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Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_15 | Pages 2 - 2
7 Aug 2024
Hebberd B Rooke C Burton K
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Background. A local authority approached us, for a cost-beneficial solution to their increasing low back pain referrals. We proposed developing a student-led clinic – an intervention delivered by students but supervised by clinicians. We then conducted scoping reviews on student-led clinics in the management of health conditions and on the self-management of back pain. The findings suggested that student-led self-management interventions for low back health should be feasible. The next step was to co-construct the intervention with key stakeholders. Co-Construction. A hybrid of Action Research and Design Science methodology was used to co-construct the intervention with five key stakeholder groups (council staff, managers and human resources, employee healthcare, students, and lecturers). Three rounds of focus groups explored the ‘problem’, the possible solutions, the process, and the content. Themes were taken from each of these focus groups and the similarities and differences were analysed. This analysis and subsequent synthesis with the evidence base created potential intervention models, which were discussed and refined with the stakeholder groups. Intervention. The proposed intervention is focused on providing evidence informed biopsychosocial support for work-relevant back pain, based on identifying obstacles and solutions to improve coping with back health at work. An onboarding workshop challenges positively their thinking around back pain and work. This is followed by up to three 1:1 sessions that support the individual to identify work-relevant back health goals and agree a plan to achieve them using techniques to facilitate behaviour change. Conclusion. The intervention is evidence informed and aims to address the prioritised needs of the stakeholders. Conflicts of interest. No conflicts of interest. Sources of funding. National Health Service Education


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_9 | Pages 32 - 32
1 Oct 2022
Astek A Sparkes V Sheeran L
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Background. Chronic low back pain (CLBP) is the leading cause of disability worldwide. Immersive virtual reality (IVR) can be delivered using head mounted display (HMD) to interact with 3D virtual environment (VE). IVR has shown promising results in management of chronic pain conditions, using different mechanisms (e.g., exposure to movement and distraction). However, it has not been widely tested for CLBP. Future development of IVR intervention needs inputs from gatekeepers to determine key considerations, facilitators and barriers. This qualitative study aimed to explore views and opinions of physiotherapists about IVR intervention for adults with CLBP. Methods. Four focus groups were conducted online, with 16 physiotherapists. A demonstration of existing IVR mechanisms was presented. The data were transcribed and analysed through descriptive thematic analysis. Results. IVR was thought to be a suitable adjunct for a subgroup of patients who are reluctant to engage with standard care. Motivation to perform challenging physical tasks was believed to be a potential benefit. Safety, possibility of addiction, and transferability of acquired skills from VE to ‘real world’ and hygiene were concerns and the intervention was preferred to be used under clinical supervision. VE personalisation to patient's goal and preference with delivery and progression being gradual depending upon patient's abilities was suggested. Technical knowledge was seen as a facilitator, while cost and technology acceptance were barriers for future implementation. Conclusion. Future studies would need to consider the reported views of physiotherapists to inform development and implementation of IVR intervention for CLBP. Conflicts of interest: No conflict of interest. Sources of funding: Funded by the government of Saudi Arabia


Background and study purpose. A recent systematic review with meta-analysis of eight randomised controlled trials concluded that Cognitive Functional Therapy (CFT) for low back pain might be effective in reducing disability, pain and fear-avoidance beliefs. However, the descriptions of a CFT intervention are not always clear. This study aimed to rate the replicability of the CFT interventions and control groups in the systematic review. Methods. Two reviewers independently extracted data from the study articles, protocols and appendices into Microsoft Excel using the Template for Intervention Description and Replication (TIDieR) checklist. This checklist has 12 items to describe the ‘why’, ‘what’, ‘who’, ‘how’, ‘where’, ‘when and how much’, ‘tailoring’, ‘modifications’, and ‘how well’ for each intervention. We rated the replicability of the CFT interventions and control groups as ‘reported’, ‘partially reported’ and ‘not reported’ and resolved discrepancies by consensus. Results. No studies reported 100% of the TIDieR items; the mean ‘reported’ rating was 54% (range 33–67%) for the CFT interventions and 35% (range 8–67%) for controls. The six most replicable items were the same for both CFT and control groups. These were ‘brief name’ (CFT=100%; control=100%), ‘why’ (CFT=100%; control=50%), ‘how’ (CFT=100%; control=50%), ‘what procedures’ (CFT=88%; control=63%), ‘where’ (CFT=88%; control=75%) and ‘planned adherence’ (CFT=75%; control=38%). Items that were not sufficiently ‘reported’ for either CFT or control groups included ‘when and how much’, ‘tailoring’ and ‘adherence’. Conclusion. Incomplete descriptions of CFT interventions mean that clinicians and patients cannot implement those that have demonstrated effectiveness, and poor descriptions of control groups prevent researchers from replicating them in future studies. Conflict of interest. No conflicts of interest. Sources of funding. No funding obtained


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_9 | Pages 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 40 - 40
7 Aug 2024
Herbert T Malone M Rhind N Cooper K
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Background. Chronic pain is a significant burden and represents a major issue for world healthcare systems. Interventions include medication, surgery, pain management programmes, and social support through peer support groups. These groups are often informal, providing informational, emotional, and social support to members. The aim of this project is to co-produce guidance on how to establish a peer support programme for people living with chronic, non-cancer pain that is informed by evidence, theory, and stakeholder experience. Methods. This project is using Steps 1–4 of the Intervention Mapping (IM) approach to inform the research. Online workshops consisting of people living with chronic pain, third sector representatives, healthcare professionals, and researchers are being used to co-produce the guidance. Results. To date, 2 of the 4 planned workshops have been conducted. These have identified the needs of people living with chronic pain, goals for the peer support programme, and expectations of how a peer support programme should be executed. Topics for inclusion in the programme and their content have been identified, with further workshops to refine this planned. The final stage of this project will identify methods of delivery, specific resources that should be developed, and the training to be provided to peer support volunteers. Conclusion. The project has identified the diverse needs of people living with chronic pain and how these may be addressed by a peer support programme. It has identified flexible options that can be recommended to those who want to set up a programme and a variety content that may be included. Conflicts of Interest. None. Sources of Funding. Robert Gordon University


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_9 | Pages 60 - 60
1 Sep 2019
Stegeman P Speijer L Hamelink J Sterken M Soer R Wolff A Preuper HS Reneman M Nijeweme - d'Hollosy WO
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Aims. The aim of this study was to investigate the agreement of physician assistants (PAs) in the triaging of patients with Low Back Pain (LBP) based on self-reported data. Patients and methods. A cross sectional vignette study among four PAs was carried out. Vignettes (cases) were constructed including 26 factors that can be self-reported, identified in literature that have predictive value in treatment outcomes (for example red flags indicating serious underlying conditions and yellow flags indicating psychosocial factors). All vignettes were randomly assigned to the PAs who should determine what intervention would be most optimal to the patient (rehabilitation, injections, medications, surgery, primary care psychology, primary care physical therapy). PAs were allowed to advise more than one intervention. Per vignette, 3 PAs were assigned randomly to advise on intervention. Fleish kappas were calculated to determine the interrater reliability. Results. Twenty-five vignettes were judged by 3 of the 4 PAs. Per advise, Fleish kappa values varied between k=0.65 for surgery and medication to k=0.77 for rehabilitation, which can be interpreted as substantial agreement. Conclusion. Based on self-reported data provided by patients, PAs can triage patients with substantial agreement. Adding more information based on history, physical examination and imaging, may influence these outcomes. This study adds to the merit of using questionnaires for guiding clinicians in their triaging process. No conflicts of interest. No funding obtained


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_9 | Pages 14 - 14
1 Oct 2022
Williamson E Boniface G Marian I Dutton S Maredza M Petrou S Garrett A Morris A Hansen Z Ward L Nicolson P Barker K Fairbank J Fitch J Rogers D Comer C French D Mallen C Lamb S
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Purpose and background. To evaluate the clinical and cost-effectiveness of a physical and psychological group intervention (BOOST programme) compared to physiotherapy assessment and advice (best practice advice [BPA]) for older adults with neurogenic claudication (NC) which is a debilitating spinal condition. Methods and results. A randomised controlled trial of 438 participants. The primary outcome was the Oswestry Disability Index (ODI) at 12 months. Data was also collected at 6 months. Other outcomes included Swiss Spinal Stenosis Questionnaire (symptoms), ODI walking item, 6-minute walk test (6MWT) and falls. The analysis was intention-to-treat. We collected the EQ5D and health and social care use to estimate cost-effectiveness. Participants were, on average, 74.9 years old (SD 6.0). There was no significant difference in ODI scores between groups at 12 months (adjusted mean difference (MD): −1.4 [95% Confidence Intervals (CI) −4.03,1.17]), but, at 6 months, ODI scores favoured the BOOST programme (adjusted MD: −3.7 [95% CI −6.27, −1.06]). Symptoms followed a similar pattern. The BOOST programme resulted in greater improvements in walking capacity (6MWT MD 21.7m [95% CI 5.96, 37.38]) and ODI walking item (MD −0.2 [95% CI −0.45, −0.01]) and reduced falls risk (odds ratio 0.6 [95% CI 0.40, 0.98]) compared to BPA at 12 months. Probability that the BOOST programme is cost-effective ranged from 67%–89% across cost-effectiveness thresholds. Conclusions. The BOOST programme improves mobility and reduces falls in older adults with NC compared to BPA at 12 months follow-up. It is good value for the NHS. Future iterations of the programme will consider ways to reduce symptoms and disability long-term. Conflicts of interest: No conflicts of interest. Sources of funding: National Institute of Health Research – Programme for Applied Research NIHR - PTC-RP-PG-0213-20002: Better Outcomes for Older people with Spinal Trouble (BOOST). Publication and presentations: The clinical effectiveness paper has just been accepted for publication in the Journal of Gerontology Series A. The health economic analysis is not yet published. It was presented at the Physiotherapy UK conference and the International Back and Neck Pain Forum in 2021


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_6 | Pages 4 - 4
1 Feb 2016
Geraghty A Stanford R Roberts L Little P Hill J Foster N Hay E Yardley L
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Background:. Internet interventions provide an opportunity to encourage patients with LBP to self-manage and remain active, by tailoring advice and providing evidence-based support for increasing physical activity. This paper reports the development of the ‘SupportBack’ internet intervention, designed for use with usual primary care, as the first stage of a feasibility RCT currently underway comparing: usual primary care alone; usual care plus the internet intervention; usual care plus the internet intervention with physiotherapist telephone support. Methods:. The internet intervention delivers a 6-week, tailored programme focused on graded goal setting, self-monitoring, and provision of tailored feedback to encourage physical activity/exercise increases or maintenance. 22 patients with back pain from primary care took part in ‘think aloud’ interviews, to qualitatively explore the intervention, provide feedback on its relevance and quality and identify any extraneous content or omissions. Results:. Valuable feedback and suggested amendments from patients included individually-tailoring the activity programme, using the individual's current pain or activity level. Patients reported that the goal setting module was helpful, and were content with the range of activities offered by ‘SupportBack’. The majority of patients reported they would accept their GP's recommendation and use a credible internet intervention such as this programme to help improve self-management. Conclusions:. The development of the ‘SupportBack’ internet intervention has worked with patients to create an acceptable online tailored resource to supplement primary care management for patients with low back pain. The intervention is currently being trialled to determine feasibility and the most appropriate way to support its delivery


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_2 | Pages 15 - 15
1 Feb 2018
Steele J Fisher J Bruce-Low S Smith D Osborne N Newell D
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Purpose and Background. Strengthening the lumbar extensor musculature is a common recommendation for CLBP. Although reported as effective, variability in response in CLBP populations is not well investigated. This study investigated variability in responsiveness to isolated lumbar extension (ILEX) resistance training in CLBP participants by retrospective analysis of 3 RCTS. Methods and Results. Data from 77 intervention participants was available (males = 43, females = 34) 37 control participants (males = 20, females = 17). Intervention participants all underwent 12wks of ILEX resistance training and changes in ILEX strength, pain (VAS) and disability (ODI) measured. True inter-individual response variability was examined through calculation of difference in the standard deviation of change scores for both control and intervention. Intervention participants were classified into using k-means cluster analysis for strength changes and using MCIC cut-offs for VAS and ODI. Analysis suggested true inter-individual responses to the intervention existed. Participants were classified for strength changes as low (n = 31), medium (n = 36), and high responders (n = 10). Participants were classified for VAS changes as negative (n = 3), non-responders (n = 34), responders (n = 15), and high responders (n = 19). Participants were classified for ODI changes as negative (n = 2), non-responders (n = 21), responders (n = 29), and high responders (n = 25). Conclusion. Considerable variation exists in response to ILEX resistance training in CLBP. Future work should identify factors prognostic of successful outcomes. Conflicts of interest: None. Funding obtained: None


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_6 | Pages 6 - 6
1 Feb 2016
Toomey E Matthews J Hurley D
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Purpose and background:. Implementation fidelity (IF) is the extent to which an intervention is implemented as intended by its developers, and increases confidence that changes in study outcomes are due to the effect of the intervention itself and not due to variability in implementation. The aim of this study was to evaluate the IF within a behaviour-change self-management intervention for people with chronic low back pain and/or osteoarthritis, consisting of six weekly sessions (SOLAS ISRCTN49875385). Methods:. In a sample of data, the intervention was delivered by physiotherapists (n=9) in seven sites. IF was assessed using self-report (by physiotherapists) of all sessions (n=60), direct observations (by the research team) of 40% of the sessions (n=24) and audio-recorded observations (by the research team) of all sessions (n=60) using checklists. Data were analysed in SPSSv20 to assess % agreement between methods and fidelity scores. Results:. Agreement between direct observations and audio-recordings was 86.6%, with inter-rater reliability of 84.6% of the audio-recordings. Agreement between the direct observations and self-report was 74.6%. Four sites scored above 80% (‘high’ fidelity) with three scoring between 70 and 80% (‘moderate fidelity’). Four physiotherapists scored between 83–100% with five scoring from 72.5% to 78.8%. There was no significant difference in the fidelity scores across sessions with scores ranging from 74% to 88.8%. Conclusions:. Self-report data may be of limited use for assessing IF, though it may have benefits in terms of enhancing IF. Overall, fidelity levels ranged from moderate to high which will provide valuable information for the interpretation of the trial's clinical effectiveness


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_10 | Pages 5 - 5
1 May 2017
Marley J McDonough S Tully M Bunting B O'Hanlon J Porter-Armstrong A
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Background. Chronic musculoskeletal pain increases an individual's risk of developing many chronic diseases and the risk of all-cause early mortality. There is irrefutable evidence supporting the role of physical activity (PA) in reducing these risks. Sustaining changes to PA behaviours is challenging and efforts are needed to understand the barriers and facilitators of change. Understanding these factors is a vital step in developing behaviour change interventions. Objectives. Explore barriers and facilitators to engaging in PA in adults accessing pain services. Explore barriers and facilitators to promoting PA by healthcare professionals, exercise professionals and charity staff/expert patients. Methods. A qualitative study using the theoretical domains framework (TDF). Two focus groups were conducted with service users (n=18). Three focus groups were held with; healthcare professionals (n=8); exercise professionals (n=6) and charity staff/expert patients (n=8). Two independent reviewers thematically analysed transcripts. Barriers and facilitators were subsequently coded according to the domains of the TDF. Results. For all groups barriers were frequently mapped to the domain ‘environmental context and resources’. Although there was variation across the groups, barriers were also frequently mapped to the domains of ‘knowledge’, ‘beliefs about consequences’, and ‘belief about capabilities’. For service-users' facilitators were frequently mapped to ‘social influences’. Conclusion. The TDF was used to identify deficits that are likely to influence behaviours; targeted intervention strategies have been developed to specifically target these deficits. The interventions that have been developed consider not only the behaviour of those at whom the intervention is targeted, but also those involved in its delivery. No conflicts of interest. Sources of funding: This research was funded by the Public Health Agency, HSC R&D Division through a Doctoral Fellowship awarded to J Marle


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_I | Pages 47 - 47
1 Jan 2012
Lonsdale C Murray A Humphreys MT McDonough S Williams G Hurley D
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Purpose. This pilot study tested the feasibility of a self-determination theory-based communication skills training programme designed to increase physiotherapists' psychological needs supportive behaviour when treating patients with chronic low back pain (CLBP>12 weeks). Methods. Both control (n = 4) and intervention (n = 3) physiotherapists received one hour of evidence-based CLBP management education. Intervention group physiotherapists also received six hours of autonomy-support training, utilizing the ‘5A’ health behaviour change model. Consenting participants [intervention n=16, mean (SD) age = 49.00 years (14.91); control n=12, mean (SD) age = 43.42 (11.70yrs)] completed the primary [self-reported PA, adherence to prescribed exercises, pain, disability, satisfaction] and secondary outcomes [psychological needs support, autonomous motivation, competence] at Week 1 and at Week 4. Results. Compared with controls, intervention group participants reported more PA (d = .26 in Week 1, d = .50 in Week 4), greater adherence to home exercises (d = .40 in Week 1, d = .15 in Week 4) and larger improvements in satisfaction (d = .41). Decreases in pain levels were similar in both groups and improvements in functional outcomes were less for the intervention group (d =. 25), who also reported similar or higher levels of autonomy support (d = .24 in Week 1, no difference in Week 4), autonomous motivation (no difference in Week 1, d = .21 in Week 4), and perceived competence (d = .32 in Week 1, d = .46 in Week 4). Conclusion. Findings provided preliminary evidence supporting the feasibility of this intervention and a fully powered RCT is planned


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXVI | Pages 53 - 53
1 Jun 2012
Quraishi N Giannoulis K Copas D
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Introduction. Metastatic Spinal Cord Compression (MSCC) is a well recognised complication of cancer and a surgical emergency. We present the results of a prospective audit of process focusing on the timing of intervention for these patients from presentation/diagnosis to surgery. Methods. Prospective audit of all patients referred to a tertiary spine unit over 6 months (April –September 2010). All data captured on an excel database. Results. During the study period, 36 patients were referred to our unit with suspected MSCC. Thirty patients (mean age 64.9 years (46-89)) had confirmed MSCC, and of these 25 underwent decompression/stabilisation surgery (vertebroplasty/kyphoplasty (4), declined operation/unfit (7)). The presenting symptoms in the MSCC group were pain and neurological deterioration (16), pain only (7) and progressive neurology (3). The mean duration of pain was 131 days (3 days-over 2 years), and neurological progression was 14 days (1-120 days; Frankel C (3), D (16), E (7)) Four patients were non-ambulatory and 3 had urinary incontinence. The tumour histologies were Prostate (6), Renal (4), Breast (4), Haematological (4), Lung (3), Unknown (1), Others (3). The time from presentation to surgery was 12.9 hours (160mins- 36 hours) if the MRI was organised in our unit. But, if all patients with MSCC were included, together with those referred from other hospitals, the mean time from radiological diagnosis (MRI) to surgery was 29 hours (range 160 mins- >76 hours). Conclusion. This audit of process over 6 months shows that if MSCC is suspected, then patients should be referred to a specialist centre with out of hours MRI provision and where definitive treatment can take place


Aims

Psychoeducative prehabilitation to optimize surgical outcomes is relatively novel in spinal fusion surgery and, like most rehabilitation treatments, they are rarely well specified. Spinal fusion patients experience anxieties perioperatively about pain and immobility, which might prolong hospital length of stay (LOS). The aim of this prospective cohort study was to determine if a Preoperative Spinal Education (POSE) programme, specified using the Rehabilitation Treatment Specification System (RTSS) and designed to normalize expectations and reduce anxieties, was safe and reduced LOS.

Methods

POSE was offered to 150 prospective patients over ten months (December 2018 to November 2019) Some chose to attend (Attend-POSE) and some did not attend (DNA-POSE). A third independent retrospective group of 150 patients (mean age 57.9 years (SD 14.8), 50.6% female) received surgery prior to POSE (pre-POSE). POSE consisted of an in-person 60-minute education with accompanying literature, specified using the RTSS as psychoeducative treatment components designed to optimize cognitive/affective representations of thoughts/feelings, and normalize anxieties about surgery and its aftermath. Across-group age, sex, median LOS, perioperative complications, and readmission rates were assessed using appropriate statistical tests.


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_9 | Pages 13 - 13
1 Oct 2022
Webber R Reddington M Arris S Mawson S
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Background. Advice and education are considered vital components of back pain care within national guidelines. However, a recent systematic review only found low grade evidence for a small average effect. They also reported wide heterogeneity in intervention design and delivery. This review aimed to understand why intervention design varied and what limited effectiveness by examining the underlying theoretical foundations of the studies from that review. Method. Population, context, selection criteria, intervention(s), control, outcome measures, how the intervention was hypothesised to produce outcomes and author recommendations based on results of the study were extracted from text records. The extent to which the advice included matched a published international consensus statement on evidence-based advice for back pain was recorded. Whether interventions or settings were complex was determined using the Medical Research Council complex intervention development and evaluation guidance and the extent to which they met complexity reporting criteria was recorded. Results. The review included 26 trials conducted over 25 years. Differences In causal pathways could explain diversity in intervention design but these were not clearly described or evaluated. All studies were complex in terms of intervention and setting. This was rarely considered in intervention and trial design or when discussing the results. Although interventions were frequently described in detail only a few explained the process and justification of the design. Theories of education or behaviour change were rarely applied. Conclusion. These studies have not deepened our understanding of how education improves outcomes. Future RCTs should engage more with theory and other theory-based research methods should to be considered. Conflict of interest: No conflicts of interest. Sources of funding: No funding


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_9 | Pages 29 - 29
1 Oct 2022
Hohenschurz-Schmidt D Vase L Scott W Annoni M Barth J Bennell K Renella CB Bialosky J Braithwaite F Finnerup N de C Williams AC Carlino E Cerritelli F Chaibi A Cherkin D Colloca L Côte P Darnall B Evans R Fabre L Faria V French S Gerger H Häuser W Hinman R Ho D Janssens T Jensen K Lunde SJ Keefe F Kerns R Koechlin H Kongsted A Michener L Moerman D Musial F Newell D Nicholas M Palermo T Palermo S Pashko S Peerdeman K Pogatzki-Zahn E Puhl A Roberts L Rossettini G Johnston C Matthiesen ST Underwood M Vaucher P Wartolowska K Weimer K Werner C Rice A Draper-Rodi J
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Background. Specifically designed control interventions can account for expectation effects in clinical trials. For the interpretation of efficacy trials of physical, psychological, and self-management interventions for people living with pain, the design, conduct, and reporting of control interventions is crucial. Objectives. To establish a quality standard in the field, core recommendations are presented alongside additional considerations and a reporting checklist for control interventions. Methods. Three Delphi rounds with 64 experts in placebo research and/or non-pharmacological clinical trials were conducted. The panel was presented with a systematic review and meta-analysis of control and blinding methods. A draft guidance document included 63 consensus items (≥80% agreement) and was discussed with patient partners. Finally, the draft guidance and results from stakeholder interviews were discussed at consensus meetings with Delphi participants and patient representatives. Results. Forty-four experts completed the process. When treatment efficacy or mechanisms are to be studied, the advocated principle is to design control interventions as similar as possible to the tested intervention, apart from the components that the study examines. Structured reasoning in the planning phase, early engagement with stakeholders, feasibility work, and piloting will enhance the quality and acceptability of control interventions. With participant blinding being a primary objective, blinding effectiveness should be routinely assessed and reported. Transparent and detailed reporting will improve interpretability and repeatability of clinical trials. Conclusion. This guideline provides the much-needed standards to enhance the quality of efficacy clinical trials in physical, psychological, and self-management intervention research, ultimately improving patient care. Study registration: . https://osf.io/jmyhq/. Conflict of interest: The authors declare no competing interests. Sources of Funding: Alain and Sheila Diamond Charitable Trust PhD Studentship


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_15 | Pages 27 - 27
7 Aug 2024
Zhou T Salman D McGregor A
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Purpose and Background. Clinical practice guidelines (CPGs) recommend self-management for low back pain (LBP). Our recent narrative review on self-management needs revealed a consensus with respect to the critical components of self-management interventions. With mobile health advancements, apps offer innovative support for LBP management. This study aims to identify current apps for the self-management of LBP, assessing them for their quality, intervention content, theoretical approaches, and risk management approaches. Methods and Results. We identified 69 apps for LBP self-management from a systematic search in the UK iTunes and Google Play stores. The most recommended interventions are muscle stretching (n=51, 73.9%), muscle strengthening (n=42, 60.9%), and core stability exercises (n=32, 46.4%). The average MARS (SD) overall score for the included apps was 2.4 (0.44) out of a possible 5 points, with the engagement and information dimension scoring the lowest at 2.1. In terms of theoretical and risk management approaches, no apps offered a theoretical care model and all failed to specify the age group targeted; only one (1.4%) provided a tailored care approach; 18 (26.1%) included intervention progression; and 11 (15.9%) reported management safety checks. Conclusion. This study shows that app developers generally select interventions endorsed by CPGs. However, the application of a biopsychosocial care model is not being considered. Most of them are of low quality, lacking theoretical approaches to care and consideration of associated risks. It is essential to involve clinicians and patients in developing LBP self-management apps to improve the quality and related approach. Conflicts of interest. None. Sources of funding. No funding obtained. This study has been published in JMIR mHealth and uHealth


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_15 | Pages 41 - 41
7 Aug 2024
Pavlova A Cooper K Deane J Hart-Winks E Hemming R Johnson K
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Purpose and background. Nearly 70% of UK physiotherapists experience work-related musculoskeletal disorders (WRMSDs) during their career, with a significant proportion occurring in the back and being attributed to patient handling tasks. Evidence suggests that manual handling training alone is ineffective and interventions among nurses indicate that a tailored approach, including targeted exercise (TE), can reduce WRMSD rates. This study aimed to explore physiotherapists’ perspectives of WRMSDs, patient handling, and the role of TE in reducing WRMSDs among physiotherapists. Methods and Results. Key informant interviews were conducted with 4 physiotherapy operational leads and 1 manual handling trainer from NHS Grampian. Interviews were transcribed and Framework Analysis was utilised to identify key themes, including challenges, barriers, and facilitators. Following this, two online focus groups were conducted with 7 qualified NHS physiotherapists across the UK. Views of manual handling training varied across specialities, with some finding it comprehensive and adaptable, and others finding it less applicable to patients in their speciality or community setting. Physiotherapist views on fitness for work varied, with some highlighting the necessity of TE to ensure workforce health whilst others considered exercise to be a personal matter. Facilitators to implementation identified by participants were having support from management and a strong justification for the exercise content. Varied work schedules and facilities were identified as barriers to implementation of a work-based TE intervention. Conclusion. Varying perspectives on TE interventions and barriers to implementation were identified. This work will inform future research to develop TE interventions in consultation with key stakeholders. Conflicts of Interest. No conflicts of interest. Source of Funding. NHS Endowment Research Grant 22/001


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_9 | Pages 6 - 6
1 Oct 2022
Veerappa P Wellington K Billington J Kelsall C Madi M Berg A Khatri M Austin R Baker A Bourne J
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Purpose of Study and Background. Degenerative cervical myelopathy resulting in cord compromise is a progressive condition that results in significant quality of life limitations. Surgical treatment options available are anterior and/or posterior decompression of the affected levels. Patients are counselled pre-operatively that the aim of surgical intervention is to help prevent deterioration of neurology. Anecdotal evidence suggested improvements in both EMS and PROMs in this cohort of patients. A 2-year prospective study tested this hypothesis. Methodology and Results. 67 patients undergoing anterior cervical surgery were followed up to two years. Myelopathic features, radiological cord compression, myelomalacia change and levels of surgery were recorded. Pre/post intervention myelopathy scores/grades, and PROM's were recorded. Paired t-test was performed when comparing pre/post intervention scores and Annova test when comparing results across levels. Our prospective study identified statistically significant improvements in European myelopathy scores and grade and patient reported clinical outcomes in the said population. Conclusions. DCSM patients undergoing anterior surgery demonstrated statistically significant improvement in PROMs and EMS scores and grades. This has been demonstrated irrespective of number of surgical levels. Conflicts of Interest: None. Sources of Funding: None. Previously presented as a poster at Cervical Spine Research Society, Paris 2020-Virtual Meeting


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_15 | Pages 35 - 35
7 Aug 2024
Alotibi FS Hendrick P Moffatt F
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Background. Immersive virtual reality (VR) demonstrates potential benefits in patients with chronic low back pain (CLBP). However, few studies have investigated the feasibility and the acceptability of introducing immersive VR for use with patients with CLBP and in the Kingdom of Saudi Arabia (KSA). Aim. To investigate immersive VR's feasibility, tolerability, and acceptability as a rehabilitation intervention for adult patients with CLBP and explore the views of relevant Health Care Practitioners (HCPs) in the KSA. Methodology and Methods. A multi-centre, mixed-methods, explanatory sequential design was adopted to test immersive VR's feasibility, tolerability, and acceptability. An uncontrolled feasibility trial was conducted. The immersive VR intervention involved a training session followed by three sessions over one week using commercially available hardware and software. Feasibility outcomes were collected from patients immediately post-intervention. Patients and HCPs were recruited for semi-structured interviews. Results. Thirty-three patients and three HCPs were recruited. The feasibility a priori criteria were met for recruitment, retention, dropout, completeness of questionnaire data, treatment compliance and fidelity. Adverse events included one who reported aggravation of tinnitus, whereas two experienced dizziness. Qualitative data suggested that entertainment and motivation were key enablers. Barriers included technological capability and HCPs’ perceptions that immersive VR was time-consuming. Conclusion. The results suggested that immersive VR was feasible, acceptable, and tolerable among patients with CLBP and HCPs in clinical settings in the KSA. Further research focusing on the effectiveness is warranted in this field. Conflicts of Interest. None. Sources of Funding. None. Trial registration number. ISRCTN14434517