Using Virtual Reality Applications for Younger Patients With Chronic Pain

July 29, 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

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Elizabeth A Pickle, MD
  • Phone Number: 2 (412) 692-8700
  • Email: pickleea@upmc.edu

Study Contact Backup

Study Locations

  • United States
    • Pennsylvania
      • Allison Park, Pennsylvania, United States, 15101-4146
        • Children's Hospital of Pittsburgh

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Physical Therapy and VR
Device: Virtual reality gaming
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
Other: Physical therapy exercises
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Elizabeth Pickle

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 24, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 1, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 1, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 5, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 31, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY25080026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No current plans exist to share this data.

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.

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