- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07630350
Using Virtual Reality Applications for Younger Patients With Chronic Pain
June 1, 2026 updated by: 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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Elizabeth A Pickle, MD
- Phone Number: 2 (412) 692-8700
- Email: pickleea@upmc.edu
Study Contact Backup
- Name: Natalie Sorek
- Phone Number: 412-692-5480 DPT
- Email: pickleea@upmc.edu
Study Locations
-
-
Pennsylvania
-
Allison Park, Pennsylvania, United States, 15101-4146
- Children's Hospital of Pittsburgh
-
Contact:
- Elizabeth Pickle, MD
- Phone Number: 2 412) 692-8700
- Email: pickleea@upmc.edu
-
Contact:
- Natalie Sorek, DPT
- Phone Number: 412-692-5480
- Email: sorekn3@upmc.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Physical Therapy and VR
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Intensity Based on Numeric Rating Scale
Time Frame: Weekly assessment from enrollment to the end of treatment at 6 weeks
|
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
Time Frame: Weekly assessment from enrollment to the end of treatment at 6 weeks
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient-Reported Outcomes Measurement Information System (PROMIS) Self-Efficacy
Time Frame: Weekly assessment from enrollment to the end of treatment at 6 weeks
|
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
|
Weekly assessment from enrollment to the end of treatment at 6 weeks
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Catastrophizing
Time Frame: Weekly assessment from enrollment to the end of treatment at 6 weeks
|
13-item questionnaire on thoughts and feelings during pain answered with not at all, mildly, moderately, severely, extremely.
|
Weekly assessment from enrollment to the end of treatment at 6 weeks
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Interference
Time Frame: Weekly assessment from enrollment until the end of treatment at 6 weeks
|
15-item questionnaire about sleep interference with each question answered never, almost never, sometimes, almost always, always
|
Weekly assessment from enrollment until the end of treatment at 6 weeks
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS) Psychological Stress Experience
Time Frame: Weekly assessment from enrollment to the end of treatment at 6 weeks
|
19-item questionnaire about psychological stress experience which can be answered never, rarely, sometimes, often, always
|
Weekly assessment from enrollment to the end of treatment at 6 weeks
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS) Depressive Symptoms
Time Frame: Weekly assessment from enrollment to the end of treatment at 6 weeks
|
14-item questionnaire about depressive symptoms that can be answered never, almost never, sometimes, often, almost always
|
Weekly assessment from enrollment to the end of treatment at 6 weeks
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety
Time Frame: Weekly assessment from enrollment to the end of treatment at 6 weeks
|
15-item questionnaire that can be answered never, almost never, sometimes, often, almost always
|
Weekly assessment from enrollment to the end of treatment at 6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Elizabeth A Pickle, MD, University of Pittsburgh Medical Center Children's Hospital of Pittsburgh
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
June 1, 2026
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
March 1, 2027
Study Registration Dates
First Submitted
June 1, 2026
First Submitted That Met QC Criteria
June 1, 2026
First Posted (Actual)
June 5, 2026
Study Record Updates
Last Update Posted (Actual)
June 5, 2026
Last Update Submitted That Met QC Criteria
June 1, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY25080026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
We do not currently have plans to share IPD; however, patients will be consented for the potential use of de-identified data by other researchers in the future.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chronic Pain Management
-
Bjorn AngKarolinska Institutet; The Swedish Research Council; Göteborg University; Forte; Dalarna...Not yet recruitingPain Management | Pain, Chronic | Chronic Pain, WidespreadSweden
-
Universidade Federal de PernambucoActive, not recruitingChronic Pain and Comorbid Emotional Problems | Chronic Pain ManagementBrazil
-
The University of Texas Health Science Center,...RecruitingJoint Pain | Chronic Knee Pain | Chronic Pain (Back / Neck) | Chronic Pain ManagementUnited States
-
Eisai LimitedCompleted
-
Ciusss de L'Est de l'Île de MontréalRecruiting
-
Piramal Critical Care, Ltd.CompletedManagement of Chronic PainUnited States
-
noiVita SrlsCompletedChronic Pain | Pain Management | Pain (Visceral, Somatic, or Neuropathic) | Chronic Pain (Back / Neck)Italy
-
Vanderbilt University Medical CenterUniversity of WashingtonCompletedNon-pharmacologic Management of Chronic PainUnited States
-
Vastra Gotaland RegionActive, not recruitingChronic Pain | Pain ManagementSweden
-
Ain Shams UniversityRecruiting
Clinical Trials on Virtual reality gaming
-
University of Alabama at BirminghamCompleted
-
University of Alabama at BirminghamWithdrawnSpinal Cord Injuries
-
University of British ColumbiaTerminatedStroke | Stroke, Ischemic | Stroke Hemorrhagic | Stroke, LacunarCanada
-
Georgetown UniversityInternational Rett Syndrome Foundation Rettsyndrome.orgRecruiting
-
Riphah International UniversityRecruitingFine Motor Skills | Down's SyndromePakistan
-
Virginia Commonwealth UniversityRecruitingBreast Cancer | Virtual Reality | Anthracycline Related Cardiotoxicity in Breast Cancer | TrastuzumabUnited States
-
Chalmers University of TechnologyGöteborg University; Sahlgrenska University Hospital, SwedenActive, not recruitingStroke | Upper Extremity DysfunctionSweden
-
Royal Cornwall Hospitals TrustRecruitingBariatric Surgery | PrehabilitationUnited Kingdom
-
Unity Health TorontoOntario Ministry of Health and Long Term Care; Heart and Stroke Foundation... and other collaboratorsCompletedIschemic StrokeThailand, Canada, Argentina, Brazil, Peru
-
Acibadem UniversityRecruitingArtificial Intelligence | Advanced Cardiac Life SupportTurkey