The Impact of Insomnia on Pain Sensitivity and the Trajectory of Exercise Induced Muscular Pain: a Case Control Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Muscle damage severity: Muscle pain
研究概览
简要总结
Sleep is a critical determinant of physiological recovery and pain regulation. Growing evidence suggests that sleep disruption directly heightens central and peripheral pain sensitivity to sensory stimuli (e.g., mechanical pressure, thermal stimuli), serving as a significant risk factor for the onset and persistence of musculoskeletal pain. However, the precise mechanisms through which sleep quality regulates bodily sensory sensitivity and influences the onset, progression, and recovery trajectories of acute musculoskeletal pain in the general public remain insufficiently understood.
This study aims to investigate the relationship between sleep condition, pain sensitivity, and musculoskeletal pain dynamics in healthy adults from the general population, regardless of their physical activity levels. Utilizing a standardized, safe, and fully reversible exercise-induced muscle soreness (EIMS) protocol as an experimental pain model, this project will continuously evaluate participants' quantitative sensory testing (QST) profiles and sleep parameters.
The findings from this study will advance the mechanistic understanding of sleep-mediated pain modulation, providing evidence-based insights to inform future targeted sleep management and pain prevention interventions.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 18 to 60 years
- •Right hand and foot dominant
排除标准
- •History of any chronic musculoskeletal pain or presence of existing pain during recruitment
- •Previous major injuries or surgery involving the lower limbs
- •Sleep disorders other than insomnia
- •Clinically diagnosed psychiatric disorders
- •Contraindications to vigorous exercise identified through the physical activity readiness questionnaire (PAR-Q)
- •Work night shifts or rotating shift schedules
研究组 & 干预措施
Insomnia
干预措施: Eccentric exercise (Other)
Healthy contry
干预措施: Eccentric exercise (Other)
结局指标
主要结局
Muscle damage severity: Muscle pain
时间窗: Day 0 to Day 14
Muscle pain will be measured by an 11-point NRS, with 0 represents "no pain" and 10 indicating "worst imaginable pain". The Outcome will be recorded at rest, reach for the floor with knees straight, and during a validated hamstring provocative manoeuvre, the "taking-off shoe" test.
Muscle damage severity: Muscle soreness
时间窗: Day 0 to Day 14
Muscle soreness will be measured by an 7-point Likert scale, with 0= A complete absence of soreness," 1 = "A light soreness in the muscle felt only when touched/a vague ache," 2 = "A moderate soreness felt only when touched/a slight persistent pain," 3 = "A light muscle soreness when walking up and down stairs," 4 = "A light muscle soreness when walking on flat surface," 5 = "A moderate muscle soreness, stiffness, or weakness when walking," 6 = "A severe muscle soreness, stiffness, or weakness that limits my ability to move."
Pain Sensitivity: Thermal pain threshold
时间窗: Day 7 and Day 9
Thermal thresholds will be measured with a 30 × 30 mm thermode (TSA 2, Medoc Ltd., Ramat Yishai, Israel). The thermode will be placed gently on the skin without causing deformation. Using the method of limits, temperature will increase or decrease at 1℃/second within a 0 - 51℃ range, with a baseline temperature of 32℃. Participants will press the stop button when the thermal sensation first becomes painful. The mean value of five consecutive trials will be used in the analysis.
Pain Sensitivity: Mechanical pain threshold
时间窗: Day 7 and Day 9
Mechanical pain threshold will be evaluated using standardised weighted pinprick stimulators (MRC System GmbH, Heidelberg, Germany) with a 0.25mm flat contact area. Seven fixed intensities (8 mN - 512 mN) will be applied. The final threshold will be calculated as the geometric mean of the ascending and descending stimulus intensities from five series.
Pain Sensitivity: Pressure pain threshold
时间窗: Day 7 and Day 9
Pressure pain threshold will be assessed with a digital pressure algometer (Medoc Ltd., Ramat Yishai, Israel) equipped with a 1 cm2 rubber probe. Pressure will be applied at 30 Kpa per second until participants perceive painful. Three trials will be performed, and the mean scores will be calculated to determine the PPT.
Pain Sensitivity: Temporal summation of mechanical pain (TSP-M)
时间窗: Day 7 and Day 9
The pinprick stimulator will assess TSP-M at 256 mN. Ten stimuli will be delivered at 1-second intervals over a 1 cm2 area. Pain intensity will be rated on an 11-point NRS after the first and the 10th stimuli. If the NRS pain rating remains 0 out of 10 for three consecutive 256 mN stimuli, intensity will be increased to 512 mN, and the trial will be repeated. TSP-M will be calculated as the NRS difference between the first stimulus and the 10th stimulus.
Pain Sensitivity: Temporal summation of heat pain (TSP-H)
时间窗: Day 7 and Day 9
TSP-H will be measured with a 9 cm2 thermode (TSA 2, Medoc Ltd., Ramat Yishai, Israel). Two sequences of 10 heat pulses at 46 ℃ and 48 ℃ will be delivered with a 5-minute interval. Each pulse has a 0.5 s duration and will be delivered from a 40 ˚C baseline at a 13°C/s ramp rate and 2.5 s interstimulus interval. The participant will rate pain intensity on an 11-point NRS after each stimulus. TSP-H will be defined as the NRS difference between the 10th stimulus and the first stimulus for each temperature.
Pain Sensitivity: Conditioned pain modulation (CPM)
时间窗: Day 7 and Day 9
CPM will be evaluated using a noxious conditioning stimulus (CS) and a test stimulus (TS). The CS will be contact heat applied to the dominant volar forearm between the distal third of the forearm and the ulnar styloid. Temperature will be set 1.1 °C above the participant's HPT for 120s, starting from 32 ℃ with an 8°C/s ramp using the TSA 2 device (Medoc Ltd., Ramat Yishai, Israel). During the CPM assessment, if participants could not tolerate the CS (i.e., pain intensity over 8 on the11-point NPRS) or if they reported a pain intensity below 4 on the 11-point NPRS, the temperature of the CS will be adjusted to ensure a safe and adequate stimulus intensity. The TS will be applied to the thenar eminence of the non-dominant hand using a pressure algometer (Medoc Ltd., Ramat Yishai, Israel) to determine PPT before and immediately after the CS. The CPM effect will be calculated by subtracting the PPT measured before the CS from the PPT measured after the CS.
次要结局
- Sleep Questionnaires: the Insomnia Severity Index (ISI)(Day 0 and Day 7)
- Sleep Questionnaires: The Pittsburgh Sleep Quality Index (PSQI)(Day 0 and Day 7)
- Sleep diary: Total Sleep Time(Day 0 to Day 14)
- Sleep diary: Sleep Onset Latency (SOL)(Day 0 to Day 14)
- Sleep diary: Wake After Sleep Onset (WASO)(Day 0 to Day 14)
- Sleep diary: Sleep Efficiency (SE)(Day 0 to Day 14)
- Actigraphy: Total Sleep Time (TST)(Day 0 to Day 14)
- Actigraphy: Sleep Onset Latency (SOL)(Day 0 to Day 14)
- Actigraphy: Wake After Sleep Onset (WASO)(Day 0 to Day 14)
- Actigraphy: Sleep Efficiency (SE)(Day 0 to Day 14)
- Psychological measurement: Depression, Anxiety, and Stress Scale (DASS-21)(Day 0, Day 7, and Day 9)
- Psychological measurement: Pain Catastrophizing Scale (PCS)(Day 0, Day 7, and Day 9)
- Psychological measurement: Fear of Pain Questionnaire (FPQ-9)(Day 0, Day 7, and Day 9)
- Psychological measurement: Tampa Scale for Kinesiophobia (TSK-11)(Day 0, Day 7, and Day 9)
- Physical Activity Level: International Physical Activity Questionnaire - Short Form (IPAQ-SF)(Day 0, Day 7, and Day 9)