Background. Over 55,000 spinal operations are performed annually in the NHS. Effective postoperative analgesia facilitates early mobilisation and assists rehabilitation and hospital discharge, but is difficult to achieve with conventional, opioid-based, oral analgesia. The clinical and cost-effectiveness of two alternative techniques, namely intrathecal opioid and the more novel erector-spinae plane blockade, is unknown. The Pain Relief After Instrumented Spinal Surgery (PRAISE) trial aims to evaluate these techniques. Methods. PRAISE is a multicentre, prospective, parallel group, patient-blinded, randomised trial, seeking to recruit 456 adult participants undergoing elective, posterior lumbar-instrumented spinal surgery from up to 25 NHS hospitals. Participants will be randomised 1:1:1 to receive (1) Usual Care with local wound infiltration, (2) Intrathecal Opioid plus Usual Care with local wound infiltration or (3) Erector Spinae Plane blockade plus Usual Care with no local wound infiltration. The primary outcome is pain on movement on a 100mm visual analogue scale at 24 hours post-surgery. Secondary outcomes include pain at rest, leg pain, quality of recovery (QoR-15), postoperative opioid consumption, time to mobilisation, length of hospital stay, health utility (EQ-5D-5L), adverse events and resource use. Parallel economic evaluation will estimate incremental cost-effectiveness ratios. Results. Differences in the primary outcome at 24 hours will be estimated by mixed-effects linear regression modelling, with fixed effects for randomisation factors and other important prognostic variables, and random effects for centre, using the as-randomised population. Treatment effects with 95% confidence intervals will be presented. Conclusion. The study is due to open in May 2024 and complete in 2026. Conflicts of Interest. No conflicts of interest declared. Sources of Funding. NIHR Health Technology Award – grant number NIHR153170. Trial presentations so far. APOMP 2023 and 2024; RCOA conference, York, November 2023; Faculty of Pain Management training day, London, February 2024

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

Background. FORECAST is a prospective longitudinal cohort study exploring mechanism-based prognostic factors for pain persistence in sciatica. Here, we share an update on this largest deeply-phenotyped primary care sciatica cohort. Methods/results. Our cohort includes 180 people with sciatica (score >4 on Stynes’ Sum Score), aged 18–85, within 3 months of symptom onset. Psychosocial factors, self-reported sensory profiling, clinical examination, quantitative sensory testing (QST), biological samples (blood and skin samples), and Magnetic Resonance Neurography of lumbar nerve roots were collected at baseline. Pain persistence was determined at three and twelve months with the Sciatica Bothersomeness Index (SBI) and a numeric pain rating scale (NRS) as primary outcomes. Recruitment nears completion, with 160 participants enrolled to date. 127 and 96 participants have completed 3 and 12 months follow-up respectively. Overall, 56% of our cohort are female, with a mean age (SD) of 54.14yrs (16.57). Ethnicity data approximates local populations. SBI at baseline was (median [IQR]) 13[10-17], and interim longitudinal data shows stepwise improvement at 3 and 12 months. Baseline ‘average’ pain intensity was 5.56 (2.15) for leg pain, and 4.14(2.82) for low back pain (LBP). Overall, pain scores decreased at 3 and 12 months, with greater reductions in leg pain than LBP at 12 months. However, around 55–80% and 40–65% of people reported persistent pain at 3 and 12 months respectively. Conclusion. Leg pain severity was moderate and higher than LBP at baseline. All primary outcome measures demonstrate improvement over time, however 40–65% of patients report persistent pain at 12 months. Conflicts of interest. LR: Paid facilitation of post-graduate courses internationally. SK, MT, FP, KM, WS, CP, CR, SC: No conflicts of interest. GC: Editor in Chief of Health Psychology Review. Director of board of directors, MentalCHealth Care setting NoordWestVlaanderen. JF: Copyright holder of ODI (Oswestry Disability Index). Served on a data monitoring committee for a clinical trial of 2 different surgical approaches to cervical disc herniation (FORVAD). Member of HTA Prioritisation Committee B: Inside hospital Care from 2015-February 2019. Member of HTA Interventional Procedures Panel from 2010–2015. Trustee and board member of 3 spine related charities – Back to Back; British Scoliosis Research Foundation and BackCare. Expert instructed by both claimant and defendant solicitors in negligence and person injury cases. GB: Paid consultancy (RNA-seq) with Ivy Farm and Coding.bio. ABS: Paid post-graduate lecturing internationally. Co-chair NeupSig sciatica working group (unpaid). Sources of funding. This project is funded by UKRI and Versus Arthritis as part of the UKRI Strategic Priorities Fund (SPF) Advanced Pain Discovery Platform (APDP), a co-funded initiative by UKRI (MRC, BBSRC, ESRC), Versus Arthritis, the Medical Research Foundation and Eli Lilly and Company Ltd (Grant MR/W027003/1). Additional funding has been received from the back to back charity to expand longitudinal components of the study. LR has received support with PhD fees from the CSP charitable trust. ABS is supported by a Wellcome Trust Clinical Career Development Fellowship. (222101/Z/20/Z). WS is partly funded through the National Institute for Health and Care Research (NIHR) Biomedical Research Centre at the South London and Maudsley NHS Foundation Trust and King's College London. FP is funded by a Dorothy Hodgkin Career Development Fellowship in Chemistry in association with Somerville College. GB is supported by the Wellcome Trust (223149/Z/21/Z) and Diabetes UK (19/0005984). GC and KRM are partly funded by UKRI and Versus Arthritis as part of the Advanced Pain Discovery Platform (APDP) PAINSTORM (MR/W002388/1). The UKRI and Versus Arhthritis (APDP) are the major funders of FORECAST. All other funders provided either some people support, or funded projects with legacy data that we reuse

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. Repeated lumbar spine surgery has been associated with inferior clinical outcomes. This study aimed to examine and quantify the impact of this association in a national clinical register cohort. Methods. This is a population-based study from the Norwegian Registry for Spine surgery (NORspine). We included 26,723 consecutive cases operated for lumbar spinal stenosis or lumbar disc herniation from January 2007 to December 2018. The primary outcome was the Oswestry Disability Index (ODI), presented as the proportions reaching a patient-acceptable symptom state (PASS; defined as an ODI raw score ≤ 22) and ODI raw and change scores at 12-month follow-up. Secondary outcomes were the Global Perceived Effect scale, the numerical rating scale for pain, the EuroQoL five-dimensions health questionnaire, occurrence of perioperative complications and wound infections, and working capability. Binary logistic regression analysis was conducted to examine how the number of previous operations influenced the odds of not reaching a PASS. Results. The proportion reaching a PASS decreased from 66.0% (95% confidence interval (CI) 65.4 to 66.7) in cases with no previous operation to 22.0% (95% CI 15.2 to 30.3) in cases with four or more previous operations (p < 0.001). The odds of not reaching a PASS were 2.1 (95% CI 1.9 to 2.2) in cases with one previous operation, 2.6 (95% CI 2.3 to 3.0) in cases with two, 4.4 (95% CI 3.4 to 5.5) in cases with three, and 6.9 (95% CI 4.5 to 10.5) in cases with four or more previous operations. The ODI raw and change scores and the secondary outcomes showed similar trends. Conclusion. We found a dose-response relationship between increasing number of previous operations and inferior outcomes among patients operated for degenerative conditions in the lumbar spine. This information should be considered in the shared decision-making process prior to elective spine surgery. Cite this article: Bone Joint J 2023;105-B(4):422–430

Aims. We compared decompression alone to decompression with fusion surgery for lumbar spinal stenosis, with or without degenerative spondylolisthesis (DS). The aim was to evaluate if five-year outcomes differed between the groups. The two-year results from the same trial revealed no differences. Methods. The Swedish Spinal Stenosis Study was a multicentre randomized controlled trial with recruitment from September 2006 to February 2012. A total of 247 patients with one- or two-level central lumbar spinal stenosis, stratified by the presence of DS, were randomized to decompression alone or decompression with fusion. The five-year Oswestry Disability Index (ODI) was the primary outcome. Secondary outcomes were the EuroQol five-dimension questionnaire (EQ-5D), visual analogue scales for back and leg pain, and patient-reported satisfaction, decreased pain, and increased walking distance. The reoperation rate was recorded. Results. Five-year follow-up was completed by 213 (95%) of the eligible patients (mean age 67 years; 155 female (67%)). After five years, ODI was similar irrespective of treatment, with a mean of 25 (SD 18) for decompression alone and 28 (SD 22) for decompression with fusion (p = 0.226). Mean EQ-5D was higher for decompression alone than for fusion (0.69 (SD 0.28) vs 0.59 (SD 0.34); p = 0.027). In the no-DS subset, fewer patients reported decreased leg pain after fusion (58%) than with decompression alone (80%) (relative risk (RR) 0.71 (95% confidence interval (CI) 0.53 to 0.97). The frequency of subsequent spinal surgery was 24% for decompression with fusion and 22% for decompression alone (RR 1.1 (95% CI 0.69 to 1.8)). Conclusion. Adding fusion to decompression in spinal stenosis surgery, with or without spondylolisthesis, does not improve the five-year ODI, which is consistent with our two-year report. Three secondary outcomes that did not differ at two years favoured decompression alone at five years. Our results support decompression alone as the preferred method for operating on spinal stenosis. Cite this article: Bone Joint J 2024;106-B(7):705–712

Aims. Surgical approaches to cervical ossification of the posterior longitudinal ligament (OPLL) remain controversial. The purpose of the present study was to analyze and compare the long-term neurological recovery following anterior decompression with fusion (ADF) and posterior laminectomy and fusion with bone graft and internal fixation (PLF) based on > ten-year follow-up outcomes in a single centre. Methods. Included in this retrospective cohort study were 48 patients (12 females; mean age 55.79 years (SD 8.94)) who were diagnosed with cervical OPLL, received treatment in our centre, and were followed up for 10.22 to 15.25 years. Of them, 24 patients (six females; mean age 52.88 years (SD 8.79)) received ADF, and the other 24 patients (five females; mean age 56.25 years (SD 9.44)) received PLF. Clinical data including age, sex, and the OPLL canal-occupying ratio were analyzed and compared. The primary outcome was Japanese Orthopaedic Association (JOA) score, and the secondary outcome was visual analogue scale neck pain. Results. Compared with the baseline, neurological function improved significantly after surgery in all patients of both groups (p < 0.001). The JOA recovery rate in the ADF group was significantly higher than that in the PLF group (p < 0.001). There was no significant difference in postoperative cervical pain between the two groups (p = 0.387). The operating time was longer and intraoperative blood loss was greater in the PLF group than the ADF group. More complications were observed in the ADF group than in the PLF group, although the difference was not statistically significant. Conclusion. Long-term neurological function improved significantly after surgery in both groups, with the improvement more pronounced in the ADF group. There was no significant difference in postoperative neck pain between the two groups. The operating time was shorter and intraoperative blood loss was lower in the ADF group; however, the incidence of perioperative complications was higher. Cite this article: Bone Jt Open 2024;5(9):768–775

Aims. Closed suction subfascial drainage is widely used after instrumented posterior spinal fusion in patients with a spinal deformity. The aim of this study was to determine the effect of this wound drainage on the outcomes in patients with adolescent idiopathic scoliosis (AIS). This was a further analysis of a randomized, multicentre clinical trial reporting on patients after posterior spinal fusion using segmental pedicle screw instrumentation. In this study the incidence of deep surgical site infection (SSI) and chronic postoperative pain at two years’ follow-up are reported. Methods. We conducted a randomized, multicentre clinical trial on adolescents undergoing posterior spinal fusion for AIS using segmental pedicle screw instrumentation. A total of 90 consecutive patients were randomized into a ‘drain’ or ‘no drain’ group at the time of wound closure, using the sealed envelope technique (1:1). The primary outcomes in the initial study were the change in the level of haemoglobin in the blood postoperatively and total blood loss. A secondary outcome was the opioid consumption immediately after surgery. The aim of this further study was to report the rate of deep SSI and persistent postoperative pain, at two years' follow-up. Results. As previously reported, the mean 48-hour opioid consumption was significantly higher in the no drain group (2.0 mg/kg (SD 0.8) vs 1.4 mg/kg (SD 0.7); p = 0.005). There were no delayed deep SSIs. At two years’ follow-up, the mean Scoliosis Research Society 24-item questionnaire (SRS-24) total score did not differ between the groups (4.11 (SD 0.47) vs 4.16 (SD 0.33); p = 0.910). The mean SRS-24 pain score was 4.28 (SD 0.48) in the no drain group compared with 4.33 (SD 0.66) in the drain group (p = 0.245). Seven patients (19%) in the no drain group and six in the drain group (14%) reported moderate to severe pain (numerical rating scale ≥ 4) at two years’ follow-up (p = 0.484). The general self-image domain score was significantly higher in the no drain group compared with the drain group (4.02 (SD 0.74) vs 4.59 (SD 0.54); p < 0.001). Conclusion. The main finding in this study was that more severe pain immediately after surgery did not result in a higher incidence of chronic pain in the no drain group compared with the drain group. Back pain and health-related quality of life at two years’ follow-up did not differ between the groups. The patient-reported self-image domain was significantly better in the no drain group compared with the drain group. Cite this article: Bone Joint J 2024;106-B(10):1176–1181

Aims. The number of patients undergoing surgery for degenerative cervical radiculopathy has increased. In many countries, public hospitals have limited capacity. This has resulted in long waiting times for elective treatment and a need for supplementary private healthcare. It is uncertain whether the management of patients and the outcome of treatment are equivalent in public and private hospitals. The aim of this study was to compare the management and patient-reported outcomes among patients who underwent surgery for degenerative cervical radiculopathy in public and private hospitals in Norway, and to assess whether the effectiveness of the treatment was equivalent. Methods. This was a comparative study using prospectively collected data from the Norwegian Registry for Spine Surgery. A total of 4,750 consecutive patients who underwent surgery for degenerative cervical radiculopathy and were followed for 12 months were included. Case-mix adjustment between those managed in public and private hospitals was performed using propensity score matching. The primary outcome measure was the change in the Neck Disability Index (NDI) between baseline and 12 months postoperatively. A mean difference in improvement of the NDI score between public and private hospitals of ≤ 15 points was considered equivalent. Secondary outcome measures were a numerical rating scale for neck and arm pain and the EuroQol five-dimension three-level health questionnaire. The duration of surgery, length of hospital stay, and complications were also recorded. Results. The mean improvement from baseline to 12 months postoperatively of patients who underwent surgery in public and private hospitals was equivalent, both in the unmatched cohort (mean NDI difference between groups 3.9 points (95% confidence interval (CI) 2.2 to 5.6); p < 0.001) and in the matched cohort (4.0 points (95% CI 2.3 to 5.7); p < 0.001). Secondary outcomes showed similar results. The duration of surgery and length of hospital stay were significantly longer in public hospitals. Those treated in private hospitals reported significantly fewer complications in the unmatched cohort, but not in the matched cohort. Conclusion. The clinical effectiveness of surgery for degenerative cervical radiculopathy performed in public and private hospitals was equivalent 12 months after surgery. Cite this article: Bone Joint J 2023;105-B(1):64–71

Aims. The aims of this study were first, to determine if adding fusion to a decompression of the lumbar spine for spinal stenosis decreases the rate of radiological restenosis and/or proximal adjacent level stenosis two years after surgery, and second, to evaluate the change in vertebral slip two years after surgery with and without fusion. Methods. The Swedish Spinal Stenosis Study (SSSS) was conducted between 2006 and 2012 at five public and two private hospitals. Six centres participated in this two-year MRI follow-up. We randomized 222 patients with central lumbar spinal stenosis at one or two adjacent levels into two groups, decompression alone and decompression with fusion. The presence or absence of a preoperative spondylolisthesis was noted. A new stenosis on two-year MRI was used as the primary outcome, defined as a dural sac cross-sectional area ≤ 75 mm. 2. at the operated level (restenosis) and/or at the level above (proximal adjacent level stenosis). Results. A total of 211 patients underwent surgery at a mean age of 66 years (69% female): 103 were treated by decompression with fusion and 108 by decompression alone. A two-year MRI was available for 176 (90%) of the eligible patients. A new stenosis at the operated and/or adjacent level occurred more frequently after decompression and fusion than after decompression alone (47% vs 29%; p = 0.020). The difference remained in the subgroup with a preoperative spondylolisthesis, (48% vs 24%; p = 0.020), but did not reach significance for those without (45% vs 35%; p = 0.488). Proximal adjacent level stenosis was more common after fusion than after decompression alone (44% vs 17%; p < 0.001). Restenosis at the operated level was less frequent after fusion than decompression alone (4% vs 14%; p = 0.036). Vertebral slip increased by 1.1 mm after decompression alone, regardless of whether a preoperative spondylolisthesis was present or not. Conclusion. Adding fusion to a decompression increased the rate of new stenosis on two-year MRI, even when a spondylolisthesis was present preoperatively. This supports decompression alone as the preferred method of surgery for spinal stenosis, whether or not a degenerative spondylolisthesis is present preoperatively. Cite this article: Bone Joint J 2022;104-B(12):1343–1351

Purpose and Background. Guidelines recommend biopsychosocial care for chronic, complex musculoskeletal conditions, including non-specific low back pain. The aims were: 1/ to assess how patients with low back pain respond to osteopathic treatment, both before and after an osteopath has completed a Biopsychosocial Pain Management (BPM) course; and 2/ to assess if it is feasible and acceptable for osteopath participants to receive weekly SCED data and use it to guide patient management. Methods and Results. A multiple baseline single case experimental design trial (. clinicaltrials.gov. , on 18/10/2021, ID number NCT05120921) with 11 UK osteopaths was conducted. Patients were randomised to early, middle or late treatment start dates. Statistical analysis assessed the change between baseline, intervention and follow-up periods. Primary outcomes were the Numeric Pain Rating (NPR) and Patient Specific Function Scales (PSFS), measured during the baseline, the 6-week intervention, and during a 12-week follow-up period. At baseline, the osteopaths reported stronger biopsychosocial attitudes to pain, compared to biomedical beliefs (PABS: 34 behavioural scale; 29 biomedical scale). Overall, patient participants showed daily increases in symptoms during the pre-treatment phase (+0.24/day, p<0.001), and daily decreases during treatment (−2.94 over the treatment phase, p<0.001), which continued post-treatment (−3.36 over 12 weeks, p=0.04). Similar improvements were observed for function. Conclusion. Osteopathic care was shown to help patients with persistent low back pain. Patient recruitment was challenging because of the randomisation. With further development, the method shows feasibility as a means of enhancing research activity among practising clinicians. Previous presentations or publications of the work. The protocol was published (. https://doi.org/10.1016/j.ijosm.2023.100660. ) and presented at SBPR in 2022. The results were presented to an osteopathic conference in October 2023. Ethics approval was received from the University College of Osteopathy Research Ethics Committee. Conflicts of interests. Jerry Draper-Rodi receives fees from the sales of the e-learning course on the biopsychosocial management on the UCO CPD platform. Sources of funding. The research was funded by the Osteopathic Foundation

Aims. A variety of surgical methods and strategies have been demonstrated for Andersson lesion (AL) therapy. In 2011, we proposed and identified the feasibility of stabilizing the spine without curettaging the vertebral or discovertebral lesion to cure non-kyphotic AL. Additionally, due to the excellent reunion ability of ankylosing spondylitis, we further came up with minimally invasive spinal surgery (MIS) to avoid the need for both bone graft and lesion curettage in AL surgery. However, there is a paucity of research into the comparison between open spinal fusion (OSF) and early MIS in the treatment of AL. The purpose of this study was to investigate and compare the clinical outcomes and radiological evaluation of our early MIS approach and OSF for AL. Methods. A total of 39 patients diagnosed with AL who underwent surgery from January 2004 to December 2022 were retrospectively screened for eligibility. Patients with AL were divided into an MIS group and an OSF group. The primary outcomes were union of the lesion on radiograph and CT, as well as the visual analogue scale (VAS) and Oswestry Disability Index (ODI) scores immediately after surgery, and at the follow-up (mean 29 months (standard error (SE) 9)). The secondary outcomes were total blood loss during surgery, operating time, and improvement in the radiological parameters: global and local kyphosis, sagittal vertical axis, sagittal alignment, and chin-brow vertical angle immediately after surgery and at the follow-up. Results. Data for 30 patients with AL were evaluated: 14 in the MIS group and 16 in the OSF group. All patients were followed up after surgery; no nonunion complications or instrumentation failures were observed in either group. No significant differences in the VAS and ODI scores were identified between the two groups. Mean ODI improved from 51 (SE 5) to 17 (SE 5) in the MIS group and from 52 (SE 6) to 19 (SE 5) in the OSF group at the follow-up. There were significant improvements in total blood loss (p = 0.025) and operating time (p < 0.001) between the groups. There was also no significant difference in local kyphosis six months postoperatively (p = 0.119). Conclusion. Early MIS is an effective treatment for AL. MIS provides comparable clinical outcomes to those treated with OSF, with less total blood loss and shorter operating time. Our results support and identify the feasibility of solid immobilization achieved by posterior instrumentation without bone graft via MIS for the treatment of AL. Cite this article: Bone Jt Open 2024;5(10):886–893

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. 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

Background. Osteopathy has been shown to be effective in the management of chronic low back pain. Guidelines recommend biopsychosocial care for chronic, complex musculoskeletal conditions, including non-specific low back pain but there is a lack of evidence comparing standard osteopathic care, which has traditionally been based on dated and disputed biomechanical theories of dysfunction, with more contemporary biopsychosocial approaches. Methods and results. A multiple baseline single case experimental design trial with 11 UK osteopaths and 60 patients is currently assessing effectiveness of osteopathic treatment for patients with non-specific low back pain of more than 12 weeks’ duration. Patients are randomised to early, middle, or late treatment start dates to increase the validity of inferences about the effects of treatment. Osteopaths have participated in one course on the study protocol and processes pre-participation and will take an e-learning course on the biopsychosocial management of patients with low back pain after the first patient recruitment stage. Statistical analysis will assess the degree and rate of change between baseline, intervention and follow-up periods, and whether differences in effect are observed after the osteopaths have completed the biopsychosocial patient management training course. Primary outcomes will be the Numeric Pain Rating and Patient Specific Function Scales, measured daily at baseline and for 6 weeks during the intervention stage, and weekly or fortnightly during a 12-week follow-up period. Conclusion. This experimental design will offer osteopaths in practice the opportunity to engage in research evaluating the effectiveness of osteopathic care and the influence of a training programme to augment biopsychosocial osteopathic care. Study registration: . https://clinicaltrials.gov/ct2/show/NCT05120921. Sources of funding: The Osteopathic Foundation. Conflict of interest: The authors declare no competing interests. Previous publication of work: This protocol is under review with a peer-reviewed journal

Background. 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. Methods and Results. 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. Conclusion. Using an outcome that matches exercise targets in LBP trials appears to produce greater SMDs than an unmatched primary outcome. Future trials should consider primary outcome selection aligned with exercise treatment targets. Sources of Funding: L Wood's PhD is funded by the Research Institute for Primary Care and Health Sciences, Keele University. Prof NE Foster is a UK National Institute for Health Research Senior Investigator, and was supported by a UK National Institute for Health 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. Conflicts of interest: No conflicts of interest

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

Background. 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. Methods and Results. 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. Conclusion. The majority of included trials did not match the primary outcome domain to the treatment targets of the exercise intervention. Further research will explore if better matching between treatment targets and outcomes may change the conclusions of exercise trials in CLBP. No conflicts of interest. Sources of Funding: This PhD is funded by the Research Institute for Primary Care and Health Sciences, Keele University. Prof NE Foster is a UK National Institute for Health Research Senior Investigator, and was supported by a UK National Institute for Health 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

Aims. With resumption of elective spine surgery services in the UK following the first wave of the COVID-19 pandemic, we conducted a multicentre British Association of Spine Surgeons (BASS) collaborative study to examine the complications and deaths due to COVID-19 at the recovery phase of the pandemic. The aim was to analyze the safety of elective spinal surgery during the pandemic. Methods. A prospective observational study was conducted from eight spinal centres for the first month of operating following restoration of elective spine surgery in each individual unit. Primary outcome measure was the 30-day postoperative COVID-19 infection rate. Secondary outcomes analyzed were the 30-day mortality rate, surgical adverse events, medical complications, and length of inpatient stay. Results. In all, 257 patients (128 males) with a median age of 54 years (2 to 88) formed the study cohort. The mean number of procedures performed from each unit was 32 (16 to 101), with 118 procedures (46%) done as category three prioritization level. The majority of patients (87%) were low-medium “risk stratification” category and the mean length of hospital stay was 5.2 days. None of the patients were diagnosed with COVID-19 infection, nor was there any mortality related to COVID-19 during the 30-day follow-up period, with 25 patients (10%) having been tested for symptoms. Overall, 32 patients (12%) developed a total of 34 complications, with the majority (19/34) being grade 1 to 2 Clavien-Dindo classification of surgical complications. No patient required postoperative care in an intensive care setting for any unexpected complication. Conclusion. This study shows that safe and effective planned spinal surgical services can be restored avoiding viral transmission, with diligent adherence to national guidelines and COVID-19-secure pathways tailored according to the resources of the individual spinal units. Cite this article: Bone Jt Open 2021;2(12):1096–1101

Purpose of the study and background. A 2011 Cochrane review concluded that spinal manipulative therapy (SMT) is no better than other interventions for reducing pain and improving function in chronic low back pain (CLBP). Using individual participant data (IPD) from trials has advantages, among others: a more precise estimate of the effect and the potential to identify moderators. Our objective was to assess the effect of SMT in adults with CLBP and to identify relevant moderators. Methods. All trials from the 2011 Cochrane review were included in this IPD. We updated the search (April 2016) IPD from eligible studies was requested. Primary outcomes were pain intensity (VAS/NRS) and back-specific function (RMDQ). Risk of bias was assessed. For the treatment effect, an one-stage approach (mixed model technique, intention-to-treat principle) was used; a second-stage approach was conducted as confirmation. For the moderator analyses, one-stage approach was conducted for 19 variables. Results. We obtained IPD from 21 RCTs (n= 4638). Most studies were pragmatic comparing the SMT effect to recommended therapies (e.g. exercise). Effects for SMT were slightly, but not clinically better compared to other therapies for primary outcomes. For the moderator analysis, 8 moderators showed a statistical significant effect at a specific time point (e.g. for SMT vs recommended therapy: age, both pain and function at 26 weeks). But for none of the moderators a consistent effect was identified across time points. Conclusion. Findings of the Cochrane review were confirmed. No clinically-relevant moderators were identified for SMT compared to other therapies for pain and function at any follow-up measure. No conflicts of interest. Sources of funding: European Chiropractic Research fund