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Item Design and methods of the Care Management for the Effective Use of Opioids (CAMEO) trial(Elsevier, 2021-07) Bushey, Michael A.; Slaven, James; Outcalt, Samantha D.; Kroenke, Kurt; Kempf, Carol; Froman, Amanda; Sargent, Christy; Baecher, Brad; Zillich, Alan; Damush, Teresa M.; Saha, Chandan; French, Dustin D.; Bair, Matthew J.; Medicine, School of MedicineLow back pain is the most common pain condition seen in primary care, with the most common treatment being analgesic medications, including opioids. A dramatic increase in opioid prescriptions for low back pain over the past few decades has led to increased non-medical use and opioid overdose deaths. Cognitive behavioral therapy (CBT) for chronic pain is an evidence-based non-pharmacological treatment for pain with demonstrated efficacy when delivered using collaborative care models. No previous studies have tested CBT compared to analgesic optimization that includes opioid management in primary care. This paper describes the study design and methods of the CAre Management for the Effective use of Opioids (CAMEO) trial, a 2-arm, randomized comparative effectiveness trial in seven primary care clinics. CAMEO enrolled 261 primary care veterans with chronic (6 months or longer) low back pain of at least moderate severity who were receiving long-term opioid therapy and randomized them to either nurse care management focused on analgesic treatment and optimization (MED) or cognitive behavioral therapy (CBT). All subjects undergo comprehensive outcome assessments at baseline, 3, 6, 9, and 12 months by interviewers blinded to treatment assignment. The primary outcome is pain severity and interference, measured by the Brief Pain Inventory (BPI) total score. Secondary outcomes include health-related quality of life, fatigue, sleep, functional improvement, pain disability, pain beliefs, alcohol and opioid problems, depression, anxiety, and stress.Item Massage Effectiveness for Primary Care Patients with Chronic Low Back Pain and Below Normal SF-36v2 Mental Health Scores: Secondary Analysis(2014-05) Munk, Niki; Elder, William; Love, MargaretPurpose: The challenging condition of chronic low back pain (CLBP) is often complicated by negative mental health factors. Non-pharmacological approaches to address CLBP alone and in combination with mental health issues are needed. A recently completed NIH funded study examined the effectiveness of clinical massage therapy (CMT) on functional health outcomes for CLBP patients referred to CMT by their PCP regardless of mental health status save psychosis. CMT was found to have significant and clinically meaningful effectiveness for patients (N=85) in the primary outcomes: Oswestry Disability Index, SF-36v2 mental and physical components and pain domain (in review). The purpose this study's secondary analysis is to determine the extent to which participants that began the study below normal in the SF-36v2 mental health component had clinically meaningful change. Methods: CLBP patients referred by their PCP were assigned to community massage practitioners (CMPs) to receive up to ten, 1-hour CMT sessions over 12-weeks. Individual treatment plans were formulated by study CMPs. Secondary data analyses were conducted examining a subpopulation (n=41) of those beginning the study at below normal (<45) for the SF-36v2 mental health component score. Results: Mean change for those