Efficacy of a Virtual Reality Neuroscience-based Therapy (VRNT) for Chronic Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Change in Pain Intensity and Interference
研究概览
简要总结
Participants with chronic back pain will complete an online Qualtrics eligibility survey. After signing a consent form, eligible participants enter a two-week baseline period ("Baseline Period"), during which they complete two assessments of the Primary and Secondary Outcome Measures and Potential Mediators. After the baseline period, participants are randomized into a Virtual Reality group: VR Distraction-based Therapy or VR Skills-based Therapy, with a 1:1 allocation ratio of participants to each treatment. Both groups receive education on pain neuroscience and complete training on the use of the VR hardware and software. Next, both groups complete an intervention for 8 weeks ("Treatment Period"), after which they return the VR equipment. Several surveys are administered online during the Treatment Period. After the Treatment Period, both groups complete three post-treatment surveys at weeks 8, 20, and 32.
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 aged 18 to
- •Self-reported diagnosis of chronic low back pain without radicular symptoms.
- •Chronic low back pain duration of 6 months or more, and pain at least half the days in the last 6 months.
- •Lower back pain as primary chronic pain complaint (greater than pain in other bodily regions).
- •Average pain intensity of 4 or more out of 10 for the past week (from BPI-SF).
- •English fluency (8th grade level).
- •Willing to comply with study procedures/restrictions.
- •Access to Wi-Fi.
- •Implicit de facto internet and computer literacy.
排除标准
- •Applicants, who are pregnant, planning pregnancy, or breastfeeding
- •Back pain associated with compensation / litigation within 1 year.
- •Leg pain greater than back pain (suggests neuropathic pain; may be less responsive to psychological therapy).
- •Chronic pain other than chronic back pain.
- •Diagnoses of schizophrenia, multiple personality dissociative identity disorder.
- •History of major depressive disorder not controlled with medication or other conditions that produce significant cognitive or emotional disability.
- •History of substance abuse.
- •Inability to undergo MRI (determined at screening; see XVI: Risks to Participants).
- •Any clinically significant unstable medical abnormality or acute or chronic disease of cardiovascular, gastrointestinal, respiratory (e.g., chronic obstructive pulmonary disease), hepatic, or renal systems; including: history of cardiovascular disease or issues (e.g., recent heart attack), stroke; brain surgery, or brain tumor; Diabetes; cancer (last 12 months); diagnosis of a specific inflammatory disorder: rheumatoid arthritis, polymyalgia rheumatica, scleroderma, Lupus; polymyositis; or Cauda Equina syndrome.
- •History of seizure disorder, epilepsy, convulsions, or increased intracranial pressure anytime except pediatric febrile seizures.
- •History of vertigo, dizziness, susceptibility to motion sickness
- •History of head injury within 6 months,
- •Unexplained, unintended weight loss of 'â• 20 lbs in past year. Self-reported history of (digital) eye strain or computer vision syndrome. Unable or unwilling to meet study attendance requirements. MRI contraindications as determined by MRI safety screen (e.g., pregnancy, metal in body, claustrophobia, using the standard screen conducted by the MRI imaging facility).
研究组 & 干预措施
Virtual Reality Neuropsychological Therapy
Participants start the treatment period with three introductory sessions:
- A 34-minute pain education video that introduces the neuroscience of acute and chronic pain, drivers of pain chronification, pain triggers, and the scientific principles behind the VRNT.
- A session to customize the VR experience to match the participant's experience using a display of a personalized 3-dimensional audiovisual representation of each patient's pain.
- A training session on the use of the VR hardware. The participant will receive a workbook to guide them through each day's session.
Participants may continue their other pain treatment regimes, and are asked to notify the research team of any changes.
干预措施: Skills-based Virtual Reality Therapy (Device)
Virtual Reality Neuroscience Therapy
Participants start the treatment period with two introductory sessions: 1. A 7-minute pain education video that introduces the neuroscience of pain-focused attention, distraction, and the scientific principles behind VRNT. 2. A training session on the use of the VR hardware. The participant will receive a workbook (Attachment 'VRNT Workbook') to guide them through each day's session. Participants may continue their other pain treatment regimes, and are asked to notify the research team of any changes.
干预措施: Distraction-based Virtual Reality Therapy (Device)
结局指标
主要结局
Change in Pain Intensity and Interference
时间窗: Change from pre-treatment to post-treatment = 8 weeks
Brief Pain Inventory-short form (BPI-SF). Measured on a Scale of 0 to 10, 0 = no pain, 10 = worst pain imaginable.
次要结局
- Stress(Change from pre-treatment to post-treatment = 8 weeks)
- Pain Interference(Change from pre-treatment to post-treatment = 8 weeks)
- Disability(Change from pre-treatment to post-treatment = 8 weeks)
- Physical Function(Change from pre-treatment to post-treatment = 8 weeks)
- Sleep Disturbance(Change from pre-treatment to post-treatment = 8 weeks)
- Depression(Change from pre-treatment to post-treatment = 8 weeks)
- Anxiety(Change from pre-treatment to post-treatment = 8 weeks)
- Fatigue(Change from pre-treatment to post-treatment = 8 weeks)