Skip to main content
Clinical Trials/NCT05253157
NCT05253157
Completed
Not Applicable

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

XRHealth USA Inc.1 site in 1 country52 target enrollmentAugust 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Musculoskeletal Pain
Sponsor
XRHealth USA Inc.
Enrollment
52
Locations
1
Primary Endpoint
Change in Brief Pain Inventory: Interference Subscale
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 1, 2020
End Date
September 30, 2021
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Not provided

Outcomes

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.

Study Sites (1)

Loading locations...

Similar Trials