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
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
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
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
The STarT Back approach comprises subgrouping of LBP patients according to risk of persistent LBP-related disability, and matches patients to appropriate treatments. In a clinical trial and implementation study, this stratified care approach was clinically and cost-effective compared to usual non-stratified care. However, the long-term cost- effectiveness is unknown, and could be established with decision modelling. A systematic review of model-based economic evaluations in LBP found shortcomings with existing models, including inadequate characterisation of the condition in health states and absence of long-term modelling. This study conceptualises the first decision model of this stratified care approach for LBP management, and assesses long-term cost-effectiveness. A cost-utility analysis from the NHS perspective compared stratified care with usual care, in patients consulting in primary care with non-specific LBP. A Markov state-transition model was constructed where long-term patient prognosis over ten years was dependent upon physical function achieved at twelve months. Consultation with experts helped define condition health states, inform the long-term modelling, and choice of sensitivity analyses.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
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
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
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
Low back-related leg pain (LBLP) is clinically diagnosed as referred leg pain or sciatica. Within the spectrum of LBLP there may be unrecognised subgroups of patients. This study aimed to identify and describe clusters of LBLP patients using latent class analysis (LCA). The study population were 609 LBLP primary care consulters. Variables from clinical assessment were included in the LCA. Characteristics of the statistically identified clusters were described and compared to the clinically defined groups of LBLP patients.Background
Methods
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
Identification of nerve root involvement (NRI) in patients with low back-related leg pain (LBLP) can be challenging. Diagnostic models have mainly been developed in secondary care with conflicting reference standards and predictor selection. This study aims to ascertain which cluster of items from clinical assessment best identify NRI in primary care consulters with LBLP Cross-sectional data on 395 LBLP consulters were analysed. Potential NRI indicators were seven clinical assessment items. Two definitions of NRI formed the reference standards: (i) high confidence (≥80%) NRI clinical diagnosis (ii) high confidence (≥80%) NRI clinical diagnosis with confirmatory magnetic resonance imaging (MRI) findings. Multivariable logistic regression models were constructed and compared for both reference standards. Model performances were summarised using the Hosmer-Lemeshow statistic and area under the curve (AUC). Bootstrapping assessed internal validity.Background:
Methods:
Leg pain frequently accompanies low back pain and is associated with increased levels of disability and higher health costs than simple low back pain. Distinguishing between different types of low back- related leg pain (LBLP) is important for clinical management and research applications. The aim of this systematic review was to identify, describe and appraise papers that classify or subgroup populations with LBLP. The search strategy involved nine electronic databases including Medline and Embase, reference lists of eligible studies and relevant reviews. Selected papers were quality appraised independently by two reviewers using a standardised scoring tool.Background
Methods
60% of back pain patients report pain radiation in the leg(s), which is associated with worse symptoms and poorer recovery. The majority are treated in primary care, but detailed information about them is scarce. The objective of this study is to describe the characteristics of patients with back and leg pain-seeking treatment in primary care. Adult patients consulting their GP with back and leg pain were invited to the study. Participants completed questionnaires including sociodemographic, physical and psychosocial measures. They also underwent standardised clinical assessments by physiotherapists, and received an MRI scan.Background
Methods
Pain with radiation to the leg is a common presentation in back pain patients. Radiating leg pain is either referred pain or radicular, commonly described as sciatica. Clinically distinguishing between these types of leg pain is recognized as difficult but important for management purposes. The aim of this study was to investigate inter-therapist agreement when diagnosing referred or radicular pain. Thirty-six primary care consulters with low back-related leg pain were assessed and diagnosed as referred or radicular leg pain by one of six trained experienced musculoskeletal physiotherapists. Assessments were videoed, excluding any diagnosis discourse, and viewed by a second physiotherapist who made an independent diagnosis. Therapists rated their confidence with diagnosis and reasons for their decision. Data was summarized using percentage agreements and kappa (K) coefficients with two sided 95% confidence intervals (CI).Background
Methods
One untested back pain treatment model is to stratify management depending on prognosis (low, medium or high-risk). This 2-arm RCT investigated: (i) overall clinical and cost-effectiveness of stratified primary care (intervention), versus non-stratified current best practice (control); and (ii) whether low-risk patients had non-inferior outcomes, and medium/high-risk groups had superior outcomes. 1573 adults with back pain (+/− radiculopathy) consulting at 10 general practices in England responded to invitations to attend an assessment clinic, at which 851 eligible participants were randomised (intervention n=568; control n=283). Primary outcome using intention-to-treat analysis was the difference in change in the Roland-Morris Disability Questionnaire (RMDQ) score at 12 months. Secondary outcomes included 4-month RMDQ change between arms overall, and at risk-group level at both time-points. The economic evaluation estimated incremental quality-adjusted life years (QALYs) and back pain-related health care costs.Background
Methods
Research on people's own experiences of living with sciatica is limited and this study aims to contribute to a better understanding of the impact of sciatica and its treatment. Longitudinal study based on in-depth interviews at baseline, six and twelve months follow-up. Thirty seven people were interviewed (15 men, 22 women) using a topic guide that allowed for detailed exploration of their story. All interviews were digitally recorded, fully transcribed, imported in the NVivo data management system and analysed thematically using the constant comparative method.Purpose and background
Methods
Although low back pain (LBP) with leg pain, is considered by most a poor prognostic indicator, it is at the same time believed to have a favourable natural resolution, and is often treated along similar lines to non-specific LBP, in line with current guidelines. It is unclear whether patients with LBP and leg pain are a distinct subgroup that might benefit from early identification and targeted interventions. We set out to investigate the impact of LBP with leg pain on health outcomes and health resources compared with that of LBP alone, and to explore which factors contribute to the observed disability outcomes. A systematic literature search of all English language peer reviewed publications was conducted using Medline, EMBASE, and CINAHL for the years 1994 to 2009.Purpose and background
Methods
