The Effect of Different rTMS Interventions on Acute Experimental Muscular Pain in Individuals Comorbid With Insomnia
2026年9月14日 更新者：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.
調査の概要
状態
募集
研究の種類
介入
入学 (推定)
30
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Leo Guohui Lin
- 電話番号：+852 94267004
- メール：guohui-leo.lin@connect.polyu.hk
研究場所
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-
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Hong Kong、香港
- 募集
- The Hong Kong Polytechnic University
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コンタクト：
- Leo Guohui Lin
- 電話番号：+852 94267004
- メール：guohui-leo.lin@connect.polyu.hk
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
はい
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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アクティブコンパレータ：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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偽コンパレータ：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Muscle damage severity: Muscle soreness
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Sleep diary: Sleep Onset Latency (SOL)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年8月31日
一次修了 (推定)
2027年8月31日
研究の完了 (推定)
2027年8月31日
試験登録日
最初に提出
2026年9月2日
QC基準を満たした最初の提出物
2026年9月14日
最初の投稿 (実際)
2026年9月18日
学習記録の更新
投稿された最後の更新 (実際)
2026年9月18日
QC基準を満たした最後の更新が送信されました
2026年9月14日
最終確認日
2026年8月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- Insomnia-DOMS-rTMS-2026
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個々の参加者データ (IPD) を共有する予定はありますか?
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