Abstract

<h3>BACKGROUND CONTEXT</h3> Low back pain (LBP) has a lifetime prevalence of 70-80%. Access to timely and personalized, evidence-based care is key to prevent chronification [1-3]. Digital solutions may increase accessibility to treatment, while reducing healthcare-related costs [4, 5]. <h3>PURPOSE</h3> To assess the outcomes and engagement of a fully remote multimodal digital care program (DCP) on a real-world cohort of patients with acute LBP stratified by pain level at baseline. <h3>STUDY DESIGN/SETTING</h3> Interventional, single-arm, cohort study of individuals with acute LBP who received a home-based DCP. This study is part of a trial that was prospectively approved by the New England Institutional Review Board (number 120190313) and registered on ClinicalTrials.gov (NCT04092946). <h3>PATIENT SAMPLE</h3> A total of 406 patients at program start, 332 (81.8%) completed the intervention. <h3>OUTCOME MEASURES</h3> Primary outcome was the mean change in disability (Oswestry Disability Index - ODI) until the end of the program. Secondary outcomes included change in pain (NPRS), analgesic consumption, surgery likelihood, depression (PHQ-9), anxiety (GAD-7), fear-avoidance beliefs (FABQ-PA), work productivity (WPAI) and engagement. <h3>METHODS</h3> This DCP integrates an FDA-listed class II medical device comprised of two inertial motion trackers, a mobile app on a dedicated tablet, and a cloud-based portal which interfaces between the patient and an assigned physical therapist, who monitors the patient and performs the necessary adjustments during intervention. The DCP combines exercise and education, including major components of cognitive behavioral therapy. Outcomes changes were modeled using Latent growth curve analysis with full maximum likelihood estimation for missing data. Three risk subgroups were created based on pain levels at baseline, according to the pain thresholds proposed by Miró et al.,[6]: (i) mild (<3), (ii) moderate (4-6) and (iii) severe (7). <h3>RESULTS</h3> A significant disability reduction of 55.1% (14.93, 95%CI 13.95; 15.91) was observed, corresponding to an 76.1% responder rate (30% cut-off). Disability reduction strongly correlated with improvements in pain (61.0%), depression (55.4%) and productivity (65.6%). Surgery likelihood (59.1%), fear-avoidance beliefs (46.3%), anxiety (59.5%), and analgesic consumption (from 35.7% at baseline to 10.8% at program end) were similarly reduced. Patient satisfaction score was 8.7/10.0 (SD 1.4). Significant improvements in all LBP risk subgroups were seen after the DCP, with higher reductions in pain, ODI, analgesics intake, and productivity impairment in the high-risk subgroup, suggesting that higher risk individuals are not less likely to respond this treatment, as has been reported in other studies [7]. <h3>CONCLUSIONS</h3> This study demonstrated the utility of a multimodal DCP for patients with acute LBP. Very high adherence rates and patient satisfaction were observed, alongside clinically significant reductions in all assessed outcomes, consistent with the growing body of evidence supporting the management of acute LBP with DCPs[7]. 1. Lancet 1999;354:581-5. 2. Best Pract Res Clin Rheumatol 2010;24:769-81. 3. Bull World Health Organ 2003;81:646-56. 4. J Med Internet Res 2017;19:e179. 5. J Med Internet Res 2016;18:e139. 6. Disabil Rehabil 2017;39:1131-1135. 7. Am J Phys Med Rehabil 2019;98:850-858. <h3>FDA DEVICE/DRUG STATUS</h3> This abstract does not discuss or include any applicable devices or drugs.

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