Complement Proteins L-Ficolin and M-Ficolin Are Increased in Patients With Axial Spondyloarthritis and Decrease After Tumor Necrosis Factor Inhibitor Treatment.

OBJECTIVE: We have previously reported elevated levels of the complement lectin pathway proteins L-ficolin and H-ficolin in patients with axial spondyloarthritis (axSpA) compared with healthy controls. The aim of the present study was to investigate these biomarkers in a cross-sectional cohort of patients suffering from low back pain (LBP). Further, we aimed to investigate changes in lectin pathway protein levels after initiation of adalimumab (ADA; a tumor necrosis factor inhibitor) in a longitudinal cohort of patients with axSpA. METHODS: Lectin pathway protein levels (mannan-binding lectin [MBL], collectin liver 1, H-ficolin, L-ficolin, M-ficolin, MBL-associated serine protease [MASP]-1, MASP-2, MASP-3, MBL-associated protein 19 [MAp19], and MAp44) in EDTA plasma were determined in 2 well-characterized cohorts: (1) a clinical cross-sectional cohort of patients with LBP, including patients with axSpA (n = 23), patients with unspecific LBP (uLBP) with ≥ 1 SpA features (n = 55), and patients with uLBP without SpA features or magnetic resonance imaging findings suggestive of axSpA (n = 64); and (2) a randomized double-blinded, placebo-controlled trial cohort of patients with axSpA (n = 49) initiating ADA therapy. Lectin pathway protein levels were determined using immunoassays. RESULTS: Plasma levels of L-ficolin and M-ficolin were significantly increased in the cross-sectional cohort of newly diagnosed patients with axSpA compared with clinically relevant controls with uLBP (all P < 0.05). Both L-ficolin and M-ficolin decreased significantly after ADA therapy (P < 0.05). CONCLUSION: L-ficolin and M-ficolin levels are elevated in newly diagnosed patients with axSpA compared with clinically relevant controls. Both L-ficolin and M-ficolin levels decrease significantly after initiating ADA therapy. These findings provide new insights into the inflammatory processes in axSpA and support the involvement of complement in axSpA pathogenesis.

Exploring usual care for patients with low back pain in primary care: a cross-sectional study of general practitioners, physiotherapists and chiropractors.

OBJECTIVES: To explore the elements and composition of care provided by general practitioners (GPs), physiotherapists (PTs) and chiropractors (DCs) to patients with low back pain (LBP). DESIGN: Observational study. SETTING: Primary care setting, Denmark. PARTICIPANTS: Primary care clinicians (GPs, PTs and DCs) in the Region of Southern Denmark were invited to register consecutive adult patient visits with LBP as the primary complaint. PRIMARY OUTCOME MEASURES: Clinicians reported care elements provided to patients with LBP. Elements varied due to professional differences (eg, prescriptive rights). Data were descriptively analysed, on group and individual levels, for frequency and combination of care elements, and practice patterns were explored with latent class analysis. RESULTS: The clinicians (33 GPs, 67 PTs and 43 DCs with a median experience of 15 years and 59% were females) registered 3500 patient visits. On average, the visits involved patients aged 51 years, and 51% were with females. The frequencies of common care elements across professions were information (42%-56% of visits between professions) and advice (56%-81%), while other common elements for GPs were pain medication (40%) and referrals to PTs (36%), for PTs, use of exercises (81%) and for DCs, use of manual therapy (96%). Substantial variation was observed within professions and distinct practice patterns, with different focuses of attention to information and advice versus exercise and manual therapy, were identified for PTs and DCs. CONCLUSIONS: These data indicate substantial variation in the care elements provided by GPs, PTs and DCs to LBP patients. The compositions of care and practice patterns identified challenge the understanding of usual care as a uniform concept and professions as homogeneous groups. Strategic use of particular care elements in different parts of treatment courses is indicated. Longitudinal data and qualitative enquiry are needed to assess if or how care is tailored to individual patients.

Demographic and clinical characteristics of patients with low back pain in primary and secondary care settings in Southern Denmark.

OBJECTIVE: To describe and compare the demographic and clinical characteristics of patients with acute or chronic low back pain across all health care settings treating this condition.Design and setting: Concurrent prospective survey registration of all consecutive consultations regarding low back pain at general practitioners, chiropractors, physiotherapists, and the secondary care spine centre in Southern Denmark. SUBJECTS: Patients ≥16 years of age with low back pain. MAIN OUTCOME MEASURE: Demographic characteristics, symptoms, and clinical findings were registered and descriptively analysed. Pearson's chi-square tested differences between the populations in the four settings. Multiple logistic regression assessed the odds of consulting specific settings, and t-test assessed differences between patients attending for a first and later consultation. RESULTS: Thirty-six general practitioners, 44 chiropractors, 74 physiotherapists, and 35 secondary care Spine Centre personnel provided information on 5645 consultations, including 1462 first-visit consultations. The patients differed significantly across the settings. Patients at the Spine Centre had the most severe symptoms and signs and were most often on sick leave. Compared to the other populations, the chiropractor population was younger, whereas the physiotherapist population was older, more often females, and had prolonged symptoms. In general practice, first-time consultations were with milder cases while patients who attended for a second or later consultation had the worst symptoms, findings, and risk of sick leave compared to the other primary care settings. CONCLUSION: The demographic and clinical characteristics of patients with low back pain differ considerably across the health care settings treating them.KEY POINTSThe study describes the symptoms and clinical findings of patients with low back pain consulting the Danish health care system in all its settings.Patients with chiropractors were youngest, while those with physiotherapists were the oldest and most frequently female.First consultations in general practice were generally with the least symptomatic patients while those returning for a subsequent consultation had more severe disease including more sick leave compared to patients in the other primary care settings.Our findings call for caution when generalizing between health care settings for patients with low back pain.

The effect of an integrated multidisciplinary rehabilitation programme for patients with chronic low back pain: Long-term follow up of a randomised controlled trial.

OBJECTIVE: To compare the long-term effectiveness of an integrated rehabilitation programme with an existing rehabilitation programme, in terms of back-specific disability, in patients with chronic low back pain. DESIGN: A single-centre, pragmatic, two-arm parallel, randomised controlled trial. SETTING: A rheumatology rehabilitation centre in Denmark. SUBJECTS: A total of 165 adults (aged ⩾ 18 years) with chronic low back pain. INTERVENTIONS: An integrated programme (a pre-admission day, two weeks at home, two weeks inpatient followed by home-based activities, plus two 2-day inpatient booster sessions, and six-month follow-up visit) was compared with an existing programme (four-week inpatient, and six-month follow-up visit). MAIN MEASURE: The primary outcome was disability measured using the Oswestry Disability Index after one year. Secondary outcomes included pain intensity (Numerical Rating Scale), pain self-efficacy (Pain Self-Efficacy Questionnaire), health-related quality of life (EuroQol-5 Domain 5-level (EQ-5D)), and depression (Major Depression Inventory). Analysis was by intention-to-treat, using linear mixed models. RESULTS: 303 patients were assessed for eligibility of whom 165 patients (mean age 50 years (SD 13) with a mean Oswestry Disability Index score of 42 (SD 11)) were randomly allocated (1:1 ratio) to the integrated programme (n = 82) or the existing programme (n = 83). The mean difference (integrated programme minus existing programme) in disability was -0.53 (95% CI -4.08 to 3.02); p = 0.770). No statistically significant differences were found in the secondary outcomes. CONCLUSION: The integrated programme was not more effective in reducing long-term disability in patients with chronic low back pain than the existing programme.

Experiences and challenges to cross-sectoral care reported by patients with low back pain. A qualitative interview study.

BACKGROUND: Cross-sectoral care comprises interdisciplinary and coordinated efforts for patients with complex care needs involving various competencies and professions across the primary health care sector, hospital sector, and municipal services. Cross-sectoral care can increase the effectiveness of rehabilitation programmes, but the treatment courses often lack coherence. Establishing successful treatment pathways requires a better understanding of the health care challenges faced by patients with low back pain. The aim of this study was to explore how patients with low back pain experience cross-sectoral care. METHOD: A qualitative interview study including 25 patients with low back pain. Patients were recruited in connection with their appointment at the Spine Centre of Southern Denmark. Recruitment stopped when the interviews no longer added new knowledge to the subject. The data were analysed using a systematic text condensation approach. RESULTS: Patients with low back pain experienced cross-sectoral care to be fragmented, with episodes lacking collaboration, information, and acknowledgement of their problem. They desired recognition of having a serious back problem and of being more than the diagnosis itself. Patients found it hard to keep track of their course of treatment due to a perceived lack of organisational support and collaboration between professionals. The patients called for more information about the treatment plan and the reasons for further referral in order to better understand and manage their treatment. CONCLUSION: Patients' experiences indicate a need for a stronger person-centred approach in cross-sectoral care, in which the individual's experiences of living with low back pain are taken into account.

The effect of an integrated multidisciplinary rehabilitation programme alternating inpatient interventions with home-based activities for patients with chronic low back pain: a randomized controlled trial.

OBJECTIVE: To compare the effectiveness of an integrated rehabilitation programme with an existing rehabilitation programme in patients with chronic low back pain. DESIGN: A single-centre, pragmatic, two-arm parallel, randomized controlled trial (1:1 ratio). SETTING: A rheumatology inpatient rehabilitation centre in Denmark. SUBJECTS: A total of 165 adults (aged ⩾ 18 years) with chronic low back pain. INTERVENTIONS: An integrated rehabilitation programme comprising an alternation of three weeks of inpatient stay and 12 weeks of home-based activities was compared with an existing rehabilitation programme of four weeks of inpatient stay. MAIN MEASURES: Patient-reported outcomes were collected at baseline and at the 26-week follow-up. The primary outcome was back-specific disability (Oswestry Disability Index). Secondary outcomes included pain intensity (Numerical Rating Scale), pain self-efficacy (Pain Self-Efficacy Questionnaire), health-related quality of life (EuroQol-5 Domain 5-level (EQ-5D)), and depression (Major Depression Inventory). A complete case analysis was performed. RESULTS: A total of 303 patients were assessed for eligibility of whom 165 (mean age: 50 years (SD 13) and mean Oswestry Disability Index score 42 (SD 11)) were randomized (83 to existing rehabilitation programme and 82 to integrated rehabilitation programme). Overall, 139 patients provided the 26-week follow-up data. Baseline demographic and clinical characteristics were comparable between programmes. The between-group difference in the Oswestry Disability Index score when adjusting for the corresponding baseline score was -0.28 (95% confidence interval (CI): -4.02, 3.45) which was neither statistically nor clinically significant. No significant differences were found in the secondary outcomes. CONCLUSION: An integrated rehabilitation programme was no more effective than an existing rehabilitation programme at the 26-week follow-up.

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

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.

National clinical guidelines for non-surgical treatment of patients with recent onset neck pain or cervical radiculopathy.

PURPOSE: To summarise recommendations about 21 selected non-surgical interventions for recent onset (<12 weeks) non-specific neck pain (NP) and cervical radiculopathy (CR) based on two guidelines from the Danish Health Authority. METHODS: Two multidisciplinary working groups formulated recommendations based on the GRADE approach. RESULTS: Twelve recommendations were based on evidence and nine on consensus. Management should include information about prognosis, warning signs, and advise to remain active. For treatment, guidelines suggest different types of supervised exercise and manual therapy; combinations of exercise and manual therapy before medicine for NP; acupuncture for NP but not CR; traction for CR; and oral NSAID (oral or topical) and Tramadol after careful consideration for NP and CR. CONCLUSION: Recommendations are based on low-quality evidence or on consensus, but are well aligned with recommendations from guidelines from North America. The working groups recommend intensifying research relating to all aspects of management of NP and CR.