- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05552430
Virtual Reality for Pain in Acute Orthopedic Injuries
October 17, 2023 updated by: Ryan A., Mace, PHD, Massachusetts General Hospital
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
Intervention / Treatment
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ryan A Mace, PhD
- Phone Number: 617-643-7641
- Email: rmace@mgh.harvard.edu
Study Contact Backup
- Name: Julie Brewer
- Phone Number: 617-643-4129
- Email: jrbrewer@mgh.harvard.edu
Study Locations
-
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
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.
|
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 |
---|---|---|
Credibility and Expectancy Questionnaire
Time Frame: 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).
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Pre-intervention (week 0) only
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Client Satisfaction Questionnaire
Time Frame: 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).
|
Post-intervention (week 8) only
|
System Usability Scale
Time Frame: Post-intervention (week 8) only
|
Assess global user experience of the VR device, with higher percentile rankings (range = 0-100) indicating greater usability.
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Post-intervention (week 8) only
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient's Global Impression of Change
Time Frame: Post-intervention (week 8) only
|
Assess perceptions of overall improvement in pain and physical function during the program.
|
Post-intervention (week 8) only
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Motion Sickness and Nausea
Time Frame: Post-intervention (week 8) only
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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).
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Post-intervention (week 8) only
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Feasibility of Recruitment
Time Frame: Throughout the study completion, approximately 1 year
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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).
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Throughout the study completion, approximately 1 year
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Acceptability of Treatment
Time Frame: Pre-intervention (week 0), Post-intervention (week 8)
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Acceptability of virtual reality based on module completion (≥70% complete 6 out of 8 weeks, good; ≥ 80% complete 6 out of 8 weeks, excellent).
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Pre-intervention (week 0), Post-intervention (week 8)
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Adherence to Pain Surveys
Time Frame: Pre-intervention (week 0), Post-intervention (week 8)
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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).
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Pre-intervention (week 0), Post-intervention (week 8)
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Feasibility of Outcome Assessments
Time Frame: Pre-intervention (week 0), Post-intervention (week 8)
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Feasibility of collecting complete outcome assessments (≥70% have no missing data, good; ≥80% have no missing data, excellent).
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Pre-intervention (week 0), Post-intervention (week 8)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain medications
Time Frame: Pre-intervention (week 0), Post-intervention (week 8)
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Number of days that narcotic and non-narcotic pain medications were taken in the last week.
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Pre-intervention (week 0), Post-intervention (week 8)
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Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function
Time Frame: Pre-intervention (week 0), Post-intervention (week 8)
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Assess one's ability to carry out activities that require physical actions, ranging from self-care to social and work.
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Pre-intervention (week 0), Post-intervention (week 8)
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Short Musculoskeletal Functional Assessment (SMFA) Questionnaire
Time Frame: Pre-intervention (week 0), Post-intervention (week 8)
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Assess disability specific to musculoskeletal injury and pain.
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Pre-intervention (week 0), Post-intervention (week 8)
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Numerical Rating Scale (NRS)
Time Frame: Pre-intervention (week 0), Bi-weekly, Post-intervention (week 8)
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Assess pain intensity at rest and with activity.
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Pre-intervention (week 0), Bi-weekly, Post-intervention (week 8)
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Pain Catastrophizing Scale (PCS)
Time Frame: Pre-intervention (week 0), Post-intervention (week 8)
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Assess catastrophic thinking about pain.
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Pre-intervention (week 0), Post-intervention (week 8)
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Pain Anxiety Scale (PASS)
Time Frame: Pre-intervention (week 0), Post-intervention (week 8)
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Assess pain-specific anxiety.
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Pre-intervention (week 0), Post-intervention (week 8)
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Pain Self-Efficacy Questionnaire (PSEQ)
Time Frame: Pre-intervention (week 0), Post-intervention (week 8)
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Assess confidence to engage in physical activity despite pain.
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Pre-intervention (week 0), Post-intervention (week 8)
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Chronic Pain Acceptance Questionnaire (CPAQ)
Time Frame: Pre-intervention (week 0), Post-intervention (week 8)
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Assess ability to engage in meaningful activities despite pain.
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Pre-intervention (week 0), Post-intervention (week 8)
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Center for Epidemiologic Study of Depression (CESD) Scale
Time Frame: Pre-intervention (week 0), Post-intervention (week 8)
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Assess depression.
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Pre-intervention (week 0), Post-intervention (week 8)
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Cognitive and Affective Mindfulness Scale (CAMS)
Time Frame: Pre-intervention (week 0), Post-intervention (week 8)
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Assess state of mindfulness taught during the program.
|
Pre-intervention (week 0), Post-intervention (week 8)
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Defense and Veterans Pain Rating Scale (DVPRS)
Time Frame: Pre-intervention (week 0), Bi-weekly, Post-intervention (week 8)
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Assess pain interference and pain intensity
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Pre-intervention (week 0), Bi-weekly, Post-intervention (week 8)
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Measure of Current Status (MOCS)
Time Frame: Pre-intervention (week 0), Post-intervention (week 8)
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Assess general coping ability taught during the program.
|
Pre-intervention (week 0), Post-intervention (week 8)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ryan A Mace, PhD, Massachusetts General Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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)
October 19, 2023
Last Update Submitted That Met QC Criteria
October 17, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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