Trials Sponsors Conditions Drugs Pricing

Conditions

Lower Back Pain Lumbar Radiculopathy

Keywords

epidural steroid injectionvirtual realitydistractionsedationlumbar radiculopathy

Outcome Measures

Primary Outcomes (1)

Pain Score During Procedure
0-10 verbal rating scale (higher scores indicate greater pain)
Immediately after procedure

Secondary Outcomes (18)

Amount of Local Anesthetic Required
At the start of the procedure
Subcutaneous Skin Wheal Pain Score
Immediately after skin wheal
Procedure Satisfaction
In postanesthetic care unit (within 1 hour)
Ability to Communicate
In postanesthetic care unit (within 1 hour)
Procedure-related Anxiety
In postanesthetic care unit (within 1 hour)
+13 more secondary outcomes

Study Arms (3)

Virtual reality (VR)

EXPERIMENTAL

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.

Device: Virtual reality

Sedation

ACTIVE COMPARATOR

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.

Drug: Intravenous sedation

Standard care

OTHER

Interventions

Virtual realityDevice

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.

Virtual reality (VR)

Intravenous sedationDrug

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.

Eligibility Criteria

Age18 Years - 90 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Males and females; ages 18-90 years
Lumbosacral radicular pain with a baseline average of leg pain score of \> 4/10, MRI findings (if available) consistent with symptoms, duration of pain \> 6 weeks, and no previous lumbar spine surgery.

Sponsors & Collaborators

The Geneva Foundation
Othercollaborator
United States Naval Medical Center, San Diego
US federal agencycollaborator
Walter Reed National Military Medical Center

Study Sites (1)

Johns Hopkins Medical Institutions

Baltimore, Maryland, 21205, United States

Related Publications (2)

Indovina P, Barone D, Gallo L, Chirico A, De Pietro G, Giordano A. Virtual Reality as a Distraction Intervention to Relieve Pain and Distress During Medical Procedures: A Comprehensive Literature Review. Clin J Pain. 2018 Sep;34(9):858-877. doi: 10.1097/AJP.0000000000000599.
PMID: 29485536RESULT
Mallari B, Spaeth EK, Goh H, Boyd BS. Virtual reality as an analgesic for acute and chronic pain in adults: a systematic review and meta-analysis. J Pain Res. 2019 Jul 3;12:2053-2085. doi: 10.2147/JPR.S200498. eCollection 2019.
PMID: 31308733RESULT

MeSH Terms

Conditions

Low Back PainRadiculopathy

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care

Results Point of Contact

Title: Steven P. Cohen
Organization: Northwestern University

Study Officials

Whitley Lucio
Walter Reed National Military Medical Center
STUDY DIRECTOR
Steven P Cohen, MD
Johns Hopkins Uinversity - SOM Ane Pain
PRINCIPAL INVESTIGATOR
Nuj Tontisirin, MD
Ramathibodi Hospital, Mahidol University
STUDY DIRECTOR
Pornpan Chalermkitpanit, MD
King Chulalongkorn Memorial Hospital, Chulalongkorn University
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Enrollment

146 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: OUTCOMES ASSESSOR
Masking Details: Outcome assessor will be unaware of treatment allocation but the patient and provider cannot be.
Purpose: SUPPORTIVE CARE
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

May 7, 2021

First Posted

May 14, 2021

Study Start

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (18)

Study Arms (3)

Virtual reality (VR)

Sedation

Standard care

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations