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Summary. Each patient received Cognitive Reassurance appropriate for and proportionate to his/her capacity through evidence informed explanation/education to enhance effective self-care and realistic self-management. Background and pathway. Changes to back and neck pain commissioning by our CCG required GPs not to refer to manual therapy until six weeks and upgrade GP care beyond that previous. 100 consecutive patients requesting GP appointment reporting back/neck pain were directed to a pragmatic service provided by an experienced manual therapy practitioner. Cognitive Reassurance reflecting evidenced informed biopsychosocial and salutogenic thinking was given at initial consultation/assessment. Patients were contacted at 10 and 20 days to ascertain their status. One sub-group suggested an opportunity for long-term follow-up. Pilot Objectives. Providing Cognitive Reassurance for achieving greater levels of patient engagement with self-management. Demonstrate full clinical triage by primary care providers is effective/practical. Demonstrate a need for appropriate contracting models. ————————–. Outcomes 100 patients. Wait time. 2d. Inappropriate self-referral directed to GPs. 25%. DNAs. 7%. Referral for medication –. 28%. Prescribed AQP manual therapy. 35%. Outcomes 36 patients decided at 20 days no further treatment needed . Treatments averaged. 1.8/pt (Range 0–4). Patients deciding no treatment needed beyond initial consultation. 4%. Patients requesting further consultation during the 12 months following:. 4%. Conclusion. Patient experience measured by an external moderator showed 94% highly satisfied or satisfied. Clinical triage was acceptable to patients and GPs. Adapting to the needs of each patient requires a more pragmatic model of contracting to be created. The opportunity for a further pilot are considered


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. 101-B, Issue SUPP_9 | Pages 15 - 15
1 Sep 2019
de Zoete A Rubinstein S de Boer M van Tulder M Underwood M Hayden J Buffart L Ostelo R
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Purpose of the study and background. A 2011 Cochrane review concluded that spinal manipulative therapy (SMT) is no better than other interventions for reducing pain and improving function in chronic low back pain (CLBP). Using individual participant data (IPD) from trials has advantages, among others: a more precise estimate of the effect and the potential to identify moderators. Our objective was to assess the effect of SMT in adults with CLBP and to identify relevant moderators. Methods. All trials from the 2011 Cochrane review were included in this IPD. We updated the search (April 2016) IPD from eligible studies was requested. Primary outcomes were pain intensity (VAS/NRS) and back-specific function (RMDQ). Risk of bias was assessed. For the treatment effect, an one-stage approach (mixed model technique, intention-to-treat principle) was used; a second-stage approach was conducted as confirmation. For the moderator analyses, one-stage approach was conducted for 19 variables. Results. We obtained IPD from 21 RCTs (n= 4638). Most studies were pragmatic comparing the SMT effect to recommended therapies (e.g. exercise). Effects for SMT were slightly, but not clinically better compared to other therapies for primary outcomes. For the moderator analysis, 8 moderators showed a statistical significant effect at a specific time point (e.g. for SMT vs recommended therapy: age, both pain and function at 26 weeks). But for none of the moderators a consistent effect was identified across time points. Conclusion. Findings of the Cochrane review were confirmed. No clinically-relevant moderators were identified for SMT compared to other therapies for pain and function at any follow-up measure. No conflicts of interest. Sources of funding: European Chiropractic Research fund


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_9 | Pages 37 - 37
1 Sep 2019
Webber R Partridge R Grindell C
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Study Aim. To design an educational resource for people with lower back pain (LBP) using creative co-production. Background. Beliefs associated with a traditional biomedical view of LBP can be a barrier to recovery. Education that reframes the problem as complex and multifactorial may help patients except and engage with more positive attitudes and behaviours. Creative co-production provides a different approach to research intervention development. It encourages a collaborative problem-solving and non-hierarchical approach to knowledge mobilisation. Method. A four-phased approach to creative co-production was used based on methods developed by the Translating Knowledge into Action (TK2A) theme of NIHR CLAHRC YH. Service users and providers were brought together in a series of workshops. Initially the lived experience of LBP was explored to generate a shared understanding of the complexities of living with and managing LBP. Then activities designed to promote divergent and convergent thinking were used for idea generation. From these ideas a series of contextually sensitive prototypes were developed and tested on a small scale. Following further iterations the final prototype, ready for implementation, was presented to all key stake holders. Results. The project produced a new interactive educational resource prototype to promote positive behaviours and attitudes for people living with LBP that can be accessed early on in the health care journey. Conclusion. The creative methods applied in this project allowed patients and staff to work together, flattening hierarchies to produce pragmatic and contextually specific outputs fit for purpose in the complex clinical environment. Project funding: Sheffield Teaching Hospitals Charitable Trust supported by National Institute for Health Research Collaborations for Leadership in Applied Research and Care Yorkshire and Humber (NIHR CLAHRC YH). No conflicts of interest


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_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. 100-B, Issue SUPP_2 | Pages 30 - 30
1 Feb 2018
Bartys S Stochkendahl M Buchanan E
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Background. Work disability due to low back pain (LBP) is a global concern, resulting in significant healthcare costs and welfare payments. In recognition of this, recent UK policy calls for healthcare to become more ‘work-focused’. However, an ‘evidence-policy’ gap has been identified, resulting in uncertainty about how this is to be achieved. Clear, evidence-based recommendations relevant to both policy-makers and healthcare practitioners are required. Methods. A policy theory approach combining scientific evidence with governance principles in a pragmatic manner was undertaken. This entailed extracting evidence from a recent review of the system influences on work disability due to LBP* (focused specifically on the healthcare system) and appraising it alongside the most recent review evidence on the implementation of clinical guidance, and policy material aimed at developing work-focused healthcare. Results. It was found that further resources are needed to assist healthcare professionals (HCPs) to engage in work discussions with LBP patients, which can often be complex and challenging. HCPs themselves often have misconceptions about the work-health relationship and the related evidence-based guidance. System-level barriers that reduce access to suitable healthcare at the right time, and those that increase conflict with other key stakeholders (e.g. the workplace and welfare/compensatory systems) were found to be significant obstacles. Supportive policy and legislation that (a) embeds work as a health outcome, and (b) enables all key stakeholders to collaborate would be a major vehicle to facilitate work-focused healthcare for LBP. Conclusions. Accepting that work-focused healthcare for LBP is required does not diminish the challenge it presents. Evidence-based recommendations relevant for both policy and practice would enable a better understanding of what works for whom, and at what cost. *A full description and results of the evidence synthesis were presented at the Society's Annual Meeting 2016 and will be presented at the 15th International Forum for Back and Neck Pain Research in Primary Care 2017. These results also form part of a chapter in ISSLS Online Textbook 2017. Conflicts of interest; None. Sources of funding: None


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_2 | Pages 12 - 12
1 Feb 2018
Sugavanam T Fordham B Hansen Z Williamson E Boniface G Usama A Richmond H Lamb S
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Purpose of study. To evaluate implementation of the Back Skills Training (BeST) programme in clinical practice within the National Health Service (NHS). Background. The BeST programme is a group Cognitive Behavioural Approach (CBA) for people with persistent (≥6 weeks) low back pain (LBP). This intervention has been shown to be clinically and cost-effective in a large pragmatic trial. To aid implementation of the BeST programme, an online training intervention (iBeST) was developed. Methods. iBest was promoted through marketing activities (e.g. conferences, social media, evidence briefs) prior to release and launched in March 2016 for NHS health care professionals. Impact of iBeST is being evaluated by measuring number enrolled, course completion, implementation intention, clinical delivery, perceived competence, attitudes/beliefs towards LBP, knowledge and satisfaction. Data is collected at pre and post-training, 4 months and 12 months after course completion. A service evaluation is also being conducted to measure clinical impact. Patients taking part in the BeST programme as part of routine treatment complete questionnaires at baseline, post-treatment, 3 months and 12 months after the programme to assess pain, disability, recovery, satisfaction and usefulness of BeST. Results. 881 clinicians have enrolled on iBeST and 260 have completed training (target: 250). 28 NHS sites are delivering the BeST programme. 385 and 290 participants have provided baseline and post treatment data respectively (target: 400). Data collection is ongoing. Conclusion. Implementation is challenging but iBeST has been well received by NHS clinicians and we plan to report further results of the impact and service evaluation. Conflict of interest: None. Source of funding: This research is funded by the National Institute for Health Research (NIHR) Collaboration for Leadership in Applied Health Research and Care Oxford at Oxford Health NHS Foundation Trust. The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health


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.


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_2 | Pages 3 - 3
1 Feb 2018
Cherkin D Hill J Sowden G Foster N
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Purpose & Background. The STarT Back risk-stratification approach uses the STarT Back Tool to categorise patients with low back pain (LBP) at low, medium or high-risk of persistent disabling pain, in order to match treatments. The MATCH trial (NCT02286141) evaluated the effect of implementing an adaptation of this approach in a United States healthcare setting. Methods. This was a pragmatic cluster randomised trial with a pre-intervention baseline period. Six primary care clinics were pair-randomised, three to an intensive stratified care quality improvement intervention and three as controls. LBP patients were invited to provide outcomes two weeks after their primary care visit, and two and six months later. Primary outcomes were physical function (RMDQ) and pain (0–10 NRS), and secondary outcomes including healthcare use and treatments provided received. Analysis was intention-to-treat. Results. Patient outcomes were obtained from intervention (n=690) and control (n=864) clinics. At six months between-group differences in adjusted mean change scores did not significantly favour stratified care for RMDQ; 0.50 (95%CI −0.55, 1.55) or pain NRS 0.13 (95%CI −0.37, 0.63). There were no significant between group differences in any secondary patient outcome. Process data showed that the STarT Back tool was used with 47% of LBP patients in the intervention clinics but there was no differences in the treatments provided. Conclusions. Implementation of a LBP stratified care approach in this United States healthcare setting showed moderate use of the STarT Back tool, but no change in treatments received by patients, and no benefits on patient outcomes. Conflicts of interest: None. Sources of funding: Funding for this trial was provided by the Patient Centered Care Research Institute (“Evaluation of a Patient-Centered Risk Stratification Method for Improving Primary Care for Back Pain”: Contract #398) and by the National Center for Complementary and Integrative Health/NIH (“Implementing Evidence-Based Treatments for Persistent Back Pain into Primary Care”: Grant #R21AT0007326). Martin Levine, Diane Piekara, and Pam Rock received support to participate in the quality improvement activities from Group Health. Nadine Foster and Jonathan Hill were supported through an NIHR Research Professorship (NIHR-RP-011-015) to Nadine Foster. Nadine Foster is an NIHR Senior Investigator. The views expressed are those of the authors and not necessarily those of the Patient Centered Care Research Institute, NIH, NHS, the NIHR or the Department of Health


The Bone & Joint Journal
Vol. 105-B, Issue 1 | Pages 64 - 71
1 Jan 2023
Danielsen E Gulati S Salvesen Ø Ingebrigtsen T Nygaard ØP Solberg TK

Aims

The number of patients undergoing surgery for degenerative cervical radiculopathy has increased. In many countries, public hospitals have limited capacity. This has resulted in long waiting times for elective treatment and a need for supplementary private healthcare. It is uncertain whether the management of patients and the outcome of treatment are equivalent in public and private hospitals. The aim of this study was to compare the management and patient-reported outcomes among patients who underwent surgery for degenerative cervical radiculopathy in public and private hospitals in Norway, and to assess whether the effectiveness of the treatment was equivalent.

Methods

This was a comparative study using prospectively collected data from the Norwegian Registry for Spine Surgery. A total of 4,750 consecutive patients who underwent surgery for degenerative cervical radiculopathy and were followed for 12 months were included. Case-mix adjustment between those managed in public and private hospitals was performed using propensity score matching. The primary outcome measure was the change in the Neck Disability Index (NDI) between baseline and 12 months postoperatively. A mean difference in improvement of the NDI score between public and private hospitals of ≤ 15 points was considered equivalent. Secondary outcome measures were a numerical rating scale for neck and arm pain and the EuroQol five-dimension three-level health questionnaire. The duration of surgery, length of hospital stay, and complications were also 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.


Orthopaedic Proceedings
Vol. 96-B, Issue SUPP_4 | Pages 26 - 26
1 Feb 2014
Lonsdale C Hall A Williams GC McDonough SM Ntoumanis N Murray A Hurley DA
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Purpose of the study and background. Physical activity and exercise therapy are among the guideline recommendations for the rehabilitation of people with chronic low back pain (CLBP ≥ 3 months); however, patient adherence is often poor. CONNECT is a theory-based communication skills training programme designed to enhance physiotherapists' support of their CLBP patients' psychological needs in order to increase adherence to their home-based rehabilitation programme. Methods and results. The CONNECT trial [Current Controlled Trials ISRCTN63723433] included six Dublin-area public clinics and their physiotherapists (n = 24) who received eight hours of communication skills training from a psychologist [experimental group] and physiotherapists (n = 26) from six equivalent clinics who formed a treatment as usual pragmatic control condition. New patients (n = 255, 54% female) diagnosed with CLBP and receiving physiotherapy at one of these clinics completed ratings of home-based adherence at 1, 4, 12, and 24 weeks after their initial treatment session; 24 weeks was the primary endpoint. Due to the nature of the intervention, physiotherapists were aware of treatment allocation; patients and assessors were blinded. Intention to treat analysis using a linear mixed model approach indicated that patients in the experimental group rated their home-based adherence significantly higher than patients in the control condition across time-points (P = .01), but the difference was not significant at the 24-week follow-up (P > .05). Conclusions. The CONNECT intervention had a positive effect on patients' self-rated adherence to home-based rehabilitation for CLBP, but the impact was not maintained over 24 weeks. Further analysis from the CONNECT trial will investigate its effects on pain and function, as well as hypothesised mediators of change


Bone & Joint Research
Vol. 1, Issue 7 | Pages 152 - 157
1 Jul 2012
Hamilton DF Gatherer D Jenkins PJ Maclean JGB Hutchison JD Nutton RW Simpson AHRW

Objectives

To evaluate the neck strength of school-aged rugby players, and to define the relationship with proxy physical measures with a view to predicting neck strength.

Methods

Cross-sectional cohort study involving 382 rugby playing schoolchildren at three Scottish schools (all male, aged between 12 and 18 years). Outcome measures included maximal isometric neck extension, weight, height, grip strength, cervical range of movement and neck circumference.


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.