Effectiveness of stratified treatment for back pain in Danish primary care: A randomized controlled trial

Background A randomized controlled trial (RCT) of stratified care demonstrated superior clinical outcomes and cost-effectiveness for low back pain (LBP) patients in UK primary care. This is the first study in Europe, outside of the original UK study, to investigate the clinical efficacy and cost-effectiveness of stratified care compared with current practice for patients with non-specific LBP. Methods The study was a two-armed RCT. Danish primary care patients with LBP were randomized to stratified care (n = 169) or current practice (n = 164). Primary outcomes at 3- and 12-months' follow-up were Roland Morris Disability Questionnaire (RDMQ), patient-reported global change and time off work. Secondary outcomes included pain intensity, patient satisfaction, healthcare resource utilization and quality-adjusted life years. Results Intention-to-treat analyses found no between-group difference in RMDQ scores at 3 months (0.5, 95% CI −1.8 to 0.9) or 12 months (0.4, −2.1 to 1.3). No overall differences were found between the arms at 3 and 12 months with respect to time off work or secondary outcomes. Stratified care intervention resulted in significantly fewer treatment sessions (3.5 [SD 3.1] vs. 4.5 [3.5]) and significantly lower total healthcare costs (€) (13.4 [529] vs. 228 [830], p = .002). There was no difference in cost-effectiveness (0.09, 0.05 to 0.13 vs. 0.10, 0.07–0.14, p = .70). Conclusions There was no significant difference in clinical outcomes between patients with non-specific LBP receiving stratified care and those receiving current practice. However, stratified care may reduce total healthcare costs if implemented in Danish primary care. Significance Stratified care for low back pain based on risk profile is recommended by recent evidence based clinical guidelines. This study is the first broad replication of the STarT Back Trial in Europe. Therefore, the study adds to the body of knowledge evaluating the effectiveness of stratified care for low back pain in primary care, and provides insight into the effects of stratification on clinical practice

Supervised and non-supervised Nordic walking in the treatment of chronic low back pain: a single blind randomized clinical trial

<p>Abstract</p> <p>Background</p> <p>Active approaches including both specific and unspecific exercise are probably the most widely recommended treatment for patients with chronic low back pain but it is not known exactly which types of exercise provide the most benefit. Nordic Walking - power walking using ski poles - is a popular and fast growing type of exercise in Northern Europe that has been shown to improve cardiovascular metabolism. Until now, no studies have been performed to investigate whether Nordic Walking has beneficial effects in relation to back pain.</p> <p>Methods</p> <p>A total of 151 patients with low back and/or leg pain of greater than eight weeks duration were recruited from a hospital based outpatient back pain clinic. Patients continuing to have pain greater than three on the 11-point numeric rating scale after a multidisciplinary intervention were included. Fifteen patients were unable to complete the baseline evaluation and 136 patients were randomized to receive A) Nordic walking supervised by a specially trained instructor twice a week for eight weeks B) One-hour instruction in Nordic walking by a specially trained instructor followed by advice to perform Nordic walking at home as much as they liked for eight weeks or C) Individual oral information consisting of advice to remain active and about maintaining the daily function level that they had achieved during their stay at the backcenter. Primary outcome measures were pain and disability using the Low Back Pain Rating Scale, and functional limitation further assessed using the Patient Specific Function Scale. Furthermore, information on time off work, use of medication, and concurrent treatment for their low back pain was collected. Objective measurements of physical activity levels for the supervised and unsupervised Nordic walking groups were performed using accelerometers. Data were analyzed on an intention-to-treat basis.</p> <p>Results</p> <p>No mean differences were found between the three groups in relation to any of the outcomes at baseline. For pain, disability, and patient specific function the supervised Nordic walking group generally faired best however no statistically significant differences were found. Regarding the secondary outcome measures, patients in the supervised group tended to use less pain medication, to seek less concurrent care for their back pain, at the eight-week follow-up. There was no difference between physical activity levels for the supervised and unsupervised Nordic walking groups. No negative side effects were reported.</p> <p>Conclusion</p> <p>We did not find statistically significant differences between eight weeks of supervised or unsupervised Nordic walking and advice to remain active in a group of chronic low back pain patients. Nevertheless, the greatest average improvement tended to favor the supervised Nordic walking group and - taking into account other health related benefits of Nordic walking - this form of exercise may potentially be of benefit to selected groups of chronic back pain patients.</p> <p>Trial registration</p> <p><url>http://www.ClinicalTrials.gov</url> # NCT00209820</p

Evidence‐based treatment recommendations for neck and low back pain across Europe:a systematic review of guidelines

Background and objective: This systematic review synthesized evidence from European neck and low back pain (NLBP) clinical practice guidelines (CPGs) to identify recommended treatment options for use across Europe. Databases and Data Treatment: Comprehensive searches of thirteen databases were conducted, from 1st January 2013 to 4th May 2020 to identify up-to-date evidence-based European CPGs for primary care management of NLBP, issued by professional bodies/organizations. Data extracted included; aim and target population, methods for development and implementation and treatment recommendations. The AGREE II checklist was used to critically appraise guidelines. Criteria were devised to summarize and synthesize the direction and strength of recommendations across guidelines. Results: Seventeen CPGs (11 low back; 5 neck; 1 both) from eight European countries were identified, of which seven were high quality. For neck pain, there were consistent weak or moderate strength recommendations for: reassurance, advice and education, manual therapy, referral for exercise therapy/programme, oral analgesics and topical medications, plus psychological therapies or multidisciplinary treatment for specific subgroups. Notable recommendation differences between back and neck pain included, i) analgesics for neck pain (not for back pain); ii) options for back pain-specific subgroups—work-based interventions, return to work advice/programmes and surgical interventions (but not for neck pain) and iii) a greater strength of recommendations (generally moderate or strong) for back pain than those for neck pain. Conclusions: This review of European CPGs identified a range of mainly non-pharmacological recommended treatment options for NLBP that have broad consensus for use across Europe. Significance: Consensus regarding evidence-based treatment recommendations for patients with neck and low back pain (NLBP) from recent European clinical practice guidelines identifies a wide range of predominantly non-pharmacological treatment options. This includes options potentially applicable to all patients with NLBP and those applicable to only specific patient subgroups. Future work within our Back-UP research team will transfer these evidence-based treatment options to an accessible clinician decision support tool for first contact clinicians

Brief pain re-assessment provided more accurate prognosis than baseline information for low-back or shoulder pain

Background Research investigating prognosis in musculoskeletal pain conditions has only been moderately successful in predicting which patients are unlikely to recover. Clinical decision making could potentially be improved by combining information taken at baseline and re-consultation. Methods Data from four prospective clinical cohorts of adults presenting to UK and Dutch primary care with low-back or shoulder pain was analysed, assessing long-term disability at 6 or 12 months and including baseline and 4–6 week assessments of pain. Baseline versus short-term assessments of pain, and previously validated multivariable prediction models versus repeat assessment, were compared to assess predictive performance of long-term disability outcome. A hypothetical clinical scenario was explored which made efficient use of both baseline and repeated assessment to identify patients likely to have a poor prognosis and decide on further treatment. Results Short-term repeat assessment of pain was better than short-term change or baseline score at predicting long-term disability improvement across all cohorts. Short-term repeat assessment of pain was only slightly more predictive of long-term recovery (c-statistics 0.78, 95% CI 0.74 to 0.83 and 0.75, 95% CI 0.69 to 0.82) than a multivariable baseline prognostic model in the two cohorts presenting such a model (c-statistics 0.71, 95% CI 0.67 to 0.76 and 0.72, 95% CI 0.66 to 0.78). Combining optimal prediction at baseline using a multivariable prognostic model with short-term repeat assessment of pain in those with uncertain prognosis in a hypothetical clinical scenario resulted in reduction in the number of patients with an uncertain probability of recovery, thereby reducing the instances where patients may be inappropriately referred or reassured. Conclusions Incorporating short-term repeat assessment of pain into prognostic models could potentially optimise the clinical usefulness of prognostic information

Are self-reported pain characteristics, classified using the paindetect questionnaire, predictive of outcome in people with low back pain and associated leg pain?

Objective: This study was designed to investigate whether the PainDETECT Questionnaire (PDQ) classification was predictive of outcomes at 3 and 12 months follow-up in low back pain (LBP) patients with associated leg pain. Identification of clinically important subgroups and targeted treatment is believed to be important in LBP care. The PD-Q is designed to classify whether a person has neuropathic pain, based on their self-reported pain characteristics. However, it is unknown whether this classification is a prognostic factor or predicts treatment response. Method: One hundred forty-five participants were recruited in the secondary care. Inclusion criteria were 3 to 12 months of LBP and related leg pain. Baseline PDQ scores classified participants into 3 groups ("likely" to have neuropathic pain, "uncertain," and "unlikely") but did not affect treatment decisions. The outcome measures were LBP, leg pain, activity limitation, and self-reported general health. Scores were compared between those with "likely" neuropathic pain (neuropathic group) and "unlikely" (non-neuropathic group), using Mann-Whitney, Friedman, and ? tests. Results: At baseline, the neuropathic group had worse scores on all outcome measures, and analgesic use, sick leave, and sense of coherence (P=0.000 to 0.044). At 3 months and 12 months, both groups improved (P=0.001 to 0.032). However, the groups remained different at each time point on all outcome measures (P=0.000 to 0.033) except LBP (P=0.054 to 0.214). DISCUSSION AND CONCLUSIONS: The PDQ classification was a prognostic factor but was not predictive of response to treatment that was not targeted to neuropathic pain. Further studies should investigate whether PD-Q groups are predictive of treatment response when targeted to neuropathic pain

Is the psychosocial profile of people with low back pain seeking care in Danish primary care different from those in secondary care?

Differences between the psychosocial risk factors of low back pain (LBP) patients in primary and secondary care are under-investigated. Similarly, differences in the psychosocial profile of people classified into STarT Back Screening Tool (SBT) subgroups in primary and secondary care settings have not been investigated. The aim of the study was to determine: (1) if movement-related fear, catastrophisation, anxiety and/or depression in LBP patients are different between primary and secondary care settings, and (2) if those differences are retained when stratified by SBT subgroup. This study was a cross-sectional comparison of LBP patients in Danish primary settings (405 general practitioner or physiotherapy patients) and a secondary care setting (311 outpatient spine centre patients). Psychosocial factors were measured with the Roland Morris Disability Questionnaire, the Tampa Scale of Kinesiophobia, the Coping Strategies Questionnaire (catastrophisation subscale), and the Hospital Anxiety and Depression Scale. There were significantly higher scores in secondary care for movement-related fear (1.3 points (95%CI .1-2.5) p = .030) and catastrophisation (2.0 (95%CI 1.0-3.0) p &lt; .000), lower scores on anxiety (-1.0 (95%CI -1.0-2.0) p &lt; .000) but no difference for depression. These differences in psychosocial scores were broadly retained when stratified by SBT subgroup. However, questionnaire-specific reported thresholds for important difference scores indicate the size of these differences between the care settings were unlikely to be clinically important from a patient perspective. Longitudinal studies are required to investigate the predictive ability of SBT in secondary care settings and whether treatment targeted to SBT subgroups is effective in secondary care

The predictive and external validity of the STarT Back Tool in Danish primary care

Purpose: The STarT Back Tool (SBT) was recently translated into Danish and its concurrent validity described. This study tested the predictive validity of the Danish SBT. Methods: Danish primary care patients (n = 344) were compared to a UK cohort. SBT subgroup validity for predicting high activity limitation at 3 months' follow-up was assessed using descriptive proportions, relative risks, AUC and odds ratios. Results: The SBT had a statistically similar predictive ability in Danish primary care as in UK primary care. Unadjusted relative risks for poor clinical outcome on activity limitation in the Danish cohort were 2.4 (1.7-3.4) for the medium-risk subgroup and 2.8 (1.8-3.8) for the high-risk subgroup versus 3.1 (2.5-3.9) and 4.5 (3.6-5.6) for the UK cohort. Adjusting for confounders appeared to explain the lower predictive ability of the Danish high-risk group. Conclusions: The Danish SBT distinguished between low- and medium-risk subgroups with a similar predictive ability of the UK SBT. That distinction is useful information for informing patients about their expected prognosis and may help guiding clinicians' choice of treatment. However, cross-cultural differences in the SBT psychosocial subscale may reduce the predictive ability of the high-risk subgroup in Danish primary care

Authors’ reply to the comment by Zhang et al

We thank Zhang et al. (2021) for their interest in our work (Corp et al 2021). As the authors point out these are new versions of the AGREE reporting tools and inevitably there will be some delay in their implementation. Overall, we concur that in the future teams conducting reviews of guidelines should take the points raised in this letter into consideration