Safety and Effectiveness of Virtual Reality Utilizing RelieVRx for Total Knee Arthroplasty (TKA) for the Reduction of Acute Postoperative Pain and Opioid Use
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 3
- 主要终点
- Acute Postoperative Pain
研究概览
简要总结
This is a single-center, prospective, randomized, controlled study of the appliedVR RelieVRx headset in subjects undergoing Total Knee Arthroplasty (TKA). This study will evaluate two primary endpoints - effectiveness of a single use of RelieVRx in the reduction of acute postoperative pain by 20%; and overall effectiveness of RelieVRx as an opioid-sparing intervention, where opioid consumption is reduced by at least 20% over a 90-day postoperative period in the interventional, standard of care (SOC) plus RelieVRx group compared to the control, SOC group.
详细描述
This is a single-center, prospective, randomized, controlled study of the appliedVR RelieVRx headset in subjects undergoing Total Knee Arthroplasty (TKA). Patients will be randomized to one of the two groups after study enrollment, and patients in the test arm will be educated about the device preoperatively to facilitate its use in the acute post-operative period. The goals of VR will be presented in the context of an alternate method of pain control to opioids. This study will evaluate two primary endpoints - effectiveness of a single use of RelieVRx in the reduction of acute postoperative pain by 20%; and overall effectiveness of RelieVRx as an opioid-sparing intervention, where opioid consumption is reduced by at least 20% over a 90-day postoperative period in the interventional, standard of care (SOC) plus RelieVRx group compared to the control, SOC group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
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
- •Subject is ≥ 18 years old
- •Subject is willing and able to read, comprehend, and sign the study informed consent form in English prior to study specific procedure
- •Subject is scheduled for Total Knee Arthroplasty (TKA) surgery
- •Subject has a score of 1-3 based on the American Society of Anesthesiologists Physical Status Classification System
- •Subject attended the pre-op Total Joint Arthroplasty Patient Education class (Proven Recovery Program©)
- •Subject agrees to be enrolled in Force Therapeutics, a web-based, digital rehabilitation and education program
- •Subject has family member or community support during post-surgical recovery period
排除标准
- •Diagnosed with chronic pain syndrome
- •Body Mass Index (BMI) ≥ 40
- •Current tobacco user at time of surgery
- •Uncontrolled sleep apnea
- •Bilateral TKA
- •Current or recent history (in past year) of substance abuse disorder
- •Uncontrolled diabetes (HbA1c ≥ 7.0) 7.8 at time of surgery
- •History of Pulmonary Embolism (PE) or Deep Vein Thrombosis (DVT)
- •Currently being treated with blood thinners at time of surgery
- •Diagnosis of Rheumatoid Arthritis (RA)
- •Has Methicillin-resistant Staphylococcus aureus (MRSA)
- •Currently pregnant/breastfeeding or planning to in the next 3 months
- •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
研究组 & 干预措施
Standard of care group
Receive standard of care for pain management, do not receive RelieVRx headset
干预措施: multi-modality pain management (Drug)
Standard of care + RelieVRx group
Receive standard of care for pain management, plus RelieVRx headset
干预措施: RelieVRx headset (Device)
Standard of care + RelieVRx group
Receive standard of care for pain management, plus RelieVRx headset
干预措施: multi-modality pain management (Drug)
结局指标
主要结局
Acute Postoperative Pain
时间窗: 90 days
Visual Analog Pain scale; worst 0-10 best
Opioid Consumption
时间窗: 90 days
Morphine Milligram Equivalents (MME)
次要结局
- KOOS Jr. Score(90 days)
- Veterans RAND 12 Health Survey (VR-12) - Physical Component Score(90 days)