N/A
N=18
Virtual Reality for Chronic Pain and Opioid Use Disorder Pilot
Chronic Pain · Opioid Use Disorder
Bottom Line
View on ClinicalTrials.gov: NCT05546749 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcome: Primary: Change in Pain Intensity — -1.38; 0.33 score on a scale — p=0.17
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- RelieVRx (Device); Sham VR (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Albert Einstein College of Medicine
- Primary completion
- Jul 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Pain Intensity |
-1.38; 0.33 | 0.17 |
| PRIMARY Change in Opioid Craving |
-2.86; 9.17 | 0.32 |
| PRIMARY Percentage of Participants Contacted That Are Enrolled |
10; 8 | — |
| SECONDARY Change in Pain Interference |
-2.25; 1.67 | — |
| SECONDARY Change in Sleep |
0; 3 | — |
| SECONDARY Change in Cognitive Function |
1.5; -0.67 | — |
| SECONDARY Change in Social Function |
2; 0.333 | — |
| SECONDARY Change in Physical Function |
1.13; -1.83 | — |
| SECONDARY Change in Depression |
-2.38; -2.5 | — |
| SECONDARY Change in Anxiety |
-2.88; -1.0 | — |
Summary
This is a pilot feasibility study of a virtual reality device for patients with co-morbid chronic pain and opioid use disorder.
Eligibility Criteria
Inclusion Criteria
- ≥18 years old
- English proficiency
- receiving methadone treatment for DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, 5th Edition) confirmed Opioid Use Disorder (OUD) in the Montefiore network for at least 12 weeks, with no dose change in 14 days to ensure treatment stability
- chronic pain of at least moderate pain severity (score ≥4 on the Pain, Enjoyment of Life, and General Activity (PEG) scale)
- willingness to participate in all study components
- ability to provide informed consent, assessed using consent teach-back
Exclusion Criteria
- conditions that could make participation in VR hazardous or cause adverse effects (current or prior diagnosis of epilepsy, seizure disorder, dementia, or migraines, any medical condition predisposing to nausea or dizziness, hypersensitivity to flashing light or motion)
- conditions that could prevent proper use of the VR headset (stereoscopic vision or severe hearing impairment, or injury to eyes, face, or neck that prevents use of the VR headset)
- acute exacerbation of psychiatric conditions that preclude the ability to participate in the study
Data sourced from ClinicalTrials.gov (NCT05546749). 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.