Change in Pain With Virtual Reality-augmented Remote Rehabilitative Care

NCT05253157 | Completed

• 1 other identifier: #2022B1014
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Musculoskeletal Pain

Keywords

chronic pain; virtual reality; pain management; tele-rehabilitation

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  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

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• none

Sponsors & Collaborators

• XRHealth USA Inc.: lead

Study Sites (1)

XRHealth USA, Inc

Brookline, Massachusetts, 02446, United States

Location

Related Publications (12)

• 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.

  PMID: 33990113 BACKGROUND

• 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.

  PMID: 30321424 BACKGROUND

• 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.

  PMID: 32343836 BACKGROUND

• 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.

  PMID: 31343702 BACKGROUND

• 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.

  PMID: 29904806 BACKGROUND

• 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.

  PMID: 22770840 BACKGROUND

• 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.

  PMID: 27997539 BACKGROUND

• 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.

  PMID: 28495661 BACKGROUND

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

  PMID: 8080219 BACKGROUND

• 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.

  PMID: 15042521 BACKGROUND

• 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.

  PMID: 15322437 BACKGROUND

• 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.

  PMID: 2691207 BACKGROUND

MeSH Terms

Conditions

Musculoskeletal Pain; Chronic Pain; Agnosia

Condition Hierarchy (Ancestors)

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

Study Officials

• Lorna Brown

  XRHealth USA Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2022
• First Posted: February 23, 2022
• Study Start: August 1, 2020
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: February 23, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)