Virtual Reality for Pain in Acute Orthopedic Injuries

NCT05552430 | Completed Results FDA Device

• 1 other identifier: 2022P001500
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

pain; disability; injury; orthopedics; rehabilitation; mind-body

Outcome Measures

Primary Outcomes (4)

• Credibility and Expectancy Questionnaire (CEQ)- Credibility Subscale

  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).

  Pre-intervention (week 0) only

• Credibility and Expectancy Questionnaire (CEQ)- Expectancy Subscale

  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).

  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. Usability was determined by the number of participants with System Usability Scale scores 68 and above (≥70% good, ≥ 80% excellent).

  Post-intervention (week 8) only

Secondary Outcomes (6)

• Patient's Global Impression of Change

  Post-intervention (week 8) only

• Motion Sickness and Nausea

  Post-intervention (week 8) only

• Feasibility of Enrollment

  Throughout the study completion, approximately 1 year

• Acceptability of Treatment

  Pre-intervention (week 0), Post-intervention (week 8)

• Adherence to Pain Surveys

  Pre-intervention (week 0), Post-intervention (week 8)

Other Outcomes (17)

• Non-narcotic Pain Medications

  Pre-intervention (week 0), Post-intervention (week 8)

• Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance

  Pre-intervention (week 0), Post-intervention (week 8)

• Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function

  Pre-intervention (week 0), Post-intervention (week 8)

Study Arms (1)

Skills-Based VR

EXPERIMENTAL

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

Interventions

RelieveVRx DEVICE

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.

Skills-Based VR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Wounds and Injuries; Arm Injuries; Athletic Injuries; Knee Injuries; Wrist Injuries; Ankle Injuries; Foot Injuries; Hand Injuries; Finger Injuries; Leg Injuries; Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Ryan Mace
• Organization: Center for Health Outcomes and Interdisciplinary Research, Massachusetts General Hospital

rmace@mgh.harvard.edu

617-724-7030

Study Officials

• Ryan A Mace, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Psychologist

Study Record Dates

• First Submitted: September 20, 2022
• First Posted: September 23, 2022
• Study Start: October 17, 2022
• Primary Completion: October 12, 2023
• Study Completion: October 12, 2023
• Last Updated: August 22, 2024
• Results First Posted: August 22, 2024

Record last verified: 2024-08

Locations

US (1)