The Impact of Insomnia on Pain Sensitivity and the Trajectory of Exercise-induced Muscular Pain
14 de setembro de 2026 atualizado por: The Hong Kong Polytechnic University
The Impact of Insomnia on Pain Sensitivity and the Trajectory of Exercise Induced Muscular Pain: a Case Control Study
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.
Visão geral do estudo
Status
Recrutamento
Intervenção / Tratamento
Tipo de estudo
Observacional
Inscrição (Estimado)
80
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Leo Guohui Lin
- Número de telefone: +852 94267004
- E-mail: guohui-leo.lin@connect.polyu.hk
Locais de estudo
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Hong Kong, Hong Kong
- Recrutamento
- The Hong Kong Polytechnic University
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Contato:
- Leo Guohui Lin
- Número de telefone: +852 94267004
- E-mail: guohui-leo.lin@connect.polyu.hk
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Sim
Método de amostragem
Amostra Não Probabilística
População do estudo
Healthy Adult with or without insomnia
Descrição
Inclusion Criteria:
- Adults aged 18 to 60 years
- Right hand and foot dominant
Exclusion Criteria:
- 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
- Pregnant
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
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Insomnia
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Eccentric hamstring exercise
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Healthy contry
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Eccentric hamstring exercise
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Muscle damage severity: Muscle pain
Prazo: Day 0 to Day 14
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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.
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Day 0 to Day 14
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Muscle damage severity: Muscle soreness
Prazo: Day 0 to Day 14
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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."
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Day 0 to Day 14
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Pain Sensitivity: Thermal pain threshold
Prazo: Day 7 and Day 9
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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.
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Day 7 and Day 9
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Pain Sensitivity: Mechanical pain threshold
Prazo: Day 7 and Day 9
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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.
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Day 7 and Day 9
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Pain Sensitivity: Pressure pain threshold
Prazo: Day 7 and Day 9
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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.
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Day 7 and Day 9
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Pain Sensitivity: Temporal summation of mechanical pain (TSP-M)
Prazo: Day 7 and Day 9
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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.
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Day 7 and Day 9
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Pain Sensitivity: Temporal summation of heat pain (TSP-H)
Prazo: Day 7 and Day 9
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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.
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Day 7 and Day 9
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Pain Sensitivity: Conditioned pain modulation (CPM)
Prazo: Day 7 and Day 9
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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.
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Day 7 and Day 9
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Sleep diary: Sleep Onset Latency (SOL)
Prazo: Day 0 to Day 14
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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.
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Day 0 to Day 14
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Sleep diary: Wake After Sleep Onset (WASO)
Prazo: Day 0 to Day 14
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Assessed using a daily consensus sleep diary.
WASO is calculated as the total duration of wakefulness (in minutes) between initial sleep onset and final awakening, derived from the number of night awakenings multiplied by their average duration.
Lower values indicate better sleep continuity.
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Day 0 to Day 14
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Sleep diary: Sleep Efficiency (SE)
Prazo: Day 0 to Day 14
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Assessed using a daily consensus sleep diary.
Sleep Efficiency is calculated as the percentage of time in bed spent asleep: [(Total Sleep Time / Total Time in Bed) × 100].
Total Sleep Time is derived from total time in bed (time between bedtime and rise time) minus sleep onset latency and nocturnal wakefulness (calculated from the number and duration of night awakenings).
Scores range from 0% to 100%, with higher percentages indicating better sleep quality.
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Day 0 to Day 14
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Actigraphy: Total Sleep Time (TST)
Prazo: Day 0 to Day 14
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Measured objectively using a wrist-worn ActiGraph accelerometer and validated sleep-scoring algorithms.
Total Sleep Time is defined as the total amount of time spent sleeping between bedtime and rise time.
Higher values indicate longer sleep duration.
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Day 0 to Day 14
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Actigraphy: Wake After Sleep Onset (WASO)
Prazo: Day 0 to Day 14
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Measured objectively using a wrist-worn ActiGraph accelerometer.
WASO is defined as the total number of minutes spent awake after initial sleep onset and before final awakening, as determined by epoch-by-epoch movement counts.
Lower values indicate better sleep continuity and fewer night awakenings.
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Day 0 to Day 14
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Actigraphy: Sleep Efficiency (SE)
Prazo: Day 0 to Day 14
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Measured objectively using a wrist-worn ActiGraph accelerometer.
Sleep Efficiency is calculated as the percentage of time in bed spent asleep: [(Total Sleep Time / Total Time in Bed) × 100].
Values range from 0% to 100%, with higher percentages indicating better sleep quality and efficiency.
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Day 0 to Day 14
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Sleep Questionnaires: the Insomnia Severity Index (ISI)
Prazo: Day 0 and Day 7
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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
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Day 0 and Day 7
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Sleep Questionnaires: The Pittsburgh Sleep Quality Index (PSQI)
Prazo: Day 0 and Day 7
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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.
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Day 0 and Day 7
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Psychological measurement: Depression, Anxiety, and Stress Scale (DASS-21)
Prazo: Day 0, Day 7, and Day 9
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Assessed using the 21-item Depression Anxiety Stress Scales (DASS-21).
The instrument consists of three 7-item subscales measuring depression, anxiety, and stress.
Each item is rated on a 4-point Likert scale ranging from 0 ("did not apply to me at all") to 3 ("applied to me very much or most of the time").
Sum scores for each subscale are calculated and multiplied by 2 to yield total scores ranging from 0 to 42 for each dimension (Depression: 0-42, Anxiety: 0-42, Stress: 0-42), with a total overall score ranging from 0 to 126.
Higher scores indicate greater levels of psychological distress/severity.
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Day 0, Day 7, and Day 9
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Psychological measurement: Pain Catastrophizing Scale (PCS)
Prazo: Day 0, Day 7, and Day 9
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Assessed using the 13-item Pain Catastrophizing Scale (PCS) to evaluate catastrophic thoughts and feelings associated with pain (comprising rumination, magnification, and helplessness subscales).
Each item is rated on a 5-point Likert scale from 0 ("not at all") to 4 ("all the time").
The total score ranges from 0 to 52, with higher scores indicating higher levels of pain catastrophizing.
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Day 0, Day 7, and Day 9
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Psychological measurement: Fear of Pain Questionnaire (FPQ-9)
Prazo: Day 0, Day 7, and Day 9
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Assessed using the 9-item short form of the Fear of Pain Questionnaire (FPQ-9) to assess fear of different painful experiences across severe pain, minor pain, and medical pain domains.
Each item is rated on a 5-point Likert scale from 1 ("not at all") to 5 ("extreme").
The total score ranges from 9 to 45, with higher scores indicating greater fear of pain.
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Day 0, Day 7, and Day 9
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Psychological measurement: Tampa Scale for Kinesiophobia (TSK-11)
Prazo: Day 0, Day 7, and Day 9
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Assessed using the 11-item Tampa Scale for Kinesiophobia (TSK-11) to evaluate fear of movement or (re)injury.
Each item is scored on a 4-point Likert scale ranging from 1 ("strongly disagree") to 4 ("strongly agree").
The total score ranges from 11 to 44, with higher scores indicating greater fear of movement/kinesiophobia.
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Day 0, Day 7, and Day 9
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Sleep diary: Total Sleep Time
Prazo: Day 0 to Day 14
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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.
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Day 0 to Day 14
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Actigraphy: Sleep Onset Latency (SOL)
Prazo: Day 0 to Day 14
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Measured objectively using a wrist-worn ActiGraph accelerometer.
Sleep Onset Latency is defined as the period of time (in minutes) between the initial bedtime (lights out) and the onset of continuous sleep detected by the algorithm.
Lower values indicate faster sleep onset and better sleep initiation.
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Day 0 to Day 14
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Physical Activity Level: International Physical Activity Questionnaire - Short Form (IPAQ-SF)
Prazo: Day 0, Day 7, and Day 9
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Assessed using the 7-item International Physical Activity Questionnaire - Short Form (IPAQ-SF).
The questionnaire measures the duration (minutes) and frequency (days) of walking, moderate-intensity activities, and vigorous-intensity activities performed over the last 7 days.
Total physical activity volume is calculated as MET-minutes per week (MET-min/week) using standardised MET energy expenditure values: Walking = 3.3 METs, Moderate PA = 4.0 METs, and Vigorous PA = 8.0 METs.
Total score is the sum of (METs × minutes × days) across all three domains, with scores starting from 0 and no strict upper limit.
Higher scores indicate higher levels of overall physical activity.
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Day 0, Day 7, and Day 9
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
26 de agosto de 2026
Conclusão Primária (Estimado)
31 de agosto de 2027
Conclusão do estudo (Estimado)
31 de agosto de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
2 de setembro de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
14 de setembro de 2026
Primeira postagem (Real)
18 de setembro de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
18 de setembro de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
14 de setembro de 2026
Última verificação
1 de agosto de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Dor
- Manifestações Neurológicas
- Doenças musculoesqueléticas
- Doenças do Sistema Nervoso
- Doenças Musculares
- Transtornos Mentais, Desordem Mental
- Distúrbios do Sono Vigília
- Distúrbios do Sono Intrínsecos
- Dissônias
- Condições Patológicas, Sinais e Sintomas
- Sinais e sintomas
- Dor musculoesquelética
- Distúrbios de Iniciação e Manutenção do Sono
Outros números de identificação do estudo
- Insomnia-DOMS-2026
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .