Research into Non-Opioid Therapies for Pain at Department of Veterans Affairs

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Research into Non-Opioid Therapies for Pain at Department of Veterans Affairs David Atkins, MD, MPH Director, Health Services Research & Development Service

August 2018 Chronic Pain and Opioid use among Among Service Members after Combat Deployment

Unique Aspects of VA for Pain Research Serves 6 million Veterans at over 1000 sites of care Focus on implementation, spread, fidelity Emphasis on self-care, telehealth, caregiver issues Global budget Need to assess value of new interventions Demand for different approaches, virtual options Steady increase in provision of CIH in VA 2015: 93% of medical centers offer 2+ CIH modalities Pain often overlaps with other co-morbidities Need to address mental health, SUD, social support August 2018 COVER Commission 3

Results: What CIH Did Veterans Use in Past Year 52% used any type of CIH approach in the past year (n=1,230): 44% massage therapy 11% mantram meditation 37% chiropractic 10% Tai Chi 34% mindfulness 9% guided imagery 24% non-mindful/mantram medit. 9% healing/therapeutic touch or reiki 25% yoga 8% creative art therapy 20% progressive relaxation 7% biofeedback 17% acupuncture 6% Pilates 17% movement therapy 6% Qi Gong 15% animal assisted therapy 5% Native American healing 14% acupressure 4% EMDR 12% reflexology 3% using hypnotherapy/hypnosis August 2018 COVER Commission 4 6

Office of Research and Development Biomedical and Laboratory (BLR&D) supports preclinical (cellular and animal) research to understand molecular, genomic, and physiological Clinical Science (CSR&D): Human subject research to identify causes of disease and to test the effectiveness of new drugs, therapy, or devices. Cooperative Studies Program (CSP) large, multi-site trials Health Services (HSR&D): Studies issues of health care system and delivery, including access, quality and safety, costs and value, implementation, and patient experience. Rehabilitation (RR&D): Novel approaches to restore full and productive lives to Veterans with traumatic amputation, central nervous system injuries, loss of sight or hearing, or other physical and cognitive impairments. August 2018 COVER Commission 5

VA-ORD FY2018 Pain Portfolio Combination Surgical Cell/Gene CIH Tai Chi Yoga Spine Acupuncture Other: Diagnostics Health Svcs Mechanistic Model Dev t Non-Pharma Pharma Activity Exercise Tech-based Orthotics Electroceuticals Biobehavioral Health Coaching Whole health VETERANS HEALTH ADMINISTRATION Total # of Projects - 151

Studies on CIH & pain CIH Interventions Conditions Chronic musculoskeletal pain Lower back pain Muscle pain Neck pain Acupuncture Biofeedback Exercise training Guided imagery Hypnosis Massage Meditation Spinal cord manipulation Tai Chi Yoga Outcomes Cost of healthcare utilization Health-related QOL Mental health (anxiety, depression, stress) Opioid use Pain severity August 2018 COVER Commission 7

2016: VA State of the Art Conference Non-Opioid Therapy for Chronic Musculoskeletal Pain Multiple therapies have sufficient evidence to support broad implementation Manual therapies Acupuncture Manipulation Massage Exercise/movement therapies Exercise (aerobic, resistance coordination/stabilization,) Tai Chi Yoga Behavioral/psychological therapies Cognitive Behavioral Therapy (CBT) Acceptance & Commitment Therapy (ACT) Mindfulness-Based Stress Reduction (MBSR) Kligler B, et al. J Gen Intern Med 2018;33(S1):S16-23

Evidence gaps relate to dose, delivery, and strategies to enhance participation For most therapies, need further study of Delivery approaches (e.g., in-person vs. on-line, group vs. individual) Dose (e.g., frequency, intensity, duration) Strategies for engaging patients, improving adherence, and maintaining benefits For care delivery models, need further study of multi-site implementation Becker WC, et al. J Gen Intern Med 2018;33(S1):S11-15

Ongoing Non-Opiod Research at VA PMC Trial (Taylor and Zeliadt) : 1) practitioner-delivered care (acupuncture & chiropractic) ; 2) self-care therapies (yoga, meditation and Tai Chi) vs 3) combination VOICE Trial Krebs (PCORI) low-intensity (Telecare pharmacist CM) to high-intensity (integrated pain team) strategy f Cost effectiveness of CIH for chronic pain Caregiver-assisted vs. therapist massage for chronic pain Yoga vs. structured exercise Pain management in patients with co-occuring substance use

Conclusions Growing evidence base for the effectiveness of non-opioid therapies, stepped-care and integrated pain therapy. Remaining challenges involve how to make patient-centered approaches scalable, affordable and accountable across a diverse system.

Extra Slides

Veterans Pain Care Organizational Improvement Comparative Effectiveness (VOICE) Trial Randomized trial of 2 care delivery strategies for Veterans with chronic pain on long-term opioids Telecare Collaborative Management (pharmacist care manager) = low intensity arm Integrated Pain Team = high intensity arm Objective: To improve effectiveness and safety of pain management by increasing use of non-opioid therapies & supporting opioid dose reduction Funded by PCORI OPD-1511-33052 and supported by VA resources and facilities

Two VA studies highlighted as having most promising approach to multi-modal stepped care Peterson K, et al. J Gen Intern Med 2018;33(S1):S71-81

Evidence-based Synthesis Program The Evidence Synthesis Program produces summaries of existing evidence based on careful review of individual research studies. Evidence Maps are a convenient way to summarize a large body of research using published reviews. Evidence map topics: Evidence Map of Acupuncture (2013) Evidence Map of Yoga for High-Impact Conditions Affecting Veterans (2014) Evidence Map of Mindfulness (2014) Evidence Map of Tai Chi (2014) Massage for Pain: An Evidence Map (2016) Evidence Map on Guided Imagery, Biofeedback, & Hypnosis (in progress) August 2018 COVER Commission 15

Evidence Map: Acupuncture & Pain Hempel, S., Taylor, S. L., Solloway, M., Miake-Lye, I. M., Beroes, J. M., Shanman, R., Booth, M. J., Siroka, A. M., Shekelle, P. G. Evidence Map of Acupuncture. VA-ESP Project #05-226; 2013 No effect? effect Possible effect Positive effect 16

Other ESP reviews CAM & PTSD (2011) Computerized CBT (2013) Repetitive TMS for Treatment-Resistant Depression (2014) CIH Use for Preventing or Reducing Opioid Use (2016) Cannabis & Chronic Pain/PTSD (2017) Stellate Ganglion Block for PTSD (2017) HBOT for TBI &/or PTSD (2018) Cranial Electrical Stimulation (2018) August 2018 COVER Commission 17