Clinical trial NCT04152447: Virtual Reality for Pain Management in Orthopaedic Patients
Official title: Virtual Reality for Pain Management in Orthopaedic Patients: A Prospective Randomized Control Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Musculoskeletal
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Orthopaedic Trauma Association
First posted: 2019-11-05
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Opioid Usage During the Postoperative Hospitalization
timeFrame: Post-operative period, an average of 3 days
Secondary outcomes:
measure: Length of Stay
timeFrame: Post-operative period, an average of 3 days
measure: Patient-reported Pain Scores
timeFrame: Post-operative period, an average of 3 days
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Marilyn Heng, MD
role: PRINCIPAL_INVESTIGATOR
References: