Virtual Reality for Pain in Acute Orthopedic Injuries

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

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.

Study Overview

• Status: Completed
• Conditions: Injuries; Injury;Sports; Injury, Knee; Injury Arm; Injury Wrist; Injury, Ankle; Injury Foot; Injury, Hand; Injury Finger; Injury Leg
• Intervention / Treatment: Device: RelieveVRx

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Outpatient adults in the Level 1 Trauma Center
2. Age 18 or older
3. Able to meaningfully participate meaningfully (English fluency and literacy) and stable living situation
4. Acute musculoskeletal injury (e.g., fracture, dislocation, rupture) 1-2 months earlier (acute phase).
5. Pain Catastrophizing Scale ≥20 or Pain Anxiety Symptom Scale-20 ≥40
6. Has access to internet (Wi-Fi or wireless)
7. 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
8. 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)
9. Cleared by orthopedic surgeon for study participation

Exclusion Criteria:

1. Current or prior diagnosis of epilepsy, seizure disorder, dementia, migraines, or other neurological diseases that are contraindicated for VR
2. Medical condition predisposing to nausea or dizziness.
3. Hypersensitivity to flashing light or motion.
4. Vision or severe hearing impairment.
5. Injury to eyes, face, or neck that impedes comfortable use of virtual reality
6. Diagnosed with a medical illness expected to worsen in the next 3 months (e.g., malignancy)
7. Other serious injuries that occurred with the orthopedic injury or surgical complications (e.g., infection, need for repeat surgery)
8. Current or prior untreated mental illness, substance use disorder, or suicidal ideation
9. Self-reported pregnancy
10. Currently in litigation or under Workman's Comp
11. 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Patient's Global Impression of Change	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.	Post-intervention (week 8) only
Feasibility of Enrollment	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).	Throughout the study completion, approximately 1 year
Acceptability of Treatment	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).	Pre-intervention (week 0), Post-intervention (week 8)
Adherence to Pain Surveys	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).	Pre-intervention (week 0), Post-intervention (week 8)
Feasibility of Outcome Assessments	The feasibility of data collection was determined by the percentage of participants with no missing outcomes data (≥70% good, ≥80% excellent).	Pre-intervention (week 0), Post-intervention (week 8)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Non-narcotic Pain Medications	Number of days that non-narcotic pain medications were taken in the last week.	Pre-intervention (week 0), Post-intervention (week 8)
Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance	The PROMIS Sleep Disturbance is an 8-item self-report of challenges affecting sleep and overall sleep quality and satisfaction over the past seven days. PROMIS Sleep Disturbance items are scored between 1 and 5: not at all (1) to very much (5), never (1) to always (5), and very poor (1) to very good (5). Total raw scores are converted to T-scores, with higher T-score values (e.g., 50 indicates the population mean with a standard deviation of 10) indicating worse outcome (greater sleep disturbance or worse sleep quality).	Pre-intervention (week 0), Post-intervention (week 8)
Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function	The PROMIS Physical Function is an 8-item self-report to assess participants' general ability to complete daily living activities. PROMIS Physical Function items are scored on a 1 (unable to do) to 5 (without any difficulty) or 1 (cannot do) to 5 (not at all) point scale. Total scores are converted to T-scores, with higher T-score values (e.g., 50 indicates the population mean with a standard deviation of 10) indicating greater better outcome (higher physical function).	Pre-intervention (week 0), Post-intervention (week 8)
Short Musculoskeletal Functional Assessment (SMFA) Questionnaire- Dysfunction Index	The Short Musculoskeletal Function Assessment (SMFA) is a 46-item self-report to assess the extent to which one's injury interferes with their ability to complete daily living activities. The SMFA Dysfunction Intex contains 34 items that assess musculoskeletal function. SMFA items are scored on a 1 (no problems/difficulty) to 5 (unable to do) scale. Total scores are calcuted by summing items 1-34 for the Dysfunction Index. Total scores are standardized [(Actual raw score - lowest possible raw score/possible raw score range) *100], with high scores indicating poor function (standardized subscale range, min = 0, max = 100).	Pre-intervention (week 0), Post-intervention (week 8)
Short Musculoskeletal Functional Assessment (SMFA) Questionnaire - Bother Index	The Short Musculoskeletal Function Assessment (SMFA) is a 46-item self-report to assess the extent to which one's injury interferes with their ability to complete daily living activities. The SMFA Bother Index has 12 items that assess symptom burden. SMFA items are scored on a 1 (no problems/difficulty) to 5 (unable to do) scale. Total scores are calculated by summing items 35-46 for the Bothersome Index. Total scores are standardized [(Actual raw score - lowest possible raw score/possible raw score range) *100], with high scores indicating poor function (standardized subscale range, min = 0, max = 100).	Pre-intervention (week 0), Post-intervention (week 8)
Numerical Rating Scale (NRS) - Pain at Rest	The Numerical Rating Scale (NRS) is a 2-item self-report that assesses participants' pain intensity at rest during the past week. One of two NRS items (pain at rest) is reported and scored on a 0 (no pain) to 10 (worst ever) scale.	Assessed Pre-intervention (week 0), Bi-weekly, Post-intervention (week 8). Pre-intervention (week 0) and Post-intervention (week 8) reported.
Numerical Rating Scale (NRS) - Pain With Activity	The Numerical Rating Scale (NRS) is a 2-item self-report that assesses participants' pain intensity with activity during the past week. One of two NRS items (pain with activity) reported and scored on a 0 (no pain) to 10 (worst ever) scale.	Assessed Pre-intervention (week 0), Bi-weekly, Post-intervention (week 8). Pre-intervention (week 0) and Post-intervention (week 8) reported.
Pain Catastrophizing Scale (PCS)	The Pain Catastrophizing Scale (PCS) is a 13-item self-report of catastrophic thoughts and emotions related to pain. The PCS-13 is scored on 0 (not at all) to 4 (all the time) scale. Higher scores (range = 0-52) indicate greater pain catastrophizing.	Pre-intervention (week 0), Post-intervention (week 8)
Pain Anxiety Scale (PASS)	The Pain Anxiety Symptoms Scale (PASS) is a 20-item self-report of fear and anxiety related to pain. The PASS-20 is scored on 0 (never) to 5 (always) scale. Higher scores (range= 0-100) indicate greater pain anxiety.	Pre-intervention (week 0), Post-intervention (week 8)
Pain Self-Efficacy Questionnaire (PSEQ)	The Pain Self-Efficacy Questionnaire is a 10-item self-report that measures participants' confidence in completing daily tasks and leisure activities despite experiencing pain. PSEQ items are scored on a 0 (not at all confident) to 6 (completely confident) scale. Higher total sum scores (total range = 0-60) indicate greater better outcome (pain self-efficacy).	Pre-intervention (week 0), Post-intervention (week 8)
Center for Epidemiologic Study of Depression (CESD) Scale	The Center for Epidemiological Studies Depression Scale (CES-D) is a 20-item self-report that assesses how often participants' experience symptoms of depression in the last week. CES-D items are scored on a 0 (rarely or none of the time, less than 1 day) to 3 (most or all of the time, 5-7 days) scale. Higher scores (range = 0-60) indicate greater depressive symptoms.	Pre-intervention (week 0), Post-intervention (week 8)
Cognitive and Affective Mindfulness Scale (CAMS)	The Cognitive and Affective Mindfulness Scale - Revised (CAMS-R) is a 12-item self-report that measures mindfulness principles: attention regulation, present focus, awareness, and non-judgmental awareness. CAMS-R items are scored on a 1 (rarely/not at all) to 4 (almost always) scale. Higher total scores (range = 12-48) indicate greater use of mindfulness.	Pre-intervention (week 0), Post-intervention (week 8)
Defense and Veterans Pain Rating Scale (DVPRS) - Activity Subscale	The Defense and Veterans Pain Rating Scale (DVPRS) is a 4-item self-report that measures the extent to which pain interferes with usual activity, sleep, mood, and stress. One of four DVPRS (Activity Subscale) reported and scored on 0 (does not interfere) to 10 (completely interferes) scale.	Assessed Pre-intervention (week 0), Bi-weekly, Post-intervention (week 8). Pre-intervention (week 0) and Post-intervention (week 8) reported.
Defense and Veterans Pain Rating Scale (DVPRS) - Sleep Subscale	The Defense and Veterans Pain Rating Scale (DVPRS) is a 4-item self-report that measures the extent to which pain interferes with usual activity, sleep, mood, and stress. One of four DVPRS (Sleep Subscale) reported and scored on 0 (does not interfere) to 10 (completely interferes) scale.	Assessed Pre-intervention (week 0), Bi-weekly, Post-intervention (week 8). Pre-intervention (week 0) and Post-intervention (week 8) reported.
Defense and Veterans Pain Rating Scale (DVPRS) - Mood Subscale	The Defense and Veterans Pain Rating Scale (DVPRS) is a 4-item self-report that measures the extent to which pain interferes with usual activity, sleep, mood, and stress. One of four DVPRS (Mood Subscale) reported and scored on 0 (does not interfere) to 10 (completely interferes) scale.	Assessed Pre-intervention (week 0), Bi-weekly, Post-intervention (week 8). Pre-intervention (week 0) and Post-intervention (week 8) reported.
Defense and Veterans Pain Rating Scale (DVPRS) - Stress Subscale	The Defense and Veterans Pain Rating Scale (DVPRS) is a 4-item self-report that measures the extent to which pain interferes with usual activity, sleep, mood, and stress. One of four DVPRS (Stress Subscale) reported and scored is scored on 0 (does not interfere) to 10 (completely interferes) scale.	Assessed Pre-intervention (week 0), Bi-weekly, Post-intervention (week 8). Pre-intervention (week 0) and Post-intervention (week 8) reported.
Measure of Current Status (MOCS)	The Measure of Current Status (MOCS) is a 13-item self-report of the ability to use various skills to cope with daily stressors. MOCS items are scored on a 0 (I cannot do this at all) to 4 (I can do this extremely well) scale. Higher total scores (range = 0-52) indicate greater ability and confidence to utilize coping skills.	Pre-intervention (week 0), Post-intervention (week 8)

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Ryan A Mace, PhD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2022
• Primary Completion (Actual): October 12, 2023
• Study Completion (Actual): October 12, 2023

Study Registration Dates

• First Submitted: September 20, 2022
• First Submitted That Met QC Criteria: September 20, 2022
• First Posted (Actual): September 23, 2022

Study Record Updates

• Last Update Posted (Actual): August 22, 2024
• Last Update Submitted That Met QC Criteria: August 20, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: pain; rehabilitation; injury; disability; mind-body; orthopedics
• Additional Relevant MeSH Terms: Leg Injuries; Wounds and Injuries; Ankle Injuries; Athletic Injuries; Knee Injuries; Hand Injuries
• Other Study ID Numbers: 2022P001500

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes