Limbix Health, Inc. — Department of Health and Human Services SBIR Phase I: NIDA

Description

PROJECT SUMMARY ABSTRACT Chronic pain affects overmillion adults in the USresulting in disabilityloss of work productivityand overall reductions in healthmaking chronic pain a major public health problem with an economic burden estimated at $billion annuallyOpioidsthe most frequently prescribed class of drugs to control painlack evidence supporting their long term efficacy and carry arisk of misuse and abuse among pain patientshighlighting a critical need to develop effective non pharmacological interventions for painGuided imageryGIa cognitive behavioral technique for guiding patients to create multisensoryimagined scenes to increase well beingis an effective non pharmacological intervention for reducing painHoweverits effectiveness is limited by patientsandaposimaging abilitiesThe long term objective of this project is to reduce chronic pain and opioid use by developing an at home virtual realityVRGI intervention to improve chronic pain management using the Limbix VR KitGiven the enhanced immersiveness and interactivity of VRVR GI is expected to reduce pain and reliance on opioidsas well as improve functional outcomes and moodcompared to traditional audio only GI and usual careSpecific aims of this Phase I application are todevelop and add VR GI intervention prototypes for chronic pain management to the existing Limbix VR platformevaluate feasibility and usability of VR GI experiences based on patient and provider feedback andevaluate feasibility and usability of an at home VR GI intervention in aweek clinical trial and prepare for a larger subsequent clinical trialTwomin VR GI experiences that guide patients through psychoeducationrelaxation exercisesand interactive virtual worlds that allow them to control their experience of pain will be created and added to the Limbix VR platform for the interventionInitial feasibility will be assessed with chronic pain patients and providers with iterative changes made based on feedback receivedTo assess feasibility of an at home VR GI interventionadditional patients with chronic painwith chronic neck or back painCNBPandwith complex regional pain syndromeCRPSwill complete aweek intervention with at home daily practice of VR GInor audio only GInPre post treatment measures of pain intensityopioid usefunctional outcomesand mood will be collectedIntervention feasibility and patient satisfaction will be evaluated post treatment via questionnaire and qualitative interviewBased on Phase I resultsa Phase II randomized clinical trial will evaluate the efficacy of VR GI in reducing pain and reliance on opioids in CNBP and or CRPS patientsThis research directly addresses the need to improve pain treatment to prevent opioid use disorder PROJECT NARRATIVEPUBLIC HEALTH STATEMENTChronic pain is a major public health problem and has contributed to the opioid epidemicas many chronic pain patients rely on and misuse or abuse opioids during pain managementThe successful development and commercialization of an at home virtual reality guided imagery intervention could enhance the efficacy of an effective non pharmacological pain management techniqueThis intervention is expected to reduce chronic pain and reliance on opioidswhichin turncould reduce rates of opioid use disorder