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Musculoskeletal PainNCT05253157

Change in Pain With Virtual Reality-augmented Remote Rehabilitative Care

An observational study of Musculoskeletal Pain, run by XRHealth USA Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Musculoskeletal Pain
What is being tested?
Virtual Reality Augmented remote rehabilitation
How many people
52 participants
Where
1 siteUnited States
Study dates
1 Aug 2020to 30 Sep 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • none

Trial locations and contacts

1 site in 1 country.

United States1 site

  • XRHealth USA, Inc

    Brookline, Massachusetts, 02446

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Virtual Reality Augmented remote rehabilitation
Keywords
chronic pain, virtual reality, pain management, tele-rehabilitation
Medical subject headings
Musculoskeletal Pain, Chronic Pain, Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Virtual Reality Augmented remote rehabilitationOther

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Brief Pain Inventory: Interference Subscale

    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.

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

  2. Change in Brief Pain Inventory: Severity Subscale

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Feb 2022
  2. Study start1 Aug 2020
  3. Primary completion30 Sep 2021
  4. Study completion30 Sep 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Retrospective
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05253157
Sponsor's protocol ID
#2022B1014
Status last verified
Jan 2022
First submitted
21 Jan 2022
Last updated
23 Feb 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Yong RJ, Mullins PM, Bhattacharyya N. Prevalence of chronic pain among adults in the United States. Pain. 2022 Feb 1;163(2):e328-e332. doi: 10.1097/j.pain.0000000000002291.

    PubMed 33990113

  • Jette AM. The Role of Nonpharmacological Approaches to Pain Management. Phys Ther. 2018 Nov 1;98(11):907-908. doi: 10.1093/ptj/pzy099. No abstract available.

    PubMed 30321424

  • Lee AC. COVID-19 and the Advancement of Digital Physical Therapist Practice and Telehealth. Phys Ther. 2020 Jul 19;100(7):1054-1057. doi: 10.1093/ptj/pzaa079. No abstract available.

    PubMed 32343836

  • Gumaa M, Rehan Youssef A. Is Virtual Reality Effective in Orthopedic Rehabilitation? A Systematic Review and Meta-Analysis. Phys Ther. 2019 Oct 28;99(10):1304-1325. doi: 10.1093/ptj/pzz093.

    PubMed 31343702

  • Pourmand A, Davis S, Marchak A, Whiteside T, Sikka N. Virtual Reality as a Clinical Tool for Pain Management. Curr Pain Headache Rep. 2018 Jun 15;22(8):53. doi: 10.1007/s11916-018-0708-2.

    PubMed 29904806

  • Keefe FJ, Huling DA, Coggins MJ, Keefe DF, Rosenthal ZM, Herr NR, Hoffman HG. Virtual reality for persistent pain: a new direction for behavioral pain management. Pain. 2012 Nov;153(11):2163-2166. doi: 10.1016/j.pain.2012.05.030. Epub 2012 Jul 4. No abstract available.

    PubMed 22770840

  • Jones T, Moore T, Choo J. The Impact of Virtual Reality on Chronic Pain. PLoS One. 2016 Dec 20;11(12):e0167523. doi: 10.1371/journal.pone.0167523. eCollection 2016.

    PubMed 27997539

  • Garrett B, Taverner T, McDade P. Virtual Reality as an Adjunct Home Therapy in Chronic Pain Management: An Exploratory Study. JMIR Med Inform. 2017 May 11;5(2):e11. doi: 10.2196/medinform.7271.

    PubMed 28495661

  • Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap. 1994 Mar;23(2):129-38.

    PubMed 8080219

  • Tan G, Jensen MP, Thornby JI, Shanti BF. Validation of the Brief Pain Inventory for chronic nonmalignant pain. J Pain. 2004 Mar;5(2):133-7. doi: 10.1016/j.jpain.2003.12.005.

    PubMed 15042521

  • Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain. 2004 Sep-Oct;20(5):309-18. doi: 10.1097/00002508-200409000-00005.

    PubMed 15322437

  • Jaeschke R, Singer J, Guyatt GH. Measurement of health status. Ascertaining the minimal clinically important difference. Control Clin Trials. 1989 Dec;10(4):407-15. doi: 10.1016/0197-2456(89)90005-6.

    PubMed 2691207

Questions about this trial

What is this clinical trial studying?

An observational study of Musculoskeletal Pain, run by XRHealth USA Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05253157, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2022.

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