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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effects of the Nottingham Arthritis App for Arthritis Pain

Conditions
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Chronic Pain, Arthritis Hand, Opioid Use

Intervention / Treatment
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* Other: Standard of care
* Device: Nottingham AR smartphone app with active intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female adults ages 21-80 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: Major medical illness that might confound effects of pain on function (e.g., advanced cardiac or pulmonary disease) Current active alcohol or substance use disorder as evidenced from medical record Currently active unstable psychiatric status in previous three months as measured by direct observation, patient self-report, or medical record Moderate or severe cognitive impairment as demonstrated by medical diagnosis or clinical observation fMRI exclusion only: Any factors that would prevent participation in fMRI

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Standard of Care followed by AR digital treatment<br>Standard of care period without active intervention followed by Digital treatment with active intervention | Other: Standard of care<br>* Standard of care as prescribed by healthcare provider.<br>Device: Nottingham AR smartphone app with active intervention<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Milligrams of Morphine Equivalent (MME) | MME is a standard measure of opioid use | Change from baseline to day 30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Augmented Reality, Smartphone application, Digital Therapeutic