Safety and Effectiveness of Virtual Reality Utilizing EaseVRx for the Reduction of Chronic Pain and Opioid Use
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 2
- 主要终点
- Pain: Numerical Pain Rating Scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 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
排除标准
- •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
结局指标
主要结局
Pain: Numerical Pain Rating Scale
时间窗: 12 weeks
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
次要结局
- Patient Compliance(8 weeks)
- Number of Outcome Assessments Completed by Participant(12 weeks)
- Opioid Consumption(12 weeks)