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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


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_9 | Pages 28 - 28
1 Oct 2022
Newton C Singh G O'Neill S Diver C Booth V Logan P O'Sullivan K O'Sullivan P
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Purposes of the study and background. Cognitive Functional Therapy (CFT) is a complex intervention that targets the biopsychosocial nature of low back pain (LBP). The barriers and facilitators to CFT have not previously been researched in the United Kingdom National Health Service (NHS). This study aimed to explore the barriers and facilitators of CFT in the NHS ahead of a future clinical trial. Methods and results. Participants who had completed a CFT intervention for persistent LBP and physiotherapists who had previously attended a CFT training workshop were recruited. Data were collected using one to one semi-structured interviews and were analysed thematically using framework method. Eight people with LBP and ten physiotherapists consented to participate. The key findings were that UK NHS physiotherapists can be trained to deliver CFT, they valued the training and felt confident to deliver CFT successfully to patients in NHS physiotherapy departments. Peer support and mentorship from a CFT practitioner was necessary for the physiotherapists to sustain changes to their clinical practice. Participants with LBP welcomed CFT as they felt it was beneficial and enabled them to self-manage their LBP and they could recognise the difference between CFT and usual care. The barriers, mainly related to the healthcare system, included short appointment times and poor availability of follow-up appointments. Conclusion. This is the first study to establish the barriers and facilitators to the implementation of CFT in the NHS. The findings of this study were used to inform the planning, design and delivery of a feasibility randomised controlled trial. Conflicts of interest: No conflicts of interest. Sources of funding: No funding obtained


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_9 | Pages 20 - 20
1 Oct 2022
Newton C Singh G O'Neill S Diver C Booth V Logan P O'Sullivan K O'Sullivan P
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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


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_9 | Pages 25 - 25
1 Oct 2022
Geraghty A Roberts L Hill J Foster N Stuart B Yardley L Hay E Turner D Griffiths G Webley F Durcan L Morgan A Hughes S Bathers S Butler-Walley S Wathall S Mansell G Leigh L Little P
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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


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_15 | Pages 19 - 19
7 Aug 2024
Foster NE Bada E Window P Stovell M Ahuja S Beard D Gardner A
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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)


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_9 | Pages 14 - 14
1 Oct 2022
Williamson E Boniface G Marian I Dutton S Maredza M Petrou S Garrett A Morris A Hansen Z Ward L Nicolson P Barker K Fairbank J Fitch J Rogers D Comer C French D Mallen C Lamb S
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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


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_I | Pages 48 - 48
1 Jan 2012
Stochkendahl MJ Christensen HW Vach W H⊘ilund-Carlsen PF Haghfelt T Hartvigsen J
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Background and purpose. The musculoskeletal system is a common, but often overlooked, cause of chest pain. Little is known about the efficacy of spinal manipulation for this condition. The purpose of the present study is to evaluate the relative effectiveness of two conservative treatment approaches for acute musculoskeletal chest pain, 1) a spinal manipulation-based therapy as a typical example of chiropractic treatment and 2) self-management as an example of minimal intervention. Methods and results. In a non-blinded, randomised controlled trial set at an emergency cardiology department and four outpatient chiropractic clinics, 115 consecutive patients with acute chest pain and no clear medical diagnosis at initial presentation were included. After a baseline evaluation, patients with musculoskeletal chest pain were randomized to four weeks of chiropractic treatment or self-management, with post-treatment questionnaire follow-up four and 12 weeks later. Primary outcome measures were numeric change in pain intensity (11-point box numerical rating scale) and self-perceived change in pain (7-point ordinal scale). Secondary measures included Medical Outcomes Study Short Form 36 (SF-36) scores, change in pain intensity (chest, thoracic spine, neck and shoulder/arm), and self-perceived change in general health. Preliminary results will be available at the time of presentation. Conclusions. This is the first randomised controlled trial assessing chiropractic treatment versus a minimal intervention in patients with musculoskeletal chest pain. Results will indicate whether chiropractic treatment is a useful option for patients with musculoskeletal chest pain, but the design does not allow for standardisation of treatment or identification of potentially active ingredients of care


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_10 | Pages 39 - 39
1 Oct 2019
Schmidt A Foster N Laurberg T Schi⊘ttz-Christensen B Maribo T
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Purpose of the study and background. An integrated rehabilitation programme was developed and found feasible taking into account the existing evidence base, appropriate theories, and patient and public involvement. The integrated programme encompasses inpatient activities supported by a multidisciplinary team, and integration of knowledge, skills and behaviours in the patient's everyday life. The aim of this trial was to compare the effectiveness of an integrated rehabilitation programme with an existing rehabilitation programme in patients with chronic low back pain (CLBP). Methods and Results. Comparison of two parallel rehabilitation programmes in a randomised controlled trial including 165 patients with CLBP. The integrated rehabilitation programme comprised an alternation of in total three weeks of inpatient stay and in total 11 weeks of home-based activities. The existing rehabilitation programme comprised a four-week inpatient stay. Primary outcome was changes in disability (Oswestry Disability Index). Secondary outcomes were changes in pain, pain self-efficacy, health related quality of life and depression. Outcomes were collected at baseline and 26-week follow-up. Disability decreased −5.76 (95%CI; −8.31, −3.20) for the integrated programme and −5.64 (95%CI; −8.45, −2.83) for the existing programme. The adjusted difference between the two programmes was −0.28 (95%CI; −4.02, 3.45). No statistically significant difference was found in any of the secondary outcomes. Conclusion. The results of the trial were consistent, showing no significant differences in patients' outcomes when comparing an integrated rehabilitation programme with an existing programme. Conflicts of interest: None. Sources of funding: Aarhus University, The Danish Rheumatism Association and Familien Hede Nielsens Fond


The Journal of Bone & Joint Surgery British Volume
Vol. 94-B, Issue 2 | Pages 152 - 157
1 Feb 2012
Longo UG Loppini M Denaro L Maffulli N Denaro V

Osteoporotic vertebral compression fractures (VCFs) are an increasing public health problem. Recently, randomised controlled trials on the use of kyphoplasty and vertebroplasty in the treatment of these fractures have been published, but no definitive conclusions have been reached on the role of these interventions. The major problem encountered when trying to perform a meta-analysis of the available studies for the use of cementoplasty in patients with a VCF is that conservative management has not been standardised. Forms of conservative treatment commonly used in these patients include bed rest, analgesic medication, physiotherapy and bracing. . In this review, we report the best evidence available on the conservative care of patients with osteoporotic VCFs and associated back pain, focusing on the role of the most commonly used spinal orthoses. Although orthoses are used for the management of these patients, to date, there has been only one randomised controlled trial published evaluating their value. Until the best conservative management for patients with VCFs is defined and standardised, no conclusions can be drawn on the superiority or otherwise of cementoplasty techniques over conservative management


The Journal of Bone & Joint Surgery British Volume
Vol. 93-B, Issue 9 | Pages 1149 - 1153
1 Sep 2011
Muijs SPJ van Erkel AR Dijkstra PDS

Vertebral compression fractures are the most prevalent complication of osteoporosis and percutaneous vertebroplasty (PVP) has emerged as a promising addition to the methods of treating the debilitating pain they may cause. Since PVP was first reported in the literature in 1987, more than 600 clinical papers have been published on the subject. Most report excellent improvements in pain relief and quality of life. However, these papers have been based mostly on uncontrolled cohort studies with a wide variety of inclusion and exclusion criteria. In 2009, two high-profile randomised controlled trials were published in the New England Journal of Medicine which led care providers throughout the world to question the value of PVP. After more than two decades a number of important questions about the mechanism and the effectiveness of this procedure remain unanswered


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_10 | Pages 34 - 34
1 Oct 2019
Wood L Foster N Lewis M Bishop A
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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


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_9 | Pages 12 - 12
1 Sep 2019
Wood L Foster N Lewis M Bishop A
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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


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_10 | Pages 19 - 19
1 Oct 2019
Hill J Tooth S Cooper V Chen Y Lewis M Wathall S Saunders B Bartlam B Protheroe J Chudyk A Dunn K Foster N
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Background and aims. The Keele STarT Back approach is effective for stratifying patients with low back pain in primary care, but a similar approach has not been tested with a broader range of patients with musculoskeletal (MSK) pain. We report a feasibility and pilot trial examining the feasibility of a future main trial of a primary care based, risk-stratification (STarT MSK) approach for patients with back, neck, knee, shoulder or multi-site pain. Methods. A pragmatic, two-parallel arm, cluster randomised controlled trial (RCT) in 8 GP practices (4 stratified care involving use of the Keele STarT MSK tool and matched treatment options: 4 usual care). Following screening, adults with one of the five most common MSK pain presentations were invited to take part in data collection over 6 months. Feasibility outcomes included exploration of selection bias, recruitment and follow-up rates, clinician engagement with using the Keele STarT MSK tool and matching patients to treatments. Results. 524 participants (231-stratified care, 293-usual care) were recruited (target n=500) over 7 months (target 3 months), with 15-withdrawals (5-intervention, 10-controls). Minimal selection bias was identified between participants/non-participants, or trial arms. The pain-intensity follow-up rate was 88%. Clinicians used the STarT MSK tool in 41% of relevant consultations (judged as ‘partial success’) and adhered to recommended matched treatments in 69% of cases (judged as ‘success’). Conclusions. A future main RCT is feasible, with some amendments in the wording of the tool and the matched treatment options, to determine the clinical and cost-effectiveness of stratified care versus usual care for patients with MSK pain. Conflicts of interest: ‘No conflicts of interest’. Sources of Funding: This paper presents independent research funded by the National Institute for Health Research (NIHR) under its Programme Grants for Applied Research scheme (grant number: RP-PG-1211-20010). Nadine Foster is a NIHR Senior Investigator and was supported through an NIHR Research Professorship (NIHR-RP-011-015). The views expressed in this publication are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_9 | Pages 21 - 21
1 Sep 2019
Saunders B Bartlam B Artus M Foster N Konstantinou K
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Background. Sciatica is common and associated with significant impacts for the individual, health care and society. The SCOPiC randomised controlled trial (RCT) is investigating whether stratified primary care for sciatica is more effective and cost-effective than usual, non-stratified primary care. Stratified care involves subgrouping patients to one of three groups based on a combination of prognostic and clinical indicators. Patients in one of these groups are ‘fast-tracked’ with an MRI scan to spinal specialist opinion. Our aim was to understand the perspectives of clinicians on the acceptability of this ‘fast-track’ pathway. Methods. Qualitative, semi-structured interviews were conducted with general practitioners, spinal specialist physiotherapists and spinal surgeons (n=20 in total). Interviews were fully transcribed, and data were analysed using the constant comparison method. Results. Across all groups, clinicians identified potential added value in ‘fast-tracking’ some sciatica patients in terms of patient reassurance based on MRI scan findings. Whilst spinal physiotherapists felt that most ‘fast track’ patients were appropriate, some spinal physiotherapists and GPs had concerns that patients with symptom durations of less than 6 weeks might be inappropriately fast-tracked since their symptoms may still resolve without the need for invasive treatments. Spinal surgeons felt it was acceptable for patients with short symptom durations to be ‘fast-tracked’, but to provide early reassurance rather than direct treatment. Conclusion. Whilst clinicians saw added value in a group of sciatica patients being ‘fast-tracked’ to specialist opinion, there was some reservation about moving away from the usual stepped care, ‘wait and see’ approach for patients with short symptom duration. Conflicts of interest statement. No conflicts of interest. Sources of funding. This study is funded by the National Institute for Health Research Health Technology Assessment Programme (NIHR HTA project number 12/201/09) and will be published in full in Health Technology Assessment. Funding support is also received from an NIHR Research Professorship for Nadine Foster (NIHR-RP-011-015), who is an NIHR Senior Investigator, and a HEFCE Senior Clinical Lecturer award for Kika Konstantinou. The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the HTA programme, NIHR, NHS or the Department of Health and Social Care. The study was approved by the NRES Committee West Midlands – Solihull, 17/03/2015, ref: 15/WM/0078. Trial registration: ISRCTN75449581


The Bone & Joint Journal
Vol. 97-B, Issue 7 | Pages 973 - 981
1 Jul 2015
Fong DYT Cheung KMC Wong YW Cheung WY Fu ICY Kuong EE Mak KC To M Samartzis D Luk KDK

Randomised controlled trials (RCTs) that assessed the efficacy of bracing for adolescent idiopathic scoliosis have suffered from small sample sizes, low compliance and lack of willingness to participate. The aim of this study was to assess the feasibility of a comprehensive cohort study for evaluating both the efficacy and the effectiveness of bracing in patients with adolescent idiopathic scoliosis. Patients with curves at greater risk of progression were invited to join a randomised controlled trial. Those who declined were given the option to remain in the study and to choose whether they wished to be braced or observed. Of 87 eligible patients (5 boys and 63 girls) identified over one year, 68 (78%) with mean age of 12.5 years (10 to 15) consented to participate, with a mean follow-up of 168 weeks (0 to 290). Of these, 19 (28%) accepted randomisation. Of those who declined randomisation, 18 (37%) chose a brace. Patients who were more satisfied with their image were more likely to choose bracing (Odds Ratio 4.1; 95% confidence interval 1.1 to 15.0; p = 0.035). This comprehensive cohort study design facilitates the assessment of both efficacy and effectiveness of bracing in patients with adolescent idiopathic scoliosis, which is not feasible in a conventional randomised controlled trial. Cite this article: Bone Joint J 2015; 97-B:973–81


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_2 | Pages 31 - 31
1 Feb 2018
Snidvongs S Taylor R Ahmad A Thomson S Sharma M Fitzsimmons D Poulton S Mehta V Langford R
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Purposes of the study and background. Pain of lumbar facet-joint origin is a common cause of low back pain in adults, and may lead to chronic pain and disability. At present, there is no definitive research to support the use of targeted lumbar facet-joint injections to manage this pain. The study's objective was to assess the feasibility of carrying out a definitive study to evaluate the clinical- and cost-effectiveness of lumbar facet-joint injections compared to a sham procedure. Summary of methods and results. This was a blinded parallel two-arm pilot randomised controlled trial. Adult patients referred to the pain and orthopaedic clinics at Barts Health NHS Trust with non-specific low back pain of at least three months' duration were considered for inclusion. Participants who had a positive result following diagnostic single medial branch nerve blocks were randomised to receive either intra-articular lumbar facet-joint injections with steroid or a sham procedure. All participants were invited to attend a combined physical and psychological programme. Questionnaires were used to assess a range of pain and disability-related issues. Healthcare utilisation and cost data were also assessed. Of 628 participants screened for eligibility, 9 were randomised to receive the study intervention and 8 participants completed the study. Conclusions. Due to the small numbers of participants recruited to the study, we were unable to draw any conclusions on the effectiveness of intra-articular lumbar facet-joint injections in the management of non-specific low back pain. We however demonstrated our ability to develop a robust study protocol and deliver the intended interventions safely, thus addressing many of the feasibility objectives. Stronger collaborations with primary care may improve the recruitment of patients earlier in their pain trajectory, suitable for inclusion in a future trial. Conflicts of interest: None. Sources of funding: National Institute for Health Research Health Technology Assessment programme grant (reference number 11/31/02)


The Journal of Bone & Joint Surgery British Volume
Vol. 87-B, Issue 3 | Pages 352 - 355
1 Mar 2005
Wilson-MacDonald J Burt G Griffin D Glynn C

We have assessed whether an epidural steroid injection is effective in the treatment of symptoms due to compression of a nerve root in the lumbar spine by carrying out a prospective, randomised, controlled trial in which patients received either an epidural steroid injection or an intramuscular injection of local anaesthetic and steroid. We assessed a total of 93 patients according to the Oxford pain chart and the Oswestry disability index and followed up for a minimum of two years. All the patients had been categorised as potential candidates for surgery. There was a significant reduction in pain early on in those having an epidural steroid injection but no difference in the long term between the two groups. The rate of subsequent operation in the groups was similar


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_10 | Pages 7 - 7
1 May 2017
Woodman J Ballard K Glover L
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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


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_10 | Pages 8 - 8
1 May 2017
Draper-Rodi J Vogel S Bishop A
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A statement of the purposes of the study and background. The biopsychosocial (BPS) model is recommended for managing non-specific low back pain (NSLBP) but the best method for teaching the BPS model is unclear. E-learning is a promising alternative to face-to-face methods. This study was a pilot randomised controlled trial (RCT) with embedded interview study to investigate the feasibility of conducting a main RCT and to explore the impact of an BPS for NSLBP e-learning programme on experienced practitioners' attitudes to back pain. A summary of the methods used and the results. Mixed methods evaluated the impact of an evidence-based e-learning programme on participants' attitudes to back pain. A pilot RCT assessed 45 experienced osteopaths' attitudes before and after the intervention, using the Pain Attitudes and Beliefs Scale (PABS) and the Attitudes to Back Pain Scale (ABS). The qualitative study explored 9 participants' views on the e-learning programme and possible impact on their clinical practice. 91% of participants completed the course and the overall satisfaction was very high. Participants' views on the BPS model ranged between not being structural enough, already done and transformative. The e-learning programme was well accepted. It would be feasible to run a main study using the same recruitment procedures, eligibility criteria, randomisation procedure, consent process, data collection and outcome measures. Conclusion. E-learning is an appropriate tool to deliver CPD to experienced manual therapists. Although a pilot study, the results suggest a shift in practitioners' attitudes towards a more BPS view of back pain. A main trial should be undertaken to test the effectiveness of the intervention. No conflicts of interest. Funding acknowledgements: This research is part of Jerry Draper-Rodi's Professional Doctorate in Osteopathy, partly funded by the British School of Osteopathy


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_10 | Pages 3 - 3
1 May 2017
Wynne-Jones G Artus M Bishop A Lawton S Lewis M Main C Sowden G Wathall S Burton A van der Windt D Hay E
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Introduction. Early intervention is advocated to prevent long-term work absence due to musculoskeletal (MSK) pain. The SWAP trial tested whether adding a vocational advice (VA) service to best current care led to fewer days work absence over 4 months. Methods. The SWAP trial was a cluster randomised controlled trial in 6 general practices, 3 randomised to best current care (control), 3 randomised to best current care and the VA service (intervention). Patients were ≥18 years, absent from work ≤6 months or struggling at work due to MSK pain. Primary outcome was number of days absent over 4 months. Exploratory subgroup analyses examined whether the effect was larger for patients with spinal pain compared to other MSK pain. Results. 338 participants (158 intervention, 180 control) were recruited with 79% followed-up at 4 months. Participants in the intervention arm had significantly fewer days absent over 4 months (mean 9.3 days, SD 21.7) compared with control (mean 14.4 days, SD 27.7); adjusted incidence rate ratio (IRR) 0.51 (0.26, 0.99), p=0.048. This difference was largely due to fewer GP certified absent days (8.4 days versus 13.5 days). At 12 months the effect of the VA service was significantly greater in those with spinal pain compared to patients with other MSK problems (IRR. interaction. : 0.25 (95% Confidence Interval 0.10, 0.62) (p . interaction. =0.003). Conclusions. Adding a VA service to best current primary care for MSK pain leads to significantly fewer days absent from work over 4 months, with exploratory analysis indicating the VA service is particularly effective for patients with spinal pain. No conflicts of interest. This paper presents independent research funded by the National Institute for Health Research (NIHR), under its Programme Grants for Applied Research funding scheme: “Optimal management of spinal pain and sciatica in primary care” (NIHR-RP-PG-0707-10131). NEF and AB are funded by an NIHR Research Professorship (NIHR-RP-011-015). NEF and EMH are NIHR Senior Investigators. GW-J is funded by an NIHR Post-Doctoral Fellowship (PDF-2009-02-54). The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health