Clinical trial NCT05552430: 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
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2022-09-23
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Credibility and Expectancy Questionnaire (CEQ)- Credibility Subscale
timeFrame: Pre-intervention (week 0) only
measure: Credibility and Expectancy Questionnaire (CEQ)- Expectancy Subscale
timeFrame: Pre-intervention (week 0) only
measure: Client Satisfaction Questionnaire
timeFrame: Post-intervention (week 8) only
measure: System Usability Scale
timeFrame: Post-intervention (week 8) only
Secondary outcomes:
measure: Patient's Global Impression of Change
timeFrame: Post-intervention (week 8) only
measure: Motion Sickness and Nausea
timeFrame: Post-intervention (week 8) only
measure: Feasibility of Enrollment
timeFrame: Throughout the study completion, approximately 1 year
measure: Acceptability of Treatment
timeFrame: Pre-intervention (week 0), Post-intervention (week 8)
measure: Adherence to Pain Surveys
timeFrame: Pre-intervention (week 0), Post-intervention (week 8)
measure: Feasibility of Outcome Assessments
timeFrame: Pre-intervention (week 0), Post-intervention (week 8)
Other outcomes:
measure: Non-narcotic Pain Medications
timeFrame: Pre-intervention (week 0), Post-intervention (week 8)
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance
timeFrame: Pre-intervention (week 0), Post-intervention (week 8)
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function
timeFrame: Pre-intervention (week 0), Post-intervention (week 8)
measure: Short Musculoskeletal Functional Assessment (SMFA) Questionnaire- Dysfunction Index
timeFrame: Pre-intervention (week 0), Post-intervention (week 8)
measure: Short Musculoskeletal Functional Assessment (SMFA) Questionnaire - Bother Index
timeFrame: Pre-intervention (week 0), Post-intervention (week 8)
measure: Numerical Rating Scale (NRS) - Pain at Rest
timeFrame: Assessed Pre-intervention (week 0), Bi-weekly, Post-intervention (week 8). Pre-intervention (week 0) and Post-intervention (week 8) reported.
measure: Numerical Rating Scale (NRS) - Pain With Activity
timeFrame: Assessed Pre-intervention (week 0), Bi-weekly, Post-intervention (week 8). Pre-intervention (week 0) and Post-intervention (week 8) reported.
measure: Pain Catastrophizing Scale (PCS)
timeFrame: Pre-intervention (week 0), Post-intervention (week 8)
measure: Pain Anxiety Scale (PASS)
timeFrame: Pre-intervention (week 0), Post-intervention (week 8)
measure: Pain Self-Efficacy Questionnaire (PSEQ)
timeFrame: Pre-intervention (week 0), Post-intervention (week 8)
measure: Center for Epidemiologic Study of Depression (CESD) Scale
timeFrame: Pre-intervention (week 0), Post-intervention (week 8)
measure: Cognitive and Affective Mindfulness Scale (CAMS)
timeFrame: Pre-intervention (week 0), Post-intervention (week 8)
measure: Defense and Veterans Pain Rating Scale (DVPRS) - Activity Subscale
timeFrame: Assessed Pre-intervention (week 0), Bi-weekly, Post-intervention (week 8). Pre-intervention (week 0) and Post-intervention (week 8) reported.
measure: Defense and Veterans Pain Rating Scale (DVPRS) - Sleep Subscale
timeFrame: Assessed Pre-intervention (week 0), Bi-weekly, Post-intervention (week 8). Pre-intervention (week 0) and Post-intervention (week 8) reported.
measure: Defense and Veterans Pain Rating Scale (DVPRS) - Mood Subscale
timeFrame: Assessed Pre-intervention (week 0), Bi-weekly, Post-intervention (week 8). Pre-intervention (week 0) and Post-intervention (week 8) reported.
measure: Defense and Veterans Pain Rating Scale (DVPRS) - Stress Subscale
timeFrame: Assessed Pre-intervention (week 0), Bi-weekly, Post-intervention (week 8). Pre-intervention (week 0) and Post-intervention (week 8) reported.
measure: Measure of Current Status (MOCS)
timeFrame: Pre-intervention (week 0), Post-intervention (week 8)
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Ryan A Mace, PhD
role: PRINCIPAL_INVESTIGATOR
References: