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
- 188
- 试验地点
- 2
- 主要终点
- Department of Defense (DoD)/VA Pain scale
研究概览
简要总结
Randomized, 2-arm parallel group clinical trial evaluating the effectiveness of a self-administered Virtual Reality program for the treatment of chronic lower back pain compared to a placebo VR program.
详细描述
A randomized, 2-arm parallel-group clinical trial evaluating the effectiveness of a self-administered Virtual Reality (VR) program for the treatment of chronic lower back pain. The primary objective of this study is to assess the impact of skills-based VR on changes in patient-reported pain and pain interference over the course of an 8-week intervention as well as compared to a placebo VR condition. The secondary objective is to assess the impact of skill-based VR on changes in patient-reported satisfaction over the course of an 8-week intervention and compared to a placebo VR condition. A tertiary objective is to assess the impact of skills-based VR on changes in patient-reported opioid use, physical function, behavioral skills development, and health outcomes immediately following the intervention relative to a pre-intervention baseline and compared to a placebo VR condition. An exploratory objective is to assess the impact of skills-based VR on changes in patient-reported pain levels, opioid use, physical function, behavioral skills development, health outcomes, and satisfaction at the 24-week post-intervention time point and compared to a placebo VR condition.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women 18-85 years old
- •Diagnosis of low back pain without radicular symptoms
- •Pain duration of at least 6 months
- •Average pain intensity of at least 4 on the 0-10 DoD/VA Pain Scale for the past month at screening
- •English fluency
- •Willing to comply with study procedures/restrictions
排除标准
- •Unable to understand the goals of the study due to cognitive difficulty
- •Current or prior diagnosis of epilepsy, seizure disorder, dementia, migraines or other neurological disease that may prevent the use of VR
- •Medical condition predisposing to nausea or dizziness
- •Hypersensitivity to flashing light or motion
- •No stereoscopic vision or severe hearing impairment
- •Injury to eyes, face or neck that prevents comfortable use of VR
- •Pain related to cancer
- •Active suicidal ideation or severe depression
- •Previous use of EaseVR for pain
- •Current participation in any interventional research study or completed participation in past 2 months
- •Currently pregnant or planning to become pregnant
- •Does not have access to WIFI during participation in study
- •Currently works at or has an immediate family member who works for a digital health company or pharmaceutical company that provides treatments for acute or chronic pain
结局指标
主要结局
Department of Defense (DoD)/VA Pain scale
时间窗: The primary efficacy endpoint is the change from study baseline to Day 56
DoD/VA Pain scale measures pain intensity, and inference around activity, sleep, mood, and stress, each on an 11-point scale. The max score is 50 and the minimum is 0. The higher the score the worse the outcome. This will be assessed twice weekly during the 8-week intervention intervention period.
次要结局
- Patient's Global Impression of Change Scale(twice weekly during 8-week intervention, Day 56)