Virtual Reality for Pain in Acute Orthopedic Injuries

Sponsor

Massachusetts General Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05552430

Collaborator

(none)

Enrollment

Arm

9.5

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Injuries Injury Arm Injury;Sports Injury, Knee Injury Wrist Injury, Ankle Injury Foot Injury, Hand Injury Finger Injury Leg	Device: RelieveVRx	N/A

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. 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Oct 17, 2022

Anticipated Primary Completion Date :

May 1, 2023

Anticipated Study Completion Date :

Aug 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Skills-Based VR 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 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.

Arm

Intervention/Treatment

Experimental: Skills-Based VR

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

Outcome Measures

Primary Outcome Measures

Credibility and Expectancy Questionnaire [Pre-intervention (week 0) only]
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).
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.

Secondary Outcome Measures

Patient's Global Impression of Change [Post-intervention (week 8) only]
Assess perceptions of overall improvement in pain and physical function during the program.
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).
Feasibility of Recruitment [Throughout the study completion, approximately 1 year]
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).
Acceptability of Treatment [Pre-intervention (week 0), Post-intervention (week 8)]
Acceptability of virtual reality based on module completion (≥70% complete 6 out of 8 weeks, good; ≥ 80% complete 6 out of 8 weeks, excellent).
Adherence to Pain Surveys [Pre-intervention (week 0), Post-intervention (week 8)]
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).
Feasibility of Outcome Assessments [Pre-intervention (week 0), Post-intervention (week 8)]
Feasibility of collecting complete outcome assessments (≥70% have no missing data, good; ≥80% have no missing data, excellent).

Other Outcome Measures

Pain medications [Pre-intervention (week 0), Post-intervention (week 8)]
Number of days that narcotic and non-narcotic pain medications were taken in the last week.
Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function [Pre-intervention (week 0), Post-intervention (week 8)]
Assess one's ability to carry out activities that require physical actions, ranging from self-care to social and work.
Short Musculoskeletal Functional Assessment (SMFA) Questionnaire [Pre-intervention (week 0), Post-intervention (week 8)]
Assess disability specific to musculoskeletal injury and pain.
Numerical Rating Scale (NRS) [Pre-intervention (week 0), Bi-weekly, Post-intervention (week 8)]
Assess pain intensity at rest and with activity.
Pain Catastrophizing Scale (PCS) [Pre-intervention (week 0), Post-intervention (week 8)]
Assess catastrophic thinking about pain.
Pain Anxiety Scale (PASS) [Pre-intervention (week 0), Post-intervention (week 8)]
Assess pain-specific anxiety.
Pain Self-Efficacy Questionnaire (PSEQ) [Pre-intervention (week 0), Post-intervention (week 8)]
Assess confidence to engage in physical activity despite pain.
Chronic Pain Acceptance Questionnaire (CPAQ) [Pre-intervention (week 0), Post-intervention (week 8)]
Assess ability to engage in meaningful activities despite pain.
Center for Epidemiologic Study of Depression (CESD) Scale [Pre-intervention (week 0), Post-intervention (week 8)]
Assess depression.
Cognitive and Affective Mindfulness Scale (CAMS) [Pre-intervention (week 0), Post-intervention (week 8)]
Assess state of mindfulness taught during the program.
Defense and Veterans Pain Rating Scale (DVPRS) [Pre-intervention (week 0), Bi-weekly, Post-intervention (week 8)]
Assess pain interference and pain intensity
Measure of Current Status (MOCS) [Pre-intervention (week 0), Post-intervention (week 8)]
Assess general coping ability taught during the program.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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