The Effect of Different rTMS Interventions on Acute Experimental Muscular Pain in Individuals Comorbid With Insomnia
2026년 9월 14일 업데이트: 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.
연구 개요
상태
모병
연구 유형
중재적
등록 (추정된)
30
단계
- 해당 없음
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연구 연락처
- 이름: Leo Guohui Lin
- 전화번호: +852 94267004
- 이메일: guohui-leo.lin@connect.polyu.hk
연구 장소
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Hong Kong, 홍콩
- 모병
- The Hong Kong Polytechnic University
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연락하다:
- Leo Guohui Lin
- 전화번호: +852 94267004
- 이메일: guohui-leo.lin@connect.polyu.hk
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
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예
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
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디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: R DLPFC
rTMS interventions targeting the right dorsolateral prefrontal cortex (R DLPFC)
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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.
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활성 비교기: L M1
rTMS interventions targeting the left primary motor cortex (L M1)
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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.
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가짜 비교기: Sham
sham rTMS stimulation
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Muscle damage severity: Muscle soreness
기간: 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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Muscle damage severity: Muscle pain
기간: Day 0 to Day 14
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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.
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Day 0 to Day 14
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Pain sensitivity: Thermal pain threshold
기간: 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
기간: 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 (PPT)
기간: Day 7 and Day 9
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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.
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Day 7 and Day 9
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Pain sensitivity: Temporal summation of mechanical pain (TSP-M)
기간: 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)
기간: 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)
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Sleep diary: Sleep Onset Latency (SOL)
기간: 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)
기간: 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)
기간: 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: Wake After Sleep Onset (WASO)
기간: 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)
기간: 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 Pittsburgh Sleep Quality Index (PSQI)
기간: 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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Sleep Questionnaires: the Insomnia Severity Index (ISI)
기간: 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 diary: Total Sleep Time
기간: 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: Total Sleep Time (TST)
기간: 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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Actigraphy: Sleep Onset Latency (SOL)
기간: 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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Psychological measurement: Depression, Anxiety, and Stress Scale (DASS-21)
기간: Day 0 to Day 14
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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 to Day 14
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Psychological measurement: Pain Catastrophizing Scale (PCS)
기간: Day 0 to Day 14
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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 to Day 14
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Psychological measurement: Fear of Pain Questionnaire (FPQ-9)
기간: Day 0 to Day 14
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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 to Day 14
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Psychological measurement: Tampa Scale for Kinesiophobia (TSK-11)
기간: Day 0 to Day 14
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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 to Day 14
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Physical Activity Level: International Physical Activity Questionnaire - Short Form (IPAQ-SF)
기간: Day 0 to Day 14
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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.
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.
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Day 0 to Day 14
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 8월 31일
기본 완료 (추정된)
2027년 8월 31일
연구 완료 (추정된)
2027년 8월 31일
연구 등록 날짜
최초 제출
2026년 9월 2일
QC 기준을 충족하는 최초 제출
2026년 9월 14일
처음 게시됨 (실제)
2026년 9월 18일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 9월 18일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 9월 14일
마지막으로 확인됨
2026년 8월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- Insomnia-DOMS-rTMS-2026
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
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