Using Augmented Reality illusion therapy to develop a non-opioid chronic pain digital treatment

使用增强现实幻觉疗法开发非阿片类慢性疼痛数字治疗

• 批准号: 10152726
• 负责人: PAUL LAFFERTY
• 金额: $ 25.06万
• 依托单位: VRX MEDICAL INC.
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-01 至 2024-03-01
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10152726
• 关键词: Accounting; Address; Adult; Affect; Aftercare; Alternative Therapies; American; Analgesics; Area; Arthralgia; Arthritis; Augmented Reality; Base of the Brain; Body Image; Brain; Chronic; Clinical; Clinical Research; Clinical Trials; Code; Complex Regional Pain Syndromes; Custom; Data; Data Collection; Data Reporting; Degenerative polyarthritis; Diagnosis; Digit structure; Effectiveness; Feasibility Studies; Feedback; Foundations; Goals; Hand; Hand Osteoarthritis; Healthcare Systems; Illusions; Image; Knee; Lead; Length; Lighting; Medical; Neurologic Process; Operative Surgical Procedures; Opioid; Pain; Pain management; Participant; Patients; Performance; Persistent pain; Pharmaceutical Preparations; Phase; Physical therapy; Pilot Projects; Placebo Effect; Placebos; Positioning Attribute; Process; Protocols documentation; Research; Research Personnel; Risk; Self Management; Size Perception; Societies; Standardization; Stretching; Surveys; Technology; Telephone; Testing; Training; Variant; arthritic pain; base; chronic pain; chronic pain patient; commercialization; cost; design; digital; digital treatment; disability; effectiveness study; evidence base; experience; feasibility research; foot; functional MRI scan; health plan; improved; mental representation; neural network; non-opioid analgesic; novel; operation; opioid sparing; opioid use disorder; opioid user; pain patient; pain perception; pain reduction; pain relief; pain symptom; portability; product development; prototype; research and development; research study; response; side effect; smartphone Application; software development; therapy development; usability; virtual

PROJECT SUMMARY Arthritis is the leading cause of disability among adults, affecting 54 million Americans today and estimated to grow to 78 million arthritis sufferers by 2040. Arthritis is the most common chronic condition among chronic users of 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 and unwanted adverse side effects. Thus, there is an unmet need to develop an alternative therapy that can relieve joint 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 Augmented Reality (AR) to ameliorate arthritis pain in the hands, feet, and knees. Nottingham will enable customers with joint pain to self-manage their own condition at a lower cost and risk than other remedies available, including opioids 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 Mirror Therapy (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 effects that lead to long-lasting pain relief. This Phase I project will optimize the Nottingham AR therapy development and commercialization by evaluating Nottingham efficacy in a proof-of-concept feasibility study with 20 diagnosed osteoarthritis sufferers. The study is designed to further investigate the underlying mechanisms and validate the beneficial effects as compared to a placebo version of the app. Participants will receive either the AR or placebo therapy treatment for three months. Efficacy data and pre/post therapy fMRI scans will be compared for each group. Completion of Phase I will enable VRx to perform a larger Phase II clinical study to provide 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 to improve the lives of arthritis patients suffering from joint pain.

项目摘要 关节炎是成年人残疾的主要原因，今天影响了5400万美国人，据估计 到2040年，增长到7800万关节炎患者。关节炎是慢性使用者中最常见的慢性病 在美国，o opioids的占骨使用障碍社会的2000亿美元成本中的最大部分。 在关节炎的美国人中，有2500万人患有严重的关节疼痛。当前解决关节炎疼痛的方法， 例如阿片类药物，手术和物理疗法具有侵入性，昂贵，并带有相关风险，并且 不需要的不良副作用。那是有未满足的需要开发可以营救的替代疗法 对于具有数字，无药物，更永久，低风险，低成本的类似（或更好）效率的患者的关节疼痛， 可访问。 VRX Medical（VRX）开发了使用增强的智能手机应用程序“诺丁汉” 现实（AR）可以缓解手，脚和膝盖的关节炎疼痛。诺丁汉将使客户与 与其他可用疗法相比 opioid和其他类似的其他止痛药。 artritic疼痛的一个组成部分具有基于大脑的起源。 因此，使用AR改变大脑的“看到”具有相同的皮质重组优势的镜子 治疗（MT）和幻觉减轻了复杂区域疼痛综合征1型（CRPS1）患者的疼痛。还， 像镜像疗法一样，诺丁汉已承诺潜力影响大脑的皮质可塑性 这导致了持久的疼痛缓解。该阶段I项目将优化诺丁汉AR疗法开发 和通过评估诺丁汉效率在概念验证可行性研究中通过20 诊断出骨关节炎患者。该研究旨在进一步研究基本机制和 与该应用程序的安慰剂版本相比，验证有益效果。参与者将收到 AR或安慰剂治疗三个月。功效数据和治疗前/治疗后FMRI扫描将是 每组比较。第一阶段的完成将使VRX能够进行更大的II期临床研究 为阿片类药物提供替代性疼痛管理疗法。我们的最终目标是将诺丁汉带到最终 用户，付款人，雇主和健康计划，并使用这种小说，基于AR的，避免阿片类药物的疼痛治疗 改善关节疼痛患者的关节炎患者的生活。