Objective Patients with chronic low back pain (CLBP) and comorbid depression or anxiety disorders are highly prevalent. Negative affect (NA) refers to a combination of negative thoughts, emotions, and behaviors. CLBP patients with high NA have greater pain, worse treatment outcomes, and greater prescription opioid misuse. We present the protocol for SYNNAPTIC– SYNergizing Negative Affect & Pain Treatment In Chronic pain. Design A randomized comparative effectiveness study of antidepressants, fear avoidance rehabilitation, or their combination in 300 CLBP patients with high NA. SYNNAPTIC includes an adaptive design in the antidepressant or rehabilitation only arms of rerandomization after four months for non-responders. Setting A multisite trial conducted in routine pain clinical treatment settings—pain clinics and physical and occupational therapy treatment centers Methods Inclusion criteria include CLBP with elevated depression and anxiety symptoms. Antidepressant and rehabilitation treatments follow validated and effective protocols for musculoskeletal pain in patients with high NA. Power and sample size are based on superior outcomes of combination therapy of these same treatments in a 71-subject 4-arm pilot randomized controlled trial. Conclusions SYNNAPTIC addresses the lack of evidence-based protocols for the treatment of the vulnerable subgroup of patients with CLBP and high NA. We hypothesize that combination therapy of antidepressants + fear avoidance rehabilitation will be more effective than each treatment alone.

Background: Cardiovascular instability occurring during endotracheal intubation (ETI) in the critically ill is a commonly recognized phenomenon. However, this complication has not been evaluated in terms of the physiological cause (ie, decreased preload, contractility, or afterload) leading to the instability. Thus, the aim of the current investigation was to describe the hemodynamics occurring during ETI with noninvasive physiologic monitoring and to collect preliminary data on the hemodynamic effects of induction agents and positive pressure ventilation. Methods: A multicenter prospective study enrolling adult (≥18 years) critically ill patients undergoing ETI with noninvasive cardiac output monitoring in a medical/surgical intensive care unit from June 2018 to May 2019 was conducted. This study used the Cheetah Medical noninvasive cardiac output monitor to collect hemodynamic data during the peri-intubation period. Additional data collected included baseline characteristics such as illness severity, peri-intubation pharmacologic administration, and mechanical ventilation settings. Results: From the original 27 patients, only 19 (70%) patients had complete data and were included in the final analysis. Propofol was the most common sedative 8 (42%) followed by ketamine 6 (32%) and etomidate 5 (26%). Patients given propofol demonstrated a decrease in total peripheral resistance index (delta change [dynes × s/cm−5/m2]: −2.7 ± 778.2) but stabilization in cardiac index (delta change (L/min/m2]: 0.1 ± 1.5) while etomidate and ketamine demonstrated increases in total peripheral resistance index (etomidate delta change [dynes × s/cm−5/m2]: 302.1 ± 414.3; ketamine delta change [dynes × s/cm−5/m2]: 278.7 ± 418.9) but only etomidate resulted in a decrease in cardiac index (delta change [L/min/m2]: −0.3 ± 0.5). Positive pressure ventilation resulted in minimal changes to hemodynamics during ETI. Conclusions: The current study demonstrates that although propofol administration leads to a decrease in total peripheral resistance index, cardiac index is maintained while etomidate leads to a decrease in cardiac index with both etomidate and ketamine increasing total peripheral resistance index. These hemodynamic profiles are minimally affected by positive pressure ventilation. Study registration: ClinicalTrials.gov ID, NCT03525743.

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