Virtual Reality for Pain in Acute Orthopedic Injuries

Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05552430
• Other study ID #: 2022P001500
• Status: Completed
• Phase: N/A
• Start date: October 17, 2022
• Est. completion date: October 12, 2023

Study information

• Verified date: October 2023
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: October 12, 2023
• Est. primary completion date: October 12, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ankle Injuries
• Athletic Injuries
• Hand Injuries
• Injuries
• Injury Arm
• Injury Leg
• Injury, Ankle
• Injury, Knee
• Injury;Sports
• Knee Injuries
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pain medications	Number of days that narcotic and non-narcotic pain medications were taken in the last week.	Pre-intervention (week 0), Post-intervention (week 8)
Other	Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function	Assess one's ability to carry out activities that require physical actions, ranging from self-care to social and work.	Pre-intervention (week 0), Post-intervention (week 8)
Other	Short Musculoskeletal Functional Assessment (SMFA) Questionnaire	Assess disability specific to musculoskeletal injury and pain.	Pre-intervention (week 0), Post-intervention (week 8)
Other	Numerical Rating Scale (NRS)	Assess pain intensity at rest and with activity.	Pre-intervention (week 0), Bi-weekly, Post-intervention (week 8)
Other	Pain Catastrophizing Scale (PCS)	Assess catastrophic thinking about pain.	Pre-intervention (week 0), Post-intervention (week 8)
Other	Pain Anxiety Scale (PASS)	Assess pain-specific anxiety.	Pre-intervention (week 0), Post-intervention (week 8)
Other	Pain Self-Efficacy Questionnaire (PSEQ)	Assess confidence to engage in physical activity despite pain.	Pre-intervention (week 0), Post-intervention (week 8)
Other	Chronic Pain Acceptance Questionnaire (CPAQ)	Assess ability to engage in meaningful activities despite pain.	Pre-intervention (week 0), Post-intervention (week 8)
Other	Center for Epidemiologic Study of Depression (CESD) Scale	Assess depression.	Pre-intervention (week 0), Post-intervention (week 8)
Other	Cognitive and Affective Mindfulness Scale (CAMS)	Assess state of mindfulness taught during the program.	Pre-intervention (week 0), Post-intervention (week 8)
Other	Defense and Veterans Pain Rating Scale (DVPRS)	Assess pain interference and pain intensity	Pre-intervention (week 0), Bi-weekly, Post-intervention (week 8)
Other	Measure of Current Status (MOCS)	Assess general coping ability taught during the program.	Pre-intervention (week 0), Post-intervention (week 8)
Primary	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).	Pre-intervention (week 0) only
Primary	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
Primary	System Usability Scale	Assess global user experience of the VR device, with higher percentile rankings (range = 0-100) indicating greater usability.	Post-intervention (week 8) only
Secondary	Patient's Global Impression of Change	Assess perceptions of overall improvement in pain and physical function during the program.	Post-intervention (week 8) only
Secondary	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
Secondary	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).	Throughout the study completion, approximately 1 year
Secondary	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).	Pre-intervention (week 0), Post-intervention (week 8)
Secondary	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).	Pre-intervention (week 0), Post-intervention (week 8)
Secondary	Feasibility of Outcome Assessments	Feasibility of collecting complete outcome assessments (=70% have no missing data, good; =80% have no missing data, excellent).	Pre-intervention (week 0), Post-intervention (week 8)