Pain Rehabilitation Virtual Reality (PRVR): Innovations to Enhance Mobility in the Presence of Pain

Study Overview
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Brief Summary
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The proposed research is a single arm feasibility trial of pain rehabilitation virtual reality (PRVR) aimed at measuring feasibility, acceptability and utility of VR as well as changes in physical function and fear for adolescents with chronic musculoskeletal pain. The intervention includes standard physiotherapy treatment including functional goal setting and progressive exercise.

Official Title
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Pain Rehabilitation Virtual Reality (PRVR): Innovations to Enhance Mobility in the Presence of Pain

Conditions
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Chronic Pain, Musculoskeletal Pain, Fibromyalgia, Virtual Reality

Intervention / Treatment
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* Behavioral: Pain Rehabilitation Virtual Reality (PRVR)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 10 to 17 years old Musculoskeletal pain (e.g. localized [back, limb], diffuse) not due to acute trauma (e.g. active sprain or fracture) English Language Proficiency Exclusion Criteria: Significant cognitive impairment (e.g., brain injury) Significant medical or psychiatric problem that would interfere (e.g. psychosis, suicidality) Presents with a condition that interferes with virtual reality usage (e.g., history of seizure, facial injury precluding safe placement of headset, visual impairment, significant hearing impairment impact ability to follow audio instructions).

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pain Rehabilitation Virtual Reality (PRVR)<br>Participants will complete VR in PT to engage participants in a series of immersive games customized to align with individual PT needs delivered over  6-12 weeks or until clinician believes the patient is done with treatment. Patients in the PRVR arm will be given a structured HEP to practice prescribed exercises at home with integrated VR activities. PRVR participants will be allocated a VR headset for use in PT sessions and with HEP. VR will supplement treatment and be used in session (either in-person or telehealth) and at home as part of their prescribed treatment homework. | Behavioral: Pain Rehabilitation Virtual Reality (PRVR)<br>* Participants will receive approximately 8, 1-hour physiotherapy sessions delivered over the course of 6-12 weeks. Adequate dose: 75% (6 of 8 sessions).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility, Acceptability, and Utility of VR | Acceptability will be assessed via collected use metrics (e.g. how long the app was played each day) and will also qualitatively at the end of treatment through interview questions related to acceptability, ease of use, comprehensibility, and suggestions for improvement. Qualitative responses will be described and summarized. | Baseline to end of treatment at 6-8 weeks, on average | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain-related Fear and Avoidance | Fear of Pain Questionnaire Short Form (FOPQ- SF): a 10-item validated patient-reported measure of pain-related fear and avoidance. (score Min=0, Max=40; lower score indicates less fear and avoidance/better outcomes). | Baseline to end of treatment at 6-8 weeks, on average | 
| Physical Function: Lower Extremity | Lower Extremity Functional Scale (LEFS): a 20-item validated patient-reported measure of lower extremity function. (score Min=0, Max=80; lower score indicates greater disability/worse outcomes). | Baseline to end of treatment at 6-8 weeks, on average | 
| Physical Function: Upper Extremity | Upper Extremity Functional Index (UEFI): a 20- item validated patient-reported measures of | Baseline to end of treatment at 6-8 weeks, on average |