Background: Chronic spinal pain affects many in the United States and is associated with rising healthcare costs - but not improved outcomes. Education and self-care promotion are hallmarks of the recommended approach for this condition. Pain Neuroscience Education (PNE) is a method of educating patients about the neurophysiology of pain that aims to reconceptualize pain from an indicator of damage to an interpretation of input signals by the brain and nervous system. PNE has shown efficacy in controlled situations when delivered by experts, but its effectiveness has not been investigated among trained clinicians in a pragmatic setting.
Methods: A cluster randomized trial will randomly assign 16 clinic regions to either receive PNE training or continue with usual care. Patients with chronic neck or back pain will be enrolled to provide outcome data. Measures will be collected at baseline, 2 weeks, and 12 weeks. The primary outcome will be the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function computer-adapted test (PF-CAT). Pre-specified statistical analyses will compare outcomes between clinic regions assigned to PNE treatment or usual care while using random effects to account for region-level clustering.
Discussion: Pain Neuroscience Education has been shown efficacious for a variety of patient-centered outcomes for those with chronic pain, but it has not yet been investigated outside of controlled settings. This trial has the potential to promote PNE as a low-cost intervention for chronic spinal pain and affect physical therapy education.
Trial registration: ClinicalTrials.gov identifier NCT03168165 , registered May 30, 2017.
Keywords: Chronic pain; Cluster randomized trial; Low back pain; Pain neuroscience education.