Virtual Reality for Pain Management in Orthopaedic Patients

• Sponsor: Massachusetts General Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT04152447
• Collaborator: Orthopaedic Trauma Association (Other)
• Enrollment: 35
• Location: 1
• Arms: 2
• Actual Duration (Months): 14.5
• Patients Per Site Per Month: 2.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain, Musculoskeletal	Device: VR device	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 35 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Virtual Reality for Pain Management in Orthopaedic Patients: A Prospective Randomized Control Pilot Study
• Actual Study Start Date: Aug 29, 2019
• Actual Primary Completion Date: Nov 13, 2020
• Actual Study Completion Date: Nov 13, 2020

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Standard of care This arm describes the standard protocol used to aid in orthopedic recovery.
Active Comparator: VR device 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

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. Length of Stay [Post-operative period, an average of 3 days]

   Length of Stay is measured as days following surgery and before discharge.

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital	Boston	Massachusetts	United States	02114

Sponsors and Collaborators

• Massachusetts General Hospital
• Orthopaedic Trauma Association

Investigators

• Principal Investigator: Marilyn Heng, MD, Massachusetts General Hospital

Study Documents (Full-Text)

• Study Protocol - Aug 13, 2020
• Statistical Analysis Plan - Apr 29, 2021

More Information

Publications

None provided.

• Responsible Party: Marilyn Heng, Principal Investigator, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT04152447
• Other Study ID Numbers: 2018P002763
• First Posted: Nov 5, 2019
• Last Update Posted: Feb 15, 2022
• Last Verified: Feb 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Musculoskeletal Pain

Study Results

Participant Flow

Arm/Group Title	Standard of Care	VR Device
Arm/Group Description	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.	VR device: Patients use a VR device
Period Title: Overall Study
STARTED	16	19
COMPLETED	13	14
NOT COMPLETED	3	5

Baseline Characteristics

Arm/Group Title	Standard of Care	VR Device	Total
Arm/Group Description	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.	VR device: Patients use a VR device	Total of all reporting groups
Overall Participants	13	14	27
Age (Count of Participants)
<=18 years	0 0%	1 7.1%	1 3.7%
Between 18 and 65 years	6 46.2%	8 57.1%	14 51.9%
>=65 years	7 53.8%	5 35.7%	12 44.4%
Sex: Female, Male (Count of Participants)
Female	10 76.9%	7 50%	17 63%
Male	3 23.1%	7 50%	10 37%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	1 7.1%	1 3.7%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	12 92.3%	13 92.9%	25 92.6%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	1 7.7%	0 0%	1 3.7%
Region of Enrollment (participants) [Number]
United States	13 100%	14 100%	27 100%

Outcome Measures

1. Primary Outcome

Title	Opioid Usage During the Postoperative Hospitalization
Description	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

Outcome Measure Data

Analysis Population Description

This population involves the eligible patient population that has received opioids following surgery.

Arm/Group Title	Standard of Care	VR Device
Arm/Group Description	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.	VR device: Patients use a VR device
Measure Participants	13	14
Mean (95% Confidence Interval) [Morphine milligram equivalents (MME)/day]	30.3	30.8

2. Secondary Outcome

Title	Length of Stay
Description	Length of Stay is measured as days following surgery and before discharge.
Time Frame	Post-operative period, an average of 3 days

Outcome Measure Data

Analysis Population Description

The population is the population enrolled in the study: patients 18 or over who are opioid naïve and have had surgery.

Arm/Group Title	Standard of Care	VR Device
Arm/Group Description	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.	VR device: Patients use a VR device
Measure Participants	13	14
Mean (95% Confidence Interval) [days]	2.5	2

3. Secondary Outcome

Title	Patient-reported Pain Scores
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard of Care	VR Device
Arm/Group Description	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.	VR device: Patients use a VR device
Measure Participants	13	14
Mean (95% Confidence Interval) [score on a scale]	9.62	9.0

Adverse Events

Time Frame	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.
Adverse Event Reporting Description	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.
Arm/Group Title	Standard of Care		VR Device
Arm/Group Description	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.		VR device: Patients use a VR device
All Cause Mortality
	Standard of Care		VR Device
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/16 (0%)		0/19 (0%)
Serious Adverse Events
	Standard of Care		VR Device
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/16 (0%)		0/19 (0%)
Other (Not Including Serious) Adverse Events
	Standard of Care		VR Device
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/16 (0%)		0/19 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.