Virtual Reality for Pain Management in Orthopaedic Patients

Study Overview
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Brief Summary
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Investigators will determine the feasibility of a virtual reality pain control program (VR-PCP) as a non-pharmacologic adjunct for pain management while in the hospital (i.e. patient ability and willingness to use the system measured by average time spent on the device). Investigators will evaluate if there is a difference between the average daily use of opioid medications taken by patients who received usual care pain management versus patients using a VR-PCP. Investigators will assess for differences in short-term postoperative patient-reported pain intensity (PROMIS Patient Intensity v1.0) for patients who received usual care pain management versus those who also have access to a VR-PCP.

Detailed Description
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Orthopedic surgeons rank third amongst physician prescribers of opioids to adults in the United States4. The deleterious effects of the opioid epidemic have been well studied at both the individual and population level.2 3 Orthopaedic trauma patients in particular have high rates of psychological stress and disability related to protracted narcotic usage 5. However, opioid medications may not need to be the mainstay of pharmacologic pain management for patients with orthopaedic injuries. For example, one recent study from the Netherlands showed that 82% of patients with ankle fractures treated in the United States were prescribed opioids at discharge, whereas only 6% of Dutch patients were given narcotics. 6 Non-pharmacologic interventions for pain management in the acute orthopaedic injury setting deserve full investigation. Virtual reality for pain management has been used in burn patients, pediatric patients, for procedures under local anesthesia and in the chronic pain setting. Results of these investigations are promising and demonstrate reduced narcotic usage and improved pain scores.7 8 9 Currently, there are no published reports on the use of virtual reality for pain management in the orthopaedic literature. By investigating VR as a non-pharmacologic intervention for pain, orthopaedic trauma patients may be able to avoid the known risks of narcotic medication while still controlling their pain and regaining function after their injury. Our study will lay groundwork for longer-term studies to evaluate the impact of virtual reality on functional outcomes, opioid usage after hospital discharge and patient satisfaction scores. VR can also be investigated for post-operative pain control across other orthopedic subspecialties.

Official Title
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Virtual Reality for Pain Management in Orthopaedic Patients: A Prospective Randomized Control Pilot Study

Conditions
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Pain, Musculoskeletal

Intervention / Treatment
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* Device: VR device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 and older Patients who sustained factures treated with open reduction internal fixation. Polytrauma patients whose fractures are definitively fixed in one discrete operating room visit will be included. Exclusion Criteria: Cognitive impairment Injuries requiring staged surgical fixation (i.e. ex-fix to ORIF) Seizure disorder or other contraindication to VR usage Significant medical complications during hospitalization precluding use of a VR headset Significant surgical complication during hospitalization requiring unanticipated return to the operating room during index admission.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard of care<br>This arm describes the standard protocol used to aid in orthopedic recovery. | |
| Active Comparator: VR device<br>Patients randomly assigned to the experimental arm of the study were provided an Oculus Go™ device for the duration of their hospitalization. The device featured a headset with a 1280 x 1440, 60 Hz refresh rate LCD display, spatial audio (via built-in speakers; headphones were not provided or used to our knowledge, despite compatibility) and the ability to track 3 degrees of rotational freedom; it was compatible with glasses and included a soft, adjustable strap for optimal, user-based fit. A single controller, capable of recognizing hand motion, pointing, and clicking was also included. | Device: VR device<br>* Patients use a VR device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid Usage During the Postoperative Hospitalization | Opioid usage during the postoperative hospitalization measured in average daily morphine milligram equivalents (MME). Higher number is a worse outcome. | Post-operative period, an average of 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of Stay | Length of Stay is measured as days following surgery and before discharge. | Post-operative period, an average of 3 days | 
| Patient-reported Pain Scores | Patients had to answer a series of questionnaires regarding their pain level at baseline, and daily during hospitalization. The scores were tallied up. This scale is referred to as the PROMIS Pain Intensity Scale v1.0, which tracks patient reported outcomes on a scale where 3 is the minimum and 15 is the maximum. PROMIS scores are taken daily post-operation, and the score reported is the reflection of the average PROMIS score of the post-operative days, since patients did not stay for the same length following surgery. Higher score is a worse outcome. Minimum value is 0, Maximum value is 100. | Post-operative period, an average of 3 days |