Pain, Musculoskeletal
Conditions
Brief summary
1. 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). 2. 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. 3. 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
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.
Interventions
DEVICEVR device
Patients use a VR device
Sponsors
Orthopaedic Trauma Association
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Usage During the Postoperative Hospitalization | Post-operative period, an average of 3 days | Opioid usage during the postoperative hospitalization measured in average daily morphine milligram equivalents (MME). Higher number is a worse outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of Stay | Post-operative period, an average of 3 days | Length of Stay is measured as days following surgery and before discharge. |
| Patient-reported Pain Scores | Post-operative period, an average of 3 days | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 13 |
| VR Device VR device: Patients use a VR device | 14 |
| Total | 27 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Did not receive VR headset in time. | 0 | 2 |
| Overall Study | Found ineligible after enrolling | 1 | 1 |
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Treatment plan switched to an ineligible criteria | 1 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Total | Standard of Care | VR Device |
|---|---|---|---|
| Age, Categorical <=18 years | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical >=65 years | 12 Participants | 7 Participants | 5 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants | 6 Participants | 8 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 25 Participants | 12 Participants | 13 Participants |
| Region of Enrollment United States | 27 participants | 13 participants | 14 participants |
| Sex: Female, Male Female | 17 Participants | 10 Participants | 7 Participants |
| Sex: Female, Male Male | 10 Participants | 3 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 19 |
| other Total, other adverse events | 0 / 16 | 0 / 19 |
| serious Total, serious adverse events | 0 / 16 | 0 / 19 |
Outcome results
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.
Time frame: Post-operative period, an average of 3 days
Population: This population involves the eligible patient population that has received opioids following surgery.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard of Care | Opioid Usage During the Postoperative Hospitalization | 30.3 Morphine milligram equivalents (MME)/day |
| VR Device | Opioid Usage During the Postoperative Hospitalization | 30.8 Morphine milligram equivalents (MME)/day |
Secondary
Length of Stay
Length of Stay is measured as days following surgery and before discharge.
Time frame: Post-operative period, an average of 3 days
Population: The population is the population enrolled in the study: patients 18 or over who are opioid naïve and have had surgery.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard of Care | Length of Stay | 2.5 days |
| VR Device | Length of Stay | 2 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.
Time frame: Post-operative period, an average of 3 days
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard of Care | Patient-reported Pain Scores | 9.62 score on a scale |
| VR Device | Patient-reported Pain Scores | 9.0 score on a scale |