EaseVRx for the Reduction of Chronic Pain and Opioid Use
CompletedNot applicableNCT04139564
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Safety and Effectiveness of Virtual Reality Utilizing EaseVRx for the Reduction of Chronic Pain and Opioid Use
- Conditions
- Interventions
- Device: EaseVRx headset
- Device: Active control VR sham program
- Sponsor
- AppliedVR Inc.
- Collaborators
- Geisinger Clinic; National Institute on Drug Abuse (NIDA)
- Start date
- 2021-01-11
- Primary completion
- 2022-08-31
- Sex
- All
- Age range
- from 18 Years to 64 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04139564