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 A draft guidance document included 63 consensus items (≥80% agreement) and was discussed with patient partners. Finally, the draft guidance and results from stakeholder interviews were discussed at consensus meetings with Delphi participants and patient representatives.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

Purpose of the study and background. The biopsychosocial (BPS) model is now widely implemented in clinical practice. Most research on manual therapists' attitudes regarding psychosocial (PS) factors and NSLBP is from the physiotherapy profession. There is currently no literature available to understand how osteopaths integrate those factors with patients presenting with NSLBP. The University College of Osteopathy students being the future of the profession and receiving an accredited BPS teaching warranted the need for an investigation about their attitudes towards PS factors and NSLBP. Methods and results. A qualitative research design with elements of grounded theory was used. Nine final year UCO students were recruited and interviewed at the UCO teaching centre. Data collection and analysis occurred simultaneously through the constant comparative method of analysis. Three main themes emerged from the data analysis: 1) Definition and interpretation of PS factors towards LBP; 2) Assessment and management of PS factors; 3) Competence and difficulties towards PS factors. Conclusion. The level of understanding was homogeneous amongst the participants on the understanding of PS factors and their role in a NSLBP presentation. They assessed for PS factors throughout the case history and tend to rely on their instincts. Two types of strategies towards the PS factors management were identified. However, lack of clinical experience and lack of training on the management of PS factors were identified as the main barriers encountered by students when treating patient with NSLBP. No conflict of interest. No funding

Background. A cornerstone in treating low back pain (LBP) is the provision of information to patients, and the internet is increasingly being used as a source of health information delivery. However, the effect of and satisfaction with online information have been questioned. Purpose. To develop a multi-item instrument to measure an index score of satisfaction with online information for patients with LBP. Methods. The conceptualization of this patient reported outcome is modelled on the assumption of a formative model. The first draft of the questionnaire was developed based on a previous published interview study of 15 patients and evaluated for face validity by seven experts. The second draft of the questionnaire was pilot-tested in 20 patients to optimize content validity. Patients were recruited from a rehabilitation center and from social media. Results. An eight-item questionnaire was developed after assessing content and face validity. The items were related to design, readability, customization, credibility, usability, and coping. A labelled categorical scale was used for response options. Each item is scored from 0–3, where 0 indicates not at all satisfied, 1 indicates little satisfaction, 2 indicates some satisfaction, and 3 indicates very satisfied giving an overall index score between 0 and 24 points. Conclusion. An eight-item questionnaire measuring satisfaction with an index score from 0–24 points has been developed. The OPSI questionnaire is now being tested for construct validity, reproducibility and interpretation on 150 patients with LBP. No conflicts of interest. Sources of funding: Funded by the Novo Nordic Foundation (NNF17OC0024422)

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This systematic review aims to identify 3D predictors derived from biplanar reconstruction, and to describe current methods for improving curve prediction in patients with mild adolescent idiopathic scoliosis.

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To determine the major risk factors for unplanned reoperations (UROs) following corrective surgery for adult spinal deformity (ASD) and their interactions, using machine learning-based prediction algorithms and game theory.

Purposes of the study and background. MRI of the lumbar spine is a clinically important examination in low back pain (LBP) when serious underlying pathology or radiculopathy is suspected or when pain does not improve, e.g. to identify herniated discs. The general population has high confidence in this modality. Little documented knowledge exists about how the MRI results should be communicated to the patients in an optimal way. The aim of this study was to explore the patients' perspectives, i.e. worries, thoughts and interpretations of terms used when health care providers convey the MRI results. Summary of methods used and results. 79 patients with chronic LBP were included in a broader study of consultations at Funen Back Centre by which the results of MRI were conveyed. 43 of these patients were selected for a qualitative study until information saturation was reached. After the clinical consultation, each patient was interviewed using a semi-structured interview guide. The interviews were audio-recorded and fully transcribed. The transcripts were analysed using Giorgi's method as modified by Malterud. There was a broad variation in the patients' worries, thoughts and expectations prior to the consultations. Worries were linked to a diversity of possible causes (or finding no explanation) of the pain as well as consequences for function and treatment. We found a broad spectrum of interpretations of terms used, for instance content and meaning of “wear and tear” or disc herniation. Subjects had a high confidence in the reliability of MRI. Conclusion. The findings may help to improve the communication about MRI results

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Degenerative cervical spondylosis (DCS) is a common musculoskeletal disease that encompasses a wide range of progressive degenerative changes and affects all components of the cervical spine. DCS imposes very large social and economic burdens. However, its genetic basis remains elusive.

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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.

Background and purpose of the study. Uncertainty remains regarding the optimal method of diagnosing sciatica. Clinical guidelines currently recommend that investigations be used only when they are likely to change management. In clinical practice, considerable variation can occur between patient and clinician, regarding the perceived importance of investigations such as MRI scans. The aim of this study was to explore patients' experiences of investigations and to consider the impact of concordance between clinical presentation and investigation findings. Methods and results. In this qualitative study, based on the principles of interpretative phenomenological analysis, 14 participants with a clinical presentation of sciatica of likely nerve root origin, who had recently undergone investigations, were purposively recruited from an NHS, Primary Care Musculoskeletal Service in the UK. Individual, semi-structured interviews were used to collect data, which were audio-recorded and transcribed verbatim. Data were managed using a framework approach and analysed thematically. Although patients reported wanting investigations to understand the cause of symptoms and inform management, access to them was difficult and protracted. When investigations revealed potentially relevant findings, patients experienced relief, validation, empowerment and decisive decision-making. Disappointment emerged, however, regarding treatment waiting times and options, and long-term prognosis. When investigations failed to identify relevant findings, patients were unable to make sense of their symptoms, move forward in their management or relinquish their search to identify the cause. Conclusion. This study provides the first reported in-depth interpretation of patients' experience of undergoing investigations for sciatica. Important policy and practice implications have been identified for investigation referral criteria; shared-decision-making; information sharing; aligning expectations and managing disappointment. No conflicts of interest. This study was funded by an NIHR Masters in Clinical Research Fellowship awarded to CR. LR is funded, in part, by an NIHR Senior Clinical Lecturer award (Round 3)

Mesenchymal stem-cell based therapies have been proposed as novel treatments for intervertebral disc degeneration, a prevalent and disabling condition associated with back pain. The development of these treatment strategies, however, has been hindered by the incomplete understanding of the human nucleus pulposus phenotype and by an inaccurate interpretation and translation of animal to human research. This review summarises recent work characterising the nucleus pulposus phenotype in different animal models and in humans and integrates their findings with the anatomical and physiological differences between these species. Understanding this phenotype is paramount to guarantee that implanted cells restore the native functions of the intervertebral disc. Cite this article: Bone Joint Res 2013;2:169–78

Purpose and Background:. Clinical interpretations of Degenerative Lumbar Disc Disease are not described in the literature. The purpose of this study was to establish a consensus of expert clinical opinion in order to fuel further research. Methods:. A reliable and valid electronic survey was designed to include theoretical constructs relating to training and education, general knowledge, assessment and management practices. Clinicians from the Society of Back Pain Research U.K. were invited to take part. Quantitative data was collated and coded using Bristol on-line survey software, and content analysis was used to systematically code and categorize qualitative data. Results:. Respondents represented a wide range of clinical specialties. The majority graduated in the U.K. (87%), were clinically active and had greater than 9 years postgraduate clinical experience (84%). MRI (36%) and physical assessment (21%) were cited as the most important clinical assessment tools. Reduction in disc height (92%) and disc dehydration (90%) were reported as the most important variables with respect to DLDD diagnosis. The most effective treatment approaches varied from education and reassurance, pain management, cognitive behavioural approaches to core stability training and group activity. Health professionals viewed the future of care advancement in terms of improvements in patient communication (35%) and education (38%). Treatment stratification (24%) and advancing evidence based management practices through research were also regarded as essential (27%). Conclusion:. Spinal clinical experts have clear views on DLDD assessment. In terms of management the results are varied suggesting inconsistency and uncertainty

Purpose and background:. Implementation fidelity (IF) is the extent to which an intervention is implemented as intended by its developers, and increases confidence that changes in study outcomes are due to the effect of the intervention itself and not due to variability in implementation. The aim of this study was to evaluate the IF within a behaviour-change self-management intervention for people with chronic low back pain and/or osteoarthritis, consisting of six weekly sessions (SOLAS ISRCTN49875385). Methods:. In a sample of data, the intervention was delivered by physiotherapists (n=9) in seven sites. IF was assessed using self-report (by physiotherapists) of all sessions (n=60), direct observations (by the research team) of 40% of the sessions (n=24) and audio-recorded observations (by the research team) of all sessions (n=60) using checklists. Data were analysed in SPSSv20 to assess % agreement between methods and fidelity scores. Results:. Agreement between direct observations and audio-recordings was 86.6%, with inter-rater reliability of 84.6% of the audio-recordings. Agreement between the direct observations and self-report was 74.6%. Four sites scored above 80% (‘high’ fidelity) with three scoring between 70 and 80% (‘moderate fidelity’). Four physiotherapists scored between 83–100% with five scoring from 72.5% to 78.8%. There was no significant difference in the fidelity scores across sessions with scores ranging from 74% to 88.8%. Conclusions:. Self-report data may be of limited use for assessing IF, though it may have benefits in terms of enhancing IF. Overall, fidelity levels ranged from moderate to high which will provide valuable information for the interpretation of the trial's clinical effectiveness

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The aims of this study were to determine the diagnostic yield of image-guided biopsy in providing a final diagnosis in patients with suspected infectious spondylodiscitis, to report the diagnostic accuracy of various microbiological tests and histological examinations in these patients, and to report the epidemiology of infectious spondylodiscitis from a country where tuberculosis (TB) is endemic, including the incidence of drug-resistant TB.

Objectives. To investigate the views and experiences of patients with sciatica who have undergone a bespoke physiotherapy programme whilst awaiting primary lumbar microdiscectomy. Methods. This is a qualitative study, nested within a preliminary RCT. All patients were listed for primary, single-level microdiscectomy surgery. In the experimental arm of the study 29 patients had up to 6 sessions of physiotherapy over an 8 week period while on the waiting list for lumbar microdiscectomy. After surgery, they were invited to participate in an in-depth semi-structured interview. At this time patients had either decided not to have the surgery, or had undergone surgery. Interviews were audio-recorded, transcribed, and thematically analysed. Two researchers were involved in the analysis of the data to ensure the interpretation of the findings was robust, credible and trustworhy. Results:. 21 patients were interviewed with 24 patients in the sample undergoing surgery following the physiotherapy. The physiotherapy was found to be of value with patients appreciating exercises to reduce pain and discomfort, techniques for improving properly, interventions to improve gait and posture, hands-on therapy and gym work through an individually tailored treatment approach. Another strong theme was that of perceived delays for scanning and entry into secondary care. Conclusion:. The nested qualitative study provides further evidence as to the experiences and difficulties faced by patients with sciatica. An emergent theme was the difficulty in accessing what patients perceived to be appropriate care. The bespoke, patient-orientated approach was well received by both clinicians and patients and provides opportunities for its wider introduction. This abstract presents independent research funded by the National Institute for Health Research (NIHR) under its Research for Patient Benefit (RfPB) Programme (Grant

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The aim of this study was to assess the reliability of using MRI scans to calculate the Spinal Instability Neoplastic Score (SINS) in patients with metastatic spinal cord compression (MSCC).

Background and purpose. Investigating inter-vertebral biomechanics in vivo using end-of-range imaging is difficult due to high intra subject variation, measurement errors and insufficient data. Quantitative fluoroscopy (QF) can reliably measure continuous motion but may suffer from contamination from uncontrolled loading and muscle contraction which compromises comparisons between studies and limits interpretation of results. This study presents the methods used to overcome these limitations. Methods and results. Forty chronic, non-specific low back pain (CNSLPB) patients and 40 matched controls underwent QF using a passive recumbent protocol which standardised the rate and range of trunk rotation, thus reducing intra-subject variation and excluding loading and muscle contraction factors. Left, right, flexion and extension were recorded from L2-5 and vertebral motion registered using image processing algorithms, Resultant continuous inter-vertebral rotation data were normalised to produce proportional contributions of each segment throughout the trunk bend. The expected continuous proportional contributions at each level and direction were determined by calculating reference intervals (mean +/− 2SD) from controls. Prevalence of patients exceeding these ranges was determined and the association with CNSLBP calculated using Chi-squared analysis. Additionally the variance of the normalised data throughout the continuous motion for each direction was determined and summed to produce an combined number. This was used to measure the difference between patients and controls and entered into ROC curve analysis to investigate discrimination between patients and controls. Conclusion. A methodology for assessment of the differences between the continuous in vivo spine kinematics of CNSLBP patients and healthy controls has been developed and will be presented

Background. Thoracolumbar fractures are the most common spinal injuries resulting from blunt trauma. Missed spinal injuries can have serious consequences. Objective. Our objectives were to determine the utility of trauma series chest and abdomen computed tomographs for detecting clinically unrecognised vertebral fractures and to analyse those missed on clinical examination. The aim was to identify an ‘at-risk’ patient group with negative clinical examination warranting evaluation with CT screening. Material and Methods. We evaluated all computed tomography of the chest and/or abdominal that was undertaken for blunt trauma at our trauma centre from April 2009 to April 2010. Data was gathered from both CT scans and medical notes to capture demographics, mechanism of injury, fracture site and configuration. Key points were the clinical suspicion of vertebral fractures prior to CT request and identifying ‘at-risk’ patient group with factors contributing to difficulty in clinical interpretation. Results. There were a total of 303 patients in the year who underwent CT scan for blunt trauma. 51(16.8%) had a thoracolumbar vertebral fracture. There were 8 women and 43 men a mean age of 45.2 years. There were 29 (56.8%) stable and 22 (43.2%) unstable fractures. Out of the 51 total fracture patients, only 17(33.3%) had been clinically anticipated with a positive clinical examination. In the 22 unstable fractures, only 11 (50%) were expected and had clinically recorded correlating positive examination findings. Conclusion. A combination of both clinical examination and CT screening based on mechanism will likely be required to ensure adequate sensitivity with an acceptable specificity for the diagnosis of clinically significant injuries of the TL spine

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The aim of this study was to identify the risk factors for adverse events following the surgical correction of cervical spinal deformities in adults.

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Spinal deformity surgery carries the risk of neurological injury. Neurophysiological monitoring allows early identification of intraoperative cord injury which enables early intervention resulting in a better prognosis. Although multimodal monitoring is the ideal, resource constraints make surgeon-directed intraoperative transcranial motor evoked potential (TcMEP) monitoring a useful compromise. Our experience using surgeon-directed TcMEP is presented in terms of viability, safety, and efficacy.

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The aim of this study was to determine the differences in spinal imaging characteristics between subjects with or without lumbar developmental spinal stenosis (DSS) in a population-based cohort.