Clinical trial NCT05253157: Change in Pain With Virtual Reality-augmented Remote Rehabilitative Care
Official title: Changes in Pain Interference and Severity After an Episode of Virtual Reality-augmented Remote Rehabilitative Care: a Pragmatic Exploratory Descriptive Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Musculoskeletal Pain
Keywords: chronic pain
virtual reality
pain management
tele-rehabilitation
Lead sponsor: XRHealth USA Inc.
Sponsor class: INDUSTRY
First posted: 2022-02-23
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who presented for VR augmented remote rehabilitative care for the primary complaint of musculoskeletal pain.

Brief summary: Pain is among the most common chronic conditions in the adult population, often associated with decreased quality of life, functional impairments, increased medication use, increased medical expenditures, and significant economic costs. Due to the worsening opioid crisis, non-pharmacological approaches, such as rehabilitative care, are needed. However, access to in-person rehabilitative care may be limited due to transportation barriers, time constraints, and patient preference to remain at home. The COVID-19 pandemic has further exacerbated barriers to access in-person care, bringing the benefits of tele-rehabilitation into sharper focus. Remote models of care and novel treatment strategies, specifically the utilization of virtual reality (VR) augmented care are emerging as potentially viable treatment alternatives. This paper intends to explore the potential effectiveness of this method of care delivery in patients presenting for rehabilitative care with a primary complaint of pain.

Detailed description: The investigators are proposing a retrospective health and medical records review with a waiver of consent on 52 patients who had remote VR-augmented rehabilitation services from Aug 2020 to Sept of 2021 at XRHealth, a telehealth rehabilitation company utilizing virtual reality applications to augment traditional rehabilitative care. Included patients had an initial and follow-up score on the brief pain interference scale-intensity and severity to explore the association with remote care and changes over time in this validated outcome assessment. In addition, VR headset data will be analyzed to explore the usage and type of VR applications by primary treatment region to help inform the establishment of optimal treatment protocols and explore the association between changes by applications used. De-identified data will be extracted from the proprietary XR Health data portal and will include a unique patient identifier, qualitative and quantitative ratings on the patient experience with XRHealth, number of treatment visits, usage in minutes of the VR applications utilized, and scores on the Brief Pain Inventory: Interference and Severity sub scales. Individual patient records will be reviewed to extract information regarding co-morbidities, condition chronicity, and medications used.

Eligibility criteria: Inclusion Criteria:

* presented for treatment at XRHealth with the primary complaint of musculoskeletal pain

Exclusion Criteria:

* none

Primary outcomes:
measure: Change in Brief Pain Inventory: Interference Subscale
timeFrame: Change from baseline in the Brief Pain Inventory: Interference sub scale through study completion, an average of 3 months
measure: Change in Brief Pain Inventory: Severity Subscale
timeFrame: Change from baseline in the Brief Pain Inventory: Severity sub scale through study completion, an average of 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Brookline
country: United States
facility: XRHealth USA, Inc
state: Massachusetts
Study officials:
affiliation: XRHealth USA Inc.
name: Lorna Brown
role: PRINCIPAL_INVESTIGATOR
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