To evaluate the clinical and cost-effectiveness of a physical and psychological group intervention (BOOST programme) compared to physiotherapy assessment and advice (best practice advice [BPA]) for older adults with neurogenic claudication (NC) which is a debilitating spinal condition. A randomised controlled trial of 438 participants. The primary outcome was the Oswestry Disability Index (ODI) at 12 months. Data was also collected at 6 months. Other outcomes included Swiss Spinal Stenosis Questionnaire (symptoms), ODI walking item, 6-minute walk test (6MWT) and falls. The analysis was intention-to-treat. We collected the EQ5D and health and social care use to estimate cost-effectiveness. Participants were, on average, 74.9 years old (SD 6.0). There was no significant difference in ODI scores between groups at 12 months (adjusted mean difference (MD): −1.4 [95% Confidence Intervals (CI) −4.03,1.17]), but, at 6 months, ODI scores favoured the BOOST programme (adjusted MD: −3.7 [95% CI −6.27, −1.06]). Symptoms followed a similar pattern. The BOOST programme resulted in greater improvements in walking capacity (6MWT MD 21.7m [95% CI 5.96, 37.38]) and ODI walking item (MD −0.2 [95% CI −0.45, −0.01]) and reduced falls risk (odds ratio 0.6 [95% CI 0.40, 0.98]) compared to BPA at 12 months. Probability that the BOOST programme is cost-effective ranged from 67%–89% across cost-effectiveness thresholds.Purpose and background
Methods and results
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
Cognitive Functional Therapy (CFT) is a psychologically informed, physiotherapist-led intervention that targets the biopsychosocial complexity of persistent low back pain (LBP). CFT has demonstrated positive outcomes in two randomised controlled trials (RCT) but has not previously been evaluated in the United Kingdom National Health Service (NHS). This study aimed to determine the feasibility of completing a definitive RCT, that will evaluate the clinical and cost-effectiveness of CFT in comparison to usual physiotherapy care (UPC) for people with persistent LBP in the NHS. A two-arm parallel feasibility RCT compared CFT with UPC in participants with persistent LBP. Data concerning study processes, resources, management and patient reported outcome measures (disability, pain intensity, quality of life and psychosocial function) were collected at baseline, three and six-month follow-up, analysed and evaluated in order to establish feasibility. Sixty participants (n=30 CFT and n=30 UPC) were recruited with 71.6% (n=43) retained at six-month follow-up. CFT was delivered to fidelity, relevant and clinically important outcome data were rigorously collected and CFT was tolerated by participants with no safety concerns. The Roland-Morris disability questionnaire was the most suitable primary outcome measure and sample size calculations were completed for a definitive RCT. Intention to treat analysis indicated a signal of effect in favour of CFT with moderate and large between group effect sizes observed across outcome measures at six-month follow-up.Purposes of the study and background
Methods and results
To compare outcomes and costs of transforaminal endoscopic surgical discectomy (TES) with those of microdiscectomy (Micro) 48 patients with a primary lumbar disc prolapse were randomly allocated by computer to surgery. Assessments were made of leg and back pain (VAS), Oswestry Disability index (ODI), and SF-36 as primary outcomes. Cost data was collated. 25 TES and 23 Micro patients are reported with similar age, sex, smoking status and affected disc levels (14 v.17 L5/S1). Three months following surgery leg pain scores had decreased by 55 and 65% in the two groups. Patient satisfaction ratings were equal. ODI had decreased 15 points in both groups by 1yr and this improvement was maintained to 2 years (final scores: 7±3 TES v.14±13 Micro - means ±SD; p<0.05). Similar changes were noted in SF36-P. Mean bed stay was lower in the TES group (16 v. 40 hours). Other post-operative costs were similar. There were no immediate complications. One revision was required at 12 months (TES) and one at 18 months (Micro). Two patients presented with a disc prolapse at a different level and side (both TES). Results at up to two years follow-up are similar following the two interventions. Recovery was more rapid in those patients undergoing endoscopic surgery.
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 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
Scoliosis is a lateral curvature of the spine with associated rotation, often causing distress due to appearance. For some curves, there is good evidence to support the use of a spinal brace, worn for 20 to 24 hours a day to minimize the curve, making it as straight as possible during growth, preventing progression. Compliance can be poor due to appearance and comfort. A night-time brace, worn for eight to 12 hours, can achieve higher levels of curve correction while patients are supine, and could be preferable for patients, but evidence of efficacy is limited. This is the protocol for a randomized controlled trial of ‘full-time bracing’ versus ‘night-time bracing’ in adolescent idiopathic scoliosis (AIS). UK paediatric spine clinics will recruit 780 participants aged ten to 15 years-old with AIS, Risser stage 0, 1, or 2, and curve size (Cobb angle) 20° to 40° with apex at or below T7. Patients are randomly allocated 1:1, to either full-time or night-time bracing. A qualitative sub-study will explore communication and experiences of families in terms of bracing and research. Patient and Public Involvement & Engagement informed study design and will assist with aspects of trial delivery and dissemination.Aims
Methods
