Mikael Boesen, Henning Bliddal, Lars Erik Kristensen, Esben Meulengracht Flachs, Ann Isabel Kryger, Lilli Kirkeskov, Robin Christensen, Ditte Lundsgaard Andreasen, Bjarke Brandt Hansen, and Luise Moelenberg Begtrup
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. Trial registration Clinical Trials.gov: NCT02015572, In a randomized trial, Bjarke Brandt Hansen and colleagues study a complex occupational intervention for patients with low back pain., Author summary Why was this study done? Individuals with low back pain (LBP), especially those in physically demanding jobs, are at risk of taking sick leave. The resultant loss of productivity adds to the already considerable socioeconomic burden of LBP. While occupational medicine interventions can help to reduce sick leave, there is limited evidence available on the effect of such interventions in people at risk of sick leave due to LBP who receive a thorough single hospital consultation. What did the researchers do and find? This parallel-group randomized clinical trial compared an early occupational intervention added to usual care with usual care alone in patients with LBP and physically demanding jobs; of note, usual care included a clinical examination and magnetic resonance imaging scan to enable a thorough explanation of the pain, and recommendations to stay active in work. The trial showed no significant difference between the treatment groups in terms of accumulated sick leave during a 6-month period, although both groups did show improvements from baseline in pain, fear-avoidance beliefs, physical quality of life, and disability at 6 months. What do these findings mean? This study indicates that LBP interventions that include an explanation of the pain might be sufficient to limit sick leave in patients with LBP and physically demanding jobs; an approach that could be integrated into usual care and an early occupational intervention would not necessarily have to be carried out by a specialist in occupational medicine.