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治験 NCT07182006(対象:慢性疼痛、子供、思春期の)は募集未定です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
フィルター基準に一致する試験が1件見つかりました
タイル表示
Exercise as Medicine for Pediatric Chronic Pain
治験(臨床試験)の詳細は主に英語で提供されています。しかし、治験レーダーAIが支援できます!「治験を説明」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT07182006 は 介入研究 臨床試験 で、慢性疼痛、子供、思春期の に関するものです。現在は 募集未定 で、2026年4月1日 に開始予定です。66 名の参加者 の募集が計画されています。この治験は Boston Children's Hospital によって主催され、2027年3月30日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2025年9月19日 です。
概要
Youth with chronic pain struggle to go to school, play sports, or spend time with friends and family due to pain. Medications are often ineffective, and aerobic exercise may improve both pain sensitivity and participation in valued life activities. This study will be the first to examine the impact of a single session of intense aerobic exercise on pain sensitivity measures in youth with and without chronic pain syndromes to help determine if aerobic exercise can improve pain and functioning.
詳細説明
Pediatric chronic pain syndromes that occur in 11-38% of youth commonly impact participation in school, family, and recreational activities. Pediatric chronic pain and disability can persist into adulthood if left untreated. Central sensitization is an overarching mechanism of pediatric and adult chronic pain syndromes and is conceptualized as an imbalance in the facilitatory and inhibitory pathways that control pain signal traffic in the central nervous system. Aerobic exercise commonly recommended to improve pain and disability, but empirical evidence is lacking. Exercise-induced hypoalgesia (EIH) is a proposed mechanism by which aerobic exercise improves pain sensitivity and is characterized by improved pain sensitivity immediately following exercise. To date, EIH has not been studied in youth with chronic pain syndromes. Insights may reveal potential treatment targets and mechanisms by which aerobic exercise can improve pain and quality of life among youth suffering from chronic pain. This study aims to 1) evaluate and compare EIH responses in youth with and without chronic pain and 2) identify potential biopsychosocial contributors to EIH. The investigators hypothesize that EIH is robust in pain-free youth, and present but attenuated in youth with chronic pain (Aim 1) and that unhelpful beliefs about pain will attenuate the effects of exercise on pain sensitivity (Aim 2). Results from this study will provide highly relevant data to design a clinical trial studying the effects of chronic aerobic exercise on pain and disability in these youth. Identification of effective nonpharmacologic treatments for chronic pain, such as exercise, may also reduce dependence on prescription medications and improve child health.
公式タイトル
Movement as Medicine: Can a Single Bout of Aerobic Exercise Elicit Exercise-induced Hypoalgesia in Youth With and Without Chronic Pain Syndromes?
疾患/病気
慢性疼痛子供思春期の刊行物
この臨床試験について発表された科学記事と研究論文:- Chambers CT, Dol J, Tutelman PR, Langley CL, Parker JA, Cormier BT, Macfarlane GJ, Jones GT, Chapman D, Proudfoot N, Grant A, Marianayagam J. The prevalence of chronic pain in children and adolescents: a systematic review update and meta-analysis. Pain. 2024 Oct 1;165(10):2215-2234. doi: 10.1097/j.pain.0000000000003267. Epub 2024 May 15.
- Shulman J, Zurakowski D, Keysor J, Jervis K, Sethna NF. Offset analgesia identifies impaired endogenous pain modulation in pediatric chronic pain disorders. Pain. 2020 Dec;161(12):2852-2859. doi: 10.1097/j.pain.0000000000001984.
- Rice D, Nijs J, Kosek E, Wideman T, Hasenbring MI, Koltyn K, Graven-Nielsen T, Polli A. Exercise-Induced Hypoalgesia in Pain-Free and Chronic Pain Populations: State of the Art and Future Directions. J Pain. 2019 Nov;20(11):1249-1266. doi: 10.1016/j.jpain.2019.03.005. Epub 2019 Mar 21.
- Grill JD, Coghill RC. Transient analgesia evoked by noxious stimulus offset. J Neurophysiol. 2002 Apr;87(4):2205-8. doi: 10.1152/jn.00730.2001.
- Stolzman S, Danduran M, Hunter SK, Bement MH. Pain Response after Maximal Aerobic Exercise in Adolescents across Weight Status. Med Sci Sports Exerc. 2015 Nov;47(11):2431-40. doi: 10.1249/MSS.0000000000000678.
- Stolzman S, Bement MH. Does Exercise Decrease Pain via Conditioned Pain Modulation in Adolescents? Pediatr Phys Ther. 2016 winter;28(4):470-3. doi: 10.1097/PEP.0000000000000312.
その他の研究識別子
- P00049713
NCT番号
開始日
2026-04-01
最終更新日
2025-09-19
終了予定日
2027-03-30
目標参加者数
66
試験の種類
介入研究
治験の相・段階
該当なし
状況
募集未定
キーワード
aerobic exercise
chronic pain
pediatric
quantitative sensory testing
endogenous pain modulation
chronic pain
pediatric
quantitative sensory testing
endogenous pain modulation
主目的
基礎研究
割付方法
非無作為化
介入モデル
並行割当
盲検化
なし(非盲検)
群(アーム)/介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
実験的Youth with Chronic Pain Syndromes Youth with chronic pain will undergo quantitative sensory testing before and immediately after a single bout of intense aerobic exercise. | 有酸素運動 Submaximal cardiovascular endurance testing on a treadmill |
実薬対照薬Youth without Chronic Pain Syndromes Youth without chronic pain will undergo quantitative sensory testing before and immediately after a single bout of intense aerobic exercise. They will serve as a control group to determine if the intervention has different effects between groups. | 有酸素運動 Submaximal cardiovascular endurance testing on a treadmill |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Pressure Pain Thresholds (PPT) | A pressure algometer is applied 3 times to 2 sites: the dominant quadriceps and deltoid using the Force Ten FDX pressure gauge (Wagner Instruments, Greenwich, CT). The pressure at which the participant reports pain is recorded and averaged over the three trials. Higher PPTs represent less pain sensitivity. | Before and after the intervention at baseline |
Offset Analgesia Response | Percent decrease in pain reported between T2 and T3 interval of the offset analgesia test. Higher values represent greater pain inhibition. | Before and after the intervention at baseline |
Temporal Summation of Heat Pain | To evaluate constant noxious heat pain summation, a noxious heat stimulus (60/100 on a visual analogue scale) is held for 60 seconds. Temporal summation is defined by an exponential increase in pain at the test end relative to the start; greater values represent greater pain facilitation. | Before and after the intervention at baseline |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Fitkids Treadmill Test | Time to exhaustion (TTE) on the FTT provides an objective, norm-referenced marker of aerobic capacity in youth and is defined as the total time completed on the test, excluding the warm-up and cool-down phases. Data recorded includes TTE, rate of perceived exertion (Borg Scale), and maximum heart rate. Successful completion of the exercise session will be defined as achievement of \> 85% age-predicted maximum heart rate. Greater TTE represents greater aerobic fitness. | Single measurement at baseline |
Functional Disability Inventory | 15-item Likert scale of pain related disability. Higher scores represent greater disability. | Single measurement at baseline |
Tampa Kinesiophobia Scale | Likert type scale of movement related fear. Higher scores indicate greater fear. | Single measurement at baseline |
Pain Catastrophizing Scale | Likert type patient reported outcome of worry related to pain. HIgher score represent greater worries related to pain. | Single assessment at baseline |
Fear of Pain Questionnaire Child | Patient reported outcome of pain related fear. Higher scores reflect greater fear. | Single assessment at baseline. |
PROMIS Pediatric Pain Interference - Short Form 8a | Patient reported outcome of pain impact on life. Higher score reflect greater pain interference. | Single assessment at baseline |
Central Sensitization Inventory | Patient reported outcome of the frequency of symptoms commonly experienced by persons with chronic pain. Higher score represent greater central sensitization. | Single assessment at baseline. |
Numeric Pain Rating Scale | Self-reported pain intensity on an 11-point likert scale. Higher scores represent greater pain intensity. | Baseline - before and after intervention |
Highly Sensitive Child Scale | Patient reported outcome of sensitivity to common daily sensory stimuli. Higher scores represent greater sensitivity. | Single measurement at baseline |
適格基準
対象年齢
小児
試験の最低年齢
10 Years
対象性別
全て
健康なボランティアを受け入れる
はい
- Primary or secondary chronic pain syndrome
- Allodynia (pain with light touch) at testing sites (non-dominant forearm)
- Self-reported use of opioids in last week
- Comorbid condition for which exercise is deemed unsafe by a physician or the (Physical Activity Readiness Questionnaire+) PARQ+
- unable to safely ambulate on a treadmill
責任者
Julie Shulman, 研究責任者, Physical Therapy Scientist, Boston Children's Hospital
試験中央連絡先
連絡先: Julie Shulman, PhD, DPT, 781-216-1650, [email protected]
1 1カ国の場所
Massachusetts
Boston Children's Hospital at 2 Brookline Place, Brookline, Massachusetts, 02445, United States
Julie Shulman, PT, DPT, PhD, PCS, 連絡先, 781-216-1650, [email protected]
Avery Savage, BS, 連絡先, 781-216-1650, [email protected]