EaseVRx for the Reduction of Chronic Pain and Opioid Use

AppliedVR

Status: Completed

Conditions: Chronic Low-back Pain

Treatments: Device: Active control VR sham program; Device: EaseVRx headset

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT04139564

5R44DA050231 (U.S. NIH Grant/Contract)

2019-1017

Details and patient eligibility

About

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.

Full 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.

Enrollment: 108 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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108 participants in 2 patient groups

EaseVRx group

Experimental group

Description:

Each subject will be asked to complete a 56-day program using the EaseVRx virtual reality headset with assigned modules each week. Each week, subjects will be asked to complete 7 modules (one per day), each approximately 5 minutes in duration, for a total of 56 modules across the program.

Treatment:

Device: EaseVRx headset

Active control group VR Sham

Active Comparator group

Description:

Each subject will be asked to complete a program accessible via VR that includes 2d visual wildlife scenes similar to some EaseVRx content

Treatment:

Device: Active control VR sham program