An interventional study of VR device in Pain, Musculoskeletal, sponsored by Massachusetts General Hospital. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-02-15.
Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Supportive care
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.
511 studies on the registry are indexed under Musculoskeletal Pain; 113 are open to participants now.
This study's enrollment of 35 is below the median of 66 across 358 interventional studies indexed under Musculoskeletal Pain.
Browse Musculoskeletal Pain studies →Massachusetts General Hospital is the lead sponsor of 2,582 studies on the registry; 451 are open to participants now.
Of its 221 completed or terminated interventional studies of FDA-regulated products, 168 (76%) have results posted.
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Exclusion Criteria:
This arm describes the standard protocol used to aid in orthopedic recovery.
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
Patients use a VR device
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
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
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
| Milestone | Standard of Care | VR Device |
|---|---|---|
| Started | 16 | 19 |
| Completed | 13 | 14 |
| Not completed | 3 | 5 |
| Withdrew: Lost to follow-up | 1 | 0 |
| Withdrew: Treatment plan switched to an ineligible criteria | 1 | 1 |
| Withdrew: Withdrawal by subject | 0 | 1 |
| Withdrew: Found ineligible after enrolling | 1 | 1 |
| Withdrew: Did not receive vr headset in time. | 0 | 2 |
Opioid usage during the postoperative hospitalization measured in average daily morphine milligram equivalents (MME). Higher number is a worse outcome.
| Morphine milligram equivalents (MME)/day | Standard of Care | VR Device |
|---|---|---|
| Opioid Usage During the Postoperative Hospitalization | 30.3 (12.7 to 42.2) | 30.8 (18.7 to 47.2) |
Length of Stay is measured as days following surgery and before discharge.
| days | Standard of Care | VR Device |
|---|---|---|
| Length of Stay | 2.5 (2 to 4) | 2 (1 to 4) |
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.
| score on a scale | Standard of Care | VR Device |
|---|---|---|
| Patient-reported Pain Scores | 9.62 (9.0 to 11.3) | 9.0 (7.0 to 11.5) |
Collected over 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.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Standard of Care | 0/16 (0%) | 0/16 (0%) | 0/16 (0%) |
| VR Device | 0/19 (0%) | 0/19 (0%) | 0/19 (0%) |
| Age, Categorical(Participants) | Standard of Care | VR Device | Total |
|---|---|---|---|
| <=18 years | 0 | 1 | 1 |
| Between 18 and 65 years | 6 | 8 | 14 |
| >=65 years | 7 | 5 | 12 |
| Sex: Female, Male(Participants) | Standard of Care | VR Device | Total |
|---|---|---|---|
| Female | 10 | 7 | 17 |
| Male | 3 | 7 | 10 |
| Race (NIH/OMB)(Participants) | Standard of Care | VR Device | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 12 | 13 | 25 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Region of Enrollment(participants) | Standard of Care | VR Device | Total |
|---|---|---|---|
| United States | 13 | 14 | 27 |
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