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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


Bone & Joint Open
Vol. 4, Issue 8 | Pages 573 - 579
8 Aug 2023
Beresford-Cleary NJA Silman A Thakar C Gardner A Harding I Cooper C Cook J Rothenfluh DA

Aims. Symptomatic spinal stenosis is a very common problem, and decompression surgery has been shown to be superior to nonoperative treatment in selected patient groups. However, performing an instrumented fusion in addition to decompression may avoid revision and improve outcomes. The aim of the SpInOuT feasibility study was to establish whether a definitive randomized controlled trial (RCT) that accounted for the spectrum of pathology contributing to spinal stenosis, including pelvic incidence-lumbar lordosis (PI-LL) mismatch and mobile spondylolisthesis, could be conducted. Methods. As part of the SpInOuT-F study, a pilot randomized trial was carried out across five NHS hospitals. Patients were randomized to either spinal decompression alone or spinal decompression plus instrumented fusion. Patient-reported outcome measures were collected at baseline and three months. The intended sample size was 60 patients. Results. Of the 90 patients screened, 77 passed the initial screening criteria. A total of 27 patients had a PI-LL mismatch and 23 had a dynamic spondylolisthesis. Following secondary inclusion and exclusion criteria, 31 patients were eligible for the study. Six patients were randomized and one underwent surgery during the study period. Given the low number of patients recruited and randomized, it was not possible to assess completion rates, quality of life, imaging, or health economic outcomes as intended. Conclusion. This study provides a unique insight into the prevalence of dynamic spondylolisthesis and PI-LL mismatch in patients with symptomatic spinal stenosis, and demonstrates that there is a need for a definitive RCT which stratifies for these groups in order to inform surgical decision-making. Nonetheless a definitive study would need further refinement in design and implementation in order to be feasible. Cite this article: Bone Jt Open 2023;4(8):573–579


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_8 | Pages 5 - 5
1 Aug 2022
Wardell D Jayasuriya R Totton N Mills A Breakwell L Cole A
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Thermal sensors have been used in bracing research as self-reported diaries are inaccurate. Little is known about new low-profile sensors, optimal location within a brace, locational thermal micro-climate and effect of brace lining. Our objective is to Determine an optimal temperature threshold for sensor-measured and true wear time agreement. Identify optimal sensor location. Assess all factors to determine the best sensor option for the Bracing AdoleScent Idiopathic Scoliosis (BASIS) multicentre RCT. Seven Orthotimer and five iButton (DS1925L) sensors were synchronised to record temperature at five-minute intervals. Three healthy participants donned a rigid spinal brace, embedded with both sensors across four anatomical locations (abdomen/axilla/lateral-gluteal/sacral). Universal-coordinated-time wear protocols were performed in/out-doors. Intraclass correlation coefficient (ICC) assessed sensor-measured and true wear time agreement at thresholds 15–36oC. Optimal thresholds, determined by largest ICC estimate: Orthotimer: Abdomen=26oC, axilla=27oC, lateral-gluteal=24.5oC, sacral=22.5oC. iButton: Abdomen=26oC, axilla=27oC, lateral-gluteal=23.5oC, sacral=23.5oC. Warm-up time and error at optimal thresholds increased for moulded sensors covered with 6mm lining. Location: anterior abdominal wall. Excellent reliability and higher optimal thresholds, less likely to be exceeded by ambient temperature; not a pressure area. Sensor: iButton, longer battery life and larger memory than Orthotimer; allows recording at 10 min intervals for life of brace. Orthotimer only able to record every 30 mins, increasing error between true and measured wear time; Orthotimer needs 6-monthly data download. Threshold: 26oC is optimal threshold to balance warm-up and cool-down times for accurately measuring wear time. Sensor should not be covered by lining foam as this significantly prolongs warm-up time


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. 101-B, Issue SUPP_9 | Pages 32 - 32
1 Sep 2019
Lemmers G van Lankveld W van der Wees P Westert G Staal J
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Background. Routine imaging (radiography, CT, MRI) provides no health benefits for low back pain (LBP) patients and is not recommended in clinical practice guidelines. Whether imaging leads to increased costs, healthcare utilization or absence from work is unclear. Purpose. To systematically review if imaging in patients with LBP increases costs, leads to higher health care utilization or increases absence from work. METHODS. Randomized controlled trials (RCTs) and observational studies (OSs), comparing imaging versus no imaging on targeted outcomes were extracted from medical databases until October 2017. Data extraction and risk of bias assessment was performed independently by two reviewers. The quality of the body of evidence was determined using GRADE methodology. Results. Moderate quality evidence (1 RCT; n=421) supports that direct costs increase for patients undergoing radiography. Low quality evidence (3 OSs; n=9535) supports that early MRI leads to a large increase in costs. Moderate quality evidence (2 RCTs, 6 OSs; n=19392) supports that performing MRI, radiography or CT is associated with increased healthcare utilization. Two RCTs (n=667) showed no significant differences between radiography or MRI groups compared with no imaging groups on absence from work. However, the results of two observational studies (n=7765) did show significantly greater absence from work in the imaging groups compared to the no imaging-groups. Conclusions. Imaging in LBP is associated with higher medical costs and increased healthcare utilisation. There are indications that it also leads to higher absence from work. No conflicts of interest. No funding obtained


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. 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 25 - 25
1 Oct 2019
Saunders B Hill J Foster N Cooper V Protheroe J Chudyk A Chew-Graham C Campbell P Bartlam B
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Background. Improving primary care management of musculoskeletal (MSK) pain is a priority. A pilot cluster RCT tested prognostic stratified care for patients with common MSK pain presentations, including low back pain, in 8 UK general practices (4 stratified care; 4 usual care) with 524 patients. GPs in stratified care practices were asked to use i) the Keele STarT MSK tool for risk-stratification and ii) matched treatment options for patients at low-, medium- and high-risk of persistent pain. A linked qualitative process evaluation explored patients' and GPs' views and experiences of stratified care. Methods. Individual ‘stimulated-recall’ interviews with patients and GPs in the stratified care arm (n=10 patients; 10 GPs), prompted by consultation-recordings. Data were analysed thematically and mapped onto the COM-B behaviour change model; exploring the Opportunity, Capability and Motivation GPs and patients had to engage with stratified care. Results. Patients reported positive views that stratified care enabled a more ‘structured’ consultation. GPs identified difficulties integrating the STarT MSK tool in their consultation timeframe (Opportunity), but found this easier as it became more familiar. Both groups saw the tool as having added-value, but identified ‘cumbersome’ items which made it more difficult to use (Capability). GPs reported the matched treatment options aided their clinical decision-making, identified several that were not available to them (e.g. pain-management clinics) and suggested additional options (e.g. GP-management of psychosocial issues (Motivation). Conclusion. Changes to the STarT MSK tool and matched treatment options, targeting the COM-B model constructs, were identified and have been implemented in the current main trial. Conflicts of interest statement: 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). 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. Nadine Foster is a NIHR Senior Investigator and was supported through an NIHR Research Professorship (NIHR-RP-011-015). Trial registration: ISRCTN15366334


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


Bone & Joint Open
Vol. 5, Issue 7 | Pages 612 - 620
19 Jul 2024
Bada ES Gardner AC Ahuja S Beard DJ Window P Foster NE

Aims

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

Methods

An online cross-sectional survey was piloted by the multidisciplinary research team, then shared with clinical professional groups in the UK who are involved in the management of adults with severe, persistent LBP. The survey had seven sections that covered the demographic details of the clinician, five hypothetical case vignettes of patients with varying presentations, a series of questions regarding the preferred management, and whether or not each clinician would be willing to recruit the example patients into future clinical trials.


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_10 | Pages 2 - 2
1 Oct 2019
Konstantinou K Lewis M Dunn K Hill J Artus M Foster N
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Background and Purpose. Healthcare for sciatica is usually ‘stepped’ with initial advice and analgesia, then physiotherapy, then more invasive interventions if symptoms continue. The SCOPiC trial tested a stratified care algorithm combining prognostic and clinical characteristics to allocate patients into one of three groups, with matched care pathways, and compared the effectiveness of stratified care (SC) with non-stratified, usual care (UC). Methods. Pragmatic two-parallel arm RCT with 476 adults recruited from 42 GP practices and randomised (1:1) to either SC or UC (238 per arm). In SC, participants in group 1 were offered up to 2 advice/treatment sessions with a physiotherapist, group 2 were offered up to 6 physiotherapy sessions, and group 3 was ‘fast-tracked’ to MRI and spinal specialist opinion. Primary outcome was time to first resolution of sciatica symptoms (6-point ordinal scale) collected via text messages. Secondary outcomes (4 and 12 months) included leg and back pain intensity, physical function, psychological status, time-off-work, satisfaction with care. Primary analysis was by intention to treat. Results. Primary outcome data were obtained from 89.3% (88.3% SC, 90.3% UC). Survival analysis showed a small but not statistically significant difference in time to resolution of symptoms (SC reached resolution 2 weeks earlier than UC; HR 1.14 (95% CI 0.89, 1.46)). There were no significant between-arm differences in secondary outcomes. Conclusion. The SC model, tested in this trial was not more effective than UC. On average, patients in both arms made similar good improvements over time, on most outcomes. No conflicts of interest. Funding: This report presents independent research commissioned by the National Institute for Health Research (NIHR) (NIHR HTA project number 12/201/09). NEF is a Senior NIHR Investigator and was supported through an NIHR Research Professorship (NIHR-RP-011-015). KK was supported by a HEFCE Senior Clinical Lectureship award. The views and opinions expressed by authors in this publication are those of the authors and do not necessarily reflect those of the NHS, the NIHR, MRC, CCF, NETSCC, the Health Technology Assessment programme or the Department of Health


Orthopaedic Proceedings
Vol. 96-B, Issue SUPP_4 | Pages 28 - 28
1 Feb 2014
Newsome R Reddington M Breakwell L Chiverton N Cole A Michael A Boote J Dimairo M
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Purpose of study and background. The primary aim of the study was to test the feasibility of conducting a full RCT with economic analysis and help to inform the provision of physiotherapy in a specific sub-group of patients with sciatica. Methods. 60 patients waiting for primary, unilateral, single level, lumbar micro-discectomy surgery were recruited and randomised into two groups. The intervention group received a new spinal physiotherapy regimen. Primary outcome measure was the number of patients who did not require surgery at the time of consent clinic. Secondary measures were the Visual Analogue Scale (VAS) Oswestry Disability Index (ODI) and EQ5DL, taken at recruitment, 1 week before surgery and 2 weeks and 3 months after surgery. Results. 1 week before surgery, 3 patients of 30 (10.0%) in the non-physiotherapy group and 5 out of 29 (17.2%) in the physiotherapy group did not require surgery translating into a difference of −7.2% (95%CI-25.7% to 11.1%) in favour of the physiotherapy group but not statistically significant. All the secondary outcome measures demonstrated that patients in the physiotherapy group had a greater improvement but this was not statistically significant due to the small trial numbers. Conclusion. This study informs the feasibility of planning of a large RCT with regard to recruitment, adherence to treatment and outcome measures. The observational data shows that physiotherapy can have a positive impact on these patients with sciatica which diminishes with time. These results provide a framework for further studies. This paper presents independent research funded by the National Institute for Health Research (NIHR) under its Research for Patient Benefit (RfPB) Programme (Grant Reference Number PB-PG-0110-21158). The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health


Orthopaedic Proceedings
Vol. 96-B, Issue SUPP_4 | Pages 30 - 30
1 Feb 2014
Morris T Hee SW Stallard N Underwood M Patel S
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Background. We have developed a LBP (low back pain) repository with IPD (individual patient data) from therapist-delivered intervention RCT's from various institutions, nationally and internationally (19 trials, 9328 patients). We will perform IPD meta-analyses to identify and determine the most effective and cost-effective treatments for subgroups of patients. Disability due to LBP is a key outcome of interest. However, there was no common disability measurement that was used in all the RCT's. We report here our assessment as to whether different disability measures are sufficiently comparable to allow pooling across trials. Method. We used data from seven trials (n = 5015 patients) that had at least two of the following measurements: RMDQ (Roland Morris Disability Questionnaire), MVK (Modified Von Korff disability score), physical component scale of SF-12/36, Patient Specific Functional Scale, and Hannover Functional Ability Questionnaire. Within each trial, the change score between baseline and short-term follow-up was computed. These change scores were then converted from one outcome measure to another with linear regression and ridge-reroughed linear models. They were also tested for correlation and responsiveness (the ability to detect changes in condition, measured by standardised response means). Conclusion. Most of the correlations between outcome measurements were high (>0.5), but responsiveness was often significantly different. Moreover, the accuracy of the conversions was poor, e.g. >40% of predictions from the conversion of RMDQ to MVK were incorrect by more than 10 points. The lack of agreement between different outcome measures suggests that conversion between different disability measurements is not recommended


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_9 | Pages 19 - 19
1 Sep 2019
Schreijenberg M Lin C McLachlan A Williams C Kamper S Koes B Maher C Billot L
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Introduction. The PACE trial was the first randomized controlled trial (RCT) investigating the efficacy of paracetamol in acute low back pain. Non-compliance to study medication was considered to be a limitation of this RCT. In contrast to conventional statistical methods, complier average causal effects (CACE) analysis may provide unbiased estimates of the effects for participants compliant to paracetamol. Methods. Intention to treat (ITT), as-treated, propensity weighted CACE and joint modeling CACE estimates were calculated for pain intensity, disability, global perceived effect and function at two weeks of follow up with compliance defined as an average of at least four tablets per day during the first two weeks of the trial. For pain intensity, exploratory analyses were conducted using additional time points and definitions of compliance. Results. 547 participants had been randomized to placebo and 550 to regular paracetamol; of the latter group, 72% of patients was classified as compliers. Mean differences in pain intensity between paracetamol and placebo using the main time point and definition of compliance were non-significant (ITT 0.11, p = 0.49; as-treated 0.29, p = 0.12; propensity weighed CACE −0.12, p = 0.51; joint modeling CACE 0.28, p = 0.13); similar results were obtained for disability, global perceived effect and function and for additional time points and definitions of compliance. Conclusion. In compliers, paracetamol had no significant effect on pain intensity when compared to placebo; this supports the conclusions from the original analysis. However, these calculations are based on patient-reported compliance, which may not perfectly represent actual medication consumption. Conflicts of interest: AM has received funding for a postgraduate research scholarship from GlaxoSmithKline. CM has received funding to review teaching materials prepared by GlaxoSmithKline. The other authors declare no competing interests. Sources of funding: The PACE trial was an investigator-initiated study funded by a project grant from National Health and Medical Research Council of Australia. GlaxoSmithKline Australia provided subsequent supplementary funding and the paracetamol and matched placebo. CM is supported by Australian Research Council Future Fellowships FT-100100603. CL is supported by a Career Development Fellowship from the National Health and Medical Research Council, Australia (APP1061400). This secondary analysis of the PACE data has been supported by a program grant of the Dutch Arthritis Foundation and by the Foundation “De Drie Lichten” in The Netherlands


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_X | Pages 60 - 60
1 Apr 2012
Negrini S Minozzi S Bettany-Saltikov J Zaina F Chockalingam N Grivas T Kotwicki T Maruyama T Romano M Vasiliadis E
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Department of Epidemiology, ASL RM/E, Rome, Italy. School of Health and Social Care, University of Teesside, Middlesbrough, UK. Faculty of Health, Staffordshire University, Stoke on Trent, UK. Orthopaedic and Trauma Department, “Tzanio” General Hospital of Piraeus, Greece. University of Medical Sciences, Poznan, Poland. Department of Orthopaedic Surgery, Saitama Medical University, Kawagoe, Japan. Thriasio General Hospital, Athens, Greece. To evaluate the efficacy of bracing in adolescent patients with AIS. Cochrane systematic review. The following databases were searched with no language limitations: the Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, CINHAL and reference lists of articles. Extensive hand searching of grey literature was also conducted. RCT's and prospective cohort studies comparing braces with no treatment, other treatment, surgery, and different types of braces were included. Two review authors independently assessed trial quality and extracted data. Two studies were included. There was very low quality evidence from one prospective cohort study including 286 girls. 1. indicating that braces curbed curve progression, at the end of growth, (success rate 74%), better than observation, (34%) and electrical stimulation (33%). Another low quality evidence from one RCT with 43 girls indicated that a rigid brace is more successful than an elastic one (SpineCor) at limiting curve progression when measured in Cobb degrees. 2. No significant differences between the two groups in the subjective perception of daily difficulties associated with brace wearing were found. There is very low quality evidence in favour of using braces, making generalization very difficult. The results from future studies may differ from these results. In the meantime, patients' choices should be informed by multidisciplinary discussion. Future research should focus on short and long-term patient-centred outcomes as well as measures such as Cobb angles. RCTs and prospective cohort studies should follow both the SRS and the Society on Scoliosis Orthopaedic and Rehabilitation Treatment (SOSORT) criteria for bracing studies


The Bone & Joint Journal
Vol. 106-B, Issue 10 | Pages 1176 - 1181
1 Oct 2024
Helenius L Gerdhem P Ahonen M Syvänen J Jalkanen J Nietosvaara Y Helenius I

Aims

Closed suction subfascial drainage is widely used after instrumented posterior spinal fusion in patients with a spinal deformity. The aim of this study was to determine the effect of this wound drainage on the outcomes in patients with adolescent idiopathic scoliosis (AIS). This was a further analysis of a randomized, multicentre clinical trial reporting on patients after posterior spinal fusion using segmental pedicle screw instrumentation. In this study the incidence of deep surgical site infection (SSI) and chronic postoperative pain at two years’ follow-up are reported.

Methods

We conducted a randomized, multicentre clinical trial on adolescents undergoing posterior spinal fusion for AIS using segmental pedicle screw instrumentation. A total of 90 consecutive patients were randomized into a ‘drain’ or ‘no drain’ group at the time of wound closure, using the sealed envelope technique (1:1). The primary outcomes in the initial study were the change in the level of haemoglobin in the blood postoperatively and total blood loss. A secondary outcome was the opioid consumption immediately after surgery. The aim of this further study was to report the rate of deep SSI and persistent postoperative pain, at two years' follow-up.


The Bone & Joint Journal
Vol. 106-B, Issue 7 | Pages 705 - 712
1 Jul 2024
Karlsson T Försth P Öhagen P Michaëlsson K Sandén B

Aims

We compared decompression alone to decompression with fusion surgery for lumbar spinal stenosis, with or without degenerative spondylolisthesis (DS). The aim was to evaluate if five-year outcomes differed between the groups. The two-year results from the same trial revealed no differences.

Methods

The Swedish Spinal Stenosis Study was a multicentre randomized controlled trial with recruitment from September 2006 to February 2012. A total of 247 patients with one- or two-level central lumbar spinal stenosis, stratified by the presence of DS, were randomized to decompression alone or decompression with fusion. The five-year Oswestry Disability Index (ODI) was the primary outcome. Secondary outcomes were the EuroQol five-dimension questionnaire (EQ-5D), visual analogue scales for back and leg pain, and patient-reported satisfaction, decreased pain, and increased walking distance. The reoperation rate was recorded.


The Bone & Joint Journal
Vol. 104-B, Issue 9 | Pages 1067 - 1072
1 Sep 2022
Helenius L Gerdhem P Ahonen M Syvänen J Jalkanen J Charalampidis A Nietosvaara Y Helenius I

Aims

The aim of this study was to evaluate whether, after correction of an adolescent idiopathic scoliosis (AIS), leaving out the subfascial drain gives results that are no worse than using a drain in terms of total blood loss, drop in haemoglobin level, and opioid consumption.

Methods

Adolescents (aged between 10 and 21 years) with an idiopathic scoliosis (major curve ≥ 45°) were eligible for inclusion in this randomized controlled noninferiority trial (n = 125). A total of 90 adolescents who had undergone segmental pedicle screw instrumentation were randomized into no-drain or drain groups at the time of wound closure using the sealed envelope technique (1:1). The primary outcome was a drop in the haemoglobin level during first three postoperative days. Secondary outcomes were 48-hour postoperative oxycodone consumption and surgical complications.


Bone & Joint Open
Vol. 4, Issue 11 | Pages 873 - 880
17 Nov 2023
Swaby L Perry DC Walker K Hind D Mills A Jayasuriya R Totton N Desoysa L Chatters R Young B Sherratt F Latimer N Keetharuth A Kenison L Walters S Gardner A Ahuja S Campbell L Greenwood S Cole A

Aims

Scoliosis is a lateral curvature of the spine with associated rotation, often causing distress due to appearance. For some curves, there is good evidence to support the use of a spinal brace, worn for 20 to 24 hours a day to minimize the curve, making it as straight as possible during growth, preventing progression. Compliance can be poor due to appearance and comfort. A night-time brace, worn for eight to 12 hours, can achieve higher levels of curve correction while patients are supine, and could be preferable for patients, but evidence of efficacy is limited. This is the protocol for a randomized controlled trial of ‘full-time bracing’ versus ‘night-time bracing’ in adolescent idiopathic scoliosis (AIS).

Methods

UK paediatric spine clinics will recruit 780 participants aged ten to 15 years-old with AIS, Risser stage 0, 1, or 2, and curve size (Cobb angle) 20° to 40° with apex at or below T7. Patients are randomly allocated 1:1, to either full-time or night-time bracing. A qualitative sub-study will explore communication and experiences of families in terms of bracing and research. Patient and Public Involvement & Engagement informed study design and will assist with aspects of trial delivery and dissemination.