EaseVRx for the Reduction of Chronic Pain and Opioid Use

NCT ID: NCT04139564

Last Updated: 2024-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-11
• Study Completion Date: 2022-08-31

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.

Conditions

Chronic Low-back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

EaseVRx group

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.

Group Type: EXPERIMENTAL

EaseVRx headset

Intervention Type: DEVICE

EaseVRx is a virtual reality therapy intended to treat chronic pain

Active control group VR Sham

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

Group Type: ACTIVE_COMPARATOR

Active control VR sham program

Intervention Type: DEVICE

VR, 2d visual wildlife scenes similar to some EaseVRx content

Interventions

EaseVRx headset

EaseVRx is a virtual reality therapy intended to treat chronic pain

Intervention Type: DEVICE

Active control VR sham program

VR, 2d visual wildlife scenes similar to some EaseVRx content

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Geisinger Clinic

OTHER

Sponsor Role: collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

AppliedVR Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chulhyun Ahn, MD

Role: PRINCIPAL_INVESTIGATOR

Geisinger Clinic

Locations

Geisinger Medical Center

Danville, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

5R44DA050231

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2019-1017

Identifier Type: -

Identifier Source: org_study_id