Esta página foi traduzida automaticamente e a precisão da tradução não é garantida. Por favor, consulte o versão em inglês para um texto fonte.

The Effect of Different rTMS Interventions on Acute Experimental Muscular Pain in Individuals Comorbid With Insomnia

14 de setembro de 2026 atualizado por: The Hong Kong Polytechnic University

The Effect of Different rTMS Intervention on Acute Experimental Muscular Pain in Individuals Comorbid With Insomnia: a Pilot RCT

Insomnia exacerbates pain sensitivity and impairs physiological recovery from acute musculoskeletal pain. Repetitive transcranial magnetic stimulation (rTMS) has emerged as a promising non-invasive neuromodulation intervention to alleviate pain and modulate central sensory processing. However, whether rTMS can effectively mitigate insomnia-induced pain hyperalgesia and accelerate the recovery trajectory of acute musculoskeletal pain remains unclear, as does the optimal neuroanatomical stimulation target.

Building upon an established experimental pain model, this randomized, sham-controlled study aims to evaluate the restorative effects of three distinct rTMS interventions - targeting the left primary motor cortex (L M1), the right dorsolateral prefrontal cortex (R DLPFC), and a sham condition - on individuals experiencing insomnia. Following a standardized eccentric exercise protocol to induce muscle soreness, participants will receive three sessions of the allocated rTMS intervention at 0, 24, and 48 hours post-exercise. Pain sensitivity, recovery dynamics, and quantitative sensory testing (QST) metrics will be continuously monitored across the recovery timeframe.

The findings from this trial will clarify the therapeutic efficacy of rTMS in modulating acute pain under insomnia states and identify the target-specific mechanisms of cortical stimulation, offering evidence-based non-invasive interventions for musculoskeletal pain management.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

30

Estágio

  • Não aplicável

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

Locais de estudo

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

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
  • Conditions that preclude safe rTMS or pain testing (e.g., severe head trauma, intracranial hypertension, implanted ferromagnetic devices, history of epilepsy, skin conditions at stimulation sites)
  • 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

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Quadruplicar

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: R DLPFC
rTMS interventions targeting the right dorsolateral prefrontal cortex (R DLPFC)
Dispositivo: Repetitive transcranial magnetic stimulation (rTMS) on R DLPFC
Low-frequency stimulation (1 Hz) will be applied over right DLPFC-rTMS at 90% RMT, with 150 trains of 10 pulses per session, a 2-second inter-train interval, and a total of 1500 pulses over 30 min.
Comparador Ativo: L M1
rTMS interventions targeting the left primary motor cortex (L M1)
Dispositivo: Repetitive transcranial magnetic stimulation (rTMS) on L M1
High-frequency stimulation (10 Hz) will be delivered over left M1 at 90% RMT, consisting of 50 pulses per train, a 25-second inter-train interval, and 30 trains per session, yielding a total of 1500 pulses over 15 minutes.
Comparador Falso: Sham
sham rTMS stimulation
Dispositivo: Sham repetitive transcranial magnetic stimulation (rTMS)
Sham stimulation will be administered using identical parameters but delivered via the sham coil, which reproduces the auditory and somatosensory sensations of active rTMS without inducing cortical stimulation.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Muscle damage severity: Muscle soreness
Prazo: 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."
Day 0 to Day 14
Muscle damage severity: Muscle pain
Prazo: Day 0 to Day 14
Muscle pain will be measured using an 11-point NRS, with 0 representing "no pain" and 10 indicating "worst imaginable pain". The Outcome will be recorded at rest, during a reach for the floor with knees straight, and during a validated hamstring provocative manoeuvre, the "taking-off shoe" test.
Day 0 to Day 14
Pain sensitivity: Thermal pain threshold
Prazo: 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.
Day 7 and Day 9
Pain sensitivity: Mechanical pain threshold
Prazo: 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.
Day 7 and Day 9
Pain sensitivity: Pressure pain threshold (PPT)
Prazo: Day 7 and Day 9
Pressure pain threshold (PPT) 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 pain. Three trials will be performed, and the mean scores will be calculated to determine the PPT.
Day 7 and Day 9
Pain sensitivity: Temporal summation of mechanical pain (TSP-M)
Prazo: 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.
Day 7 and Day 9
Pain sensitivity: Temporal summation of heat pain (TSP-H)
Prazo: 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.
Day 7 and Day 9
Pain sensitivity: Conditioned pain modulation (CPM)
Prazo: 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.
Day 7 and Day 9

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Sleep diary: Sleep Onset Latency (SOL)
Prazo: Day 0 to Day 14
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.
Day 0 to Day 14
Sleep diary: Wake After Sleep Onset (WASO)
Prazo: Day 0 to Day 14
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.
Day 0 to Day 14
Sleep diary: Sleep Efficiency (SE)
Prazo: Day 0 to Day 14
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.
Day 0 to Day 14
Actigraphy: Wake After Sleep Onset (WASO)
Prazo: Day 0 to Day 14
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.
Day 0 to Day 14
Actigraphy: Sleep Efficiency (SE)
Prazo: Day 0 to Day 14
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.
Day 0 to Day 14
Sleep Questionnaires: The Pittsburgh Sleep Quality Index (PSQI)
Prazo: Day 0 and Day 7
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.
Day 0 and Day 7
Sleep Questionnaires: the Insomnia Severity Index (ISI)
Prazo: Day 0 and Day 7
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.
Day 0 and Day 7
Sleep diary: Total Sleep Time
Prazo: Day 0 to Day 14
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.
Day 0 to Day 14
Actigraphy: Total Sleep Time (TST)
Prazo: Day 0 to Day 14
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.
Day 0 to Day 14
Actigraphy: Sleep Onset Latency (SOL)
Prazo: Day 0 to Day 14
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.
Day 0 to Day 14
Psychological measurement: Depression, Anxiety, and Stress Scale (DASS-21)
Prazo: Day 0 to Day 14
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.
Day 0 to Day 14
Psychological measurement: Pain Catastrophizing Scale (PCS)
Prazo: Day 0 to Day 14
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.
Day 0 to Day 14
Psychological measurement: Fear of Pain Questionnaire (FPQ-9)
Prazo: Day 0 to Day 14
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.
Day 0 to Day 14
Psychological measurement: Tampa Scale for Kinesiophobia (TSK-11)
Prazo: Day 0 to Day 14
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.
Day 0 to Day 14
Physical Activity Level: International Physical Activity Questionnaire - Short Form (IPAQ-SF)
Prazo: Day 0 to Day 14
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. The 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.
Day 0 to Day 14

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

The Hong Kong Polytechnic University

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 (Estimado)

31 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

Outros números de identificação do estudo

  • Insomnia-DOMS-rTMS-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 .

Se inscrever