Reliability of Pupil Response to Acute Pain
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Percentage of change in pupil diameter
研究概览
简要总结
The purpose of this research study is to test whether researchers can reliably measure the response pupils have when an acute painful stimulus is experienced. Changes in the size of the pupil of the eye can be an indicator of brain activity in a region of the brain that is important for feeling pain.
详细描述
There is strong rationale to support a role for locus coeruleus (LC) responsivity to acute painful stimuli in regulating speed of recovery after surgery and for LC responsivity as a mechanistic link explaining the risks for slow recovery from weak Conditioned Pain Modulation (CPM), catastrophizing cognitive style, and low enzyme activity catecholamine-O-methyltransferase (COMT) genotype. Preliminary data show feasibility to perform the proposed study.
Primary Hypothesis: An observational study of pupil responses to noxious stimuli shows strong intra-individual reliability over 8 weeks.
Key secondary hypotheses: Compared to individuals homozygous for val at the val158met site of the catecholamine-O-methyltransferase (COMT) gene, those homozygous for met will show smaller pupil responses to noxious stimuli and weaker CPM.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult (18-70)
- •Pain from hip or knee arthritis of moderate intensity
- •American Society of Anesthesiologists physical status 1-3
排除标准
- •Inability to complete study questionnaires
- •Pregnancy
- •Litigation or workers compensation related to hip or knee pain
- •Taking > 50 mg morphine equivalents/day
- •History of Raynaud's disease of the feet
- •Psychotic disorder or a recent psychiatric hospitalization
- •History of eye surgery or topical eye medications that would would directly affect pupil diameter
结局指标
主要结局
Percentage of change in pupil diameter
时间窗: 8 weeks
pupil diameter in response to 5 second presentation of noxious heat stimuli
Change from Baseline Verbal Pain Scores
时间窗: 8 weeks
Verbal pain scores will be obtained during stimulus presentation
Percentage of Change in Pupil Diameter
时间窗: 8 weeks
pupil diameter in response to 5 second presentation of noxious heat stimuli
Pain Score on Visit 1
时间窗: Day 1
Participants rated their pain intensity during 5 seconds of heating the skin surface to 50 degrees. They used a scale of 0-100, with 0 being no pain at all and 100 being the worst pain imaginable. The heat was applied 5 times over 7.5 minutes and these 6 scores were averaged as their individual score.
Pain Score on Visit 2
时间窗: Week 2
Participants rated their pain intensity during 5 seconds of heating the skin surface to 50 degrees. They used a scale of 0-100, with 0 being no pain at all and 100 being the worst pain imaginable. The heat was applied 5 times over 7.5 minutes and these 6 scores were averaged as their individual score.
Pain Score on Visit 3
时间窗: Month 1
Participants rated their pain intensity during 5 seconds of heating the skin surface to 50 degrees. They used a scale of 0-100, with 0 being no pain at all and 100 being the worst pain imaginable. The heat was applied 5 times over 7.5 minutes and these 6 scores were averaged as their individual score.
Pain Score on Visit 4
时间窗: Month 2
Participants rated their pain intensity during 5 seconds of heating the skin surface to 50 degrees. They used a scale of 0-100, with 0 being no pain at all and 100 being the worst pain imaginable. The heat was applied 5 times over 7.5 minutes and these 6 scores were averaged as their individual score.
次要结局
未报告次要终点