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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. 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 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 37 - 37
7 Aug 2024
Wilson M Cole A Hewson D Hind D Hawksworth O Hyslop M Keetharuth A Macfarlane A Martin B McLeod G Rombach I Swaby L Tripathi S Wilby M
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Background. Over 55,000 spinal operations are performed annually in the NHS. Effective postoperative analgesia facilitates early mobilisation and assists rehabilitation and hospital discharge, but is difficult to achieve with conventional, opioid-based, oral analgesia. The clinical and cost-effectiveness of two alternative techniques, namely intrathecal opioid and the more novel erector-spinae plane blockade, is unknown. The Pain Relief After Instrumented Spinal Surgery (PRAISE) trial aims to evaluate these techniques. Methods. PRAISE is a multicentre, prospective, parallel group, patient-blinded, randomised trial, seeking to recruit 456 adult participants undergoing elective, posterior lumbar-instrumented spinal surgery from up to 25 NHS hospitals. Participants will be randomised 1:1:1 to receive (1) Usual Care with local wound infiltration, (2) Intrathecal Opioid plus Usual Care with local wound infiltration or (3) Erector Spinae Plane blockade plus Usual Care with no local wound infiltration. The primary outcome is pain on movement on a 100mm visual analogue scale at 24 hours post-surgery. Secondary outcomes include pain at rest, leg pain, quality of recovery (QoR-15), postoperative opioid consumption, time to mobilisation, length of hospital stay, health utility (EQ-5D-5L), adverse events and resource use. Parallel economic evaluation will estimate incremental cost-effectiveness ratios. Results. Differences in the primary outcome at 24 hours will be estimated by mixed-effects linear regression modelling, with fixed effects for randomisation factors and other important prognostic variables, and random effects for centre, using the as-randomised population. Treatment effects with 95% confidence intervals will be presented. Conclusion. The study is due to open in May 2024 and complete in 2026. Conflicts of Interest. No conflicts of interest declared. Sources of Funding. NIHR Health Technology Award – grant number NIHR153170. Trial presentations so far. APOMP 2023 and 2024; RCOA conference, York, November 2023; Faculty of Pain Management training day, London, February 2024


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. 106-B, Issue SUPP_15 | Pages 30 - 30
7 Aug 2024
Preece S Smith J Brookes N Ghio D
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Purpose. Cognitive Muscular Therapy (CMT) is a new treatment for low back pain which integrates psychological techniques for pain management alongside training to improve postural control. Rather than focus on postural alignment or strength, CMT aims to improve the regulation of postural tone (low-level activity which supports the body against gravity). This is achieved by teaching patients an awareness of compensatory paraspinal activation, which can be triggered by overactivity of the abdominal muscles. The aim of this study was to understand whether CMT could reduce symptoms associated with low back pain and improve paraspinal muscle activation. Methods and results. Fifteen patients with chronic low back pain received seven weekly sessions of CMT from a physiotherapist. Clinical data was captured at baseline and two weeks after the intervention using the Roland-Morris questionnaire and the pain catastrophising scale. Activation of the erector spinae muscle during walking was also measured at baseline and after the final intervention session. Change data were analysed using paired t-tests. There was a 75% reduction (p<0.001) in the Roland-Morris score from a mean (SD) of 9.3(2.9) to 2.3(2.6), along with a 78% reduction in pain catastrophising (p<0.002) from 16.6(13) to 3.7(4.8). Activation of the contralateral erector spinae muscles reduced by 30% (p<0.01) during the contralateral swing phase of walking. Conclusion. In this small sample, CMT delivered large clinical improvements and reduced activation of the low back muscles during walking. Larger randomised trials are now required to confirm whether CMT could outperform existing physiotherapy treatments for chronic back pain. Conflict of interest. No conflicts of interest. Source of funding. University of Salford


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. 106-B, Issue SUPP_15 | Pages 34 - 34
7 Aug 2024
Alghamdi MN Sparkes V Khot S Davies J
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Background. Embodiment- and distraction-based approaches to immersive virtual reality (IVR) show promise in treating persistent low back pain (PLBP). However, which approach is more effective is unclear. This study aims to evaluate the impact of distraction- and embodiment-based IVR on pain processing and patient-reported outcome measures in PLBP. Method. Individuals with PLBP were randomised to receive eight sessions of either distraction- or embodiment-based IVR over two weeks. Outcome measures were evaluated at baseline and after the eighth session. Pain processing was evaluated using conditioned pain modulation (CPM) and temporal summation (TS). Results. Three participants (n=2 embodiment, n=1 distraction) have completed all eight IVR sessions. Preliminary results indicate a decrease from pre to post-intervention in Numerical Pain Rating Scale score (pre: 5/10, 6/10, 5/10; post: 2/10, 5/10, 2/10) and Pain Catastrophising Scale score (pre: 34/52, 11/52, 38/52; post: 11/52, 8/52, 12/52), with no clear trend in other self-reported measures (Hospital Anxiety and Depression scale, Oswestry low back disability questionnaire, fear-avoidance beliefs questionnaire, Tampa scale of kinesiophobia). Preliminary results suggest a potential increase in NPRS absolute values from pre- to post-intervention in CPM (pre: -2.7, -2.3, -2.0; post: -3.3, -2.0, -4.3) and TS (pre-1.2, 2.5, 2.4; post: 1.4, 2.5, 3.1). Conclusion. Eight sessions of IVR may reduce pain severity and pain catastrophising in people with PLBP and may increase the efficacy of endogenous pain modulatory systems. Data collection is ongoing to compare the effect of distraction- and embodiment-based IVR. Conflicts of Interest. There are no conflicts of interest. Sources of Funding. This project is funded by the Saudi Arabia Cultural Bureau


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_15 | Pages 4 - 4
7 Aug 2024
Draper-Rodi J Abbey H Brownhill K Vogel S
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Purpose and Background. Guidelines recommend biopsychosocial care for chronic, complex musculoskeletal conditions, including non-specific low back pain. The aims were: 1/ to assess how patients with low back pain respond to osteopathic treatment, both before and after an osteopath has completed a Biopsychosocial Pain Management (BPM) course; and 2/ to assess if it is feasible and acceptable for osteopath participants to receive weekly SCED data and use it to guide patient management. Methods and Results. A multiple baseline single case experimental design trial (. clinicaltrials.gov. , on 18/10/2021, ID number NCT05120921) with 11 UK osteopaths was conducted. Patients were randomised to early, middle or late treatment start dates. Statistical analysis assessed the change between baseline, intervention and follow-up periods. Primary outcomes were the Numeric Pain Rating (NPR) and Patient Specific Function Scales (PSFS), measured during the baseline, the 6-week intervention, and during a 12-week follow-up period. At baseline, the osteopaths reported stronger biopsychosocial attitudes to pain, compared to biomedical beliefs (PABS: 34 behavioural scale; 29 biomedical scale). Overall, patient participants showed daily increases in symptoms during the pre-treatment phase (+0.24/day, p<0.001), and daily decreases during treatment (−2.94 over the treatment phase, p<0.001), which continued post-treatment (−3.36 over 12 weeks, p=0.04). Similar improvements were observed for function. Conclusion. Osteopathic care was shown to help patients with persistent low back pain. Patient recruitment was challenging because of the randomisation. With further development, the method shows feasibility as a means of enhancing research activity among practising clinicians. Previous presentations or publications of the work. The protocol was published (. https://doi.org/10.1016/j.ijosm.2023.100660. ) and presented at SBPR in 2022. The results were presented to an osteopathic conference in October 2023. Ethics approval was received from the University College of Osteopathy Research Ethics Committee. Conflicts of interests. Jerry Draper-Rodi receives fees from the sales of the e-learning course on the biopsychosocial management on the UCO CPD platform. Sources of funding. The research was funded by the Osteopathic Foundation


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


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


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


The Bone & Joint Journal
Vol. 98-B, Issue 3 | Pages 395 - 401
1 Mar 2016
Helenius I Keskinen H Syvänen J Lukkarinen H Mattila M Välipakka J Pajulo O

Aims. In a multicentre, randomised study of adolescents undergoing posterior spinal fusion for idiopathic scoliosis, we investigated the effect of adding gelatine matrix with human thrombin to the standard surgical methods of controlling blood loss. Patients and Methods. Patients in the intervention group (n = 30) were randomised to receive a minimum of two and a maximum of four units of gelatine matrix with thrombin in addition to conventional surgical methods of achieving haemostasis. Only conventional surgical methods were used in the control group (n = 30). We measured the intra-operative and total blood loss (intra-operative blood loss plus post-operative drain output). Results. Each additional hour of operating time increased the intra-operative blood loss by 356.9 ml (p < 0.001) and the total blood loss by 430.5 ml (p < 0.001). Multiple linear regression analysis showed that the intervention significantly decreased the intra-operative (-171 ml, p = 0.025) and total blood loss (-177 ml, p = 0.027). The decrease in haemoglobin concentration from the day before the operation to the second post-operative day was significantly smaller in the intervention group (-6 g/l, p = 0.013) than in the control group. . Conclusion. The addition of gelatine matrix with human thrombin to conventional methods of achieving haemostasis reduces both the intra-operative blood loss and the decrease in haemoglobin concentration post-operatively in adolescents undergoing posterior spinal fusion for idiopathic scoliosis. Take home message: A randomised clinical trial showed that gelatine matrix with human thrombin decreases intra-operative blood loss by 30% when added to traditional surgical haemostatic methods in adolescents undergoing posterior spinal fusion for idiopathic scoliosis. Cite this article: Bone Joint J 2016;98-B:395–401


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_9 | Pages 17 - 17
1 Sep 2019
Reddington M Walters S Cohen J Baxter S Cole A
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Purpose of the study. To investigate the feasibility of undertaking a definitive Randomised Controlled Trial (RCT) to determine the effectiveness of early physiotherapy for sciatica. Methods. Patients over 18 presenting to their G.P with sciatica were eligible to participate in the study, those without a clear understanding of English or had co-morbidities preventing rehabilitation were ineligible. Process and patient reported outcomes including self-rated disability, pain and general health, were collected at baseline, 6,12 and 26 weeks post randomisation. Participants were randomised into either early physiotherapy, receiving treatment within 2 weeks after randomisation or usual care with physiotherapy commencing 6 weeks post randomisation. Both groups received up to 6 treatment sessions of a patient-centred, goal orientated physiotherapy programme specific to their needs. Results. 80 participants were recruited in 10 G.P practices over 34 weeks and randomised to either early physiotherapy (n= 42) or usual care (n=38). Follow-up rates at 26 weeks were 36 (86%) in the early intervention physiotherapy group and 32 (84%) in the usual care. All feasibility objectives were achieved. The mean area under the curve for the Oswestry Disability Index (ODI) over the 26 weeks was and 16.0 (SD 14.0) in the early physiotherapy group and 16.6 (SD 11.4) in the usual care group. A difference of −0.6 (95% CI: −0.68 to 5.6) in favour of the intervention group. Conclusion. The results of the study suggest a full RCT is feasible and will provide evidence as to the optimal timing of physiotherapy for patients with sciatica. No conflicts of interest for any authors. Sources of funding: MR is the recipient of a HEE/NIHR Clinical Doctoral Research Fellowship, which funded the study


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)


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


The Bone & Joint Journal
Vol. 99-B, Issue 8 | Pages 1003 - 1005
1 Aug 2017
Todd NV

The National Institute for Health and Care Excellence has issued guidelines that state fusion for non-specific low back pain should only be performed as part of a randomised controlled trial, and that lumbar disc replacement should not be performed. Thus, spinal fusion and disc replacement will no longer be routine forms of treatment for patients with low back pain. This annotation considers the evidence upon which these guidelines are based. Cite this article: Bone Joint J 2017;99-B:1003–1005


The Bone & Joint Journal
Vol. 99-B, Issue 10 | Pages 1366 - 1372
1 Oct 2017
Rickert M Fleege C Tarhan T Schreiner S Makowski MR Rauschmann M Arabmotlagh M

Aims. We compared the clinical and radiological outcomes of using a polyetheretherketone cage with (TiPEEK) and without a titanium coating (PEEK) for instrumented transforaminal lumbar interbody fusion (TLIF). Materials and Methods. We conducted a randomised clinical pilot trial of 40 patients who were scheduled to undergo a TLIF procedure at one or two levels between L2 and L5. The Oswestry disability index (ODI), EuroQoL-5D, and back and leg pain were determined pre-operatively, and at three, six, and 12 months post-operatively. Fusion rates were assessed by thin slice CT at three months and by functional radiography at 12 months. Results. At final follow-up, one patient in each group had been lost to follow-up. Two patients in each of the PEEK and TiPEEK groups were revised for pseudarthrosis (p = 1.00). The rate of complete or partial fusion at three months was 91.7% in both groups. Overall, there were no significant differences in ODI or in radiological outcomes between the groups. Conclusion. Favourable results with identical clinical outcomes and a high rate of fusion was seen in both groups. The titanium coating appears to have no negative effects on outcome or safety in the short term. A future study to determine the effect of titanium coating is warranted. Cite this article: Bone Joint J 2017;99-B:1366–72


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


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_9 | Pages 57 - 57
1 Sep 2019
Astek A van Deursen R Sparkes V
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Purpose & Background. Back and lower limb injuries are prevalent in athletes who perform novel weight-lifting techniques with inappropriate kinematics. Visual-auditory instructions and knowledge of performance (KP) verbal instructions are utilised to help novices execute novel skills. Effectiveness of these methods on executing appropriate front-squat lifting kinematics is limited. Aim: to investigate the effects of visual-auditory instructions compared to KP verbal instructions on front-squat kinematics at sticking point in novice lifters, with improvement determined by proximity to the kinematics of an expert lifter at sticking point when performing optimal front-squat lift. Methods. Twenty-four novices were randomised into two groups and performed front-squat lift. The novices in visual-auditory group (n = 12, age = 24.33 ± 2.93 years) received videoaudio instructions, verbal group (n = 12, Age= 22.66 ± 2.34 years) received KP verbal instructions. MATLAB software measured kinematic lumbar angles, Kinovea software measured hip, knee, ankle angles at sticking point of front-squat. Data were collected from video recordings of novices and an expert pre-and post-instructions in one session and expert data were used as reference values of proximity for both groups. Results. No significant differences were found between groups in lumbar, hip, knee, and ankle angles at sticking point of front-squat lift, where improvement was determined by proximity to expert lifter's angles. There was significant improvement with in lumbar angle of both groups and hip angle (verbal group). Conclusion. Visual-auditory instructions and verbal instructions have similar effects on the front-squat kinematics (lumbar spine, hip knee and ankle) of novice lifters. No Conflict of Interests. No funding was obtained