Change in Pain With Virtual Reality-augmented Remote Rehabilitative Care

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.

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Key information

Conditions

Musculoskeletal Pain Agnosia Chronic Pain Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

XRHealth USA, Inc

Brookline, Massachusetts, 02446, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

none

Treatment and study plan

Virtual Reality Augmented remote rehabilitation

Other

XRHealth offers remote skilled therapy treatments such as education, exercise, and VR-augmented activities. The platform consists of the VRHealth portal with multiple immersive applications for measurement, motor-cognitive training, and mindfulness/cognitive behavioral applications for symptom relief, the external control application, and the XR Health data portal with real-time analytics for evaluating performance. Contraindications for VR use are assessed. Treatment sessions are 60 min long. Duration and frequency are based on clinical judgement. VR interventions used are; VR motor-cognitive: ReAct, Color Match, Memorize, Rotate, and Balloon Blast; VR Reliever: Relax 8, Luna, and Mindset. An external VR portal and mirroring software allows the clinician to view patient activities in real time. Additionally, the clinician can remotely monitor patient performance via the external portal and adjust parameters accordingly.

Primary outcomes

Change in Brief Pain Inventory: Interference Subscale

Time frame: Change from baseline in the Brief Pain Inventory: Interference sub scale through study completion, an average of 3 months

Brief Pain Inventory scale, a self-report scale originally developed to assess pain in individuals with cancer, but has been expanded for assessment of non-

malignant pain. The subscale of interference assesses how much pain interferes (over the past 24 hrs) with general activity, mood, walking ability, normal work, relations with others, sleep, and enjoyment of life on a scale of: 0=does not interfere up to 10=completely interferes.
Change in Brief Pain Inventory: Severity Subscale

Time frame: Change from baseline in the Brief Pain Inventory: Severity sub scale through study completion, an average of 3 months

The severity scale assesses worst, least, average (over the past 24 hours), and current pain on a scale of: 0=no pain up to 10=pain as bad as you can imagine.

Sponsors and collaborators

Lead sponsor

XRHealth USA Inc.

Industry

Registry information

Official study title

Changes in Pain Interference and Severity After an Episode of Virtual Reality-augmented Remote Rehabilitative Care: a Pragmatic Exploratory Descriptive Trial

Important dates

Study start: 2020
Primary completion: 2021
Study completion: 2021
First posted: Feb 23, 2022
Registry last updated: Feb 23, 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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