Background: Low back pain (LBP) is the leading cause of disability throughout the world and is economically burdensome. The recommended first line treatment for non-specific LBP is non-invasive care. A digital care program (DCP) delivering evidence-based non-invasive treatment for LBP can aid self-management by engaging patients and scales personalized therapy for patient-specific needs.
Patients: The average participant was 43 years old (SD: 11), slightly overweight (mean (SD) body mass index: 26 (4) kg/m2), and reasonably active (Godin activity score of 39). We observed no statistically significant difference in the gender ratio between groups (two-sided test of proportions, chi-squared = 1.70, p = 0.19). Nearly all participants were convinced that the DCP could help them either avoid surgery altogether (97%) or at least delay surgery (99%). The rate of opioid use in this population was 9%. A minority (12%) received some type of surgery on the back prior (>3 months) to starting the DCP, though participants still actively rehabilitating from surgery were excluded from the study. About 1 in 3 experienced pain not only in the lower back but also upper back (27%) and/or neck (32%). We observed a difference in prevalence of upper back pain (two-sided test, chi-squared = 4.2, p = 0.04). However, including upper back pain as covariate in the regression analyses did not change the results, hence this difference is not discussed further.
Methods / Measures: This study was a two-armed, randomized, controlled, unblinded trial of participants with chronic non-specific LBP. Employees and their dependents at participating employers, across 12 locations in the US, were invited to complete an online application. Employees were highly diverse, and included both office and service based roles such as data analysts, drivers, catering staff, and outdoor instructors. Participants were recruited through emails, direct mail, and posters between January and March, 2017. The trial was approved by the Western Institutional Review Board and we have complied with all ethical regulations. Participants provided informed consent and completed the intervention at home. The trial was preregistered at International Standard Randomized Controlled Trial Number (ISRCTN) 42338218. We followed CONSORT guidelines for reporting this trial.
Results: At 12 weeks, an intention-to-treat analysis showed each primary outcome—Oswestry Disability Index (p < 0.001), Korff Pain (p < 0.001) and Korff Disability (p < 0.001)—as well as each secondary outcome improved more for participants in the DCP group compared to control group. For participants who completed the DCP (per protocol), average improvement in pain outcomes ranged 52-64% (Korff: 48.8–23.4, VAS: 43.6–16.5, VAS impact on daily life: 37.3–13.4; p < 0.01 for all) and average improvement in disability outcomes ranged 31–55% (Korff: 33.1–15, ODI: 19.7–13.5; p < 0.01 for both). Surgical interest significantly reduced in the DCP group. Participants that completed the DCP had an average engagement, each week, of 90%. Future studies will further explore the effectiveness of the DCP for long-term outcomes beyond 12 weeks and for a LBP patient population with possibly greater baseline pain and disability.
Conclusions: The DCP resulted in improved LBP outcomes compared to treatment-as-usual and has potential to scale personalized evidence-based non-invasive treatment for LBP patients.
DOI: https://doi.org/10.1038/s41746-018-0076-7
