N/A
N=146
Virtual Reality as a Substitute for Procedural Sedation During Epidural Steroid Injections
Lower Back Pain · Lumbar Radiculopathy
Bottom Line
View on ClinicalTrials.gov: NCT04887285 ↗Enrolled (actual)
146
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcome: Primary: Pain Score During Procedure — 3.7; 3.2; 5.2 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Virtual reality (Device); Intravenous sedation (Drug); Standard care (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins University
- Primary completion
- Aug 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Score During Procedure |
3.7; 3.2; 5.2 | — |
| SECONDARY Amount of Local Anesthetic Required |
5.6; 5.4; 6.3 | — |
| SECONDARY Subcutaneous Skin Wheal Pain Score |
4.0; 3.8; 4.5 | — |
| SECONDARY Procedure Satisfaction |
4.7; 4.6; 4.5 | — |
| SECONDARY Ability to Communicate |
4.1; 3.7; 4.0 | — |
| SECONDARY Procedure-related Anxiety |
4.0; 4.2; 3.8 | — |
| SECONDARY Time to Discharge From Postanesthetic Care Unit |
27.0; 38.8; 24.4 | — |
| SECONDARY Participants With Positive Categorical Outcome |
25; 25; 24 | — |
| SECONDARY Average Leg Pain Score |
3.0; 3.1; 3.8 | — |
| SECONDARY Worst Leg Pain Score |
4.9; 4.8; 5.8 | — |
| SECONDARY Average Back Pain Score |
3.1; 3.5; 3.6 | — |
| SECONDARY Worst Back Pain Score |
5.1; 5.5; 5.5 | — |
| SECONDARY Patient Global Impression of Change (PGIC) |
4.7; 4.5; 4.6 | — |
| SECONDARY Number of Participants With Analgesic Reduction |
16; 19; 7 | — |
| SECONDARY Oswestry Disability Index (ODI) Score |
32; 36; 34 | — |
| SECONDARY Hospital Anxiety and Depression Scale (HADS) Scores for Anxiety and Depressions |
4.9; 5.1; 4.3 | — |
| SECONDARY Number of Participants With Complications |
5; 10; 4 | — |
| SECONDARY Percentage Change of the Spectral Edge Frequency (SEF) |
0.56; 64.05; 53.43 | — |
| SECONDARY Hospital Anxiety and Depression Scale (HADS) Scores for Depression and Anxiety |
4.0; 4.5; 3.8 | — |
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.
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)
Data sourced from ClinicalTrials.gov (NCT04887285). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.