N/A
N=107
EaseVRx for the Reduction of Chronic Pain and Opioid Use
Chronic Low-back Pain
Bottom Line
View on ClinicalTrials.gov: NCT04139564 ↗Enrolled (actual)
107
Serious AEs
0.0%
Results posted
Mar 2024
Primary outcome: Primary: Pain: Numerical Pain Rating Scale — 0.6; 1.3 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- EaseVRx headset (Device); Active control VR sham program (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- AppliedVR Inc.
- Primary completion
- Aug 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain: Numerical Pain Rating Scale |
0.6; 1.3 | — |
| SECONDARY Number of Outcome Assessments Completed by Participant |
30; 28 | — |
| SECONDARY Patient Compliance |
37; 40 | — |
| SECONDARY Opioid Consumption |
6.75; 5.67 | — |
Summary
EaseVRx, a software-based virtual reality (VR) medical device, is intended to offer users a prescription pain management tool that manages the symptoms associated with chronic pain and reduces or eliminates the risk of opioid dependence. The investigators will conduct a proof-of-concept randomized study to assess the feasibility and efficacy of using EaseVRx as a 56-day, VR-based, at-home program among 100 chronic low back pain patients by gathering pilot data on the efficacy of the intervention in decreasing pain, reducing opioid/non-opioid pharmacotherapy, and improving pain-related quality of life.
Eligibility Criteria
Inclusion Criteria
- ≥ 18 years old
- Low back pain experienced ≥ 3 days per week on average for ≥ 6 months
- Pre-medication NPRS score ≥ 5 stable for ≥ 3 months
Exclusion Criteria
- Exclusions based on potential medical or lifestyle confounders:
- Has a body mass index (BMI) > 40 kg/m2
- Pain related to cancer, fibromyalgia, or disk herniation
- History of a major psychiatric disorder not controlled with medication or has behavioral factors that would interfere with proper study procedures
- Is not ambulatory/has significant motor impairment
- Surgery in the past 3 months
- Open workers compensation claim
- Planning to have surgery in the next 3 months
- Planning to start a new exercise program in the next 3 months
- Planning to start a new treatment for their pain (e.g. medication, physiotherapy, acupuncture, electrical nerve stimulation) in the next 3 months
- Exclusions based on potential drug-related cofounders:
- Current or recent history (in past year) of substance abuse disorder
- Currently pregnant/breastfeeding or planning to in the next 3 months
- Was administered an epidural steroid during the 3 months prior to screening
- Exclusions based on ability to use EaseVR effectively:
- Comorbidities including neurological, psychosocial, sensory, or other disorders that may impact pain perception
- Diagnosis of epilepsy, dementia, migraines, or other neurological disorders that may prevent VR usage, and/or other medical conditions predisposed to nausea and dizziness
- Hypersensitivity to flashing lights or motion
- Claustrophobia
- Lack of stereoscopic vision
- Severe hearing impairment
- Injury to eyes, face, or neck that prevents comfortable VR usage
- Planning to take a vacation from their home for more than one week in the next 8 weeks
Data sourced from ClinicalTrials.gov (NCT04139564). 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.