Using Virtual Reality Applications for Younger Patients With Chronic Pain
29 de julho de 2026 atualizado por: Elizabeth Pickle
Use of Virtual Reality in Outpatient Management of Pediatric Chronic Pain of Head, Neck and Upper Extremity
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.
Visão geral do estudo
Status
Inscrevendo-se por convite
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Estimado)
20
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.
Locais de estudo
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Pennsylvania
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Allison Park, Pennsylvania, Estados Unidos, 15101-4146
- Children's Hospital of Pittsburgh
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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
- Filho
- Adulto
Aceita Voluntários Saudáveis
Não
Descrição
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
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: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Physical Therapy and VR
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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
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
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Pain Intensity Based on Numeric Rating Scale
Prazo: Weekly assessment from enrollment to the end of treatment at 6 weeks
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Ranges from 0 (no pain) to 10 (worst pain imaginable)
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Weekly assessment from enrollment to the end of treatment at 6 weeks
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Disability Classification based on the Upper Extremity Functional Scale
Prazo: Weekly assessment from enrollment to the end of treatment at 6 weeks
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20-item questionnaire asking participant to rate difficulty of specified activities using the upper extremity with possible answers ranging from 1 (extreme difficulty or unable to perform activity) to 4 (no difficulty).
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Weekly assessment from enrollment to the end of treatment at 6 weeks
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Patient-Reported Outcomes Measurement Information System (PROMIS) Self-Efficacy
Prazo: Weekly assessment from enrollment to the end of treatment at 6 weeks
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7-item questionnaire of "How sure are you that you are able to do each of the following things when you have pain?" which can be answered very sure, pretty sure, in the middle, pretty unsure, very unsure
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Weekly assessment from enrollment to the end of treatment at 6 weeks
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Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Catastrophizing
Prazo: Weekly assessment from enrollment to the end of treatment at 6 weeks
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13-item questionnaire on thoughts and feelings during pain answered with not at all, mildly, moderately, severely, extremely.
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Weekly assessment from enrollment to the end of treatment at 6 weeks
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Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Interference
Prazo: Weekly assessment from enrollment until the end of treatment at 6 weeks
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15-item questionnaire about sleep interference with each question answered never, almost never, sometimes, almost always, always
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Weekly assessment from enrollment until the end of treatment at 6 weeks
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Patient-Reported Outcomes Measurement Information System (PROMIS) Psychological Stress Experience
Prazo: Weekly assessment from enrollment to the end of treatment at 6 weeks
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19-item questionnaire about psychological stress experience which can be answered never, rarely, sometimes, often, always
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Weekly assessment from enrollment to the end of treatment at 6 weeks
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Patient-Reported Outcomes Measurement Information System (PROMIS) Depressive Symptoms
Prazo: Weekly assessment from enrollment to the end of treatment at 6 weeks
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14-item questionnaire about depressive symptoms that can be answered never, almost never, sometimes, often, almost always
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Weekly assessment from enrollment to the end of treatment at 6 weeks
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Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety
Prazo: Weekly assessment from enrollment to the end of treatment at 6 weeks
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15-item questionnaire that can be answered never, almost never, sometimes, often, almost always
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Weekly assessment from enrollment to the end of treatment at 6 weeks
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Elizabeth A Pickle, MD, University of Pittsburgh Medical Center Children's Hospital of Pittsburgh
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- Hoffman HG, Boe DA, Rombokas E, Khadra C, LeMay S, Meyer WJ, Patterson S, Ballesteros A, Pitt SW. Virtual reality hand therapy: A new tool for nonopioid analgesia for acute procedural pain, hand rehabilitation, and VR embodiment therapy for phantom limb pain. J Hand Ther. 2020 Apr-Jun;33(2):254-262. doi: 10.1016/j.jht.2020.04.001. Epub 2020 May 30.
- Goudman L, Jansen J, Billot M, Vets N, De Smedt A, Roulaud M, Rigoard P, Moens M. Virtual Reality Applications in Chronic Pain Management: Systematic Review and Meta-analysis. JMIR Serious Games. 2022 May 10;10(2):e34402. doi: 10.2196/34402.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Lo Cascio A, Cascino M, Dabbene M, Paladini A, Viswanath O, Varrassi G, Latina R. Epidemiology of Pediatric Chronic Pain: An Overview of Systematic Reviews. Curr Pain Headache Rep. 2025 Apr 1;29(1):71. doi: 10.1007/s11916-025-01380-5.
- Arcos-Holzinger M, Biebl JT, Storz C, Gutmann M, Azad SC, Holzapfel BM, Kraft E. Virtual reality in managing Complex Regional Pain Syndrome (CRPS): a scoping review. Front Neurol. 2023 Sep 7;14:1069381. doi: 10.3389/fneur.2023.1069381. eCollection 2023.
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 (Real)
24 de julho de 2026
Conclusão Primária (Estimado)
1 de dezembro de 2026
Conclusão do estudo (Estimado)
1 de março de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
1 de junho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
1 de junho de 2026
Primeira postagem (Real)
5 de junho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
31 de julho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
29 de julho de 2026
Última verificação
1 de junho de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- STUDY25080026
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Descrição do plano IPD
No current plans exist to share this data.
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
Sim
produto fabricado e exportado 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 .