Aims. Symptomatic spinal stenosis is a very common problem, and decompression surgery has been shown to be superior to nonoperative treatment in selected patient groups. However, performing an instrumented fusion in addition to decompression may avoid revision and improve outcomes. The aim of the SpInOuT feasibility study was to establish whether a definitive randomized controlled trial (RCT) that accounted for the spectrum of pathology contributing to spinal stenosis, including pelvic incidence-lumbar lordosis (PI-LL) mismatch and mobile spondylolisthesis, could be conducted. Methods. As part of the SpInOuT-F study, a pilot randomized trial was carried out across five NHS hospitals. Patients were randomized to either spinal decompression alone or spinal decompression plus instrumented fusion. Patient-reported outcome measures were collected at baseline and three months. The intended sample size was 60 patients. Results. Of the 90 patients screened, 77 passed the initial screening criteria. A total of 27 patients had a PI-LL mismatch and 23 had a dynamic spondylolisthesis. Following secondary inclusion and exclusion criteria, 31 patients were eligible for the study. Six patients were randomized and one underwent surgery during the study period. Given the low number of patients recruited and randomized, it was not possible to assess completion rates, quality of life, imaging, or health economic outcomes as intended. Conclusion. This study provides a unique insight into the prevalence of dynamic spondylolisthesis and PI-LL mismatch in patients with symptomatic spinal stenosis, and demonstrates that there is a need for a definitive RCT which stratifies for these groups in order to inform surgical decision-making. Nonetheless a definitive study would need further refinement in design and implementation in order to be feasible. Cite this article: Bone Jt Open 2023;4(8):573–579

Background. 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. Methods and results. 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. Conclusion. We believe this to be the largest trial of it's kind internationally. The trial will extend knowledge regarding the effectiveness of highly accessible internet interventions to support self-management and activity in people with LBP consulting in primary care. Conflicts of interest: No conflicts of interest. Source of funding: NIHR HTA Project number 16/111/78

Aims. 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). Methods. 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. Discussion. The primary outcome is ‘treatment failure’ (Cobb angle progression to 50° or more before skeletal maturity); skeletal maturity is at Risser stage 4 in females and 5 in males, or ‘treatment success’ (Cobb angle less than 50° at skeletal maturity). The comparison is on a non-inferiority basis (non-inferiority margin 11%). Participants are followed up every six months while in brace, and at one and two years after skeletal maturity. Secondary outcomes include the Scoliosis Research Society 22 questionnaire and measures of quality of life, psychological effects of bracing, adherence, anxiety and depression, sleep, satisfaction, and educational attainment. All data will be collected through the British Spine Registry. Cite this article: Bone Jt Open 2023;4(11):873–880

Aims. The aim of this study was to evaluate whether, after correction of an adolescent idiopathic scoliosis (AIS), leaving out the subfascial drain gives results that are no worse than using a drain in terms of total blood loss, drop in haemoglobin level, and opioid consumption. Methods. Adolescents (aged between 10 and 21 years) with an idiopathic scoliosis (major curve ≥ 45°) were eligible for inclusion in this randomized controlled noninferiority trial (n = 125). A total of 90 adolescents who had undergone segmental pedicle screw instrumentation were randomized into no-drain or drain groups at the time of wound closure using the sealed envelope technique (1:1). The primary outcome was a drop in the haemoglobin level during first three postoperative days. Secondary outcomes were 48-hour postoperative oxycodone consumption and surgical complications. Results. All 90 patients were included in the primary outcome analysis (no drain = 43; drain = 47). The mean total postoperative blood loss (intraoperative and drain output) was significantly higher in the group with a subfascial drain than in the no-drain group (1,008 ml (SD 520) vs 631 ml (SD 518); p < 0.001). The drop in haemoglobin level did not differ between the study groups over the postoperative timepoints (p = 0.290). The 48-hour opioid consumption was significantly higher in the no-drain group (2.0 mg/kg (SD 0.9) vs 1.4 (SD 0.6); p = 0.005). Two patients in the no-drain and one patient in the drain group developed a surgical site infection. Conclusion. Leaving the subfascial drain out after pedicle screw instrumentation for AIS is not associated with higher postoperative haemoglobin levels. Patients treated without a subfascial drain needed 30% more opioids during the first 48 hours than those who had a drain. Cite this article: Bone Joint J 2022;104-B(9):1067–1072

Purpose and background. 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. Methods and results. 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. Conclusions. The BOOST programme improves mobility and reduces falls in older adults with NC compared to BPA at 12 months follow-up. It is good value for the NHS. Future iterations of the programme will consider ways to reduce symptoms and disability long-term. Conflicts of interest: No conflicts of interest. Sources of funding: National Institute of Health Research – Programme for Applied Research NIHR - PTC-RP-PG-0213-20002: Better Outcomes for Older people with Spinal Trouble (BOOST). Publication and presentations: The clinical effectiveness paper has just been accepted for publication in the Journal of Gerontology Series A. The health economic analysis is not yet published. It was presented at the Physiotherapy UK conference and the International Back and Neck Pain Forum in 2021

Purposes of the study and background. 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. Methods and results. 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. Conclusion. It is feasible to conduct a randomised study of CFT in comparison to UPC for NHS patients. A future fully powered clinical and cost effectiveness RCT could be completed. Conflicts of interest: No conflicts of interest. Sources of funding: Chartered Society of Physiotherapy, Physiotherapy Research Foundation

Background. 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. Methods. 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. Results. Initial recruitment estimates suggested we needed a source population of 146,000 adults registered at approximately 30 GP practices, and a monthly trial recruitment target of 22 patients per month over 22 months. The internal pilot trial phase resulted in revisions of these estimates to 256,000 and 42 GP practices. To date, 1,623 patients have been screened for eligibility and 450 randomised. The main reason for ineligibility is low confidence in the diagnosis of sciatica. Conclusion. Our experience highlights the challenge of recruitment to clinical trials of sciatica, particularly in terms of case definition, and the need for careful planning and an internal pilot phase prior to a main trial. We believe our experience will be helpful to others conducting trials with sciatica patients. No conflicts of interest. Funding. NEF is an NIHR Senior Investigator. KK is supported through a HEFCE Senior Clinical Lecturer award. The SCOPiC trial is funded by the National Institute for Health Research Health Technology Assessment Programme (NIHR HTA project number 12/201/09). The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the NIHR, NHS or the Department of Health

Background and aims. 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. Methods. 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. Results. 524 participants (231-stratified care, 293-usual care) were recruited (target n=500) over 7 months (target 3 months), with 15-withdrawals (5-intervention, 10-controls). Minimal selection bias was identified between participants/non-participants, or trial arms. The pain-intensity follow-up rate was 88%. Clinicians used the STarT MSK tool in 41% of relevant consultations (judged as ‘partial success’) and adhered to recommended matched treatments in 69% of cases (judged as ‘success’). Conclusions. A future main RCT is feasible, with some amendments in the wording of the tool and the matched treatment options, to determine the clinical and cost-effectiveness of stratified care versus usual care for patients with MSK pain. Conflicts of interest: ‘No conflicts of interest’. Sources of Funding: This paper presents independent research funded by the National Institute for Health Research (NIHR) under its Programme Grants for Applied Research scheme (grant number: RP-PG-1211-20010). Nadine Foster is a NIHR Senior Investigator and was supported through an NIHR Research Professorship (NIHR-RP-011-015). The views expressed in this publication are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care

Background. 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. Methods. Qualitative, semi-structured interviews were conducted with general practitioners, spinal specialist physiotherapists and spinal surgeons (n=20 in total). Interviews were fully transcribed, and data were analysed using the constant comparison method. Results. Across all groups, clinicians identified potential added value in ‘fast-tracking’ some sciatica patients in terms of patient reassurance based on MRI scan findings. Whilst spinal physiotherapists felt that most ‘fast track’ patients were appropriate, some spinal physiotherapists and GPs had concerns that patients with symptom durations of less than 6 weeks might be inappropriately fast-tracked since their symptoms may still resolve without the need for invasive treatments. Spinal surgeons felt it was acceptable for patients with short symptom durations to be ‘fast-tracked’, but to provide early reassurance rather than direct treatment. Conclusion. Whilst clinicians saw added value in a group of sciatica patients being ‘fast-tracked’ to specialist opinion, there was some reservation about moving away from the usual stepped care, ‘wait and see’ approach for patients with short symptom duration. Conflicts of interest statement. No conflicts of interest. Sources of funding. This study is funded by the National Institute for Health Research Health Technology Assessment Programme (NIHR HTA project number 12/201/09) and will be published in full in Health Technology Assessment. Funding support is also received from an NIHR Research Professorship for Nadine Foster (NIHR-RP-011-015), who is an NIHR Senior Investigator, and a HEFCE Senior Clinical Lecturer award for Kika Konstantinou. The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the HTA programme, NIHR, NHS or the Department of Health and Social Care. The study was approved by the NRES Committee West Midlands – Solihull, 17/03/2015, ref: 15/WM/0078. Trial registration: ISRCTN75449581

Funding. 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. Background and Purpose. 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). Methods. Cost-utility analysis was undertaken over 12-months. Resource use and quality of life (EQ-5D-5L) data were obtained from postal questionnaires, mean costs and QALYs were calculated for each trial arm along with cost-effectiveness acceptability curves. The base case analysis was by intention-to-treat, and performed from NHS and personal social services (PSS) perspective. Sensitivity analyses included healthcare provider and societal perspectives, as well as analyses for each of the three patient groups. Results. 476 patients were randomised (238 per arm). Mean NHS/PSS costs (SD) recorded were £663.58 for SC and £617.37 for UC. Mean QALYs (SD) were 0.659 (0.173) for SC and 0.671 (0.168) for UC; the adjusted mean difference in QALYs was −0.011 (−0.035, 0.013). In this base-case analysis, the chance of SC being cost-effective at a threshold of £30,000 per QALY was only 19%. Similarly, low probabilities of effectiveness were observed in all sensitivity analyses. The chance of SC being cost-effective at a threshold of £30,000 ranged from 18% to 52% for each of the three patient groups. Conclusions. Overall, the SC model that we tested for sciatica in primary care was not a cost-effective option compared to usual, non-stratified care. No sources of funding. No conflicts of interest

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). Methods. 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. Results. Primary outcome data were obtained from 89.3% (88.3% SC, 90.3% UC). Survival analysis showed a small but not statistically significant difference in time to resolution of symptoms (SC reached resolution 2 weeks earlier than UC; HR 1.14 (95% CI 0.89, 1.46)). There were no significant between-arm differences in secondary outcomes. Conclusion. The SC model, tested in this trial was not more effective than UC. On average, patients in both arms made similar good improvements over time, on most outcomes. No conflicts of interest. Funding: 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

Purpose and Background:. 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. Methods:. 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. Results:. No significant treatment effect modifiers were identified using linear regression, however logistic regression analysis identified SES as a treatment modifier (interaction: OR = 0.65; 95% confidence interval = 0.42 to 0.98). Comparing those receiving stratified care versus best current care, the proportion of patients with poor 4 month outcome was similar for lower SES patients (35.4% vs. 37.2%), yet different for high SES patients (19.3% vs. 38.9%). No other treatment effect modifiers were identified; however exploratory analyses indicated trends for worse outcomes with increased age, patients taking ≥3 medications, those with lower education, and those with poor treatment expectations as potential treatment effect modifiers. Conclusion:. SES was identified as a treatment effect modifier in the STarT Back Trial with patients with lower SES not benefiting from stratified care. The explanations for this finding need further exploration

Background. 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. Methods. Individual ‘stimulated-recall’ interviews with patients and GPs in the stratified care arm (n=10 patients; 10 GPs), prompted by consultation-recordings. Data were analysed thematically and mapped onto the COM-B behaviour change model; exploring the Opportunity, Capability and Motivation GPs and patients had to engage with stratified care. Results. Patients reported positive views that stratified care enabled a more ‘structured’ consultation. GPs identified difficulties integrating the STarT MSK tool in their consultation timeframe (Opportunity), but found this easier as it became more familiar. Both groups saw the tool as having added-value, but identified ‘cumbersome’ items which made it more difficult to use (Capability). GPs reported the matched treatment options aided their clinical decision-making, identified several that were not available to them (e.g. pain-management clinics) and suggested additional options (e.g. GP-management of psychosocial issues (Motivation). Conclusion. Changes to the STarT MSK tool and matched treatment options, targeting the COM-B model constructs, were identified and have been implemented in the current main trial. Conflicts of interest statement: No conflicts of interest. Sources of funding: This paper presents independent research funded by the National Institute for Health Research (NIHR) under its Programme Grants for Applied Research scheme (grant number: RP-PG-1211-20010). The views expressed in this publication are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care. Nadine Foster is a NIHR Senior Investigator and was supported through an NIHR Research Professorship (NIHR-RP-011-015). Trial registration: ISRCTN15366334

Purpose & Background. 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. Methods. 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. Results. Patient outcomes were obtained from intervention (n=690) and control (n=864) clinics. At six months between-group differences in adjusted mean change scores did not significantly favour stratified care for RMDQ; 0.50 (95%CI −0.55, 1.55) or pain NRS 0.13 (95%CI −0.37, 0.63). There were no significant between group differences in any secondary patient outcome. Process data showed that the STarT Back tool was used with 47% of LBP patients in the intervention clinics but there was no differences in the treatments provided. Conclusions. Implementation of a LBP stratified care approach in this United States healthcare setting showed moderate use of the STarT Back tool, but no change in treatments received by patients, and no benefits on patient outcomes. Conflicts of interest: None. Sources of funding: Funding for this trial was provided by the Patient Centered Care Research Institute (“Evaluation of a Patient-Centered Risk Stratification Method for Improving Primary Care for Back Pain”: Contract #398) and by the National Center for Complementary and Integrative Health/NIH (“Implementing Evidence-Based Treatments for Persistent Back Pain into Primary Care”: Grant #R21AT0007326). Martin Levine, Diane Piekara, and Pam Rock received support to participate in the quality improvement activities from Group Health. Nadine Foster and Jonathan Hill were supported through an NIHR Research Professorship (NIHR-RP-011-015) to Nadine Foster. Nadine Foster is an NIHR Senior Investigator. The views expressed are those of the authors and not necessarily those of the Patient Centered Care Research Institute, NIH, NHS, the NIHR or the Department of Health

Background and purpose. Sleep disturbance is a prevalent symptom in people with chronic low back pain (CLBP >12 weeks), but there is currently no knowledge of the effectiveness of physiotherapy for this problem. This study evaluated the feasibility of a randomised controlled trial (RCT) exploring the effects of physiotherapy on sleep disturbance in CLBP [Current controlled trial ISRCTN 54009836]. Methods. A sample of 60 consenting patients with CLBP [23 M, 37 F; mean (SD) age = 44.93 (13.41) years] were recruited in Beaumont Hospital, Dublin and randomly allocated to one of three groups [supervised exercise class (SEC), walking programme (WP) and usual physiotherapy (UP)] in a concealed manner. The main outcomes were sleep quality, functional disability, pain, and quality of life at baseline, 3 and 6 months. Results. The majority of participants reported sleep disturbance (95%, n=57) and related it to their LBP (81%, n=46). At 3 months compared with the WP and SEC, participants in the UP group displayed greater reductions in average low back pain VAS (WP d=.97, SEC d=.86) and greater improvements in sleep disturbance (Pittsburgh Sleep Quality Index WP d=.59, SEC d=.29; Insomnia Severity Index WP d= .56, SEC d= .24). However, compared to UP there were greater improvements in functional disability (SF-36 PCS) in the WP (d= .32) and the SEC (d= .21). Conclusions. The results provide preliminary evidence of the effects of physiotherapy on sleep disturbance in CLBP, demonstrate the feasibility of undertaking a RCT in this field and inform refinement of the study protocol for a fully powered trial

Purposes of the study and background. Pain of lumbar facet-joint origin is a common cause of low back pain in adults, and may lead to chronic pain and disability. At present, there is no definitive research to support the use of targeted lumbar facet-joint injections to manage this pain. The study's objective was to assess the feasibility of carrying out a definitive study to evaluate the clinical- and cost-effectiveness of lumbar facet-joint injections compared to a sham procedure. Summary of methods and results. This was a blinded parallel two-arm pilot randomised controlled trial. Adult patients referred to the pain and orthopaedic clinics at Barts Health NHS Trust with non-specific low back pain of at least three months' duration were considered for inclusion. Participants who had a positive result following diagnostic single medial branch nerve blocks were randomised to receive either intra-articular lumbar facet-joint injections with steroid or a sham procedure. All participants were invited to attend a combined physical and psychological programme. Questionnaires were used to assess a range of pain and disability-related issues. Healthcare utilisation and cost data were also assessed. Of 628 participants screened for eligibility, 9 were randomised to receive the study intervention and 8 participants completed the study. Conclusions. Due to the small numbers of participants recruited to the study, we were unable to draw any conclusions on the effectiveness of intra-articular lumbar facet-joint injections in the management of non-specific low back pain. We however demonstrated our ability to develop a robust study protocol and deliver the intended interventions safely, thus addressing many of the feasibility objectives. Stronger collaborations with primary care may improve the recruitment of patients earlier in their pain trajectory, suitable for inclusion in a future trial. Conflicts of interest: None. Sources of funding: National Institute for Health Research Health Technology Assessment programme grant (reference number 11/31/02)

Aims

The optimal procedure for the treatment of ossification of the posterior longitudinal ligament (OPLL) remains controversial. The aim of this study was to compare the outcome of anterior cervical ossified posterior longitudinal ligament en bloc resection (ACOE) with posterior laminectomy and fusion with bone graft and internal fixation (PTLF) for the surgical management of patients with this condition.

Background and purpose. The musculoskeletal system is a common, but often overlooked, cause of chest pain. Little is known about the efficacy of spinal manipulation for this condition. The purpose of the present study is to evaluate the relative effectiveness of two conservative treatment approaches for acute musculoskeletal chest pain, 1) a spinal manipulation-based therapy as a typical example of chiropractic treatment and 2) self-management as an example of minimal intervention. Methods and results. In a non-blinded, randomised controlled trial set at an emergency cardiology department and four outpatient chiropractic clinics, 115 consecutive patients with acute chest pain and no clear medical diagnosis at initial presentation were included. After a baseline evaluation, patients with musculoskeletal chest pain were randomized to four weeks of chiropractic treatment or self-management, with post-treatment questionnaire follow-up four and 12 weeks later. Primary outcome measures were numeric change in pain intensity (11-point box numerical rating scale) and self-perceived change in pain (7-point ordinal scale). Secondary measures included Medical Outcomes Study Short Form 36 (SF-36) scores, change in pain intensity (chest, thoracic spine, neck and shoulder/arm), and self-perceived change in general health. Preliminary results will be available at the time of presentation. Conclusions. This is the first randomised controlled trial assessing chiropractic treatment versus a minimal intervention in patients with musculoskeletal chest pain. Results will indicate whether chiropractic treatment is a useful option for patients with musculoskeletal chest pain, but the design does not allow for standardisation of treatment or identification of potentially active ingredients of care

Introduction. 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. Methods. 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. Results. 338 participants (158 intervention, 180 control) were recruited with 79% followed-up at 4 months. Participants in the intervention arm had significantly fewer days absent over 4 months (mean 9.3 days, SD 21.7) compared with control (mean 14.4 days, SD 27.7); adjusted incidence rate ratio (IRR) 0.51 (0.26, 0.99), p=0.048. This difference was largely due to fewer GP certified absent days (8.4 days versus 13.5 days). At 12 months the effect of the VA service was significantly greater in those with spinal pain compared to patients with other MSK problems (IRR. interaction. : 0.25 (95% Confidence Interval 0.10, 0.62) (p . interaction. =0.003). Conclusions. Adding a VA service to best current primary care for MSK pain leads to significantly fewer days absent from work over 4 months, with exploratory analysis indicating the VA service is particularly effective for patients with spinal pain. No conflicts of interest. This paper presents independent research funded by the National Institute for Health Research (NIHR), under its Programme Grants for Applied Research funding scheme: “Optimal management of spinal pain and sciatica in primary care” (NIHR-RP-PG-0707-10131). NEF and AB are funded by an NIHR Research Professorship (NIHR-RP-011-015). NEF and EMH are NIHR Senior Investigators. GW-J is funded by an NIHR Post-Doctoral Fellowship (PDF-2009-02-54). The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health

Background. The available treatments for NSLBP (Non-Specific Low Back Pain) provide, typically, small to moderate average benefits to patients. The aim of this pilot cluster RCT was to test the hypothesis that the use of a patient decision aid together with an informed shared decision making consultation would produce better outcomes in satisfaction with treatment at four month follow-up. Methods. We developed a DSP (Decision Support Package). We randomised the physiotherapists and trained those in the intervention arm in informed shared decision making and communication. Participants were recruited from a local physiotherapy department and those allocated to an appointment with an intervention therapist were sent a copy of the DSP in the post. Participants then attended their appointment as usual. Results. We recruited 148 participants, 85 (57%) participants were assigned to the DSP arm. There was an 80% response rate for the primary outcome, satisfaction with treatment. The adjusted odds ratio of satisfaction with treatments from participants in the DSP arm against those in the control arm was 0.54 (95% CI: 0.19, 1.53). The difference between the treatment arms for the RMDQ (Roland Morris Disability Questionnaire) at four month follow-up was −2.27 (95% CI: −4.47, −0.08). Conclusions. There were no differences in our primary outcome measure between the groups. There was a statistically significant and clinically important difference in the RMDQ. These data have informed our decision about progression to a full trial application