Health TrialsbyHealthPanel

Using Virtual Reality Applications for Younger Patients With Chronic Pain

ConditionChronic Pain Management
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age7-21
SponsorElizabeth Pickle

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 design

Design model

Single group

Treatments tested in this trial

  • 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 intervention

    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

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Physical Therapy and VRExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Pain Intensity Based on Numeric Rating Scale

Ranges from 0 (no pain) to 10 (worst pain imaginable)

Time frame
Weekly assessment from enrollment to the end of treatment at 6 weeks
2

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).

Time frame
Weekly assessment from enrollment to the end of treatment at 6 weeks

Secondary outcomes

1

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

Time frame
Weekly assessment from enrollment to the end of treatment at 6 weeks
2

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.

Time frame
Weekly assessment from enrollment to the end of treatment at 6 weeks
3

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

Time frame
Weekly assessment from enrollment until the end of treatment at 6 weeks
4

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

Time frame
Weekly assessment from enrollment to the end of treatment at 6 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Elizabeth Pickle

Lead sponsor

University of Pittsburgh

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: