Chronic Pain ManagementNCT07630350
Using Virtual Reality Applications for Younger Patients With Chronic Pain
A study testing Virtual reality gaming and Physical therapy exercises in people with Chronic Pain Management, run by Elizabeth Pickle at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 7 to 21 years
- Conditions the study is for
- Chronic Pain Management
- What is being tested?
- Virtual reality gaming and Physical therapy exercises
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jul 2026to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Children's Hospital of Pittsburgh
Allison Park, Pennsylvania, 15101-4146
About this study
Official title: 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.
- Conditions
- Chronic Pain Management
- Being tested
- Virtual reality gaming, Physical therapy exercises
- Keywords
- pediatric, virtual reality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality gamingDevice
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 exercisesOther
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
| Study group | Role | What they receive |
|---|---|---|
| Physical Therapy and VR | Experimental | Not described Receives: Device: Virtual reality gaming; Other: Physical therapy exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity Based on Numeric Rating Scale
Ranges from 0 (no pain) to 10 (worst pain imaginable)
Measured: 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).
Measured: Weekly assessment from enrollment to the end of treatment at 6 weeks
Secondary outcomes (6)
Patient-Reported Outcomes Measurement Information System (PROMIS) Self-Efficacy
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
Measured: Weekly assessment from enrollment to the end of treatment at 6 weeks
Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Catastrophizing
13-item questionnaire on thoughts and feelings during pain answered with not at all, mildly, moderately, severely, extremely.
Measured: Weekly assessment from enrollment to the end of treatment at 6 weeks
Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Interference
15-item questionnaire about sleep interference with each question answered never, almost never, sometimes, almost always, always
Measured: Weekly assessment from enrollment until the end of treatment at 6 weeks
Patient-Reported Outcomes Measurement Information System (PROMIS) Psychological Stress Experience
19-item questionnaire about psychological stress experience which can be answered never, rarely, sometimes, often, always
Measured: Weekly assessment from enrollment to the end of treatment at 6 weeks
Patient-Reported Outcomes Measurement Information System (PROMIS) Depressive Symptoms
14-item questionnaire about depressive symptoms that can be answered never, almost never, sometimes, often, almost always
Measured: Weekly assessment from enrollment to the end of treatment at 6 weeks
Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety
15-item questionnaire that can be answered never, almost never, sometimes, often, almost always
Measured: Weekly assessment from enrollment to the end of treatment at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study start24 Jul 2026
- Primary completionDec 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Chronic Pain ManagementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Elizabeth Pickle
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Elizabeth Pickle, University of Pittsburgh
- Investigators
- Elizabeth A Pickle, MD, Principal investigator, University of Pittsburgh Medical Center Children's Hospital of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07630350
- Sponsor's protocol ID
- STUDY25080026
- Status last verified
- Jun 2026
- First submitted
- 1 Jun 2026
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No current plans exist to share this data.
Publications
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.
PubMed 27553129Estevez-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.
PubMed 32721388Kim 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.
PubMed 35450664Lo 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.
PubMed 39159449Plavoukou 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.
PubMed 40722437Stratford 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.
PubMed 37247829Lundin 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.
PubMed 37145841Lo 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.
PubMed 40167860Hoffman 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.
PubMed 32482376Goudman 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.
PubMed 35536641Chambers 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.
PubMed 38743558Arcos-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.
PubMed 37745669
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Virtual Reality in Outpatient Management of Pediatric Chronic Pain of Head, Neck and Upper Extremity
- ClinicalTrials.gov ID
- NCT07630350
- Acronym / sponsor ID
- STUDY25080026
- Conditions
- Chronic Pain Management
- Keywords
- pediatric, virtual reality
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Elizabeth PickleUniversity, hospital or other
- Study start
- 24 Jul 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 5 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Physical Therapy and VR | Experimental | Device: Virtual reality gaming, Other: Physical therapy exercises |
Who may qualify
- Ages
- 7 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual reality gamingParticipants will wear a VR headset and play games of their choosing developed by Invincikids to target mobility in the head, neck and upper extremity | Device | Physical Therapy and VR |
| Physical therapy exercisesPhysical 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 | Other | Physical Therapy and VR |
Primary outcome
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)
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).
6 secondary outcomes
Patient-Reported Outcomes Measurement Information System (PROMIS) Self-Efficacy
Time frame: 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
Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Interference
Time frame: 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
Patient-Reported Outcomes Measurement Information System (PROMIS) Depressive Symptoms
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Background: PubMed 27553129Bettini 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.
- Background: PubMed 32721388Estevez-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.
- Background: PubMed 35450664Kim 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.
- Background: PubMed 39159449Lo 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.
- Background: PubMed 40722437Plavoukou 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.
- BackgroundStratford PW, Binkley JM, Stratford DM. Development and initial validation of the upper extremity functional index. Physiotherapy Can. 2001;53:259-67
- Background: PubMed 37247829Salatino 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.
- Background: PubMed 37145841Lundin 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.
- Background: PubMed 40167860Lo 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.
- Background: PubMed 32482376Hoffman 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.
- Background: PubMed 35536641Goudman 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.
- Background: PubMed 38743558Chambers 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.
- Individual participant dataSharing planned: No. No current plans exist to share this data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elizabeth A Pickle, MD principal investigator
University of Pittsburgh Medical Center Children's Hospital of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality gaming and Physical therapy exercises in people with Chronic Pain Management, run by Elizabeth Pickle at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity Based on Numeric Rating Scale (time frame: Weekly assessment from enrollment to the end of treatment at 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07630350, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.