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Набор по приглашению NCT07630350

Using Virtual Reality Applications for Younger Patients With Chronic Pain

Без фазы С лечением Chronic Pain Management

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Virtual reality gaming, Physical therapy exercises.
Кому может быть актуально
Состояния в реестре: Chronic Pain Management. Базовые параметры: 7 лет — 21 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Use of Virtual Reality in Outpatient Management of Pediatric Chronic Pain of Head, Neck and Upper Extremity

Обзор

In this study, patients who are 7-21 years of age and have chronic pain affecting their head, neck, and/or upper limb will participate in 6 once-weekly sessions. During each of these hour-long sessions, participants will engage in physical therapy exercises, use virtual reality games focused on moving the head, neck and arm, and complete questionnaires about their pain.

Вмешательства

  • Устройство Virtual reality gaming
    Participants will wear a VR headset and play games of their choosing developed by Invincikids to target mobility in the head, neck and upper extremity
  • Другое Physical therapy exercises
    Physical therapy exercises directed by a licensed physical therapist to improve painful area mobility and function. Participants will be classified into high, moderate, and low pain irritability groups, which will determine their exercises

Первичные конечные точки

  • Pain Intensity Based on Numeric Rating Scale [Срок оценки: Weekly assessment from enrollment to the end of treatment at 6 weeks]
  • Disability Classification based on the Upper Extremity Functional Scale [Срок оценки: Weekly assessment from enrollment to the end of treatment at 6 weeks]
Вторичные конечные точки (6)
  • Patient-Reported Outcomes Measurement Information System (PROMIS) Self-Efficacy [Срок оценки: Weekly assessment from enrollment to the end of treatment at 6 weeks]
  • Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Catastrophizing [Срок оценки: Weekly assessment from enrollment to the end of treatment at 6 weeks]
  • Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Interference [Срок оценки: Weekly assessment from enrollment until the end of treatment at 6 weeks]
  • Patient-Reported Outcomes Measurement Information System (PROMIS) Psychological Stress Experience [Срок оценки: Weekly assessment from enrollment to the end of treatment at 6 weeks]
  • Patient-Reported Outcomes Measurement Information System (PROMIS) Depressive Symptoms [Срок оценки: Weekly assessment from enrollment to the end of treatment at 6 weeks]
  • Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety [Срок оценки: Weekly assessment from enrollment to the end of treatment at 6 weeks]

Критерии участия

Критерии включения

  • Patients 7-21 years of age
  • Patients who have been evaluated in the pediatric chronic pain clinic during the enrollment period or last 12 months
  • Patients who have a diagnosis of migraine, chronic neck pain, chronic shoulder or scapular pain, chronic pain of the upper limb, complex regional pain syndrome of the upper limb, amplified musculoskeletal pain syndrome affecting the upper limb, chronic joint pain affecting the upper limb

Критерии исключения

  • Patients less than 7 years or greater than 21 years of age
  • Patients who have not been evaluated in the pediatric chronic pain clinic during the enrollment period or last 12 months.
  • Patients with primary complaints of lower back pain, hip pain, knee pain, ankle pain, or abdominal pain.
  • Patients with factors limit their ability to safely tolerate wearing and operating the Meta Oculus 2 virtual reality goggles, including but not limited to claustrophobia, anxiety, vestibulo-ocular dysfunction, visual impairments, significant sitting balance impairments.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Children's Hospital of Pittsburgh — Allison Park

Публикации

  • Bettini L, Moore K. Central Sensitization in Functional Chronic Pain Syndromes: Overview and Clinical Application. Pain Manag Nurs. 2016 Oct;17(5):333-8. doi: 10.1016/j.pmn.2016.05.008. Epub 2016 Aug 21. PMID 27553129
  • Estevez-Lopez F, Maestre-Cascales C, Russell D, Alvarez-Gallardo IC, Rodriguez-Ayllon M, Hughes CM, Davison GW, Sanudo B, McVeigh JG. Effectiveness of Exercise on Fatigue and Sleep Quality in Fibromyalgia: A Systematic Review and Meta-analysis of Randomized Trials. Arch Phys Med Rehabil. 2021 Apr;102(4):752-761. doi: 10.1016/j.apmr.2020.06.019. Epub 2020 Jul 25. PMID 32721388
  • Kim YN, Gray N, Jones A, Scher S, Kozlowska K. The Role of Physiotherapy in the Management of Functional Neurological Disorder in Children and Adolescents. Semin Pediatr Neurol. 2022 Apr;41:100947. doi: 10.1016/j.spen.2021.100947. Epub 2021 Nov 19. PMID 35450664
  • Lo HHM, Zhu M, Zou Z, Wong CL, Lo SHS, Chung VC, Wong SY, Sit RWS. Immersive and Nonimmersive Virtual Reality-Assisted Active Training in Chronic Musculoskeletal Pain: Systematic Review and Meta-Analysis. J Med Internet Res. 2024 Aug 19;26:e48787. doi: 10.2196/48787. PMID 39159449
  • Plavoukou T, Staktopoulos P, Papagiannis G, Stasinopoulos D, Georgoudis G. Virtual and Augmented Reality for Chronic Musculoskeletal Rehabilitation: A Systematic Review and Exploratory Meta-Analysis. Bioengineering (Basel). 2025 Jul 8;12(7):745. doi: 10.3390/bioengineering12070745. PMID 40722437
  • Stratford PW, Binkley JM, Stratford DM. Development and initial validation of the upper extremity functional index. Physiotherapy Can. 2001;53:259-67
  • Salatino A, Zavattaro C, Gammeri R, Cirillo E, Piatti ML, Pyasik M, Serra H, Pia L, Geminiani G, Ricci R. Virtual reality rehabilitation for unilateral spatial neglect: A systematic review of immersive, semi-immersive and non-immersive techniques. Neurosci Biobehav Rev. 2023 Sep;152:105248. doi: 10.1016/j.neubiorev.2023.105248. Epub 2023 May 27. PMID 37247829
  • Lundin RM, Yeap Y, Menkes DB. Adverse Effects of Virtual and Augmented Reality Interventions in Psychiatry: Systematic Review. JMIR Ment Health. 2023 May 5;10:e43240. doi: 10.2196/43240. PMID 37145841

Идентификаторы

NCT: NCT07630350 · STUDY25080026

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗