Change in Pain With Virtual Reality-augmented Remote Rehabilitative Care

February 11, 2022 updated by: XRHealth USA Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

52

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Brookline, Massachusetts, United States, 02446
        • XRHealth USA, Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who presented for VR augmented remote rehabilitative care for the primary complaint of musculoskeletal pain.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 from baseline in the Brief Pain Inventory: Interference sub scale through study completion, an average of 3 months
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.
Change from baseline in the Brief Pain Inventory: Severity sub scale through study completion, an average of 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

XRHealth USA Inc.

Investigators

  • Principal Investigator: Lorna Brown, XRHealth USA Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2020

Primary Completion (Actual)

September 30, 2021

Study Completion (Actual)

September 30, 2021

Study Registration Dates

First Submitted

January 21, 2022

First Submitted That Met QC Criteria

February 11, 2022

First Posted (Actual)

February 23, 2022

Study Record Updates

Last Update Posted (Actual)

February 23, 2022

Last Update Submitted That Met QC Criteria

February 11, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • #2022B1014

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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