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
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
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
To evaluate the incidence of primary venous thromboembolism (VTE),
epidural haematoma, surgical site infection (SSI), and 90-day mortality
after elective spinal surgery, and the effect of two protocols for
prophylaxis. A total of 2181 adults underwent 2366 elective spinal procedures
between January 2007 and January 2012. All patients wore anti-embolic
stockings, mobilised early and were kept adequately hydrated. In
addition, 29% (689) of these were given low molecular weight heparin
(LMWH) while in hospital. SSI surveillance was undertaken using the
Centers for Disease Control and Prevention criteria.Aims
Patients and Methods
Early intervention is advocated to prevent long-term work absence due to musculoskeletal (MSK) pain. The SWAP trial tested whether adding a vocational advice (VA) service to best current care led to fewer days work absence over 4 months. The SWAP trial was a cluster randomised controlled trial in 6 general practices, 3 randomised to best current care (control), 3 randomised to best current care and the VA service (intervention). Patients were ≥18 years, absent from work ≤6 months or struggling at work due to MSK pain. Primary outcome was number of days absent over 4 months. Exploratory subgroup analyses examined whether the effect was larger for patients with spinal pain compared to other MSK pain.Introduction
Methods
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
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
The STarT Back trial demonstrated benefits from a stratified primary care model that targets low back pain (LBP) treatment according to patient prognosis (low-, medium-, or high-risk). The current IMPaCT Back study implemented this approach in everyday primary care to investigate; i) changes in GPs' and physiotherapists' attitudes, confidence and behaviours, ii) patients' clinical outcomes, and iii) cost-effectiveness. This quality improvement study involved 5 GP practices (65 GPs and 34 physiotherapists) with before and after implementation cohorts of consecutive LBP consulters using an intention to treat analysis to compare patient data. Phase 1: Usual care data collection from clinicians and patients (pre-implementation). Phase 2: Introduction of prognostic screening and targeted treatment including a minimal GP intervention (low-risk group), systematic referral to physiotherapy (medium-risk group) and to psychologically informed physiotherapy (high-risk group). Phase 3: Post-implementation data collection from clinicians and patients.Background and purpose
Method
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
Wales in collaboration with the Welsh Assembly Government, has attempted to start a national ligament register. Norway is the lead in Europe for running a successful national quality knee ligament registry. As yet there is no UK wide registry encompassing all forms of knee ligament surgery. The issue has been discussed at previous society meetings, but no consensus has been reached.Aims
Introduction
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
Proximal humeral fractures are common and often occur in osteoporotic bone. Suture fixation utilises the rotator cuff tendons as well as bone providing adequate stability and avoids complications associated with metalwork insertion. Surgical exposure was via a delto-pectoral approach with minimal dissection of the fracture site. Initially a 2 suture technique was utilized with heavy ethibond sutures passed through drill holes either side of the bicipital groove; however, because of concerns about varus instability the technique now uses a third suture placed laterally acting as a tension band to prevent varus collapse. Patients with Neer 2 and 3 part fractures treated with suture fixation were assessed clinically (using the Constant score) and radiologically at a mean of 27 months post fracture. To date 24 patients have been studied. The average age of the patients in our series was 70.2. All fractures progressed to union with no cases of radiological avascular necrosis. We had 2 cases of mal-union (-one varus and one valgus-), both with a 2-suture technique. One patient had early loss of fixation; re-exploration was performed with stability conferred by a third lateral suture. Active abduction >
120o was achieved in 9 patients with a mean Constant score of 72 compared to 89 on the un-injured contra-lateral side. We have demonstrated that suture fixation of displaced proximal humeral fractures is an effective alternative to fixation using metalwork. The advantages are that minimal soft tissue stripping of the fracture site is required and the potential problems associated with metalwork insertion into osteoporotic bone are avoided. Following one case of varus mal-union with a 2-suture technique we now routinely use a third suture to act as a lateral tension band.
self complete proforma video recording.
ii) A check-list of treatment modalities was constructed from this proforma. Twelve sessions were recorded on video (one new and one review patient for each therapist). The recordings were rated by 3 blinded, independent observers using the checklist. These were compared with the self-report audit forms relating to the same physiotherapy session.
Patient satisfaction has been identified as a key dimension in the assessment of outcome in LBP. However what outcome is important to the patient is often not considered, or is poorly assessed. Goal Attainment Scaling (GAS) is a method for systematically targeting individualised goals, and quantifying their achievement. This will provide a valid outcome measure of genuine importance to the patient.
To assess the results of this technique for stabilisation of severe spondylolisthesis, 12 patients with symptomatic severe spondylolisthesis underwent this procedure. The slipped L5 vertebra was stabilized using a hollow medullary screw through the posterior part of the body of S1 into the slipped L5 body, supplemented with pedicle screws into L5 and S1 with posterolateral fusion. At one year follow-up, all but one patient had improved in leg pain. 2 patients were aware of the prominent pedicle screws. 360° fusion was achieved without any progression of spondylolisthesis. Thus 360° fusion for severe L5-S1 spondylo-listhesis can be achieved effectively using this technique.
