigham and Women's HospitalOTHER

1,608 Previous Clinical Trials

11,469,731 Total Patients Enrolled

Media Library

Epidural Steroid Injection (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT04887285 — N/A

Lumbar Radiculopathy Research Study Groups: Virtual reality (VR), Sedation, Standard care

Lumbar Radiculopathy Clinical Trial 2023: Epidural Steroid Injection Highlights & Side Effects. Trial Name: NCT04887285 — N/A

Epidural Steroid Injection (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04887285 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research protocol in need of more participants?

"Yes, the clinicaltrials.gov portal attests that this medical research is actively recruiting patients. It was initially posted on March 28th 2022 and its most recent version was released a day later. As it stands, 126 participants are needed from 1 clinic to complete the trial."

Answered by AI

What is the size of the cohort receiving this experimental treatment?

"Affirmative, according to clinicaltrials.gov, this study is currently recruiting volunteers and was initially posted on March 28th 2022 with a recent edit made the following day. In total 126 patients are needed at 1 location."

Answered by AI

Am I eligible to apply for participation in this trial?

"Subjects with radiculitis aged between 18 and 90 years can apply to this medical trial, of which 126 participants will be selected."

Answered by AI

Are minors eligible for enrollment in this experiment?

"According to the study's criteria, patients who are eligible must be within the 18-90 year old age range. Additionally, there are 10 studies specific for minors and 258 trials devoted to senior citizens."

Answered by AI

What are the primary aims of this research project?

"This trial aims to analyse the post-procedural pain score of patients over a short period. Secondary endpoints are: amount of local anaesthetic used, subcutaneous skin wheal pain rating as captured on an 0-10 verbal scale (higher values implying greater discomfort), and ability to communicate with care providers rated using a 1-5 Likert scale (1 being complete inability)."

Answered by AI