Background and Aim of Study. Despite several hundred RCTs of exercise for persistent non-specific low back pain (NSLBP), the treatment targets of exercise are unclear. In a systematic review we observed 30 direct and indirect treatment targets of exercise described across 23 RCTs for persistent NSLBP. Since not all treatment targets and outcomes can be assessed in all RCTs, it is therefore important to prioritise these treatment targets through consensus from key stakeholders. These consensus workshops aimed to agree treatment targets for the use of exercise interventions in randomised controlled trials (RCTs) in persistent NSLBP using nominal group workshop (NGW) methodology. Methods and Results. The first UK workshop included people who had experience of exercise to manage their persistent NSLBP, clinicians who prescribe exercise for persistent NSLBP, and researchers who design exercise interventions tested in RCTs. The second workshop included participants attending an international back and neck pain research workshop. Twelve participants took part in the UK NGW and fifteen took part in the final ranking of the exercise treatment targets. In addition to the original list of 30 treatment targets, a further 26 ideas were generated. After grouping and voting, 18 treatment targets were prioritised. The top five ranked targets of exercise interventions for persistent NSLBP were: pain reduction, improvement in function, reduction of fear of movement, encouragement of normal movement and improvement of mobility. The results of the international NGW will also be presented. Conclusion. Future RCTs of exercise should consider more consistent assessment of these treatment targets. 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. Conflicts of Interest: No conflicts of interest

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

Background and Purpose. The UK's NIHR and Australia's NHMRC have funded two randomised controlled trials (RCTs) to determine if lumbar fusion surgery (LFS) is more effective than best conservative care (BCC) for adults with persistent, severe low back pain (LBP) attributable to lumbar spine degeneration. We aimed to describe clinicians’ decision-making regarding suitability of patient cases for LFS or BCC and level of equipoise to randomise participants in the RCTs. Methods. Two online cross-sectional surveys distributed via UK and Australian professional networks to clinicians involved in LBP care, collected data on clinical discipline, practice setting and preferred care of five patient cases (ranging in age, pain duration, BMI, imaging findings, neurological signs/symptoms). Clinicians were also asked about willingness to randomise each patient case. Results. Of 174 responses (73 UK, 101 Australia), 70 were orthopaedic surgeons, 34 neurosurgeons, 65 allied health professionals (AHPs), 5 others. Most worked in public health services only (92% UK, 45% Australia), or a mix of public/private (36% Australia). Most respondents chose BCC as their first-choice management option for all five cases (81–93% UK, 83–91% Australia). For LFS, UK surgeons preferred TLIF (36.4%), whereas Australian surgeons preferred ALIF (54%). Willingness to randomise cases ranged from 37–60% (UK mean 50.7%), and 47–55% (Australian mean 51.9%); orthopaedic and neuro-surgeons were more willing than AHPs. Conclusion. Whilst BCC was preferred for all five patient cases, just over half of survey respondents in both the UK and Australia were willing to randomise cases to either LFS or BCC, indicating clinical equipoise (collective uncertainty) needed for RCT recruitment. Conflicts of interest. None. Sources of funding. No specific funding obtained for the surveys. DB, SA, AG and NEF have funding from the National Institute for Health Research (NIHR) UK (FORENSIC-UK NIHR134859); NEF, DB and SA have funding from the Australian National Health and Medical Research Council (NHMRC FORENSIC-Australia GA268233). AG has funding from Orthopaedic Research UK (combined with British Association of Spine Surgeons and British Scoliosis Society) and Innovate UK. NEF is funded through an Australian National Health and Medical Research Council (NHMRC) Investigator Grant (ID: 2018182)

Background. Advice and education are considered vital components of back pain care within national guidelines. However, a recent systematic review only found low grade evidence for a small average effect. They also reported wide heterogeneity in intervention design and delivery. This review aimed to understand why intervention design varied and what limited effectiveness by examining the underlying theoretical foundations of the studies from that review. Method. Population, context, selection criteria, intervention(s), control, outcome measures, how the intervention was hypothesised to produce outcomes and author recommendations based on results of the study were extracted from text records. The extent to which the advice included matched a published international consensus statement on evidence-based advice for back pain was recorded. Whether interventions or settings were complex was determined using the Medical Research Council complex intervention development and evaluation guidance and the extent to which they met complexity reporting criteria was recorded. Results. The review included 26 trials conducted over 25 years. Differences In causal pathways could explain diversity in intervention design but these were not clearly described or evaluated. All studies were complex in terms of intervention and setting. This was rarely considered in intervention and trial design or when discussing the results. Although interventions were frequently described in detail only a few explained the process and justification of the design. Theories of education or behaviour change were rarely applied. Conclusion. These studies have not deepened our understanding of how education improves outcomes. Future RCTs should engage more with theory and other theory-based research methods should to be considered. Conflict of interest: No conflicts of interest. Sources of funding: No funding

Aims. The aim of this study was to systematically compare the safety and accuracy of robot-assisted (RA) technique with conventional freehand with/without fluoroscopy-assisted (CT) pedicle screw insertion for spine disease. Methods. A systematic search was performed on PubMed, EMBASE, the Cochrane Library, MEDLINE, China National Knowledge Infrastructure (CNKI), and WANFANG for randomized controlled trials (RCTs) that investigated the safety and accuracy of RA compared with conventional freehand with/without fluoroscopy-assisted pedicle screw insertion for spine disease from 2012 to 2019. This meta-analysis used Mantel-Haenszel or inverse variance method with mixed-effects model for heterogeneity, calculating the odds ratio (OR), mean difference (MD), standardized mean difference (SMD), and 95% confidence intervals (CIs). The results of heterogeneity, subgroup analysis, and risk of bias were analyzed. Results. Ten RCTs with 713 patients and 3,331 pedicle screws were included. Compared with CT, the accuracy rate of RA was superior in Grade A with statistical significance and Grade A + B without statistical significance. Compared with CT, the operating time of RA was longer. The difference between RA and CT was statistically significant in radiation dose. Proximal facet joint violation occurred less in RA than in CT. The postoperative Oswestry Disability Index (ODI) of RA was smaller than that of CT, and there were some interesting outcomes in our subgroup analysis. Conclusion. RA technique could be viewed as an accurate and safe pedicle screw implantation method compared to CT. A robotic system equipped with optical intraoperative navigation is superior to CT in accuracy. RA pedicle screw insertion can improve accuracy and maintain stability for some challenging areas. Cite this article: Bone Joint Res 2020;9(10):653–666

A literature review of bone graft substitutes for spinal fusion was undertaken from peer reviewed journals to form a basis for guidelines on their clinical use. A PubMed search of peer reviewed journals between Jan 1960 and Dec 2009 for clinical trials of bone graft substitutes in spinal fusion was performed. Emphasis was placed on RCTs. Small and duplicated RCTs were excluded. If no RCTs were available the next best clinical evidence was assessed. Data were extracted for fusion rates and complications. Of 929 potential spinal fusion studies, 7 RCTs met the inclusion criteria for BMP-2, 3 for BMP-7, 2 for Tricalcium Phosphate and 1 for Tricalcium Phosphate/Hydroxyapatite (TCP/HA). No clinical RCTs were found for Demineralised Bone Matrix (DBM), Calcium Sulphate or Calcium Silicate. There is strong evidence that BMP-2 with TCP/HA achieves similar or higher spinal fusion rates than autograft alone. BMP-7 achieved similar results to autograft. 3 RCTs support the use of TCP or TCP/HA and autograft as a graft extender with similar results to autograft alone. The best clinical evidence to support the use of DBMs are case control studies. The osteoinductive potential of DBM appears to be very low however. There are no clinical studies to support the use of Calcium Silicate. The current literature supports the use of BMP-2 with HA/TCP as a graft substitute. TCP or HA/TCP with Autograft is supported as a graft extender. There is not enough clinical evidence to support other bone graft substitutes. This study did not require ethics approval and no financial support was received

Background. Routine imaging (radiography, CT, MRI) provides no health benefits for low back pain (LBP) patients and is not recommended in clinical practice guidelines. Whether imaging leads to increased costs, healthcare utilization or absence from work is unclear. Purpose. To systematically review if imaging in patients with LBP increases costs, leads to higher health care utilization or increases absence from work. METHODS. Randomized controlled trials (RCTs) and observational studies (OSs), comparing imaging versus no imaging on targeted outcomes were extracted from medical databases until October 2017. Data extraction and risk of bias assessment was performed independently by two reviewers. The quality of the body of evidence was determined using GRADE methodology. Results. Moderate quality evidence (1 RCT; n=421) supports that direct costs increase for patients undergoing radiography. Low quality evidence (3 OSs; n=9535) supports that early MRI leads to a large increase in costs. Moderate quality evidence (2 RCTs, 6 OSs; n=19392) supports that performing MRI, radiography or CT is associated with increased healthcare utilization. Two RCTs (n=667) showed no significant differences between radiography or MRI groups compared with no imaging groups on absence from work. However, the results of two observational studies (n=7765) did show significantly greater absence from work in the imaging groups compared to the no imaging-groups. Conclusions. Imaging in LBP is associated with higher medical costs and increased healthcare utilisation. There are indications that it also leads to higher absence from work. No conflicts of interest. No funding obtained

Background and Purpose. Non-specific chronic low back pain (NSCLBP) poses a significant disability and economic burden worldwide. Fear avoidance is suggested to contribute to its chronicity and reduced treatment effect. National guidelines recommend exercise as a component of multidisciplinary rehabilitation but its interaction with fear avoidance is ambiguous. This systematic review examined the effect of exercise-based interventions (EBIs) on fear avoidance NSCLBP. Methods and Results. RCTs comparing EBIs to usual care in adults with NSCLBP were included. A systematic search of CINAHL, Medline, EMBASE, Web of Science, Scopus and Cochrane Library (up to January 2019) revealed 10 eligible trials. Following risk of bias assessment, 6 studies were included for data extraction and narrative synthesis. EBIs were not found superior to usual care in reducing fear avoidance at any follow-up. There was evidence that reducing fear avoidance is probably not the mechanism through which EBIs affect pain and disability. In adherent patients, EBIs did not result in greater clinically relevant improvements in pain or disability than usual care, in the short- or intermediate-term. Conclusion. Addition of EBIs as part of multidisciplinary rehabilitation is not more beneficial than that of usual care in reducing fear avoidance in NSCLBP patients. However, the findings of this review are based on heterogenous studies presenting with methodological limitations. Further high-quality research is required to examine the review's findings and investigate current physiotherapy management of fear avoidance in NSCLBP. No conflicts of interest. No funding obtained

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

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.

Purpose and Background. Strengthening the lumbar extensor musculature is a common recommendation for CLBP. Although reported as effective, variability in response in CLBP populations is not well investigated. This study investigated variability in responsiveness to isolated lumbar extension (ILEX) resistance training in CLBP participants by retrospective analysis of 3 RCTS. Methods and Results. Data from 77 intervention participants was available (males = 43, females = 34) 37 control participants (males = 20, females = 17). Intervention participants all underwent 12wks of ILEX resistance training and changes in ILEX strength, pain (VAS) and disability (ODI) measured. True inter-individual response variability was examined through calculation of difference in the standard deviation of change scores for both control and intervention. Intervention participants were classified into using k-means cluster analysis for strength changes and using MCIC cut-offs for VAS and ODI. Analysis suggested true inter-individual responses to the intervention existed. Participants were classified for strength changes as low (n = 31), medium (n = 36), and high responders (n = 10). Participants were classified for VAS changes as negative (n = 3), non-responders (n = 34), responders (n = 15), and high responders (n = 19). Participants were classified for ODI changes as negative (n = 2), non-responders (n = 21), responders (n = 29), and high responders (n = 25). Conclusion. Considerable variation exists in response to ILEX resistance training in CLBP. Future work should identify factors prognostic of successful outcomes. Conflicts of interest: None. Funding obtained: None

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.

Background and objectives. The Alexander Technique (AT) is a self-care method usually taught in one-to-one lessons. AT lessons have been shown to be helpful in managing long-term health-related conditions (Int J Clin Pract 2012;66:98−112). This systematic review aims to draw together evidence of the effectiveness of AT lessons in managing musculoskeletal (MSK) conditions, with empirically based evidence of physiological changes following AT training, to provide a putative theoretical explanation for the observed benefits of Alexander lessons. Methods and results. Systematic searches of a range of databases were undertaken to identify prospective studies evaluating AT instruction for any musculoskeletal condition, using PICO criteria, and for studies assessing the physiological effects of AT training. Citations (N=332) were assessed and seven MSK intervention studies were included for further analysis. In two large well-designed randomised controlled trials, AT lessons led to significant long-term (1 year) reductions in pain and incapacity caused by chronic back or neck pain (usual GP-led care comparator). Three smaller RCTs in chronic back and neck pain, respectively, and a pain clinic service evaluation broadly supported these findings. A pilot study reported preliminary evidence for pain reduction in knee osteoarthritis patients. Further studies showed significant improvements in general coordination, walking gait, motor control and balance, possibly resulting from improved postural muscle tone regulation and adaptability, in people with extensive AT training. Conclusion. Available evidence supports the effectiveness of AT lessons for people with chronic back or neck pain. Studies suggest some of the observed benefit may be due to improvements in movement coordination, balance and postural tone. Conflicts of interest: None. Authors are practising Alexander Technique teachers. Funding: None

Aims

People with severe, persistent low back pain (LBP) may be offered lumbar spine fusion surgery if they have had insufficient benefit from recommended non-surgical treatments. However, National Institute for Health and Care Excellence (NICE) 2016 guidelines recommended not offering spinal fusion surgery for adults with LBP, except as part of a randomized clinical trial. This survey aims to describe UK clinicians’ views about the suitability of patients for such a future trial, along with their views regarding equipoise for randomizing patients in a future clinical trial comparing lumbar spine fusion surgery to best conservative care (BCC; the FORENSIC-UK trial).

This review provides a concise outline of the advances made in the care of patients and to the quality of life after a traumatic spinal cord injury (SCI) over the last century. Despite these improvements reversal of the neurological injury is not yet possible. Instead, current treatment is limited to providing symptomatic relief, avoiding secondary insults and preventing additional sequelae. However, with an ever-advancing technology and deeper understanding of the damaged spinal cord, this appears increasingly conceivable. A brief synopsis of the most prominent challenges facing both clinicians and research scientists in developing functional treatments for a progressively complex injury are presented. Moreover, the multiple mechanisms by which damage propagates many months after the original injury requires a multifaceted approach to ameliorate the human spinal cord. We discuss potential methods to protect the spinal cord from damage, and to manipulate the inherent inhibition of the spinal cord to regeneration and repair. Although acute and chronic SCI share common final pathways resulting in cell death and neurological deficits, the underlying putative mechanisms of chronic SCI and the treatments are not covered in this review.

Department of Epidemiology, ASL RM/E, Rome, Italy. School of Health and Social Care, University of Teesside, Middlesbrough, UK. Faculty of Health, Staffordshire University, Stoke on Trent, UK. Orthopaedic and Trauma Department, “Tzanio” General Hospital of Piraeus, Greece. University of Medical Sciences, Poznan, Poland. Department of Orthopaedic Surgery, Saitama Medical University, Kawagoe, Japan. Thriasio General Hospital, Athens, Greece. To evaluate the efficacy of bracing in adolescent patients with AIS. Cochrane systematic review. The following databases were searched with no language limitations: the Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, CINHAL and reference lists of articles. Extensive hand searching of grey literature was also conducted. RCT's and prospective cohort studies comparing braces with no treatment, other treatment, surgery, and different types of braces were included. Two review authors independently assessed trial quality and extracted data. Two studies were included. There was very low quality evidence from one prospective cohort study including 286 girls. 1. indicating that braces curbed curve progression, at the end of growth, (success rate 74%), better than observation, (34%) and electrical stimulation (33%). Another low quality evidence from one RCT with 43 girls indicated that a rigid brace is more successful than an elastic one (SpineCor) at limiting curve progression when measured in Cobb degrees. 2. No significant differences between the two groups in the subjective perception of daily difficulties associated with brace wearing were found. There is very low quality evidence in favour of using braces, making generalization very difficult. The results from future studies may differ from these results. In the meantime, patients' choices should be informed by multidisciplinary discussion. Future research should focus on short and long-term patient-centred outcomes as well as measures such as Cobb angles. RCTs and prospective cohort studies should follow both the SRS and the Society on Scoliosis Orthopaedic and Rehabilitation Treatment (SOSORT) criteria for bracing studies

Study design. Literature review of the best available evidence on the accuracy of computer assisted pedicle screw insertion. Background. Pedicle screw misplacement rates with the conventional insertion technique and adequate postoperative CT examination have ranged from 5 to 29 % in the cervical spine, from 3 to 58 % in the thoracic spine, and from 6 to 41% in the lumbosacral region. Despite these relatively high perforation rates, the incidence of reported screw-related complications has remained low. Interestingly, the highest rates of neurovascular injuries have been reported from the lumbosacral spine in up to 17% of the patients. Gertzbein and Robbins introduced a 4-mm “safe zone” in the thoracolumbar spine for medial encroachment, consisting of 2-mm of epidural and 2-mm of subarachnoid space. Later, several authors have found the safety margins to be significantly smaller, suggesting that the “safe zone” thresholds of Gertzbein and Robbins do not apply to the thoracic spine, and seem to be too high even for the lumbar spine. The midthoracic and midcervical spine, as well as the thoracolumbar junction set the highest demands for accuracy in pedicle screw insertion, with no room for either translational or rotational error at e.g. T5 level. Computer assisted pedicle screw insertion (navigation) was introduced in the early 90's to increase the accuracy and safety of pedicle screw insertion. Material. PubMed literature search revealed two randomized controlled trials (RCT) comparing the in vivo accuracy of conventional and computer assisted pedicle screw insertion techniques. Three meta-analyses have assessed the published reports on the accuracy of pedicle screw insertion with or without computer assistance, one additional meta-analysis concentrated on the functional outcome of computer assisted pedicle screw insertion. Results. The RCTs by Laine et al and Rajasekaran et al achieved significantly higher screw placement accuracy with computer assistance than with the conventional techniquebased on anatomical landmarks. In a degenerative patient population, Laine et al reported a misplacement rate of 4.6% with computer assistance compared to 13.4% with the conventional technique. In addition to this quantitative difference, a qualitative difference in the misplaced screws was noticed: in the conventional group, 28 out of 37 misplaced screws were either inferior or medial, whereas in the computer assisted group, 1 out of 10 misplaced screws was situated in these ”danger zones”. In deformity surgery, Rajasekaran et al reported a 2% pedicle screw misplacement rate with a computer assisted technique compared to 23% with the conventional technique. Interestingly, in their study, the average screw insertion time in the computer assisted group was significantly shorter than with the conventional technique. The three meta-analyses, assessing up to 37 337 pedicle screws, reported significantly higher accuracy in the placement of pedicle screws with computerassistance compared with the conventional methods. The superiority of the computer assisted technique was even more obvious with abnormal surgical anatomy. CT-based and 3D-fluoroscopy-based navigation methods provided better accuracy compared to 2Dfluoroscopy-based navigation. No statistically significant benefit with computer assistance in the incidence of neuro-vascular complications, or in functional outcome was demonstrated. Conclusion. High pedicle screw misplacement rates have been reported with the conventional technique based on anatomical landmarks and intraoperative fluoroscopy. The concept of ”safe zone” is hypothetical, and underestimates the true risks of misplaced pedicle screws. Computer assistance significantly improves the accuracy and safety of pedicle screw insertion. It will, however, be difficult to correlate this increased accuracy to improved patient outcomes

Aims

Chronic low back pain due to degenerative disc disease is sometimes treated with fusion. We compared the outcome of three different fusion techniques in the Swedish Spine Register: noninstrumented posterolateral fusion (PLF), instrumented posterolateral fusion (IPLF), and interbody fusion (IBF).

The National Institute for Health and Care Excellence has issued guidelines that state fusion for non-specific low back pain should only be performed as part of a randomised controlled trial, and that lumbar disc replacement should not be performed. Thus, spinal fusion and disc replacement will no longer be routine forms of treatment for patients with low back pain. This annotation considers the evidence upon which these guidelines are based.

Cite this article: Bone Joint J 2017;99-B:1003–1005.

Aims

The aim of this study was to compare the effect of a percutaneous radiofrequency heat lesion at the medial branch of the primary dorsal ramus with a sham procedure, for the treatment of lumbar facet joint pain.