The Impacts of Fragmented Sleep on Biomechanics and Pain of the Shoulder and Knee
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Knee Pain intensity (NRS 0-10)
研究概览
简要总结
This interventional study aims to test the effects of sleep disruption on pain sensitivity and biomechanics in healthy individuals during experimental knee and shoulder pain. The main question the study aims to answer is:
1) Does sleep fragmentation increase experimental knee and shoulder pain and what are the underlying mechanisms?
Participants will receive two injections a) Hypertonic saline (painful) in the knee and b) hypertonic saline (painful) in the upper arm.
详细描述
This study will include healthy participants for one baseline session and one follow-up session separated by three nights of experimental sleep disruption.
The sleep fragmentation will involve three forced awakenings per night for three consecutive nights between sessions. These awakenings will be planned at 00:00, 02:30, and 05:00.
In each session, the participant will answer questionnaires and have their pain sensitivity assessed using cuff-pressure algometry. Following this, they will first receive a painful saline injection into the infrapatellar fat pad of the knee. After a washout period, they will receive another painful saline injection into the deltoid muscle of the shoulder. For both injections, the pain will be rated on an NRS scale (0 representing 'no pain' and 10 representing 'worst pain imaginable') every 30 seconds, and the distribution will be marked on a body chart.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy men and women aged 18-45 years
- •Must have a smartphone available during the experiment
排除标准
- •Pregnancy
- •Drug addiction, defined as the use of cannabis, opioids, or other drugs
- •Previous or current neurologic or musculoskeletal illnesses
- •Current pain
- •Lack of ability to cooperate
研究组 & 干预措施
Experimental Knee Pain and Shoulder Pain
Injection to the infrapatellar fat pad. Will always be administered first.
Injection to the deltoid muscle. Will always be administered last.
干预措施: Hypertonic saline knee and shoulder injection (Other)
结局指标
主要结局
Knee Pain intensity (NRS 0-10)
时间窗: Baseline (day 1) and follow-up (day 4)
Pain during intervention is measured continuously every 30 seconds on a numeric rating scale from 0 'no pain' to 10 'the worst pain imaginable'
Shoulder Pain intensity (NRS 0-10)
时间窗: Baseline (day 1) and follow-up (day 4)
Pain during intervention is measured continuously every 30 seconds on a numeric rating scale from 0 'no pain' to 10 'the worst pain imaginable'
次要结局
- The Pain catastrophizing Scale score(Baseline (day 1) and follow-up (day 4))
- Rapid Assessment of Physical Activity score(Baseline (day 1) and follow-up (day 4))
- Pain distribution by number of pixels marked on a body chart(Baseline (day 1) and follow-up (day 4))
- Pain sensitivity(Baseline (day 1) and follow-up (day 4))
- The Pittsburgh Sleep Quality Index score(Baseline (day 1) and follow-up (day 4))
- The Hospital Anxiety and Depression Scale score(Baseline (day 1) and follow-up (day 4))
- The Knee injury and Osteoarthritis Outcome Score(Baseline (day 1) and follow-up (day 4))
- Video-based motion capture(Baseline (day 1) and follow-up (day 4))
研究者
Kristian Kjær Petersen
Associate professor
Aalborg University