Can Virtual Reality Improve Patient Tolerance in Patients Undergoing Water Cooled Genicular Nerve Radio Frequency Ablation in Patients With Chronic Knee Pain? A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Procedural related pain
研究概览
简要总结
This study will examine the impact of virtual reality used in conjunction with sedation compared to sedation alone in patients undergoing watervcooled genicular nerve ablations for chronic knee pain.
The goals of the study is to determine the relative efficacy of virtual reality as a distraction modality when used as an adjuvant to procedural sedation compared to sedation alone for procedure related pain. To assess procedural satisfaction, and 1-month pain and functional outcomes.To explore whether virtual reality and lower procedure-related pain scores affect 1-month outcomes. And finally to determine whether demographic and clinical characteristics are associated with outcome measures.
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 (Outcomes Assessor)
盲法说明
Outcome assessor will be blinded to study randomization
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
- •Patients undergoing genicular RFA will be eligible for inclusion in the study
- •Patients with knee pain, baseline average of > 4/10
- •X-ray evidence of osteoarthritis of the knee
- •Pain duration of >6 weeks and no previous knee surgeries
- •Patients will also only be included who have never undergone a RFA on the affected knee
排除标准
- •Individuals who do not have evidence of osteoarthritis on X-ray,
- •Secondary gain expected to influence treatment outcomes
- •Poorly controlled psychiatric condition that could affect outcome (e.g. active substance abuse) or impose a barrier to participation
- •Chronic opioid use and anticoagulation therapy that cannot be stopped and could warrant a different treatment approach (e.g. phenol ablation)
- •Severe motion sickness
- •Seizure disorder
- •Vision loss
结局指标
主要结局
Procedural related pain
时间窗: 10 minutes after procedure
Reported procedural related pain on a 0-10 verbal rating scale (VRS)
次要结局
- Procedure related satisfaction(10 minutes after prodedure)
- Post procedure anxiety(10 minutes after procedure)
- Mean reduction in pain 1 month after procedure(30 days after procedure)
- Midazolam administered(10 minutes before procedure to end of prodedure)
- Fentanyl administered(10 minutes before procedure to end of prodedure)
研究者
Jason Ross
Principal Investigator
Northwestern University