Effects of the Nottingham Augmented Reality (AR) App for Arthritis Hand Joint Pain

Effects of the Nottingham Arthritis App for Arthritis Pain

The aim of this run-in design, feasibility study is to assess outcomes (including opioid-use, pain intensity, emotional function, and general physical function) for an augmented reality illusion therapy in participants with chronic hand joint pain due to arthritis.

Study Overview

• Status: Completed
• Conditions: Chronic Pain; Opioid Use; Arthritis Hand
• Intervention / Treatment: Other: Standard of care; Device: Nottingham AR smartphone app with active intervention

Detailed Description

This is a run-in design, feasibility study that uses the enrolled participants as their own control. After consenting to join the study, for the first 30 days, participants will be on their current Standard of Care (SoC). Then, for the next 30 days, the same group of participants will use the Nottingham digital treatment daily. Pre- and Post-SoC and Treatment period measures of opioid use and pain, quality of life measures will be administered and measured. Additionally, for qualifying participants, Pre- and Post-treatment functional Magnetic Resonance Imaging (fMRI) scans will be performed to assess how Nottingham AR therapy affects neuroplastic changes in the supraspinal pain network associated with the therapy sessions.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Paul Lafferty; Phone Number: 1-760-525-3739; Email: paul@vrxmedical.com

Study Locations

• United States
  • California
    • San Diego, California, United States, 92161
      • VA San Diego Healthcare System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Male and female adults ages 21-80
2. Clinical diagnosis of chronic hand pain from arthritis or as determined by study physician 3) Hand joint pain at a severity of 4 and above (on a 0 to 10 scale) daily

4) Use of prescribed opioids 5) English-speaking, literate, with stable residence 5) Able to operate a smartphone as evidenced by direct observation.

Exclusion Criteria:

1. Major medical illness that might confound effects of pain on function (e.g., advanced cardiac or pulmonary disease)
2. Current active alcohol or substance use disorder as evidenced from medical record
3. Currently active unstable psychiatric status in previous three months as measured by direct observation, patient self-report, or medical record
4. Moderate or severe cognitive impairment as demonstrated by medical diagnosis or clinical observation
5. fMRI exclusion only: Any factors that would prevent participation in fMRI

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Standard of Care followed by AR digital treatment; Standard of care period without active intervention followed by Digital treatment with active intervention	Other: Standard of care; Standard of care as prescribed by healthcare provider.; Device: Nottingham AR smartphone app with active intervention; AR software treatment delivered by smartphone app and developed by VRx Medical (VRx) using established principles of illusion therapies (e.g. mirror therapy) for pain management.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Milligrams of Morphine Equivalent (MME)	MME is a standard measure of opioid use	Change from baseline to day 30
The Pain, Enjoyment of Life and General Activity scale (PEG)	PEG is a three-Item scale assessing pain intensity and interference. Scale is from 0 (no pain) to 10 (pain as bad as you can imagine).	Change from baseline to day 30

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Non-opioid pain medicine usage	Pain medicine usage will be tracked for dose and frequency.	Change from baseline to day 30
Pain Disability Index (PDI)	PDI is a standard questionnaire designed to help patients measure the degree their daily lives are disrupted by chronic pain.	Change from baseline to day 30
Patient Health Questionnaire (PHQ-9)	PHQ-9, a Quick Depression Assessment, is a reliable and valid measure of depression. severity	Change from baseline to day 30
Resting State brain imaging data	fMRI compare pre- to post treatment - imaging data to show hyperactivities and enhanced functional connectivity in supraspinal regions associated with the affective aspect of pain perception.	Change from baseline to day 30

Collaborators and Investigators

• Sponsor: VRx Medical Inc
• Collaborators: National Institute on Drug Abuse (NIDA); San Diego Veterans Healthcare System
• Investigators: Principal Investigator: Thomas Rutledge, PhD, San Diego Veterans Healthcare System

Study record dates

Study Major Dates

• Study Start (Actual): June 13, 2022
• Primary Completion (Actual): June 16, 2023
• Study Completion (Actual): July 21, 2023

Study Registration Dates

• First Submitted: November 21, 2022
• First Submitted That Met QC Criteria: November 21, 2022
• First Posted (Actual): December 2, 2022

Study Record Updates

• Last Update Posted (Actual): July 25, 2023
• Last Update Submitted That Met QC Criteria: July 22, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Augmented Reality; Smartphone application; Digital Therapeutic
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthritis; Chronic Pain
• Other Study ID Numbers: H210106

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