Arthritis is the leading cause of disability among adults, affecting 54 million Americans today and estimated togrow to 78 million arthritis sufferers by 2040. Arthritis is the most common chronic condition among chronic usersof opioids in the US, accounting for the largest portion of the $200 billion cost to society of opioid use disorder.Of Americans with arthritis, 25 million live with severe joint pain. Current approaches to address arthritis pain,such as opioids, surgery, and physical therapies are invasive, expensive, and come with associated risks andunwanted adverse side effects. Thus, there is an unmet need to develop an alternative therapy that can relievejoint pain for patients with similar (or better) efficacy that is digital, drug-free, more permanent, low risk, low cost,and accessible. VRx Medical (VRx) has developed "Nottingham", a smartphone app that uses AugmentedReality (AR) to ameliorate arthritis pain in the hands, feet, and knees. Nottingham will enable customers withjoint pain to self-manage their own condition at a lower cost and risk than other remedies available, includingopioids and other similar addictive pain medications. A component of arthritic pain has brain-based origins;therefore, using AR to change what the brain "sees" has the same cortical reorganization benefits of MirrorTherapy (MT) and illusions that reduce pain in complex regional pain syndrome type 1 (CRPS1) patients. Also,like Mirror Therapy, Nottingham has promising potential to impact the cortical plasticity of the brain with effectsthat lead to long-lasting pain relief. This Phase I project will optimize the Nottingham AR therapy developmentand commercialization by evaluating Nottingham efficacy in a proof-of-concept feasibility study with 20diagnosed osteoarthritis sufferers. The study is designed to further investigate the underlying mechanisms andvalidate the beneficial effects as compared to a placebo version of the app. Participants will receive either theAR or placebo therapy treatment for three months. Efficacy data and pre/post therapy fMRI scans will becompared for each group. Completion of Phase I will enable VRx to perform a larger Phase II clinical study toprovide an alternative pain management therapy to opioids. Our ultimate goal is to bring Nottingham to end-users, payers, employers, and health plans and use this novel, AR-based, opioid-avoiding pain treatment toimprove the lives of arthritis patients suffering from joint pain.
Public Health Relevance Statement: PROJECT NARRATIVE
VRx Medical (VRx) has developed a smartphone app, "Nottingham", which uses Augmented Reality (AR) to
ameliorate arthritis pain in the hands, feet, and knees. Nottingham is intended to allow users to self-manage their
joint pain at a lower cost and risk than other remedies available, including opioids, surgery, and physical therapy.
This project will evaluate Nottingham efficacy in a proof-of-concept clinical trial in patients with chronic pain due
to diagnosed hand osteoarthritis.
Project Terms: Accounting ; Adult ; 21+ years old ; Adult Human ; adulthood ; Affect ; Aftercare ; After Care ; After-Treatment ; post treatment ; Pain management ; Pain Control ; Pain Therapy ; pain treatment ; Analgesics ; Analgesic Agents ; Analgesic Drugs ; Analgesic Preparation ; Anodynes ; Antinociceptive Agents ; Antinociceptive Drugs ; pain killer ; pain medication ; pain reliever ; painkiller ; Arthralgia ; Joint Pain ; Arthritis ; arthritic ; Body Image ; body perception ; Brain ; Brain Nervous System ; Encephalon ; Clinical Research ; Clinical Study ; Clinical Trials ; Data Collection ; Data Reporting ; data representation ; Diagnosis ; Pharmaceutical Preparations ; Drugs ; Medication ; Pharmaceutic Preparations ; drug/agent ; Feasibility Studies ; Feedback ; foot ; Foundations ; Goals ; Hand ; Healthcare Systems ; Health Care Systems ; Illusions ; Knee ; Lead ; Pb element ; heavy metal Pb ; heavy metal lead ; Lighting ; Illumination ; Degenerative polyarthritis ; Degenerative Arthritis ; Osteoarthritis ; Osteoarthrosis ; degenerative joint disease ; hypertrophic arthritis ; osteoarthritic ; Pain ; Painful ; Patients ; Pilot Projects ; pilot study ; Placebo Effect ; expectancy effect ; expectation effect ; nocebo ; placebo response ; Placebos ; Sham Treatment ; sham therapy ; Research ; research and development ; Development and Research ; R & D ; R&D ; Research Personnel ; Investigators ; Researchers ; Risk ; Size Perception ; Societies ; Standardization ; Surveys ; Survey Instrument ; Technology ; Telephone ; Phone ; Testing ; Self Management ; chronic pain ; Custom ; base ; improved ; Area ; Chronic ; Clinical ; Phase ; Variant ; Variation ; Medical ; Training ; disability ; Opioid ; Opiates ; non-opioid analgesic ; non-narcotic analgesic ; non-opiate analgesic ; non-opioid ; non-opioid therapeutics ; nonnarcotic analgesics ; nonopiate analgesic ; nonopioid ; nonopioid analgesics ; Protocol ; Protocols documentation ; CPRS Type I ; CPRS Type Is ; CRPS Type I ; CRPS Type II ; Causalgia ; Complex Regional Pain Syndrome Type II ; Deafferentation Pain ; Pain Syndrome Type I, Regional, Complex ; Reflex Sympathetic Dystrophy ; Reflex Sympathetic Dystrophy Syndrome ; Shoulder-Hand Syndrome ; Sudek Atrophy ; Complex Regional Pain Syndromes ; Operative Procedures ; Surgical ; Surgical Interventions ; Surgical Procedure ; surgery ; Operative Surgical Procedures ; Digit ; Digit structure ; American ; experience ; Performance ; Stretching ; novel ; Participant ; research study ; Position ; Positioning Attribute ; Coding System ; Code ; response ; develop software ; developing computer software ; software development ; portability ; Alternative Therapies ; Physiatric Procedure ; Physical Medicine Procedure ; Physical Therapeutics ; Physiotherapy ; Physical therapy ; Effectiveness ; Address ; Length ; Base of the Brain ; Data ; Neurologic Process ; Process ; Image ; imaging ; cost ; virtual ; digital ; design ; designing ; Persistent pain ; constant pain ; lasting pain ; on-going pain ; ongoing pain ; mental representation ; usability ; therapy development ; develop therapy ; intervention development ; treatment development ; prototype ; commercialization ; evidence base ; product development ; operation ; arthritic pain ; arthritis pain ; Hand Osteoarthritis ; Hand OA ; Augmented Reality ; opioid use disorder ; opiate use disorder ; pain symptom ; painful symptom ; functional MRI scan ; fMRI scan ; functional magnetic resonance imaging scan ; smartphone Application ; Android App ; Android Application ; Cell Phone Application ; Cell phone App ; Cellular Phone App ; Cellular Phone Application ; Smart Phone App ; Smart Phone Application ; Smartphone App ; iOS app ; iOS application ; iPhone App ; iPhone Application ; health plan ; health plans ; pain reduction ; reduce pain ; pain patient ; chronic pain patient ; patient with chronic pain ; pain relief ; relieve pain ; pain perception ; opioid user ; Opiate user ; Opioid drug user ; PWUO ; people who use opioids ; persons who use opioids ; neural network ; side effect ; opioid sparing ; digital treatment ; digital therapeutics ; digital therapy ; effectiveness study ; feasibility research ;
