Lead/Presenter: Matthew Bair,
COIN - Indianapolis
All Authors: Bair MJ (VA HSR&D Center for Health Information and Communication), Outcalt SD (VA HSR&D Center for Health Information and Communication), Slaven JE (Indiana University School of Medicine, Department of Biostatistics) Kroenke K (Indiana University School of Medicine, Department of Medicine) Kempf C (VA HSR&D Center for Health Information and Communication) Zillich AJ (Purdue University, Department of Pharmacy Practice) Damush TM (VA HSR&D Center for Health Information and Communication) Saha C (Indiana University School of Medicine, Department of Biostatistics) French D (VA HSR&D Center of Innovation for Complex Chronic Healthcare) Krebs EE (VA HSR&D Center for Care Delivery and Outcomes Research)
The objective of the CAMEO Trial was to compare the effectiveness of pharmacological treatment and optimization vs. cognitive behavioral therapy for Veterans with chronic lower back pain on chronic opioid therapy.
CAMEO was designed as a 2-arm, randomized clinical trial. The study setting was 5 general medicine clinics at a Veteran Affairs Medical Center and 2 community based outpatient clinics. Participants included 261 Veterans with chronic low back pain of at least moderate intensity who were on chronic opioid therapy at baseline. The pharmacological (PHARM) arm involved nurse care management focused on analgesic treatment and optimization according to an algorithm. The behavioral (BEHAV) arm involved cognitive behavioral therapy delivered by clinical psychologists. The primary outcomes were pain impact, pain intensity, and pain interference as assessed by the Brief Pain Inventory (BPI).
The mean age participants was 57.9 years, 92% men, 73% White and 21% Black. At 12 months, the adjusted mean decrease from baseline in the BPI total score (pain impact) was 0.64 points (Standard deviation [SD] = 0.22) in the BEHAV group and 1.14 points (SD = 0.23) in the PHARM group (between group difference of 0.5 points, p = 0.0423). Scores were adjusted for baseline BPI total score, depression (PHQ-9), and gender. At 12 months, BPI pain intensity decreased by 0.40 points in the BEHAV group (SD = 0.19) and 1.02 points (SD = 0.20) in the PHARM group (between group difference of 0.62, p = 0.0044). The mean decrease from baseline in the BPI interference score was 0.71 points in the BEHAV group and 1.19 points in the PHARM group (between group difference of 0.48 points; p = 0.0846). There were no differences in secondary outcomes (depression, anxiety, PTSD, and health-related quality of life) across study arms.
A nurse care management intervention focused on pharmacological management reduced pain impact and intensity more than a behavioral intervention involving cognitive behavioral therapy.
While the between-group differences were statistically significant, these differences may not be clinically significant. To improve treatment effects combination therapy is likely needed especially for patients with "complex" chronic low back pain.