Immersive Virtual Reality for Chronic Neuropathic Pain After Spinal Cord Injury: A Feasibility Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Neuropathic Pain Symptom Inventory (NPSI)
研究概览
简要总结
The aim of this study is to provide critical information about the efficacy of Immersive Virtual Reality (IVR) to decrease the experience of neuropathic pain in the upper and lower extremities of people with a spinal cord injury.
详细描述
When a spinal cord injury occurs, the spinal somatosensory circuit is thought to generate aberrant nociceptive impulses that the brain interprets as pain. Neuropathic pain (NP) affects 40 to 70% of people with SCI and is a very disabling clinical condition. Many treatment options have been offered, but provide limited effects, leaving people with SCI with a reduced quality of life. The study team believes that Immersive Virtual Reality (IVR) neurorehabilitation has the potential to be an effective treatment for chronic neuropathic pain. For this reason, the objective of this study is to evaluate the feasibility of using a virtual reality device to decrease chronic neuropathic pain in individuals with spinal cord injury.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Participant, PI and Outcome Assessor remain blinded for the entirety of the study.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Spinal cord injury survivors (chronic only)
- •Presence of neuropathic pain at or below SCI level for at least 6 months following trauma or disease of the spinal cord
- •A pain intensity of at least 2 out of 10 in the numerical pain rating scale (NPRS) test at baseline
- •Stable pharmacological treatment for at least 4 weeks prior to the study and throughout the trial
排除标准
- •Psychiatric or other neurological disorders (Participants will not be excluded for having a SCI, if they score 0-30 points on the BDI, or if they report having anxiety)
- •Head injuries causing cognitive or visual impairment
- •Severe vertigo
结局指标
主要结局
Neuropathic Pain Symptom Inventory (NPSI)
时间窗: Up to 10 Weeks
Neuropathic Pain Symptom Inventory (NPSI): This scale was developed to assess both the quantitative and qualitative qualities of neuropathic pain (NP). It includes 12 items, assessing spontaneous pain, brief attacks of pain, provoked pain and abnormal sensations in the painful area. This is a sensitive tool for measuring changes in neuropathic pain after a therapeutic intervention. Total score range for NPSI is 0-100, higher scores indicate more severity.
次要结局
- Spinal Cord Independence Measure (SCIM III)(Up to 10 Weeks)
- Immersive Tendencies Questionnaire (ITQ)(Up to 10 Weeks)
- User Experience Score (UES)(14 Days)
- Numerical Pain Rating Scale (NPRS)(16 Days)
- Beck Depression Inventory (BDI)(Up to 10 Weeks)
- Patient's Global Impression of Change (PGIC)(Up to 10 Weeks)
- UQO- Presence Questionnaire (UPO-PQ)(16 Days)
- Neuropathic Pain Scale (NPS)(Up to 10 Weeks)
研究者
David Putrino
Director of Rehabilitation Innovation
Icahn School of Medicine at Mount Sinai