Internet delivered interventions may provide a route to rapid support for behavioural self-management for low back pain (LBP) that could be widely applied within primary care. Although evidence is emerging that more complex technologies (mobile apps linked to digital wristbands) can have some impact on LBP-related disability, there is a need to determine the effectiveness of highly accessible, web-based support for self-management for LBP. We conducted a multi-centre pragmatic randomised controlled trial, testing ‘SupportBack’, an accessible internet intervention developed specifically for primary care. We aimed to determine the effectiveness of the SupportBack interventions in reducing LBP-related physical disability in primary care patients. Participants were randomised to 1 of 3 arms: 1) Usual care + internet intervention + physiotherapy telephone support, 2) Usual care + internet intervention, 3) Usual care alone. Utilising a repeated measures design, the primary outcome for the trial was disability over 12 months using the Roland Morris Disability Questionnaire (RMDQ) at 6 weeks, 3, 6 and 12 months. Results: 826 were randomised, with follow-up rates: 6 weeks = 83%; 3 months = 72%; 6 months = 70%; 12 months = 79%. Analysis is ongoing, comparing each intervention arm versus usual care alone. The key results will be presented at the conference.Background
Methods and results
Guidelines recommend epidural steroid injections (ESI) for treating severe disc-related sciatica based on trial data showing modest reductions in leg pain, disability and surgery avoidance. Despite their widespread use, there is no clear evidence about which patients are more likely to benefit from ESI. The aim of this study was to generate consensus on potential predictors of outcome following ESI for disc-related sciatica to include in data collection in a future cohort study. A list of potential predictors of outcome following ESI was generated from existing literature and a consensus meeting with seven experts. Items were subsequently presented in a two-round on-line modified Delphi study to generate consensus among experts on which items are agreed as potential predictors of outcome from ESI (consensus defined as 70% agreement with ranking of remaining items).Background
Methods
Clinical guidelines recommend epidural steroid injection (ESI) as a treatment option for severe disc-related sciatica, but there is considerable uncertainty about its effectiveness. Currently, we know very little about factors that might be associated with good or poor outcomes from ESI. The aim of this systematic review was to synthesize and appraise the evidence investigating prognostic factors associated with outcomes following ESI for patients with imaging confirmed disc-related sciatica. The search strategy involved the electronic databases Medline, Embase, CINAHL Plus, PsycINFO and reference lists of eligible studies. Selected papers were quality appraised independently by two reviewers using the Quality in Prognosis Studies (QUIPS) tool. Between study heterogeneity precluded statistical pooling of results.Background
Methods
We previously reported that osteoblasts at the curve apex in adolescent idiopathic scoliosis (AIS) exhibit a differential phenotype, compared to non-curve osteoblasts(1). However, the Hueter-Volkmann principle on vertebral body growth in spinal deformities (2) suggests this could be secondary to altered biomechanics. This study examined whether non-curve osteoblasts subjected to mechanical strain resemble the transcriptomic phenotype of curve apex osteoblasts. Facet spinal tissue was collected perioperatively from three sites, (i) the concave and (ii) convex side at the curve apex and (iii) from outside the curve (non-curve) from six AIS female patients (age 13–18 years; NRES 19/WM/0083). Non-curve osteoblasts were subjected to strain using a 4-point bending device. Osteoblast phenotype was determined by RNA sequencing and bioinformatic pathway analysis. RNAseq revealed that curve apex osteoblasts exhibited a differential transcriptome, with 1014 and 1301 differentially expressed genes (DEGs; p<0.05, fold-change >1.5) between convex/non-curve and concave/non-curve sites respectively. Non-curve osteoblasts subjected to strain showed increased protein expression of the mechanoresponsive biomarkers COX2 and C-Fos. Comparing unstimulated vs strain-induced non-curve osteoblasts, 423 DEGs were identified (p<0.05, fold-change >1.5). Of these DEGs, only 5% and 6% were common to the DEGs found at either side of the curve apex, compared to non-curve cells. Bioinformatic analysis of these strain-induced DEGs revealed a different array of canonical signalling pathways and cellular processes, to those significantly affected in cells at the curve apex. Mechanical strain of AIS osteoblasts in vitro did not induce the differential transcriptomic phenotype of AIS osteoblasts at the curve apex.
Despite several hundred RCTs of exercise for persistent non-specific low back pain (NSLBP), the treatment targets of exercise are unclear. In a systematic review we observed 30 direct and indirect treatment targets of exercise described across 23 RCTs for persistent NSLBP. Since not all treatment targets and outcomes can be assessed in all RCTs, it is therefore important to prioritise these treatment targets through consensus from key stakeholders. These consensus workshops aimed to agree treatment targets for the use of exercise interventions in randomised controlled trials (RCTs) in persistent NSLBP using nominal group workshop (NGW) methodology. The first UK workshop included people who had experience of exercise to manage their persistent NSLBP, clinicians who prescribe exercise for persistent NSLBP, and researchers who design exercise interventions tested in RCTs. The second workshop included participants attending an international back and neck pain research workshop. Twelve participants took part in the UK NGW and fifteen took part in the final ranking of the exercise treatment targets. In addition to the original list of 30 treatment targets, a further 26 ideas were generated. After grouping and voting, 18 treatment targets were prioritised. The top five ranked targets of exercise interventions for persistent NSLBP were: pain reduction, improvement in function, reduction of fear of movement, encouragement of normal movement and improvement of mobility. The results of the international NGW will also be presented.Background and Aim of Study
Methods and Results
This report presents independent research commissioned by the National Institute for Health Research (NIHR) (NIHR HTA project number 12/201/09). NEF is a Senior NIHR Investigator and was supported through an NIHR Research Professorship (NIHR-RP-011-015). KK was supported by a HEFCE Senior Clinical Lectureship award. The views and opinions expressed by authors in this publication are those of the authors and do not necessarily reflect those of the NHS, the NIHR, MRC, CCF, NETSCC, the Health Technology Assessment programme or the Department of Health. Stratified care (SC) has previously been found to be a cost-effective approach for primary care LBP patients. The SCOPiC trial compared the clinical and cost-effectiveness of a modified SC model combining prognostic and clinical characteristics to allocate sciatica patients into one of three groups (with matched care pathways) versus non-stratified, usual care (UC).Funding
Background and Purpose
Improving primary care management of musculoskeletal (MSK) pain is a priority. A pilot cluster RCT tested prognostic stratified care for patients with common MSK pain presentations, including low back pain, in 8 UK general practices (4 stratified care; 4 usual care) with 524 patients. GPs in stratified care practices were asked to use i) the Keele STarT MSK tool for risk-stratification and ii) matched treatment options for patients at low-, medium- and high-risk of persistent pain. A linked qualitative process evaluation explored patients' and GPs' views and experiences of stratified care. Individual ‘stimulated-recall’ interviews with patients and GPs in the stratified care arm (Background
Methods
An integrated rehabilitation programme was developed and found feasible taking into account the existing evidence base, appropriate theories, and patient and public involvement. The integrated programme encompasses inpatient activities supported by a multidisciplinary team, and integration of knowledge, skills and behaviours in the patient's everyday life. The aim of this trial was to compare the effectiveness of an integrated rehabilitation programme with an existing rehabilitation programme in patients with chronic low back pain (CLBP). Comparison of two parallel rehabilitation programmes in a randomised controlled trial including 165 patients with CLBP. The integrated rehabilitation programme comprised an alternation of in total three weeks of inpatient stay and in total 11 weeks of home-based activities. The existing rehabilitation programme comprised a four-week inpatient stay. Primary outcome was changes in disability (Oswestry Disability Index). Secondary outcomes were changes in pain, pain self-efficacy, health related quality of life and depression. Outcomes were collected at baseline and 26-week follow-up. Disability decreased −5.76 (95%CI; −8.31, −3.20) for the integrated programme and −5.64 (95%CI; −8.45, −2.83) for the existing programme. The adjusted difference between the two programmes was −0.28 (95%CI; −4.02, 3.45). No statistically significant difference was found in any of the secondary outcomes.Purpose of the study and background
Methods and Results
The Keele STarT Back approach is effective for stratifying patients with low back pain in primary care, but a similar approach has not been tested with a broader range of patients with musculoskeletal (MSK) pain. We report a feasibility and pilot trial examining the feasibility of a future main trial of a primary care based, risk-stratification (STarT MSK) approach for patients with back, neck, knee, shoulder or multi-site pain. A pragmatic, two-parallel arm, cluster randomised controlled trial (RCT) in 8 GP practices (4 stratified care involving use of the Keele STarT MSK tool and matched treatment options: 4 usual care). Following screening, adults with one of the five most common MSK pain presentations were invited to take part in data collection over 6 months. Feasibility outcomes included exploration of selection bias, recruitment and follow-up rates, clinician engagement with using the Keele STarT MSK tool and matching patients to treatments.Background and aims
Methods
Complex interventions, such as exercise for LBP, often have many treatment targets. Matching a primary outcome to the target(s) of exercise interventions may provide greater standardized mean differences (SMDs) than using an unmatched primary outcome. We aimed to explore whether the conclusions of exercise trials for LBP might differ with i) improved matching of outcomes to treatment targets and ii) the use of composite outcome measures. We investigated i) matching in five trials (n=1033) that used an unmatched primary outcome but included some of their matched outcomes as secondary outcomes; ii) composite outcomes in four trials (n=864). The composite consisted of standardised averaged matched outcomes. All analyses replicated the primary outcome analysis, applied to the matched or composite outcome in each dataset. When not possible, SMDs were calculated for the primary and matched outcomes. i) Of five trials, three had greater SMDs and increased statistical significance with matched outcomes (pooled effect SMD 0.35 (95% CI 0.16, 0.54), p=0.0003) compared to an unmatched primary outcome (pooled effect SMD 0.13 (95% CI 0.04, 0.23) p=0.007). ii) Of four composite outcomes: two matched trials had greater SMDs and improved statistical precision in the primary outcome than the composite outcome; two unmatched trials had greater SMDs and improved statistical precision in the composite compared to the primary outcome.Background
Methods and Results
Healthcare for sciatica is usually ‘stepped’ with initial advice and analgesia, then physiotherapy, then more invasive interventions if symptoms continue. The SCOPiC trial tested a stratified care algorithm combining prognostic and clinical characteristics to allocate patients into one of three groups, with matched care pathways, and compared the effectiveness of stratified care (SC) with non-stratified, usual care (UC). Pragmatic two-parallel arm RCT with 476 adults recruited from 42 GP practices and randomised (1:1) to either SC or UC (238 per arm). In SC, participants in group 1 were offered up to 2 advice/treatment sessions with a physiotherapist, group 2 were offered up to 6 physiotherapy sessions, and group 3 was ‘fast-tracked’ to MRI and spinal specialist opinion. Primary outcome was time to first resolution of sciatica symptoms (6-point ordinal scale) collected via text messages. Secondary outcomes (4 and 12 months) included leg and back pain intensity, physical function, psychological status, time-off-work, satisfaction with care. Primary analysis was by intention to treat.Background and Purpose
Methods
Medication prescribing patterns for patients with neuropathic low back-related leg pain (LBLP) in primary care are unknown. To estimate the proportion of patients prescribed pain medications, describe baseline characteristics of patients prescribed neuropathic pain (NP) medication and estimate the proportion of LBLP patients with refractory NP.Background
Purpose
Sciatica is common and associated with significant impacts for the individual, health care and society. The SCOPiC randomised controlled trial (RCT) is investigating whether stratified primary care for sciatica is more effective and cost-effective than usual, non-stratified primary care. Stratified care involves subgrouping patients to one of three groups based on a combination of prognostic and clinical indicators. Patients in one of these groups are ‘fast-tracked’ with an MRI scan to spinal specialist opinion. Our aim was to understand the perspectives of clinicians on the acceptability of this ‘fast-track’ pathway. Qualitative, semi-structured interviews were conducted with general practitioners, spinal specialist physiotherapists and spinal surgeons (Background
Methods
Exercise is a complex intervention, and often has more than one treatment target. Results from randomised controlled trials (RCTs) of exercise interventions for chronic low back pain (CLBP) typically show small to moderate effect sizes, but these may differ where outcomes better reflect the targets of interventions. This review aimed to describe what treatment targets, outcome domains and primary outcome measures are used in exercise RCTs, and examined how well the selected outcome domains match the treatment targets used in each RCT. A computer-aided literature search was performed in eight databases, from inception to August 2018. Inclusion criteria: RCTs in CLBP, exercise compared to a non-exercise arm, sample size >60 per arm. Title and abstract review, subsequent full text review, data extraction and risk of bias assessment were independently undertaken by pairs of reviewers. Of 18251 initially identified titles and abstracts, 23 trials were included in the review. 30 treatment targets were extracted, and 6 primary outcome domains identified. A logic model of the treatment targets and outcomes demonstrated diverse relationships. Only 5 RCTs matched their primary outcome domain to the identified treatment targets, 12 used primary outcomes that did not match the reported treatment targets, and 6 were partially matched.Background
Methods and Results
There is a paucity of prognosis research in patients with neuropathic low back-related leg pain (LBLP) in primary care. To investigate the clinical course and prognostic factors in primary care LBLP patients consulting with neuropathic pain (NP).Background
Purpose
Low back pain (LBP) is a major health challenge globally. Research has identified common trajectories of pain over time. We aimed to investigate whether trajectories described in one primary care cohort can be confirmed in another, and to determine the prognostic value of factors collected 5 years prior to the identification of the trajectory. The study was carried out on 281 patients who had consulted primary care for LBP, at that point completed a baseline questionnaire, and then returned a questionnaire at 5-years follow-up plus at least 3 (of 6) subsequent monthly questionnaires. Baseline factors were measured using validated tools. Pain intensity scores from the 5-year follow-up and monthly questionnaires were used to cluster participants into 4 previously derived pain trajectories (no or occasional mild, persistent mild, fluctuating, persistent severe), using latent class analysis. Posterior probabilities of belonging to each cluster were estimated for each participant. The posterior probabilities for the assigned clusters were very high (>0.90) for each cluster except for the smallest ‘fluctuating’ cluster (0.74). Lower social class (OR 2.9; 95% CI 1.2, 7.0), higher pain intensity (1.6 per unit; 1.2, 2.2), and pain duration greater than 3 years (2.7; 1.0, 7.3), were significantly associated with a more severe trajectory 5-years later, as were higher physical disability, emotional impact of pain, and perception pain will last a long time.Background and objectives
Methods and results
Healthcare practitioners' (HCPs) attitudes and beliefs about MSK pain influence their practice behaviour. The Pain Attitudes and Beliefs Scale (PABS), developed for use in the context of LBP, consists of two subscales (biomedical and biopsychosocial) is the most widely used measure. However, poor performance of the biopsychosocial orientation scale is attributed, in part, to inadequate conceptualisation of the orientation. To develop a new biopsychosocial scale and adapt the PABS to assess HCPs' attitudes and beliefs about common MSK pain.Purpose of the study and background
Purpose
Patients with low back-related leg pain (LBLP) can present with neuropathic pain; it is not known but is often assumed that neuropathic pain persists over time. This research aimed to identify cases with neuropathic pain that persisted at short, intermediate and longer-term time points, in LBLP patients consulting in primary care. LBLP patients in a primary care cohort study (n=606) completed the self-report version of Leeds Assessment for Neurological Symptoms and Signs (s-LANSS, score of ≥12 indicates possible neuropathic pain) at baseline, 4-months, 12-months and 3-years. S-LANSS scores and percentages of patients with score of ≥12 are described at each time-point. Multiple imputation was used to account for missing data.Background
Methods
The STarT Back risk-stratification approach uses the STarT Back Tool to categorise patients with low back pain (LBP) at low, medium or high-risk of persistent disabling pain, in order to match treatments. The MATCH trial (NCT02286141) evaluated the effect of implementing an adaptation of this approach in a United States healthcare setting. This was a pragmatic cluster randomised trial with a pre-intervention baseline period. Six primary care clinics were pair-randomised, three to an intensive stratified care quality improvement intervention and three as controls. LBP patients were invited to provide outcomes two weeks after their primary care visit, and two and six months later. Primary outcomes were physical function (RMDQ) and pain (0–10 NRS), and secondary outcomes including healthcare use and treatments provided received. Analysis was intention-to-treat.Purpose & Background
Methods
Criticisms about overuse of MRI in low back pain are well documented. Yet, with the exception of suspicion of serious pathology, little is known about factors that influence clinicians' preference for MRI. We investigated the factors associated with physiotherapists' preference for MRI for patients consulting with benign low back and leg pain (LBLP) including sciatica. Data were collected from 607 primary care patients consulting with LBLP and assessed by 7 physiotherapists, in the ATLAS cohort study. Following clinical assessment, physiotherapists documented whether he/she wanted the patient to have an MRI. Factors potentially associated with clinicians' preference for imaging were selected a priori, from patient characteristics and clinical assessment findings. A mixed-effect logistic regression model examined the associations between these factors and physiotherapists' preference for MRI.Background
Methods
Recruitment to time and target in clinical trials is a key challenge requiring careful estimation of numbers of potential participants. The SCOPiC trial ((HTA 12/201/09) (ISRCTN75449581)) is investigating the clinical and cost-effectiveness of stratified care for patients with sciatica in primary care. Here, we describe the approaches followed to achieve recruitment of our required sample size (n=470), the challenges encountered and required adaptations. We used recruitment data from the SCOPiC trial and its internal pilot, to show the differences between estimated and actual numbers of patients from consultation to participation in the trial. Patients were consented to the trial if they had a clinical diagnosis of sciatica (with at least 70% confidence) and met the trial eligibility criteria.Background
Methods
Measurement inconsistency across clinical trials is tackled by the development of a core outcome measurement set. Four core outcome domains were recommended for clinical trials in patients with non-specific LBP (nsLBP): physical functioning, pain intensity, health-related quality of life (HRQoL), and number of deaths. This study aimed to reach consensus on core instruments to measure the first three domains. The Steering Committee overseeing this project selected 17 potential core instruments for physical functioning, three for pain intensity, and five for HRQoL. Evidence on their measurement properties in nsLBP was synthesized in three systematic reviews using COSMIN methodology. Researchers, clinicians, and patients (n = 208) were invited in a Delphi survey to seek consensus on which instruments to endorse as core. Consensus was Background & purpose
Methods & Results
Neuropathic pain is a challenging pain syndrome to manage. Low back-related leg pain (LBLP) is clinically diagnosed as either sciatica or referred leg pain and sciatica is often assumed to be neuropathic. Our aim was to describe the prevalence and characteristics of neuropathic pain in LBLP patients. Analysis of cross-sectional data from a prospective, primary care cohort of 609 LBLP patients. Patients completed questionnaires, and received clinical assessment including MRI. Neuropathic characteristics (NC) were measured using the self-report version of the Leeds Assessment of Neuropathic Symptoms and Signs scale (SLANSS; score of ≥12 indicates pain with NC).Purpose of study and background
Methods
To identify treatment effect modifiers within the STarT Back Trial which demonstrated prognostic stratified care was effective in comparison to standard care for patients with low back pain. Secondary analysis of the STarT Back Trial using 688 patients with available 4-month follow-up data. Disability (baseline and 4 months) was assessed using the Roland Morris Disability Questionnaire (RMDQ) using continuous and dichotomized (>7) outcome scores. Potential treatment effect modifiers were evaluated with group x predictor interaction terms using linear and logistic regression models. Modifiers included: age, gender, education, socio-economic status (SES), employment status, work satisfaction, episode duration, general health (SF-12), number of pain medications, and treatment expectations.Purpose and Background:
Methods:
Internet interventions provide an opportunity to encourage patients with LBP to self-manage and remain active, by tailoring advice and providing evidence-based support for increasing physical activity. This paper reports the development of the ‘SupportBack’ internet intervention, designed for use with usual primary care, as the first stage of a feasibility RCT currently underway comparing: usual primary care alone; usual care plus the internet intervention; usual care plus the internet intervention with physiotherapist telephone support. The internet intervention delivers a 6-week, tailored programme focused on graded goal setting, self-monitoring, and provision of tailored feedback to encourage physical activity/exercise increases or maintenance. 22 patients with back pain from primary care took part in ‘think aloud’ interviews, to qualitatively explore the intervention, provide feedback on its relevance and quality and identify any extraneous content or omissions.Background:
Methods:
Merely publishing clinical guidelines is insufficient to ensure their implementation in clinical practice. We aimed to clarify the decision-making processes that result in the delivery of particular treatments to patients with low back pain (LBP) in primary care and to examine clinicians' perspectives on the National Institute for Health and Care Excellence (NICE) clinical guidelines for managing LBP in primary care. We conducted semi-structured interviews with 53 purposively-sampled clinicians from south-west England. Participants were: 16 General Practitioners (GPs), 10 chiropractors, 8 acupuncturists, 8 physiotherapists, 7 osteopaths, and 4 nurses. Thematic analysis showed that official guidelines comprised just one of many inputs to clinical decision-making. Clinicians drew on personal experience and inter-professional networks and were constrained by organisational factors when deciding which treatment to prescribe, refer for, or deliver to an individual patient with LBP. Some found the guideline terminology - “non-specific LBP” - unfamiliar and of limited relevance to practice. They were frustrated by disparities between recommendations in the guidelines and the real-world situation of short consultation times, difficult-to-access specialist services and sparse commissioning of guideline-recommended treatments.A statement of the purposes of the study and background:
A summary of the methods used and the results:
To explore the cost-utility of implementing stratified care for low back pain (LBP) in general practice, compared with usual care, within patient risk subgroups (low, medium and high risk of persistent disabling pain determined by the STarT Back tool). Adopting a cost-utility framework alongside a prospective, sequential comparison of separate patient cohorts (922 patients in total) with six-month follow-up, the base case analysis estimated the incremental LBP-related healthcare cost per additional quality-adjusted life year (QALY) by risk subgroup. Uncertainty was explored with cost-utility planes and acceptability curves. Sensitivity analyses examined alternative approaches (a complete case analysis, the incorporation of non-LBP-related healthcare use and estimation of societal costs relating to work absence).Purpose and background
Methods
Over two-thirds of pregnant women experience low back pain (LBP) that interferes with everyday activities, work and sleep. Acupuncture appears a safe, promising intervention but there are no high quality trial data, regarding its clinical or cost-effectiveness in comparison to standard care. EASE Back was a feasibility and pilot RCT designed to inform a full trial evaluating the addition of acupuncture to standard care for pregnancy-related LBP. In preparation for the pilot trial, phase 1 of EASE Back consisted of semi-structured interviews exploring the views of pregnant women, midwives and physiotherapists about pregnancy-related LBP, use of acupuncture, and participation in clinical trials. Transcript data were anonymised and analysed using thematic analysis. Three members of the team independently coded a sample of transcripts to develop the coding framework.Purpose and background
Methods
Recommendations in clinical practice guidelines for non-specific low back pain (NSLBP) are not necessarily translated into practice. Multiple research studies have investigated different strategies to implement best evidence into practice yet no synthesis of these studies is available. To systematically review available studies to determine whether implementation efforts in this field have been successful; to identify which strategies have been most successful in changing healthcare practitioner behaviours and patient outcomes.Background
Objectives
To compare the contribution of physical, psychological and social indicators to predicting disability after one year between consulters with low back pain (LBP) of less than 3 months duration and more than 3 months duration. Data from two large prospective cohort studies of consecutive patients consulting with LBP in general practices were merged, with disability measured by the Roland Morris Disability Questionnaire (RMDQ). There were complete data for 258 cases with acute/subacute LBP and 668 cases with chronic LBP at 12 months follow-up. Univariate and adjusted multivariate regression analyses of various potential prognostic indicators for disability at 12 months were carried out.Purpose
Methods
Patient preferences have been shown to be associated with treatment effects ( To determine the treatment preferences of LBP patients and whether these affect clinical outcome.Background
Aim
