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.

INTRODUCTION: With an increasing prevalence of citizens of older age and with overweight, the health issues related to knee osteoarthritis (OA) will intensify. Weight loss is considered a primary management strategy in patients with concomitant overweight and knee OA. However, there are no widely available and feasible methods to sustain weight loss in patients with overweight and knee OA. The present protocol describes a randomised controlled trial evaluating the efficacy and safety of the glucagon-like peptide-1 receptor agonist liraglutide in a 3 mg/day dosing in patients with overweight and knee OA.

METHODS AND ANALYSIS: 150 volunteer adult patients with overweight or obesity and knee OA will participate in a randomised, double-blind, placebo-controlled, parallel-group and single-centre trial. The participants will partake in a run-in diet intervention phase (week -8 to 0) including a low calorie diet and dietetic counselling. At week 0, patients will be randomised to either liraglutide 3 mg/day or liraglutide placebo 3 mg/day for 52 weeks as an add-on to dietetic guidance on re-introducing regular foods and a focus on continued motivation to engage in a healthy lifestyle. The co-primary outcomes are changes in body weight and the Knee Injury and Osteoarthritis Outcome Score pain subscale from week 0 to week 52.

ETHICS AND DISSEMINATION: The trial has been approved by the regional ethics committee in the Capital Region of Denmark, the Danish Medicines Agency and the Danish Data Protection Agency. An external monitoring committee (The Good Clinical Practice Unit at Copenhagen University Hospitals) will oversee the trial. The results will be presented at international scientific meetings and through publications in peer-reviewed journals.

TRIAL REGISTRATION NUMBERS: 2015-005163-16, NCT02905864, U1111-1171-4970 BASED ON PROTOCOL VERSION: V.6; 30 January 2017, 15:30 hours.

Background: One of the big contributors to physical inactivity in the elderly population is osteoarthritis (OA) of the knee. Digital motivation seems to have a positive effect on individual physical inactivity level, but limited evidence exists on the effects of digital motivation on patients with knee OA.

Objective: To investigate if motivational text messages reduce time spent physically inactive in patients with knee OA.

Method: This study was designed as an unblinded pilot randomised controlled trial, randomising participants equally (1:1) to an intervention group (motivational text messages) or control group (no intervention). Participants were recruited from six physical therapy clinics in Denmark. Inclusion criteria were age ≥ 18, diagnosed with knee OA, owner of a smartphone or tablet, and participating or commencing participation in the GLA:D® program. The primary outcome was time spent physically inactive, measured with a tri-axial accelerometer mounted on the lateral side of the thigh. Data on OA symptoms were obtained using the Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire.

Results: A total of 49 participants were screened, and 38 participants were included and randomised to either the intervention group (n = 19) or the control group (n = 19). No statistically significant difference between the two groups was found in average change of time spent physically inactive (mean difference 13.2 min/day [95% CI - 41.0 to 67.3]; P = 0.63), time spent standing (mean difference 3.0 min/day [95% CI - 22.7 to 28.7]; P = 0.81), or time spent moving (mean difference - 20.4 min/day [95% CI - 63.0 to 22.3]; P = 0.34) nor was there any difference in change between the two groups on KOOS.

Conclusion: Motivational text messages have seemed to have no effect on overall time spent physically inactive.

Trial registration: clinicaltrials.gov, NCT03339011. Registered 9 November 2017.

OBJECTIVES: To examine faecal calprotectin (F-calprotectin) levels and presence of anti-Saccharomyces cerevisiae antibodies (ASCA) and their associations with disease subtype and current status in axial SpA (axSpA).

METHODS: F-calprotectin and ASCA in serum were compared between consecutive patients with a clinical axSpA diagnosis, classified as non-radiographic axSpA (nr-axSpA; n = 40) or AS (n = 90), and with healthy controls (n = 35). Furthermore, standard axSpA outcome measures were compared between axSpA patients (nr-axSpA and AS combined) with elevated vs normal F-calprotectin, ASCA IgA and IgG, respectively.

RESULTS: Elevated F-calprotectin (⩾50 mg/kg) was observed in 27% of nr-axSpA patients, 38% of AS patients and 6% of controls. F-calprotectin was significantly higher in AS vs nr-axSpA [AS: geometric mean 41 (95% CI 32, 54) mg/kg; nr-axSpA: 24 (95% CI 16, 38) mg/kg; P = 0.037], and in each axSpA subtype vs controls. Overall, worse disease activity and physical function scores were observed among axSpA patients with elevated vs normal F-calprotectin levels, with significant differences regarding patient's visual analogue scale for global health, ASDAS using CRP, and BASFI (adjusted for age, sex, NSAID use, anti-rheumatic treatments, and CRP). ASCA titres and seropositivity (⩾10 U/ml) were similar in nr-axSpA (IgA/IgG-seropositivity: 8%/26%) and AS (7%/28%), and clinical outcome measures did not differ between patients with elevated vs normal ASCA IgA or IgG, respectively. Compared with controls (IgA/IgG-seropositivity: 0%/17%), ASCA IgA was significantly higher in both axSpA subtypes, and IgG was significantly higher in the AS group.

CONCLUSION: In patients with axSpA, gut inflammation measured by elevated F-calprotectin is associated with worse disease activity and physical function, and may be a marker of more severe disease.

BACKGROUND: Physical inactivity is common during hospitalisation and poses a threat to functional capacity and independency in the elderly.

AIM: We aimed to assess the effect of physical activity measurements with visual feedback about time spent in various activities on the average daily time spent out of bed during hospitalisation.

METHODS: We recorded physical activity during hospitalisation by accelerometers and compared the effect of the visual feedback (intervention) with no feedback (control) on time spent out of bed. Patients admitted to the pulmonary ward were invited and assigned to intervention with feedback or control with no feedback in 6 alternating waves of approximately 18 patients each. The order of feedback/no feedback was randomised at the outset of the study. The visual feedback intervention group was provided with visual feedback of the daily time spent in bed, sitting, standing, and walking. The control group did not receive feedback.

RESULTS: 93 patients completed the study with a median length of stay of 5 days. Across all patients there were no statistically significant group differences in daily time out of bed; however, patients with independent mobility spent 51 minutes (95% CI 0 to 102; P = .049) more out of bed when provided with visual feedback compared to no feedback.

CONCLUSIONS: A simple technology assisted physical activity intervention with visual feedback to encourage mobility was not effective at increasing time spent out of bed among hospitalised patients. With feedback, a subgroup of patients with independent walking abilities increased time out of bed and may benefit from this type of intervention.

TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01945749.

BACKGROUND: Exercise therapy is recommended for knee osteoarthritis (OA), but the underlying mechanisms of pain relief are not fully understood. The purpose of this study was to explore the effects of exercise on muscle perfusion assessed by dynamic contrast enhanced MRI (DCE-MRI) and its association with changes in pain in patients with knee OA.

METHODS: Exploratory outcome analyses of a randomised controlled study with per-protocol analyses ( ClinicalTrials.gov : NCT01545258) performed at an outpatient clinic at a public hospital in Denmark. We compared 12 weeks of supervised exercise therapy 3 times per week (ET) with a no attention control group (CG). Analyses of covariance (ANCOVA) were used to assess group mean differences in changes from baseline to week 12 in knee muscle perfusion quantified by DCE-MRI, patient-reported pain and function using the Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire, knee extensor and flexor muscle strength tests, and the six-minute walking test (6MWT). Spearman's correlation coefficients were used to determine the correlation between changes in DCE-MRI variables, KOOS, muscle strength, and 6MWT. The potential effect mediation of the DCE-MRI perfusion variables was investigated in a post-hoc mediation analysis.

RESULTS: Of 60 participants randomised with knee osteoarthritis, 33 (ET, n = 16, CG, n = 17) adhered to the protocol and had complete DCE-MRI data. At follow-up, there were significant group differences in muscle perfusion changes and clinically relevant group differences in KOOS pain changes (10.7, 95% CI 3.3 to 18.1, P = 0.006) in favor of ET. There were no significant between-group differences on muscle strength and function. The changes in pain and muscle perfusion were significantly correlated (highest Spearman's rho = 0.42, P = 0.014). The mediation analyses were generally not statistically significant.

CONCLUSION: The pain-reducing effects of a 12-week exercise program are associated with changes in knee muscle perfusion quantified by DCE-MRI in individuals with knee OA, but whether the effects are mediated by muscle perfusion changes remains unclear.

TRIAL REGISTRATION: ClinicalTrials.gov: NCT01545258 , first posted March 6, 2012.

BACKGROUND: More advanced disc degeneration on magnetic resonance imaging (MRI) is found in individuals with low back pain. However, it is unclear whether this grading is independent of the scanner's field strength.

PURPOSE: To compare disc degeneration on high- versus low-field MRI.

MATERIAL AND METHODS: Low back pain patients were enrolled to undergo high-field (3 T) MRI, followed by low-field (0.25 T) MRI of the lumbar spine within 3 h. Three radiologists graded the disc degeneration on Pfirrmann's grading scale with a hiatus of 3 months. A subsample was regraded 6 months later. Reproducibility was measured by weighted kappa statistics (using PROC FREQ statement with AGREE in the TABLES statement for SAS), absolute agreement (i.e. 1:1 agreement/the total number) and the difference in the prevalence (McNemar test).

RESULTS: Moderate to substantial agreement (κ = 0.52-0.62) and absolute agreement of 43.8-66.1% were found between field strengths. Low-field MRI tended to have numerically higher and lower grades than high-field MRI resulting in a significant difference in the prevalence of grades ( p < 0.001). Both field strengths resulted in a moderate to substantial inter-reader agreement (low-field: κ = 0.63, 0.63, 0.54 and high-field: κ = 0.55, 0.43, 0.53) and intra-reader agreement (high-field: κ = 0.57, 0.77, 0.67 and low-field: κ = 0.51, 0.50, 0.70). Only, the reader with the shortest experience had better agreement with high-field compared to low-field.

CONCLUSIONS: There were a significant difference in the prevalence of disc degeneration grading between 0.25 T and 3 T MRI. Therefore, field strength should be taken into consideration when comparing studies using disc degeneration grading as an outcome.

OBJECTIVE: The Outcome Measures in Rheumatology (OMERACT) Safety Working Group objective was to identify harm domains from existing outcome measurements in rheumatology.

METHODS: Systematically searching the MEDLINE database on January 24, 2017, we identified full-text articles that could be used for harm outcomes in rheumatology. Domains/items from the identified instruments were described and the content synthesized to provide a preliminary framework for harm outcomes.

RESULTS: From 435 possible references, 24 were read in full text and 9 were included: 7 measurement instruments were identified. Investigation of domains/items revealed considerable heterogeneity in the grouping and approach.

CONCLUSION: The ideal way to assess harm aspects from the patients' perspective has not yet been ascertained.

BACKGROUND: There is a need to develop evidence-based occupational therapy programs aiming at enhancing the ability to perform Activities of Daily Living (ADL) among persons living with chronic conditions. Information from different sources is to be integrated in the development process. Thus, it is necessary to engage both occupational therapists and persons living with chronic conditions in suggesting ideas on how to enhance the ADL ability.

OBJECTIVE: To identify, organize and prioritize ideas on how to enhance ability to perform ADL in persons with chronic conditions.

MATERIAL AND METHOD: Group Concept Mapping, involving brainstorming, sorting, labeling, rating and validation of ideas, was applied among persons with chronic conditions (n = ≤ 18) and occupational therapists (n = ≤ 23). Multidimensional scaling analysis and cluster analyzes were applied.

RESULTS: 149 ideas were identified and organized into seven clusters related to applying new adaptational strategies, personal factors, social surroundings and relevant services and opportunities. Each cluster contained ideas of high priority to persons with chronic conditions and/or occupational therapists.

CONCLUSION: A span of highly relevant themes, illustrated the complexity of enhancing ADL ability. This should be considered in the development of interventions aiming at enhancing ADL ability in persons with chronic conditions.