Using Virtual Reality Applications for Younger Patients With Chronic Pain
29 luglio 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Iscrizione su invito
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Stimato)
20
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Pennsylvania
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Allison Park, Pennsylvania, Stati Uniti, 15101-4146
- Children's Hospital of Pittsburgh
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
Accetta volontari sani
No
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Pain Intensity Based on Numeric Rating Scale
Lasso di tempo: 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
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Patient-Reported Outcomes Measurement Information System (PROMIS) Self-Efficacy
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Investigatore principale: Elizabeth A Pickle, MD, University of Pittsburgh Medical Center Children's Hospital of Pittsburgh
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- 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.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
24 luglio 2026
Completamento primario (Stimato)
1 dicembre 2026
Completamento dello studio (Stimato)
1 marzo 2027
Date di iscrizione allo studio
Primo inviato
1 giugno 2026
Primo inviato che soddisfa i criteri di controllo qualità
1 giugno 2026
Primo Inserito (Effettivo)
5 giugno 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
31 luglio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
29 luglio 2026
Ultimo verificato
1 giugno 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- STUDY25080026
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Descrizione del piano IPD
No current plans exist to share this data.
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Sì
prodotto fabbricato ed esportato dagli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .