Virtual Reality for Pain Management in Orthopaedic Patients

Pain, Musculoskeletal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04152447
• Other study ID #: 2018P002763
• Status: Completed
• Phase: N/A
• Start date: August 29, 2019
• Est. completion date: November 13, 2020

Study information

• Verified date: February 2022
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: November 13, 2020
• Est. primary completion date: November 13, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Musculoskeletal Pain
• Pain, Musculoskeletal

Intervention

Device:
• VR device
Patients use a VR device

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Orthopaedic Trauma Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Post-operative period, an average of 3 days
Secondary	Length of Stay	Length of Stay is measured as days following surgery and before discharge.	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.	Post-operative period, an average of 3 days