Using Virtual Reality Applications for Younger Patients With Chronic Pain

NCT07630350 | Not Yet Recruiting FDA Device

• 1 other identifier: STUDY25080026
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Pain Management

Keywords

pediatric; virtual reality

Outcome Measures

Primary Outcomes (2)

• Pain Intensity Based on Numeric Rating Scale

  Ranges from 0 (no pain) to 10 (worst pain imaginable)

  Weekly assessment from enrollment to the end of treatment at 6 weeks

• Disability Classification based on the Upper Extremity Functional Scale

  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).

  Weekly assessment from enrollment to the end of treatment at 6 weeks

Secondary Outcomes (6)

• Patient-Reported Outcomes Measurement Information System (PROMIS) Self-Efficacy

  Weekly assessment from enrollment to the end of treatment at 6 weeks

• Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Catastrophizing

  Weekly assessment from enrollment to the end of treatment at 6 weeks

• Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Interference

  Weekly assessment from enrollment until the end of treatment at 6 weeks

• Patient-Reported Outcomes Measurement Information System (PROMIS) Psychological Stress Experience

  Weekly assessment from enrollment to the end of treatment at 6 weeks

• Patient-Reported Outcomes Measurement Information System (PROMIS) Depressive Symptoms

  Weekly assessment from enrollment to the end of treatment at 6 weeks

Study Arms (1)

Physical Therapy and VR

EXPERIMENTAL

Device: Virtual reality gaming; Other: Physical therapy exercises

Interventions

Virtual reality gaming DEVICE

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 and VR

Physical therapy exercises OTHER

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

Physical Therapy and VR

Eligibility Criteria

• Age: 7 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Elizabeth Pickle: lead

Study Sites (1)

Children's Hospital of Pittsburgh

Allison Park, Pennsylvania, 15101-4146, United States

Location

Related Publications (13)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Stratford PW, Binkley JM, Stratford DM. Development and initial validation of the upper extremity functional index. Physiotherapy Can. 2001;53:259-67

  BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 40167860 BACKGROUND

• 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.

  PMID: 32482376 BACKGROUND

• 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.

  PMID: 35536641 BACKGROUND

• 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.

  PMID: 38743558 BACKGROUND

• 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.

  PMID: 37745669 BACKGROUND

MeSH Terms

Interventions

Exercise Therapy

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Elizabeth A Pickle, MD

  University of Pittsburgh Medical Center Children's Hospital of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elizabeth A Pickle, MD

CONTACT

(412) 692-8700; pickleea@upmc.edu

Natalie Sorek

CONTACT

DPT; pickleea@upmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: June 1, 2026
• First Posted: June 5, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: June 5, 2026

Record last verified: 2026-06

Locations

US (1)