Virtual Reality for Pain in Acute Orthopedic Injuries

Study Overview
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Brief Summary
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The goal of this study is to pilot test a skills-based virtual reality (VR) for acute orthopedic injury. It will measure the feasibility, signals of improvement, exploratory pain mechanisms, and user experience of an established skills-based program (RelieveVRx) for acute orthopedic injury.

Detailed Description
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This study will use mixed-methods to investigate the feasibility of skills-based virtual reality (VR) for acute orthopedic injury in an open pilot with individual exit interviews (target N=10). Participants will be patients with acute orthopedic musculoskeletal injuries who are at risk for chronic pain and disability (PCS ≥ 20 and PASS-20 ≥ 40) and meet inclusionary/exclusionary criteria. Participants will be recruited through the MGH Orthopedics Department, flyers, and the Rally research platform. Participants will self-administer a skills-based virtual reality (VR) program at home over an 8-week period. Participants will attend two in-person study assessments to complete study assessments (surveys and an fNIRS imaging session). The primary outcome for the pilot will be a-priori Go/No-Go feasibility markers (feasibility, acceptability, fidelity, credibility, expectancy, satisfaction) of the VR program and data collection procedures to increase the success of subsequent trials. Exploratory measures include: multi-modal assessment of pain intensity, pain-specific coping (catastrophizing, self-efficacy, acceptance), disability, physical function, and emotional function (depression, anxiety, stress). The VR headset will collect usage data and daily smartphone surveys will track changes in pain during the 8-week intervention. Completers will have the opportunity to attend 30 min individual exit interviews to understand patients' perception of the VR and their experience with the study procedures to increase the success of larger trials.

Official Title
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Physical and Psychological Measures of Pain in Acute Orthopedic Injuries: Use of At-home Virtual Reality

Conditions
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Injury, Hand, Injury Foot, Injury Finger, Injury Leg, Injuries, Injury Arm, Injury;Sports, Injury, Knee, Injury Wrist, Injury, Ankle

Intervention / Treatment
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* Device: RelieveVRx


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Outpatient adults in the Level 1 Trauma Center Age 18 or older Able to meaningfully participate meaningfully (English fluency and literacy) and stable living situation Acute musculoskeletal injury (e.g., fracture, dislocation, rupture) 1-2 months earlier (acute phase). Pain Catastrophizing Scale ≥20 or Pain Anxiety Symptom Scale-20 ≥40 Has access to internet (Wi-Fi or wireless) Willing to participate and comply with the requirements of the study protocol, including virtual reality program and questionnaire completion No psychotropics or stable for >6 weeks Free of concurrent psychotropic medication for at least 2 weeks prior to initiation of treatment, OR stable on current psychotropic medication for a minimum of 6 weeks and willing to maintain a stable dose (i.e., no psychotropics or stable for >6 weeks) Cleared by orthopedic surgeon for study participation Exclusion Criteria: Current or prior diagnosis of epilepsy, seizure disorder, dementia, migraines, or other neurological diseases that are contraindicated for VR Medical condition predisposing to nausea or dizziness. Hypersensitivity to flashing light or motion. Vision or severe hearing impairment. Injury to eyes, face, or neck that impedes comfortable use of virtual reality Diagnosed with a medical illness expected to worsen in the next 3 months (e.g., malignancy) Other serious injuries that occurred with the orthopedic injury or surgical complications (e.g., infection, need for repeat surgery) Current or prior untreated mental illness, substance use disorder, or suicidal ideation Self-reported pregnancy Currently in litigation or under Workman's Comp Practice of cognitive-behavioral therapy, yoga/meditation, or other mind body techniques once per week for 45 minutes or more within the last 3 months

Ages Eligible for Study
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Minimum Age: 18 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: Skills-Based VR<br>Participants will complete daily skills-based Virtual Reality (VR) sessions for 8 weeks (an average of 6 minutes per day) to determine the feasibility of at-home VR technology to aid the recovery of acute orthopedic musculoskeletal injuries. The VR device software is equipped with pain-specific treatment modules (e.g., Pain Education, Relaxation/Interoception, Mindful Escapes, and Pain Distraction Games) derived from evidence-based principles of cognitive behavioral therapy (CBT), mindfulness, and pain neuroscience education. | Device: RelieveVRx<br>* Participants will complete daily skills-based Virtual Reality (VR) sessions for 8 weeks (an average of 6 minutes per day) to determine the feasibility of at-home VR technology to aid the recovery of acute orthopedic musculoskeletal injuries. The VR device software is equipped with pain-specific treatment modules (e.g., Pain Education, Relaxation/Interoception, Mindful Escapes, and Pain Distraction Games) derived from evidence-based principles of cognitive behavioral therapy (CBT), mindfulness, and pain neuroscience education.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Credibility and Expectancy Questionnaire | Participants' treatment expectancy and perceived credibility, determined by the percentage of participants with scores (range = 3-27) over the scale's midpoint (≥70% good, ≥ 80% excellent). | Pre-intervention (week 0) only | 
| Client Satisfaction Questionnaire | Participants' treatment satisfaction, determined by the percentage of participants with scores (range = 3-12) over the scale's midpoint (≥70% good, ≥ 80% excellent). | Post-intervention (week 8) only | 
| System Usability Scale | Assess global user experience of the VR device, with higher percentile rankings (range = 0-100) indicating greater usability. | Post-intervention (week 8) only | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient's Global Impression of Change | Assess perceptions of overall improvement in pain and physical function during the program. | Post-intervention (week 8) only | 
| Motion Sickness and Nausea | Assess adverse experiences with VR, determined by the percentage of participants with responses (range = 0 never to 3 always) below the scale's midpoint (≥70% good, ≥ 80% excellent). | Post-intervention (week 8) only | 
| Feasibility of Recruitment | We will report number of participants who agree to participate out of those approached, evaluated at the end of study for all participants (≥70% good, ≥ 80% excellent). | Throughout the study completion, approximately 1 year | 
| Acceptability of Treatment | Acceptability of virtual reality based on module completion (≥70% complete 6 out of 8 weeks, good; ≥ 80% complete 6 out of 8 weeks, excellent). | Pre-intervention (week 0), Post-intervention (week 8) | 
| Adherence to Pain Surveys | Adherence to smartphone-based surveys of pain intensity (at rest, with activity) and pain interference with daily activities in the last 24 hours (≥70% good, ≥80% excellent). | Pre-intervention (week 0), Post-intervention (week 8) | 
| Feasibility of Outcome Assessments | Feasibility of collecting complete outcome assessments (≥70% have no missing data, good; ≥80% have no missing data, excellent). | Pre-intervention (week 0), Post-intervention (week 8) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain, disability, injury, orthopedics, rehabilitation, mind-body