• Ajay D Wasan, Robert R Edwards, Kevin L Kraemer, Jong Jeong, Megan Kenney, Kevin Luong, Marise C Cornelius, Caitlin Mickles, Bhagya Dharmaraj, Essa Sharif, Anita Stoltenberg, Trent Emerick, Jordan F Karp, Matt J Bair, Steven Z George, and William M Hooten.
• Department of Anesthesiology and Perioperative Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA 15206, United States.
• Pain Med. 2023 Aug 4; 24 (Suppl 1): S105S114S105-S114.

ObjectivePatients 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. Patients with CLBP 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).DesignA randomized comparative-effectiveness study of antidepressants, fear-avoidance rehabilitation, or their combination in 300 patients with CLBP with high NA. In the antidepressant- or rehabilitation-only arms, SYNNAPTIC includes an adaptive design of re-randomization after 4 months for nonresponders.SettingA multisite trial conducted in routine pain clinical treatment settings: pain clinics and physical and occupational therapy treatment centers.MethodsInclusion 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 with these same treatments in a 71-subject 4-arm pilot randomized controlled trial.ConclusionsSYNNAPTIC 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 plus fear-avoidance rehabilitation will be more effective than each treatment alone.Trial RegistrationClinicalTrials.gov ID: NCT04747314.© The Author(s) 2023. Published by Oxford University Press on behalf of the American Academy of Pain Medicine.

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