NCT03796481已完成不适用
Sleep, Pain and Function in People With Chronic Spinal Pain and Comorbid Insomnia Compared to People With Chronic Spinal Pain Without Insomnia.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 123
- 试验地点
- 2
- 主要终点
- Brief Pain Inventory (Numeric Rating Scale): Pain intensity
研究概览
简要总结
This study is focused on people with chronic spinal pain. To investigate the impact of sleep problems on pain and function, 45 people with chronic spinal pain and comorbid insomnia will be compared to 45 people with chronic spinal pain without insomnia.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Brief Pain Inventory (Numeric Rating Scale): Pain intensity
时间窗: Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021.
Self-reported pain: The question "please rate your pain by circling the one number that best describes your pain on the AVERAGE" is used as the primary outcome measure to evaluate pain intensity. Scale ranges from 0 to 10, with higher scores indicating more self-reported pain.
次要结局
- Sleep: Polysomnography (PSG) using the portable Alice PDX system, Philips Respironics Inc(Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021.)
- Brief Pain Inventory: Pain Interference(Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021.)
- Central sensitization Inventory(Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021.)
- Insomnia Severity Index(Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021.)
- Epworth Sleepiness Scale(Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021.)
- Physical Activity using Actigraphy(Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021.)
- Pressure Pain Thresholds(Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021.)
- Hospital Anxiety and Depression rating scale(Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021.)
- Pittsburg Sleep Quality Index(Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021.)
- DBAS (i.e. Dysfunctional Beliefs and Attitudes about Sleep)(Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021.)
- Brugmann Fatigue Scale(Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021.)
- Short Form Health Survey - 36 items Mental Health(Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021.)
- Short Form Health Survey - 36 items Physical Health(Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021.)
研究者
研究点 (2)
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