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NCT Number: NCT07630350

Using Virtual Reality Applications for Younger Patients With Chronic Pain

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.

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Key information

Conditions

Chronic Pain Management

Age range

7 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 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

Primary outcomes

  1. 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)

  2. 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).

Secondary outcomes

  1. 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

  2. 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.

  3. 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

  4. 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

  5. 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

  6. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Elizabeth A Pickle, MD

CONTACT

[email protected]

(412) 692-8700 ext. 2

Natalie Sorek

CONTACT

[email protected]

DPT ext. 412-692-5480

Sponsors and collaborators

Lead sponsor

Elizabeth Pickle

Other

Registry information

Official study title

Use of Virtual Reality in Outpatient Management of Pediatric Chronic Pain of Head, Neck and Upper Extremity

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jun 5, 2026
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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