Abstract
BackgroundChronic 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.MethodsA 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.DiscussionPain 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 registrationClinicalTrials.gov identifier NCT03168165, registered May 30, 2017.
Highlights
Chronic spinal pain affects many in the United States and is associated with rising healthcare costs - but not improved outcomes
Pain Neuroscience Education (PNE) is an education method used by physical therapists to help patients understand the biology, physiology, and psychosocial factors influencing their pain experience [17, 18], and to reconcile faulty cognitions and beliefs associated with persistent pain and disability [19]
We will randomly assign clinic regions to either receive PNE training for physical therapists employed in clinics within the region or usual care (UC) - with no additional training for physical therapists working in the region clinics
Summary
Design and setting This is a two-arm, single-blind, cluster randomized control trial to take place in 16 clinic regions within a large private rehabilitation practice in Atlanta, Georgia and Birmingham, Alabama. We assume that the primary outcome will be ascertained in 90% of enrolled patients Under these assumptions, our cluster randomized design with 316 enrolled patients will provide approximately 80% power with 2-sided α = 0.05 to detect a mean difference in the PROMIS PF-CAT between clinic regions assigned to the PNE and usual care interventions. Our cluster randomized design with 316 enrolled patients will provide approximately 80% power with 2-sided α = 0.05 to detect a mean difference in the PROMIS PF-CAT between clinic regions assigned to the PNE and usual care interventions This calculation does not account for the savings in power that will result from adjusting for the baseline level of the outcome, and is likely to be slightly conservative
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