Date Published: August 16, 2019
Publisher: Public Library of Science
Author(s): Bjarke Brandt Hansen, Lilli Kirkeskov, Luise Moelenberg Begtrup, Mikael Boesen, Henning Bliddal, Robin Christensen, Ditte Lundsgaard Andreasen, Lars Erik Kristensen, Esben Meulengracht Flachs, Ann Isabel Kryger, Rachelle Buchbinder
Abstract: BackgroundOccupational 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 findingsWe 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.ConclusionsWhen 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 registrationClinical Trials.gov: NCT02015572
Partial Text: The lifetime prevalence of low back pain (LBP) is about 70% . In the US alone, an estimated $87 billion is spent annually on healthcare for individuals with back pain, which has been one of the fastest growing healthcare expenses . Sick leave and productivity loss add to this considerable socioeconomic burden . Despite considerable resources being used to prevent LBP, the incidence curve has still not declined, and this has led to greater attention on tertiary prevention [4,5]. Occupational attachment is associated with physical and mental well-being . Therefore, attachment to the labor market is recommended in the management of patients who have developed LBP [7,8], and cognitive behavioral therapy focusing on biopsychosocial aspects (e.g., fear-avoidance behavior) has proven effective [5,9,10]. Combining workplace interventions with physical exercise seems to reduce LBP disability and sick leave among workers with musculoskeletal disorders [7,11]. Recent studies of interventions for chronic LBP focusing on occupational attachment found not only a decrease in disability but also a better cost-effectiveness when compared with usual care in a primary healthcare setting [10,11]. A similar effect has been seen on sick leave in a secondary healthcare setting . Most guidelines for LBP care advocate the use of reassurance, analgesics, and recommendations to stay active and continue working . A thorough explanation of the pain has been successful in altering fear-avoidance behavior and seems to reduce sick leave in patients with LBP [13,14]. Occupational intervention is usually given as an add-on to usual care. Therefore, the GOBACK trial was conducted to test whether individuals with LBP in physically demanding jobs at risk of sick leave gain further benefit when adding a 3-month complex early occupational intervention to a single hospital consultation, when this consultation includes a thorough explanation of the pain (i.e., clinical examination and MRI) and recommendations to stay active and continue working.
The objective of the GOBACK trial was to evaluate whether a 3-month complex early occupational intervention, given as an add-on to a single hospital consultation, decreases sick leave among patients with LBP at risk of taking sick leave during a 6-month period. Improvements from baseline to 6 months were observed in pain, fear-avoidance beliefs, physical HRQoL, and disability in both groups, and no statistically significant differences were found between the groups in accumulated sick leave (P = 0.422). A per-protocol analysis that included the 40 participants who received a workplace visit as part of the additional occupational intervention did not show an add-on benefit in terms of sick leave (P = 0.945). A post-hoc analysis was performed including only participants who reported their job to be very physically demanding. Still, there was no statistically significant benefit of the additional intervention in terms of sick leave (P = 0.754). These findings indicate that LBP interventions comprising an explanation of the pain based on a clinical examination and MRI, combined with instructions to stay active and continue working, might be sufficient to keep patients with physically demanding jobs and at risk of sick leave due to LBP out of sick leave.
When given an explanation for the pain based on a clinical examination and an MRI scan, followed by instructions to stay active and continue working, workers in physically demanding jobs at risk of sick leave due to LBP do not benefit from a 3-month complex early additional occupational intervention. This indicates that occupational elements may be integrated into usual care and do not necessarily have to be carried out by a specialist in occupational medicine, who can focus on sick-listed patients or primary prevention.