EaseVRx for the Reduction of Chronic Pain and Opioid Use

NCT04139564 | Completed Results

• 2 other identifiers: 2019-10175R44DA050231
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Low-back Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Number of Outcome Assessments Completed by Participant

  12 weeks

• Patient Compliance

  8 weeks

• Opioid Consumption

  12 weeks

Study Arms (2)

EaseVRx group

EXPERIMENTAL

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.

Device: EaseVRx headset

Active control group VR Sham

ACTIVE COMPARATOR

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

Device: Active control VR sham program

Interventions

EaseVRx headset DEVICE

EaseVRx is a virtual reality therapy intended to treat chronic pain

EaseVRx group

Active control VR sham program DEVICE

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

Active control group VR Sham

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• ≥ 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

You may not qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• AppliedVR Inc.: lead
• Geisinger Clinic: collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

Location

Results Point of Contact

• Title: Vice President of Research
• Organization: AppliedVR

tmaddox@appliedvr.io

13108901584

Study Officials

• Chulhyun Ahn, MD

  Geisinger Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2019
• First Posted: October 25, 2019
• Study Start: January 11, 2021
• Primary Completion: August 31, 2022
• Study Completion: August 31, 2022
• Last Updated: March 27, 2024
• Results First Posted: March 27, 2024

Record last verified: 2024-03

Locations

US (1)