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OpenTrials
Completed

NCT Number: NCT04152447

Virtual Reality for Pain Management in Orthopaedic Patients

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.

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Key information

Conditions

Pain, Musculoskeletal Muscular Diseases Musculoskeletal Diseases Musculoskeletal Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

VR device

Device

Patients use a VR device

Primary outcomes

  1. Opioid Usage During the Postoperative Hospitalization

    Time frame: 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 outcomes

  1. Length of Stay

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Orthopaedic Trauma Association

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 5, 2019
Registry last updated
Feb 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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