Chronic Pain Management
Conditions
Keywords
pediatric, virtual reality
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.
Interventions
DEVICEVirtual 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
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
Sponsors
Elizabeth Pickle
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
7 Years to 21 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity Based on Numeric Rating Scale | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Patient-Reported Outcomes Measurement Information System (PROMIS) Self-Efficacy | 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 |
| Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Catastrophizing | 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. |
| Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Interference | 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 |
| Patient-Reported Outcomes Measurement Information System (PROMIS) Psychological Stress Experience | 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 |
| Patient-Reported Outcomes Measurement Information System (PROMIS) Depressive Symptoms | 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 |
| Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety | 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 |
Countries
United States
Contacts
CONTACTElizabeth A Pickle, MD
CONTACTNatalie Sorek
PRINCIPAL_INVESTIGATORElizabeth A Pickle, MD
University of Pittsburgh Medical Center Children's Hospital of Pittsburgh
Outcome results
None listed