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| Name | Class |
|---|---|
| Orthopaedic Trauma Association | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of care | No Intervention | This arm describes the standard protocol used to aid in orthopedic recovery. | |
| VR device | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VR device | Device | Patients use a VR device |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marilyn Heng, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard of Care | The standard of care for orthopaedic trauma patients is a multimodal pain management approach aimed at minimizing narcotic usage, particularly in our geriatric fracture patients. Standard practice is to never give so much opioids, to any patient, that the renders them confused or obtunded. In this study, we follow MGH nursing protocols for the group receiving the standard of care. |
| FG001 | VR Device | VR device: Patients use a VR device |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard of Care | The usual care for pain management at our institution consists of standing Tylenol, oxycodone PRN and IV Dilaudid PRN for breakthrough pain. Existing MGH nursing protocols evaluate when to give PRN narcotics to patients based on functional pain levels and are aimed at minimizing narcotic use. In elderly patients, the PRN dose of narcotics prescribed is generally half that of their younger counterparts (2.5-5mg q4h PRN versus 5-10mg q4h PRN in younger patients). Geriatric fracture patients admitted to the orthopaedic trauma service are comanaged with geriatricians who also carefully monitor the effects of these medications. In this manner, the standard of care for orthopaedic trauma patients is a multimodal pain management approach aimed at minimizing narcotic usage, particularly in our geriatric fracture patients. Standard practice is to never give so much opioids, to any patient, that the renders them confused or obtunded. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | This population involves the eligible patient population that has received opioids following surgery. | Posted | Mean | 95% Confidence Interval | Morphine milligram equivalents (MME)/day | Post-operative period, an average of 3 days |
|
Adverse event data was collected over the span of 1 year and 2 months, from the consent of the first patient through the discharge of the final patient from the hospital. For each patient, Adverse events were tracked on the period from baseline to discharge from the hospital, which differed per patient but averaged to around 3 days following surgery.
Given the non-invasive nature of the VR headsets, we subcategorize serious Adverse Events as device-related or non device-related. For non-medical issues, we handled them on an event-to-event basis, informing the study staff and triaging. When postoperative complications occur in a patient enrolled in the study, the PI will immediately be notified. The PI will be responsible for collecting laboratory data and medical history to ensure that the AE was not device related.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard of Care | The usual care for pain management at our institution consists of standing Tylenol, oxycodone PRN and IV Dilaudid PRN for breakthrough pain. Existing MGH nursing protocols evaluate when to give PRN narcotics to patients based on functional pain levels and are aimed at minimizing narcotic use. In elderly patients, the PRN dose of narcotics prescribed is generally half that of their younger counterparts (2.5-5mg q4h PRN versus 5-10mg q4h PRN in younger patients). Geriatric fracture patients admitted to the orthopaedic trauma service are comanaged with geriatricians who also carefully monitor the effects of these medications. In this manner, the standard of care for orthopaedic trauma patients is a multimodal pain management approach aimed at minimizing narcotic usage, particularly in our geriatric fracture patients. Standard practice is to never give so much opioids, to any patient, that the renders them confused or obtunded. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Marilyn Heng | Massachusetts General Hospital | 617-643-0149 | mheng@mgh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 13, 2020 | Dec 16, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 29, 2021 | Jan 24, 2022 | SAP_002.pdf |
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| ID | Term |
|---|---|
| D059352 | Musculoskeletal Pain |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
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| Post-operative period, an average of 3 days |
| Withdrawal by Subject |
|
| Found ineligible after enrolling |
|
| Did not receive VR headset in time. |
|
| BG001 | VR Device | VR device: Patients use a VR device |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | VR Device | VR device: Patients use a VR device |
|
|
| Secondary | Length of Stay | Length of Stay is measured as days following surgery and before discharge. | The population is the population enrolled in the study: patients 18 or over who are opioid naïve and have had surgery. | Posted | Mean | 95% Confidence Interval | days | Post-operative period, an average of 3 days |
|
|
|
| Secondary | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | Post-operative period, an average of 3 days |
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | VR Device | VR device: Patients use a VR device | 0 | 19 | 0 | 19 | 0 | 19 |
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |