Chronic pain affects over 100 million adults in the US, resulting in disability, loss of work productivity, and overall reductions in health, making chronic pain a major public health problem with an economic burden estimated at $560-635 billion annually. Opioids, the most frequently prescribed class of drugs to control pain, lack evidence supporting their long-term efficacy and carry a 15-26% risk of misuse and abuse among pain patients, highlighting a critical need to develop effective non-pharmacological interventions for pain. Guided imagery (GI), a cognitive-behavioral technique for guiding patients to create multisensory, imagined scenes to increase well-being, is an effective non-pharmacological intervention for reducing pain. However, its effectiveness is limited by patients' imaging abilities. The long-term objective of this project is to reduce chronic pain and opioid use by developing an at-home virtual reality (VR)-GI intervention to improve chronic pain management using the Limbix VR Kit. Given the enhanced immersiveness and interactivity of VR, VR-GI is expected to reduce pain and reliance on opioids, as well as improve functional outcomes and mood, compared to traditional audio-only GI and usual care.
Specific aims of this Phase I application are to: 1) develop and add VR-GI intervention prototypes for chronic pain management to the existing Limbix VR platform, 2) evaluate feasibility and usability of VR-GI experiences based on patient and provider feedback and 3) evaluate feasibility and usability of an at-home VR-GI intervention in a 2-week clinical trial and prepare for a larger subsequent clinical trial. Two 15-min VR-GI experiences that guide patients through psychoeducation, relaxation exercises, and interactive virtual worlds that allow them to control their experience of pain will be created and added to the Limbix VR platform for the intervention. Initial feasibility will be assessed with chronic pain patients and providers with iterative changes made based on feedback received. To assess feasibility of an at-home VR-GI intervention, 36 additional patients with chronic pain (18 with chronic neck or back pain, CNBP, and 18 with complex regional pain syndrome, CRPS) will complete a 2-week intervention with at-home daily practice of VR-GI (n = 24) or audio-only GI (n = 12). Pre-post treatment measures of pain intensity, opioid use, functional outcomes, and mood will be collected. Intervention feasibility and patient satisfaction will be evaluated post-treatment via questionnaire and qualitative interview. Based on Phase I results, a Phase II randomized clinical trial will evaluate the efficacy of VR-GI in reducing pain and reliance on opioids in CNBP and/or CRPS patients. This research directly addresses the need to improve pain treatment to prevent opioid use disorder.

Public Health Relevance

(PUBLIC HEALTH STATEMENT) Chronic pain is a major public health problem and has contributed to the opioid epidemic, as many chronic pain patients rely on and misuse or abuse opioids during pain management. The successful development and commercialization of an at-home virtual reality guided imagery intervention could enhance the efficacy of an effective non-pharmacological pain management technique. This intervention is expected to reduce chronic pain and reliance on opioids, which, in turn, could reduce rates of opioid use disorder.

National Institute of Health (NIH)
National Institute on Drug Abuse (NIDA)
Small Business Innovation Research Grants (SBIR) - Phase I (R43)
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Special Emphasis Panel (ZDA1)
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Angelone, Leonardo Maria
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Limbix Health, Inc.
Palo Alto
United States
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