Background. Guidelines recommend epidural steroid injections (ESI) for treating severe disc-related sciatica based on trial data showing modest reductions in leg pain, disability and surgery avoidance. Despite their widespread use, there is no clear evidence about which patients are more likely to benefit from ESI. The aim of this study was to generate consensus on potential predictors of outcome following ESI for disc-related sciatica to include in data collection in a future cohort study. Methods. A list of potential predictors of outcome following ESI was generated from existing literature and a consensus meeting with seven experts. Items were subsequently presented in a two-round on-line modified Delphi study to generate consensus among experts on which items are agreed as potential predictors of outcome from ESI (consensus defined as 70% agreement with ranking of remaining items). Results. An initial list of 53 items was generated and 90 experts were invited from seven countries to participate in the on-line Delphi study. Response rates were 48% (n=44) and 73% (n=33) for round 1 and 2 respectively. Twenty-eight additional items suggested by participants in round 1 were included in round 2. Of the 81 items, 14 reached consensus; across domains of medication use, previous surgery, pain intensity, psychosocial factors, imaging findings and type of injection. Highest ranked of remaining items included work-related and clinical assessment items. Conclusion. Based on expert consensus, items that can be routinely collected in clinical practice were identified as potential predictors of outcomes following ESI. These will be tested in a future multicentre cohort study. Conflicts of interest: No conflicts of interest. Sources of funding: This study is supported by Health Education England and the National Institute for Health Research (HEE/ NIHR ICA Programme Clinical Lectureship, Dr Siobhan Stynes, NIHR300441). The views expressed are those of the author(s) and not necessarily those of the NHS, the National Institute for Health Research or the Department of Health and Social Care

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. Specifically designed control interventions can account for expectation effects in clinical trials. For the interpretation of efficacy trials of physical, psychological, and self-management interventions for people living with pain, the design, conduct, and reporting of control interventions is crucial. Objectives. To establish a quality standard in the field, core recommendations are presented alongside additional considerations and a reporting checklist for control interventions. Methods. Three Delphi rounds with 64 experts in placebo research and/or non-pharmacological clinical trials were conducted. The panel was presented with a systematic review and meta-analysis of control and blinding methods. A draft guidance document included 63 consensus items (≥80% agreement) and was discussed with patient partners. Finally, the draft guidance and results from stakeholder interviews were discussed at consensus meetings with Delphi participants and patient representatives. Results. Forty-four experts completed the process. When treatment efficacy or mechanisms are to be studied, the advocated principle is to design control interventions as similar as possible to the tested intervention, apart from the components that the study examines. Structured reasoning in the planning phase, early engagement with stakeholders, feasibility work, and piloting will enhance the quality and acceptability of control interventions. With participant blinding being a primary objective, blinding effectiveness should be routinely assessed and reported. Transparent and detailed reporting will improve interpretability and repeatability of clinical trials. Conclusion. This guideline provides the much-needed standards to enhance the quality of efficacy clinical trials in physical, psychological, and self-management intervention research, ultimately improving patient care. Study registration: . https://osf.io/jmyhq/. Conflict of interest: The authors declare no competing interests. Sources of Funding: Alain and Sheila Diamond Charitable Trust PhD Studentship

Aims. Developmental cervical spinal stenosis (DcSS) is a well-known predisposing factor for degenerative cervical myelopathy (DCM) but there is a lack of consensus on its definition. This study aims to define DcSS based on MRI, and its multilevel characteristics, to assess the prevalence of DcSS in the general population, and to evaluate the presence of DcSS in the prediction of developing DCM. Methods. This cross-sectional study analyzed MRI spine morphological parameters at C3 to C7 (including anteroposterior (AP) diameter of spinal canal, spinal cord, and vertebral body) from DCM patients (n = 95) and individuals recruited from the general population (n = 2,019). Level-specific median AP spinal canal diameter from DCM patients was used to screen for stenotic levels in the population-based cohort. An individual with multilevel (≥ 3 vertebral levels) AP canal diameter smaller than the DCM median values was considered as having DcSS. The most optimal cut-off canal diameter per level for DcSS was determined by receiver operating characteristic analyses, and multivariable logistic regression was performed for the prediction of developing DCM that required surgery. Results. A total of 2,114 individuals aged 64.6 years (SD 11.9) who underwent surgery from March 2009 to December 2016 were studied. The most optimal cut-off canal diameters for DcSS are: C3 < 12.9 mm, C4 < 11.8 mm, C5 < 11.9 mm, C6 < 12.3 mm, and C7 < 13.3 mm. Overall, 13.0% (262 of 2,019) of the population-based cohort had multilevel DcSS. Multilevel DcSS (odds ratio (OR) 6.12 (95% CI 3.97 to 9.42); p < 0.001) and male sex (OR 4.06 (95% CI 2.55 to 6.45); p < 0.001) were predictors of developing DCM. Conclusion. This is the first MRI-based study for defining DcSS with multilevel canal narrowing. Level-specific cut-off canal diameters for DcSS can be used for early identification of individuals at risk of developing DCM. Individuals with DcSS at ≥ three levels and male sex are recommended for close monitoring or early intervention to avoid traumatic spinal cord injuries from stenosis. Cite this article: Bone Joint J 2024;106-B(11):1333–1341

Purposes of the study and background. Clinical assessment of spinal function is a routine part of low back pain (LBP) assessment, yet there is no clear consensus on what constitutes ‘spinal dysfunction’ and how this informs treatment. This study's aims to develop a spinal function classification framework by gaining expert academic and clinical consensus on (i) spinal function assessment tests (ii) encountered LBP motor control/movement impairment (MCI/MI) sub-types (iii) their characteristics and (iii) exercises and feedback for each sub-type. Methods and Results. An online 2-round Delphi-survey of 4 world-leading academic experts and 36 clinical physiotherapists world-wide was employed. A five-point response scale was used to rate level of agreement on 174 items with a priori consensus defined by a ≠>80% level of agreement (LOA). Out of 15 spinal function assessment tests, 5 reached consensus with forward bend and sitting/standing tests highest scoring. 7 MCI/MI sub-types reached consensus as clinically encountered. 12 out of 128 of posture/movement descriptors within the 7 sub-types reached consensus. 7 exercises gained consensus in being considered as ‘important’ or ‘very important’ with exercises involving sitting, standing, forward bend scoring highest. Consensus was reached on MCI/MI sub-type specific exercises, compensation strategies and feedback to remedy these compensations. Conclusion. Academic and clinical expert consensus derived list of movement/posture descriptors, assessment tests and exercises considered clinically important provides a first to date, spinal function assessment classification framework for non-specific LBP. This offers a conceptual model for developing technologies (e.g. wearable sensors) to harness clinically useful information relating to spinal function, exercise performance and feedback for effective implementation of exercise therapies for non-specific LBP. No conflicts of interest. Sources of Funding: Health and Care Research Wales, RCBC Postdoctoral Research Fellowship

Purpose and Background. Clinical practice guidelines (CPGs) recommend self-management for low back pain (LBP). Our recent narrative review on self-management needs revealed a consensus with respect to the critical components of self-management interventions. With mobile health advancements, apps offer innovative support for LBP management. This study aims to identify current apps for the self-management of LBP, assessing them for their quality, intervention content, theoretical approaches, and risk management approaches. Methods and Results. We identified 69 apps for LBP self-management from a systematic search in the UK iTunes and Google Play stores. The most recommended interventions are muscle stretching (n=51, 73.9%), muscle strengthening (n=42, 60.9%), and core stability exercises (n=32, 46.4%). The average MARS (SD) overall score for the included apps was 2.4 (0.44) out of a possible 5 points, with the engagement and information dimension scoring the lowest at 2.1. In terms of theoretical and risk management approaches, no apps offered a theoretical care model and all failed to specify the age group targeted; only one (1.4%) provided a tailored care approach; 18 (26.1%) included intervention progression; and 11 (15.9%) reported management safety checks. Conclusion. This study shows that app developers generally select interventions endorsed by CPGs. However, the application of a biopsychosocial care model is not being considered. Most of them are of low quality, lacking theoretical approaches to care and consideration of associated risks. It is essential to involve clinicians and patients in developing LBP self-management apps to improve the quality and related approach. Conflicts of interest. None. Sources of funding. No funding obtained. This study has been published in JMIR mHealth and uHealth

Background and study purpose. A recent systematic review with meta-analysis of eight randomised controlled trials concluded that Cognitive Functional Therapy (CFT) for low back pain might be effective in reducing disability, pain and fear-avoidance beliefs. However, the descriptions of a CFT intervention are not always clear. This study aimed to rate the replicability of the CFT interventions and control groups in the systematic review. Methods. Two reviewers independently extracted data from the study articles, protocols and appendices into Microsoft Excel using the Template for Intervention Description and Replication (TIDieR) checklist. This checklist has 12 items to describe the ‘why’, ‘what’, ‘who’, ‘how’, ‘where’, ‘when and how much’, ‘tailoring’, ‘modifications’, and ‘how well’ for each intervention. We rated the replicability of the CFT interventions and control groups as ‘reported’, ‘partially reported’ and ‘not reported’ and resolved discrepancies by consensus. Results. No studies reported 100% of the TIDieR items; the mean ‘reported’ rating was 54% (range 33–67%) for the CFT interventions and 35% (range 8–67%) for controls. The six most replicable items were the same for both CFT and control groups. These were ‘brief name’ (CFT=100%; control=100%), ‘why’ (CFT=100%; control=50%), ‘how’ (CFT=100%; control=50%), ‘what procedures’ (CFT=88%; control=63%), ‘where’ (CFT=88%; control=75%) and ‘planned adherence’ (CFT=75%; control=38%). Items that were not sufficiently ‘reported’ for either CFT or control groups included ‘when and how much’, ‘tailoring’ and ‘adherence’. Conclusion. Incomplete descriptions of CFT interventions mean that clinicians and patients cannot implement those that have demonstrated effectiveness, and poor descriptions of control groups prevent researchers from replicating them in future studies. Conflict of interest. No conflicts of interest. Sources of funding. No funding obtained

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

Background. Involving research users in setting priorities for research is essential to ensure research outcomes are patient-centred and to maximise research value and impact. The Musculoskeletal (MSK) Disorders Research Advisory Group Versus Arthritis led a research priority setting exercise across MSK disorders. Methods. The Child Health and Nutrition Research Initiative (CHRNI) method of setting research priorities with a range of stakeholders were utilised. The MSKD RAG identified, through consensus, four research Domains: Mechanisms of Disease; Diagnosis and Impact; Living Well with MSK disorders and Successful Translation. Following ethical approval, the research priority exercise involved four stages and two surveys, to: 1) gather research uncertainties; 2) consolidate these; 3) score uncertainties using agreed criteria of importance and impact on a score of 1–10; and 4) analyse scoring, for prioritisation. Results. The first survey had 209 respondents, who described 1290 research uncertainties, which were refined into 68 research questions. 285 people responded to the second survey. The largest group of respondents represented patients and carers, followed by researchers and healthcare professionals. A ranked list was produced, with scores ranging between 12 and 18. Key priorities included developing and testing new treatments, better targeting of treatments, early diagnosis, prevention and better understanding and management of pain, with an emphasis on understanding underpinning mechanisms. Conclusions. For the first time, we have summarised priorities for research across MSKD, from discovery science to applied clinical and health research, including translation. We present a call to action to researchers and funders to target these priorities. Conflict of Interest: None. Sources of funding: We thank the funder, Versus Arthritis for their support of the research advisory groups and this activity

A Core Outcome Set (COS) for treatment of adolescent idiopathic scoliosis (AIS) is essential to ensure that the most meaningful outcomes are evaluated and used consistently. Measuring the same outcomes ensures evidence from clinical trials and routine clinical practice of different treatments can be more easily compared and combined, therefore increasing the quality of the evidence base. The SPINE-COS-AYA project aims to develop a gold standard COS which can be used internationally in research and routine clinical practice to evaluate the treatment (surgical and bracing) of AIS. In this qualitative study, the views of adolescents and young adults with AIS (10-25 years of age), their family members and healthcare professionals in a UK region were sought, via interviews, on treatment outcomes. Participants were purposively recruited from a variety of sources including NHS outpatient clinics and social media. Semi-structured interviews were analysed using thematic analysis. Key findings will be presented, to include potential core outcome domains identified by the different subgroups. The core outcome domains identified in this research programme will subsequently form part of an international consensus survey to agree a COS. In future, if the COS is used by healthcare staff and researchers, it will be easier for everyone, including patients and their families, to assess which treatment works best

Aim. To develop a clinical core set of outcome measures that is accepted for relevance, feasibility and validity by stakeholders and useful for a) interaction between patient and professional, b) internal quality improvement, and c) external transparency in patients with NSLBP in primary care physical therapy. Method. We used a consensus-driven modified RAND-UCLA Delphi technique. We conducted seven separate steps with panellists (physical therapists, patient representatives, health insurers) to select accepted outcomes. These seven steps consisted of a literature search, two online surveys, patient interviews, an experts meeting, a consensus meeting and final approval of an advisory board. Results of previous steps were discussed during the consensus meeting, and then panellists voted for inclusion per measure. The final core set was rated on relevance and feasibility on a 9-point Likert scale, when the median was ≥7 the core set was accepted. Results. 34 panellists in two online surveys, five panellists in an expert committee, ten patients for semi-structured interviews and 26 panellists in a consensus meeting participated in the study. 12 outcome measures were rated and discussed and finally six outcome measures were accepted. The final core set was accepted with a median of 7. Conclusion. This study present an outcome set that is accepted by stakeholders as having added value for a) interaction between patient and professional, b) internal quality improvement, and c) external transparency in patients with NSLBP in primary care physical therapy. In a next project this outcome set will be tested on his reliability and feasibility in a large pilot. No conflicts of interest. Sources of funding: Health insurance company CZ, the Netherlands

Purpose of the Study. To develop an online self-assessment and self-management tool (BACKonLINE™) for discerning between people with characteristics of predominantly centrally (CD) or peripherally (PD) driven LBP. Background. Low back pain (LBP) may worsen with time, making appropriate treatment important. In the NHS Physiotherapy services LBP patients may wait for 14–24 weeks for treatments. Many factors contribute to LBP, but it is predominantly initially viewed as a result of peripheral tissue damage. However, evidence show that persistent LBP is associated with amplification in pain processing in the central nervous system (central sensitisation). Sometimes, this may drive symptoms, resulting in poorer outcomes and requiring longer management. Timely assessment and appropriate management is therefore paramount. Method. Design: 2-round Delphi study. Sample: Purposive sample of international LBP physiotherapy experts. For Round1, series of questions were developed using literature search on characterising clinical features of LBP with predominantly CD or PD pain. Participants were asked to score questions on a 7-point Likert scale on their importance in differentiating between CD and PD pain. Round2, sent to Round1 participants, aimed to reach final consensus on BACKonLINE™. Consensus for both rounds was pre-set at ≥70%. Results. In Round1, 38 experts participated. Out of 55 questions, 33 (60%) reached consensus. Participants added 11 new questions. Round2 included 44 questions and sent to Round1 participants. In Round2, 40 (90.9%) questions reached final consensus. Conclusion. This study displays an agreement among LBP physiotherapy experts on the importance of characterising CD and PD pain. Forty (90.9%) questions reached final consensus and formulated BACKonLINE™. Conflicts of interest. No conflicts of interest. Sources of funding. Civil Service Commission, Kuwait

Background & purpose. Measurement inconsistency across clinical trials is tackled by the development of a core outcome measurement set. Four core outcome domains were recommended for clinical trials in patients with non-specific LBP (nsLBP): physical functioning, pain intensity, health-related quality of life (HRQoL), and number of deaths. This study aimed to reach consensus on core instruments to measure the first three domains. Methods & Results. The Steering Committee overseeing this project selected 17 potential core instruments for physical functioning, three for pain intensity, and five for HRQoL. Evidence on their measurement properties in nsLBP was synthesized in three systematic reviews using COSMIN methodology. Researchers, clinicians, and patients (n = 208) were invited in a Delphi survey to seek consensus on which instruments to endorse as core. Consensus was a-priori set at 67% of participants agreeing on endorsing an instrument. Two Delphi rounds were run (response rates = 44% and 41%). Agreement was reached on endorsing the Oswestry Disability Index (ODI 2.1a) for physical functioning, the Numeric Rating Scale (NRS) for pain intensity, but not on other instruments. Several participants demanded to have free of charge core instruments. Taking these results into account, the steering committee formulated the following recommendations: ODI 2.1a or 24-item Roland Morris Disability Questionnaire for physical functioning, NRS for pain intensity, Short-Form 12 or 10-item PROMIS Global Health for HRQoL. Conclusion. A core outcome measurement set is available for clinical trials in patients with nsLBP. High quality clinimetric studies directly comparing recommended and not recommended instruments are required. Conflict of interest: None. Source of funding: EUROSPINE, The Spine Society of Europe

Background and purpose:. Inconsistent outcome reporting is a problematic issue in systematic reviews of clinical trials in non-specific LBP (NSLBP). To facilitate statistical pooling and improve reliability of reviews, the development of a core outcome set (COS) is recommended. In 1998, Deyo et al. proposed a standardized set of domains and measurement instruments for LBP clinical research. An international steering committee (ISC) was formed to update 1998 recommendations, and to determine, at first, which outcome domains should be included in a COS for clinical trials in NSLBP. Methods:. The ISC used the OMERACT framework 2.0 to draw a list of potential core domains. This list was presented in a 3-round Delphi survey, in which researchers, clinicians and patients were invited to participate. Criteria for consensus were established a-priori and quantitative responses were analysed together with arguments provided by Delphi participants. The ISC discussed the results and made final decisions. Results:. 280 ‘experts’ were selected and invited to participate in the Delphi survey. Response rates in the three rounds were: 52%, 50%, and 45%. A list of 41 potential core domains was presented but 28 of them did not reach sufficient consensus to be presented in the third round, where overall consensus was reached on three domains: ‘physical functioning’, ‘pain intensity’ and ‘health-related quality of life’. Conclusion:. ‘Physical functioning’, ‘pain intensity’ and ‘health-related quality of life’ were included in this COS, together with the reporting on ‘number of deaths’. The next step in the development of this COS will be to determine which measurement instruments are most fit-for-purpose to measure these outcome domains

Aims

To systematically evaluate whether bracing can effectively achieve curve regression in patients with adolescent idiopathic scoliosis (AIS), and to identify any predictors of curve regression after bracing.

Purpose of the study and background. The preliminary study aimed to establish clinical and research expert opinion with regards to the key components of an assessment of a person with Mechanical Low Back Pain (MLBP). We aimed to identify the key subjective questions and objective tests which would be helpful for clinicians to develop the most appropriate self-management exercise programme. This is the first part of the study to develop the ‘Back-to-Fit’ digital tool offering personalised self-management exercise solutions for people with MLBP. Summary of the methods. A Bristol online survey which included a questionnaire with a series of open and closed questions was developed using the literature and was distributed among clinicians/researchers with a background in the clinical management of MLBP. The questionnaire included 6 demographic questions followed by sections related to subjective questions and objective tests of the MLBP assessment. 71 participants responded to the survey. Results. In the subjective assessment component, ≥80% level of agreement was obtained for 17 of 26 proposed subjective questions and 05 of the 21 suggested objective tests. Two more questions and two objective tests to be included in the assessment had been suggested by the partcipants. Conclusion. These expert agreements on questions and opinions provides an indication of the key subjective and objective components to be included in a self-assessment tool in a personalised self-management platform for MLBP. Further testing with a multiple round Delphi study in a large sample of experts is now required to obtain consensus for the above findings. Conflicts of interest: No conflicts of interest. Sources of funding: Biomechanics and Bioengineering Research Centre Versus Arthritis, Cardiff University, UK

Purpose. To establish if the subjective features of both bilateral leg pain and sexual dysfunction are presenting features in cauda equina syndrome (CES). Background. There appears to be conflicting expert opinion ‘red flag’ symptoms in the context of CES with many experts basing clinical decisions on the objective clinical findings only. Bilateral radiculopathy has been suggested as a possible sign of suspected CES, although a consensus statement by BASS and SBNS makes no reference to either this or sexual dysfunction. However, bilateral leg pain is included in the NICE clinical knowledge summary and sexual dysfunction is highlighted within CES guidance by the American Association of Neurological Surgeons. Methods. The clinical documentation of patients undergoing urgent magnetic resonance imaging (MR) due to clinical suspicion of cauda equina syndrome (CES) was reviewed over 12 months. Patients questioned regarding sexual function were included in this retrospective analysis (n=179), along with those with bilateral leg pain (n=294). Patients with confirmed cauda equina compression (CES +ve) were compared to those without (CES -ve). A logistic regression was applied to find the odds ratio. Results. In CES +ve 37.5% had sexual dysfunction, 48% had bilateral leg pain. CES –ve 14% had sexual dysfunction, 27% bilateral leg pain. Both significant to p=0.015 with an odds ratio of 3.6 and 2.5 respectively. Conclusions. Both sexual dysfunction and bilateral leg pain do appear to be ‘red flags’ for CES and should therefore be asked in the ED to aid clinical reasoning when suspecting this diagnosis. No conflicts of interest. No funding obtained

Aims

The aim of this study was to determine whether early surgical treatment results in better neurological recovery 12 months after injury than late surgical treatment in patients with acute traumatic spinal cord injury (tSCI).

Aims

To determine whether side-bending films in scoliosis are assessed for adequacy in clinical practice; and to introduce a novel method for doing so.

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.