Feasibility of Virtual Reality Delivery of Pain Neuroscience Education
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Acceptability Measures
研究概览
简要总结
Randomized Clinical Trail (RCT) for patients already planned to attend physical therapy for chronic low back pain. Patients will be randomized to receive Physical Therapy (PT) as usual or PT plus pain education delivered via virtual-reality headset.
详细描述
There is an increasing emphasis in physical therapy and healthcare in general on enhancing patients' ability to self-manage spinal pain as a strategy to reduce disability for impacted individuals and escalating healthcare costs. This change in emphasis requires a paradigm shift on the part of practitioners and patients alike in how they conceptualize and respond to pain. PNE is a promising education strategy that has been shown to influence patient-reported outcomes in those with chronic pain and has been shown to influence the provider's beliefs about pain. However, the delivery of this education has proven difficult for providers in terms of comfortability and time-efficiency. A standardized delivery a PNE by experts in the field could prove efficient and effective.
STUDY DESIGN The investigators' overall goal is to determine the feasibility of VR-delivered pain neuroscience education (PNE). Secondarily, the investigators would like to see if these interventions are best targeted to specific individuals. To accomplish these goals, the investigators will conduct a randomized clinical trial, randomly assigning participants to receive virtual reality (VR) education in addition to usual care or usual care with no additional education.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •i. Age 18-75 at time of first physical therapy session ii. Primary reason for physical therapy is low back pain iii. History of low back pain >/= 12 weeks
排除标准
- •i. Age >75y/o or <18 y/o ii. Red flag condition that prohibits participation in physical therapy:
- •Systemic metabolic disorder
- •Neurological or muscular degenerative disorder (including Epilepsy)
- •Systemic infection
- •Cardiopulmonary or pulmonary disorder with contraindication to physical exercise iii. Recent spinal surgery (<12 months) iv. Specific spinal pathologies, such as severe stenosis or spondylolisthesis or fracture v. Acute radiculopathy or compromised nerve root vi. Currently known to be pregnant
结局指标
主要结局
Acceptability Measures
时间窗: 6 weeks
Patient satisfaction and acceptability of VR-delivered PNE.
Rate of Recruitment
时间窗: 6 weeks
Count of all potentially eligible subjects (count kept by office coordinators of patients offered the study); count of those determined eligible by research team; count of those that choose to consent. Reasons for no contact or choosing not to enroll will be collected when able.
Adherence
时间窗: 6 weeks
Number of visits completed, number of VR modules completed.
次要结局
- Pain Self-Efficacy Questionnaire (PSEQ):(6 weeks)
- Pain Catastrophizing Scale (PCS)(6 weeks)
- Oswestry Disability Index (ODI(6 weeks)
- Global Rating of Change (GROC(6 weeks)
- Back Beliefs Questionnaire (BBQ):(6 weeks)
- Numeric Pain Rating Scale (NPRS)(6 weeks)
- Neurophysiology of Pain Questionnaire (NPQ)(6 weeks)
- Fear Avoidance Beliefs Questionnaire (FABQ)(6 weeks)
- Brief Resiliency Scale (BRS):(6 weeks)
- Working Alliance Inventory (WAI):(6 weeks)
研究者
Elizabeth Lane
Co-Investigator
University of Utah