Clinical trial NCT04139564: EaseVRx for the Reduction of Chronic Pain and Opioid Use
Official title: Safety and Effectiveness of Virtual Reality Utilizing EaseVRx for the Reduction of Chronic Pain and Opioid Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low-back Pain
Lead sponsor: AppliedVR Inc.
Sponsor class: INDUSTRY
Collaborators: name: Geisinger Clinic
name: National Institute on Drug Abuse (NIDA)
First posted: 2019-10-25
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

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

Primary outcomes:
measure: Pain: Numerical Pain Rating Scale
timeFrame: 12 weeks
Secondary outcomes:
measure: Number of Outcome Assessments Completed by Participant
timeFrame: 12 weeks
measure: Patient Compliance
timeFrame: 8 weeks
measure: Opioid Consumption
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
Study officials:
affiliation: Geisinger Clinic
name: Chulhyun Ahn, MD
role: PRINCIPAL_INVESTIGATOR
References: