The Impact of Insomnia on Pain Sensitivity and the Trajectory of Exercise-induced Muscular Pain
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-60
SponsorThe Hong Kong Polytechnic University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Adults aged 18 to 60 years
Right hand and foot dominant
Disqualifiers
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
Trial population
Healthy Adult with or without insomnia
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Eccentric exercise
Other interventionEccentric exercise
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Insomnia1 intervention
Group B: Healthy contry1 intervention
Trial outcomes
Primary outcomes
1
Muscle damage severity: Muscle pain
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.
Time frame
Day 0 to Day 142
Muscle damage severity: Muscle soreness
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."
Time frame
Day 0 to Day 143
Pain Sensitivity: Thermal pain threshold
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.
Time frame
Day 7 and Day 94
Pain Sensitivity: Mechanical pain threshold
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.
Time frame
Day 7 and Day 9Secondary outcomes
1
Sleep Questionnaires: the Insomnia Severity Index (ISI)
The ISI is a 7-item self-report questionnaire assessing the nature, severity, and impact of insomnia. Each item is rated on a 5-point Likert scale (0 to 4). The total score ranges from 0 to 28, with higher scores indicating greater severity of insomnia
Time frame
Day 0 and Day 72
Sleep Questionnaires: The Pittsburgh Sleep Quality Index (PSQI)
The PSQI is a 19-item self-report questionnaire that evaluates sleep quality and disturbances over a 1-month time interval. It generates seven component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Each component is scored from 0 to 3. The sum of these seven component scores yields a global PSQI score ranging from 0 to 21, where higher scores indicate poorer sleep quality.
Time frame
Day 0 and Day 73
Sleep diary: Total Sleep Time
Assessed using a daily consensus sleep diary. Total Sleep Time is calculated as the total time spent asleep, derived from the total time in bed (bedtime to rise time) minus sleep onset latency and wake after sleep onset. Higher values indicate longer sleep duration.
Time frame
Day 0 to Day 144
Sleep diary: Sleep Onset Latency (SOL)
Assessed using a daily consensus sleep diary. Sleep Onset Latency is the estimated time (in minutes) it takes to fall asleep after turning off the lights. Lower values indicate better sleep onset.
Time frame
Day 0 to Day 14Sponsors and contacts
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Source ClinicalTrials.gov