ICF-Based Assessment of Functioning in Daily Clinical Practice. A Promising Direction Toward Patient-Centred Care in Patients With Low Back Pain

Background: Patient-centred care has received increased attention in recent years. Patient-Reported Outcomes (PROs) and shared decision-making are key components of Patient-Centred care. Low back pain (LBP) is a complex symptom affected by multiple, interacting factors. Therefore, evidence strongly recommend a biopsychosocial and patient-centred approach in the assessment and management. The International Classification of Functioning, Disability and Health (ICF) provide a biopsychosocial model for describing functioning and disability. ICF is widely acknowledged, but implementation into clinical practice is lacking. To support the use of a biopsychosocial and patient-centred approach in daily clinical practice among patients with LBP we developed a practice-friendly tool based on ICF; the LBP assessment tool.Objective: To compare an ICF-based assessment facilitated by the LBP assessment tool with standard care in terms of the use of PROs and shared decision-making in order to promote patient-centred care in patients with LBP.Methods: A non-randomized controlled design was used. Eligible patients were allocated to one of two groups: the ICF group, assessed with the LBP assessment tool or the control group, assessed with a conventional LBP assessment. Primary outcome includes use of PROs. Secondary outcomes include use of a graphical overview displaying the patient profile and shared decision-making. A patient evaluation questionnaire was used to collect data.Results: Seven hundred ten patients were assessed for eligibility of whom 531 were allocated to the ICF group (n = 299) or the control group (n = 232). A significantly higher use of PRO data (p < 0.00) and the patient profile (p < 0.00) was reported in favor of the ICF group. Patients in the ICF group also experienced being more involved in decision-making (p = 0.01).Conclusions: This study showed that a functioning assessment, by means of the LBP assessment tool, increased use of PROs and shared decision-making when compared to a conventional LBP assessment. Additionally, this study demonstrated that routine use of ICF-based PRO data and shared decision-making promoted patient-centred care in patients with LBP. The LBP assessment tool may be a strong candidate for a user-friendly ICF-based tool with the potential to support health professionals in a shift toward a biopsychosocial and patient-centred approach to patients with LBP

Real-life efficacy of pregabalin for the treatment of peripheral neuropathic pain in daily clinical practice in Denmark:the NEP-TUNE study

OBJECTIVE: The aim of this study was to provide evidence regarding the real-life efficacy of pregabalin in the treatment of peripheral neuropathic pain (NeP) in Denmark. METHODS: In this prospective, observational, noninterventional study, pregabalin (Lyrica(®)) was prescribed following usual clinical practice. Compared with baseline, the primary study end points after 3 months of observation were changes in 1) the average level of pain during the past week, 2) the worst level of pain during the past week, and 3) the least level of pain during the past week. The Wilcoxon signed-rank test was used to perform paired analyses, and a multivariate regression analysis investigated factors driving change in pain. RESULTS: A total of 86 of the 128 patients included were regarded as efficacy evaluable (those completing 3 months of pregabalin treatment). Patients (59 years) were long-time sufferers of peripheral NeP, and 38% of them had comorbidities. The majority had previously been treated with tricyclic antidepressants or gabapentin. The average dose of pregabalin was 81.5 mg/d at baseline and 240 mg/d after 3 months. A clinically and statistically significant improvement of 2.2 points in the average level of pain intensity was found after 3 months. The higher the pain intensity at baseline, the higher was the reduction of the pain score. Positive results were also found for pain-related sleep interference, patients’ global impression of change, quality of life, and work and productivity impairment. Twenty-one patients reported 28 adverse events. CONCLUSION: This real-life study indicates that for some patients (two-thirds), addition of pregabalin for peripheral NeP helps to reduce their pain intensity significantly

Decreased plasma levels of soluble CD18 link leukocyte infiltration with disease activity in spondyloarthritis

INTRODUCTION: Spondyloarthritis (SpA) comprises a group of diseases often associated with HLA-B27 and characterized by inflammation of the entheses and joints of the axial skeleton. The inflammatory process in SpA is presumably driven by innate immune cells but is still poorly understood. Thus, new tools for monitoring and treating inflammation are needed. The family of CD18 integrins is pivotal in guiding leukocytes to sites of inflammation, and CD18 hypomorphic mice develop a disease resembling SpA. Previously, we demonstrated that altered soluble CD18 (sCD18) complexes in the blood and synovial fluid of patients with arthritis have anti-inflammatory functions. Here, we study the mechanisms for these alterations and their association with SpA disease activity. METHODS: Plasma levels of sCD18 in a study population with 84 patients with SpA and matched healthy controls were analyzed with a time-resolved immunoflourometric assay (TRIFMA). Binding of sCD18 to endothelial cells and fibroblast-like synoviocytes (FLSs) was studied with confocal microscopy. Shedding of CD18 from peripheral blood mononuclear cells (PBMCs) was studied with flow cytometry and TRIFMA. RESULTS: Plasma levels of sCD18 were decreased in patients with SpA compared with healthy volunteers (P <0.001), and the lowest levels were in the HLA-B27-positive subgroup (P <0.05). In a multiple regression model, the sCD18 levels exhibited an inverse correlation with the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) (P <0.05), the level of morning stiffness (P <0.05), the Bath Ankylosing Spondilitis Metrology Index (P <0.05), the physician global assessment score (P <0.01), and the sacroiliac magnetic resonance imaging activity score (P <0.05). The mechanisms for these changes could be simulated in vitro. First, sCD18 in plasma adhered to inflammation-induced intercellular adhesion molecule 1 (ICAM-1) on endothelial cells and FLS, indicating increased consumption. Second, CD18 shedding from SpA PBMCs correlated inversely with the BASDAI (P <0.05), suggesting insufficient generation. CD18 was shed primarily from intermediate CD14(++) CD16(+) monocytes, supporting the view that alterations in innate immunity can regulate the inflammatory processes in SpA. CONCLUSIONS: Taken together, the failure of patients with SpA to maintain adequate sCD18 levels may reflect insufficient CD18 shedding from monocytes to counterbalance the capture of sCD18 complexes to inflammation-induced ICAM-1. This could increase the availability of ICAM-1 molecules on the endothelium and in the synovium, facilitating leukocyte migration to the entheses and joints and aggregating disease activity

Somatic experiencing® for patients with low back pain and comorbid posttraumatic stress disorder – protocol of a randomized controlled trial

Abstract Background Research has almost exclusively focused on the neck in order to explain the mechanisms of persistent pain after motor vehicle collisions (MVC). However, studies have shown that low back pain after MVC is as common as neck pain. Also, posttraumatic stress disorder (PTSD) is common after MVCs, and evidence indicate that PTSD may be linked to the development of pain and disability. PTSD has even been proposed as “the missing link” for some in the development of chronic low back pain. Unfortunately, PTSD often goes unattended in low back pain rehabilitation and very few randomized controlled studies exists targeting both conditions. Hence, the aim of the present study is to investigate the potential additional effect of the trauma therapy “Somatic Experiencing®” (SE) in addition to physiotherapy (PT) compared to PT alone for patients with chronic low back pain and comorbid PTSD. Methods The study is a two-group randomized controlled clinical trial in which participants (n = 140) are recruited consecutively from a large Danish spine center in the Region of Southern Denmark, between January 2016 and December 2017. Patients are randomly allocated to one of the two conditions: SE + PT or PT alone. Measurements of effect are carried out at baseline before randomization, post-intervention, 6 and 12 months post-randomization. The primary outcome is a 20% reduction in disability (Rolland Morris Disability Questionnaire) at 6 months post-randomization. Secondary outcomes are: PTSD symptoms, pain intensity, pain-catastrophizing, fear of movement, anxiety and depression. Discussion Comorbid PTSD is currently not targeted in back pain rehabilitation although highly prevalent. If the SE intervention shows to have an additional effect on disability and pain, the study is likely to have a positive impact on the management of chronic low back pain and will have immediate clinical applicability. Trial registration Current Controlled Trials Registration August 4, 2017: NCT03244046. Retrospectively registered