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Virtual Reality for Pain in Acute Orthopedic Injuries

Primary Purpose

Injuries, Injury Arm, Injury;Sports

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

RelieveVRx

About this trial

This is an interventional treatment trial for Injuries focused on measuring pain, disability, injury, orthopedics, rehabilitation, mind-body

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Massachusetts General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Skills-Based VR

Arm Description

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.

Outcomes

Primary Outcome Measures

Credibility and Expectancy Questionnaire

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

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

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

Assess perceptions of overall improvement in pain and physical function during the program.

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).

Feasibility of Recruitment

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

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

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

Feasibility of collecting complete outcome assessments (≥70% have no missing data, good; ≥80% have no missing data, excellent).

Full Information

NCT ID

NCT05552430

First Posted

September 20, 2022

Last Updated

October 17, 2023

Sponsor

Massachusetts General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05552430

Brief Title

Virtual Reality for Pain in Acute Orthopedic Injuries

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Completed

Study Start Date

October 17, 2022 (Actual)

Primary Completion Date

October 12, 2023 (Actual)

Study Completion Date

October 12, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Massachusetts General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Skills-Based VR

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

RelieveVRx

Intervention Description

Primary Outcome Measure Information:

Title

Credibility and Expectancy Questionnaire

Description

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).

Time Frame

Pre-intervention (week 0) only

Title

Client Satisfaction Questionnaire

Description

Participants' treatment satisfaction, determined by the percentage of participants with scores (range = 3-12) over the scale's midpoint (≥70% good, ≥ 80% excellent).

Time Frame

Post-intervention (week 8) only

Title

System Usability Scale

Description

Assess global user experience of the VR device, with higher percentile rankings (range = 0-100) indicating greater usability.

Time Frame

Post-intervention (week 8) only

Secondary Outcome Measure Information:

Title

Patient's Global Impression of Change

Description

Assess perceptions of overall improvement in pain and physical function during the program.

Time Frame

Post-intervention (week 8) only

Title

Motion Sickness and Nausea

Description

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).

Time Frame

Post-intervention (week 8) only

Title

Feasibility of Recruitment

Description

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).

Time Frame

Throughout the study completion, approximately 1 year

Title

Acceptability of Treatment

Description

Acceptability of virtual reality based on module completion (≥70% complete 6 out of 8 weeks, good; ≥ 80% complete 6 out of 8 weeks, excellent).

Time Frame

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

Title

Adherence to Pain Surveys

Description

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).

Time Frame

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

Title

Feasibility of Outcome Assessments

Description

Feasibility of collecting complete outcome assessments (≥70% have no missing data, good; ≥80% have no missing data, excellent).

Time Frame

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

Other Pre-specified Outcome Measures:

Title

Pain medications

Description

Number of days that narcotic and non-narcotic pain medications were taken in the last week.

Time Frame

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

Title

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

Description

Assess one's ability to carry out activities that require physical actions, ranging from self-care to social and work.

Time Frame

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

Title

Short Musculoskeletal Functional Assessment (SMFA) Questionnaire

Description

Assess disability specific to musculoskeletal injury and pain.

Time Frame

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

Title

Numerical Rating Scale (NRS)

Description

Assess pain intensity at rest and with activity.

Time Frame

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

Title

Pain Catastrophizing Scale (PCS)

Description

Assess catastrophic thinking about pain.

Time Frame

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

Title

Pain Anxiety Scale (PASS)

Description

Assess pain-specific anxiety.

Time Frame

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

Title

Pain Self-Efficacy Questionnaire (PSEQ)

Description

Assess confidence to engage in physical activity despite pain.

Time Frame

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

Title

Chronic Pain Acceptance Questionnaire (CPAQ)

Description

Assess ability to engage in meaningful activities despite pain.

Time Frame

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

Title

Center for Epidemiologic Study of Depression (CESD) Scale

Description

Assess depression.

Time Frame

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

Title

Cognitive and Affective Mindfulness Scale (CAMS)

Description

Assess state of mindfulness taught during the program.

Time Frame

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

Title

Defense and Veterans Pain Rating Scale (DVPRS)

Description

Assess pain interference and pain intensity

Time Frame

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

Title

Measure of Current Status (MOCS)

Description

Assess general coping ability taught during the program.

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ryan A Mace, PhD

Organizational Affiliation

Massachusetts General Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Massachusetts General Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

12. IPD Sharing Statement

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Virtual Reality for Pain in Acute Orthopedic Injuries

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