Performance Assessment of the PMD-200 (Physiological Monitor Device), a Novel Pain Monitor, in Subjects With Degenerative Lumbar Spine Disease Who Requires Surgical Procedure
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- discrimination between nonpainful period to painful period
研究概览
简要总结
Performance assessment of the PMD-200, a novel pain monitor, in subjects with degenerative lumbar spine disease who requires surgical procedure
详细描述
The proposed study is design to further demonstrates the capability of the Nociception Level, (NoL) Index in identify and discriminate between painful event and non-painful period following pain stimulus of Straight Leg Raising (SLR) test in patients with degenerative lumbar spine disease. This feasibility study may provide first indication for a validation method that will be able to evaluate the outcome of a surgical procedure within the degenerative lumbar spine patient. Currently, there is lack of understanding of long-term outcomes after such surgeries.
In this study, the investigators plan to demonstrate that the NoL Index may serve as an indicator to the surgical procedure outcome. It will compare the objective measurement of the NoL to the patient Visual Analogue Scale (VAS) score and disability questionnaire that will characterize the subject pain perception prior and following the surgical procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age over 18 and less than 65 (18 < Age < 65).
- •The subject suffer from unilateral degenerative lumbar spine disease
- •The subject suffer from leg pain only in one leg, while no pain in the other leg.
- •The subject was hospitalized in the neurosurgery department of the hospital in order to undergoes spinal surgery due to the above disease
- •A signed Informed Consent Form (ICF) has been obtain from the subject
排除标准
- •The subject has a bi-lateral degenerative lumbar spine disease
- •The subject is pregnant
结局指标
主要结局
discrimination between nonpainful period to painful period
时间窗: Through study completion, about one year
To demonstrate that the NoL index can discriminate between nonpainful period to painful period, prior and following SLR test
次要结局
- Correlates with changes in pain levels(Through study completion, about one year)