abstract: 'Background Occupational medicine seeks to reduce sick leave; however, evidence for an add-on effect to usual care is sparse. The objective of the GOBACK trial was to test whether people with low back pain (LBP) in physically demanding jobs and at risk of sick leave gain additional benefit from a 3-month complex intervention that involves occupational medicine consultations, a work-related evaluation and workplace intervention plan, an optional workplace visit, and a physical activity program, over a single hospital consultation and an MRI. Methods and findings We enrolled people from the capital region of Denmark to an open-label, parallel-group randomized controlled trial with a superiority design from March 2014 through December 2015. In a hospital setting 305 participants (99 women) with LBP and in physically demanding jobs were randomized to occupational intervention (n = 153) or no additional intervention (control group; n = 152) added to a single hospital consultation giving a thorough explanation of the pain (i.e., clinical examination and MRI) and instructions to stay active and continue working. Primary outcome was accumulated sick leave days due to LBP during 6 months. Secondary outcomes were changes in neuropathic pain (painDETECT questionnaire {[}PDQ]), pain 0-10 numerical rating scale (NRS), Fear-Avoidance Beliefs Questionnaire (FABQ), Roland-Morris Disability Questionnaire (RMDQ), Short Form Health Survey (SF-36) for physical and mental health-related quality of life (HRQoL), and self-assessed ability to continue working (range 0-10). An intention-to-treat analysis of sick leave at 6 months showed no significant difference between groups (mean difference in days suggestively in favor of no additional intervention: 3.50 {[}95\% CI -5.08 to 12.07], P = 0.42). Both groups showed significant improvements in average pain score (NRS), disability (RMDQ), fear-avoidance beliefs about physical activities and work (FABQ), and physical HRQoL (SF-36 physical component summary); there were no significant differences between the groups in any secondary outcome. There was no statistically significant improvement in neuropathic pain (PDQ score), mental HRQoL (SF-36 mental component summary), and self-assessed ability to stay in job. Four participants could not complete the MRI or the intervention due to a claustrophobic attack or accentuated back pain. Workplace visits may be an important element in the occupational intervention, although not always needed. A per-protocol analysis that included the 40 participants in the intervention arm who received a workplace visit as part of the additional occupational intervention did not show an add-on benefit in terms of sick leave (available cases after 6 months, mean difference: -0.43 days {[}95\% CI -12.8 to 11.94], P = 0.945). The main limitations were the small number of sick leave days taken and that the comprehensive use of MRI may limit generalization of the findings to other settings, for example, general practice. Conclusions When given a single hospital consultation and MRI, people in physically demanding jobs at risk of sick leave due to LBP did not benefit from a complex additional occupational intervention. Occupational interventions aimed at limiting biopsychological obstacles (e.g., fear-avoidance beliefs and behaviors), barriers in the workplace, and system barriers seem essential to reduce sick leave in patients with LBP. This study indicates that these obstacles and barriers may be addressed by thorough usual care.' affiliation: 'Hansen, BB (Corresponding Author), Copenhagen Univ Hosp, Parker Inst, Bispebjerg, Denmark. Hansen, BB (Corresponding Author), Copenhagen Univ Hosp, Parker Inst, Frederiksberg, Denmark. Hansen, BB (Corresponding Author), Copenhagen Univ Hosp, Dept Occupat \& Environm Med, Bispebjerg, Denmark. Hansen, BB (Corresponding Author), Copenhagen Univ Hosp, Dept Occupat \& Environm Med, Frederiksberg, Denmark. Hansen, Bjarke Brandt; Bliddal, Henning; Christensen, Robin; Kristensen, Lars Erik, Copenhagen Univ Hosp, Parker Inst, Bispebjerg, Denmark. Hansen, Bjarke Brandt; Bliddal, Henning; Christensen, Robin; Kristensen, Lars Erik, Copenhagen Univ Hosp, Parker Inst, Frederiksberg, Denmark. Hansen, Bjarke Brandt; Begtrup, Luise Moelenberg; Andreasen, Ditte Lundsgaard; Flachs, Esben Meulengracht; Kryger, Ann Isabel, Copenhagen Univ Hosp, Dept Occupat \& Environm Med, Bispebjerg, Denmark. Hansen, Bjarke Brandt; Begtrup, Luise Moelenberg; Andreasen, Ditte Lundsgaard; Flachs, Esben Meulengracht; Kryger, Ann Isabel, Copenhagen Univ Hosp, Dept Occupat \& Environm Med, Frederiksberg, Denmark. Kirkeskov, Lilli, Copenhagen Univ Hosp, Ctr Social Med, Bispebjerg, Denmark. Kirkeskov, Lilli, Copenhagen Univ Hosp, Ctr Social Med, Frederiksberg, Denmark. Boesen, Mikael, Copenhagen Univ Hosp, Dept Radiol, Bispebjerg, Denmark. Boesen, Mikael, Copenhagen Univ Hosp, Dept Radiol, Frederiksberg, Denmark. Christensen, Robin, Univ Southern Denmark, Odense Univ Hosp, Dept Clin Res, Res Unit Rheumatol, Odense, Denmark.' article-number: e1002898 author: Hansen, Bjarke Brandt and Kirkeskov, Lilli and Begtrup, Luise Moelenberg and Boesen, Mikael and Bliddal, Henning and Christensen, Robin and Andreasen, Ditte Lundsgaard and Kristensen, Lars Erik and Flachs, Esben Meulengracht and Kryger, Ann Isabel author-email: dr.bjarke@gmail.com author_list: - family: Hansen given: Bjarke Brandt - family: Kirkeskov given: Lilli - family: Begtrup given: Luise Moelenberg - family: Boesen given: Mikael - family: Bliddal given: Henning - family: Christensen given: Robin - family: Andreasen given: Ditte Lundsgaard - family: Kristensen given: Lars Erik - family: Flachs given: Esben Meulengracht - family: Kryger given: Ann Isabel da: '2023-09-28' doi: 10.1371/journal.pmed.1002898 eissn: 1549-1676 files: [] issn: 1549-1277 journal: PLOS MEDICINE keywords-plus: 'HEALTH-CARE; SICK-LEAVE; QUESTIONNAIRE; WORKPLACE; MANAGEMENT; WORKERS; RETURN; RATES' language: English month: AUG number: '8' number-of-cited-references: '33' orcid-numbers: 'Bliddal, Henning/0000-0002-7951-1668 Boesen, Mikael/0000-0002-8774-6563 Christensen, Robin/0000-0002-6600-0631 Hansen, Bjarke Brandt/0000-0002-4440-1960 Flachs, Esben Meulengracht/0000-0002-2252-8426' papis_id: 0c7b316434483e8885b6c193555a90e0 ref: Hansen2019earlyoccupational researcherid-numbers: 'Kristensen, Lars Erik/AAZ-2615-2020 ' times-cited: '9' title: 'Early occupational intervention for people with low back pain in physically demanding jobs: A randomized clinical trial' type: article unique-id: WOS:000489050500023 usage-count-last-180-days: '1' usage-count-since-2013: '4' volume: '16' web-of-science-categories: Medicine, General \& Internal year: '2019'