Clinical trial

Can Distraction Substitute for Procedural Sedation and Improve Tolerance in Patients Receiving Epidural Steroid Injection for Pain? A Randomized Controlled Trial

Name

IRB00255275

Description

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.

Trial arms

Trial start

2022-03-28

Estimated PCD

2023-08-15

Trial end

2023-08-15

Status

Completed

Treatment

Virtual reality

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.

Arms:

Virtual reality (VR)

Intravenous sedation

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.

Arms:

Sedation

Standard care

Patients will receive superficial local anesthetic with 1% lidocaine. Local anesthetic will be administered by the physician performing the procedure titrated to patient comfort.

Arms:

Standard care

Other names:

Local anesthetic only

Size

146

Primary endpoint

Pain score during procedure

Immediately after procedure

Eligibility criteria

Inclusion Criteria: * 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. * Documented diagnosis of radicular pain caused by herniated disc, central stenosis, foraminal stenosis, degenerative disk disease * Willingness to adhere to undergo ESI with either sedation (midazolam and or fentanyl) or with virtual reality * Able to appear for a follow up visit between 24-40 days following the intervention Exclusion Criteria: * MRI findings discordant with symptoms (absence of herniated disc, spinal stenosis or severe disc degeneration without nerve root impingement (e.g. annular tears) that could explain symptoms) * Previous lumbosacral spine surgery at the area affected * Prior ESI within the past 6 months * Allergy to contrast dye * Poorly controlled psychiatric conditions that could affect outcomes (e.g. active substance abuse) or impose a barrier to participation (e.g. anxiety disorder requiring procedural sedation) * Morbid obesity (BMI \>40)

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'Outcome assessor will be unaware of treatment allocation but the patient and provider cannot be.', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 146, 'type': 'ACTUAL'}}

Updated at

2023-10-23

1 organization

1 product

2 indications

Organization

Johns Hopkins University

Product

Intravenous Sedation

Indication

low back pain

Indication

Sciatica