Virtual Reality for Pain in Acute Orthopedic Injuries

Not Applicable

Completed

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

Interventions: Device: RelieveVRx

Registration Number: NCT05552430

Lead Sponsor: Massachusetts General Hospital

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 10

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Skills-Based VR	RelieveVRx	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.

Primary Outcome Measures

Name	Time	Method
Client Satisfaction Questionnaire	Post-intervention (week 8) only	Participants' treatment satisfaction, determined by the percentage of participants with scores (range = 3-12) over the scale's midpoint (≥70% good, ≥ 80% excellent).
System Usability Scale	Post-intervention (week 8) only	Assess global user experience of the VR device, with higher percentile rankings (range = 0-100) indicating greater usability. Usability was determined by the number of participants with System Usability Scale scores 68 and above (≥70% good, ≥ 80% excellent).
Credibility and Expectancy Questionnaire (CEQ)- Credibility Subscale	Pre-intervention (week 0) only	Participants' perceived credibility, determined by the percentage of participants with scores (range = 3-27, higher scores mean better outcomes) over the scale's midpoint (≥70% good, ≥ 80% excellent).
Credibility and Expectancy Questionnaire (CEQ)- Expectancy Subscale	Pre-intervention (week 0) only	Participants' treatment expectancy, determined by the percentage of participants with scores (range = 3-27, higher scores mean better outcomes) over the scale's midpoint (≥70% good, ≥ 80% excellent).

Secondary Outcome Measures

Name	Time	Method
Patient's Global Impression of Change	Post-intervention (week 8) only	The number of participants that improved "much or very much" or "minimally" on the Patient's Global Impression of Change Scores for pain, emotional, and physical function during the VR program.
Feasibility of Enrollment	Throughout the study completion, approximately 1 year	We will report the number of participants who agree to participate out of those eligible, evaluated at the end of study for all participants (≥70% good, ≥ 80% excellent).
Motion Sickness and Nausea	Post-intervention (week 8) only	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).
Adherence to Pain Surveys	Pre-intervention (week 0), Post-intervention (week 8)	Adherence to Pain Surveys was determined by the percentage of participants who responded to at least 5/7 days for at least 6/8 weeks during the intervention period (≥70% good, ≥80% excellent).
Acceptability of Treatment	Pre-intervention (week 0), Post-intervention (week 8)	Acceptability of treatment was determined by the percentage of participants who completed at least 6 of 8 weeks of VR modules (≥70%, good; ≥ 80% excellent).
Feasibility of Outcome Assessments	Pre-intervention (week 0), Post-intervention (week 8)	The feasibility of data collection was determined by the percentage of participants with no missing outcomes data (≥70% good, ≥80% excellent).