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.
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
36
Standard of care as prescribed by healthcare provider.
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.
VA San Diego Healthcare System
San Diego, California, United States
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).
Time frame: Change from baseline to day 30
Milligrams of Morphine Equivalent (MME)
MME is a standard measure of opioid use
Time frame: 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.
Time frame: Change from baseline to day 30
Non-opioid pain medicine usage
Pain medicine usage will be tracked for dose and frequency.
Time frame: 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.
Time frame: 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
Time frame: Change from baseline to day 30
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