EaseVRx for the Reduction of Chronic Pain and Opioid Use

Chronic Low-back Pain Clinical Trial

Official title:

Safety and Effectiveness of Virtual Reality Utilizing EaseVRx for the Reduction of Chronic Pain and Opioid Use

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04139564
• Other study ID #: 2019-1017
• Secondary ID: 5R44DA050231
• Status: Completed
• Phase: N/A
• Start date: January 11, 2021
• Est. completion date: August 31, 2022

Study information

• Verified date: March 2024
• Source: AppliedVR Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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. EaseVRx is based on principles of cognitive behavioral therapy, pain psychology, mindfulness-based stress reduction, biofeedback, and distraction therapy commonly used in interdisciplinary pain rehabilitation programs. 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. While VR has been tested in academic medical centers and shown to be efficacious in the management of acute pain, this study will investigate the feasibility of VR use at home to manage chronic pain in preparation for a larger efficacy trial.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: August 31, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Low-back Pain
• Chronic Pain
• Low Back Pain

Intervention

Device:
• EaseVRx headset
EaseVRx is a virtual reality therapy intended to treat chronic pain
• Active control VR sham program
VR, 2d visual wildlife scenes similar to some EaseVRx content

Locations

Country	Name	City	State
United States	Geisinger Medical Center	Danville	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
AppliedVR Inc.	Geisinger Clinic, National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain: Numerical Pain Rating Scale	Numerical Pain Rating Scale; scale from 0 to 10 with higher numbers implying greater pain; The outcome values presented below are the difference between baseline pain and pain at 12 weeks. Specifically, baseline pain score minus 12 week pain score; A positive difference implies that pain was reduced	12 weeks
Secondary	Number of Outcome Assessments Completed by Participant	Thirty four assessments were attempted. This measure notes the total number of assessments completed by each participant	12 weeks
Secondary	Patient Compliance	number of VR modules completed. For the EaseVRx group this would be the number of EaseVRx modules completed with worst 0 - 56 best. For the Active control VR Sham group this would be the number of ShamVR modules completed with worst 0 - 56 best.	8 weeks
Secondary	Opioid Consumption	Morphine Milligram Equivalents (MME)	12 weeks