Effectiveness and cost-effectiveness of radiofrequency denervation versus placebo for chronic and moderate to severe low back pain: study protocol for the RADICAL randomised controlled trial.

INTRODUCTION: Low back pain (LBP) is the leading global cause of disability. Patients with moderate to severe LBP who respond positively to a diagnostic medial nerve branch block can be offered radiofrequency denervation (RFD). However, high-quality evidence on the effectiveness of RFD is lacking. METHODS AND ANALYSIS: RADICAL (RADIofrequenCy denervAtion for Low back pain) is a double-blind, parallel-group, superiority randomised controlled trial. A total of 250 adults listed for RFD will be recruited from approximately 20 National Health Service (NHS) pain and spinal clinics. Recruitment processes will be optimised through qualitative research during a 12-month internal pilot phase. Participants will be randomised in theatre using a 1:1 allocation ratio to RFD or placebo. RFD technique will follow best practice guidelines developed for the trial. Placebo RFD will follow the same protocol, but the electrode tip temperature will not be raised. Participants who do not experience a clinically meaningful improvement in pain 3 months after randomisation will be offered the alternative intervention to the one provided at the outset without disclosing the original allocation. The primary clinical outcome will be pain severity, measured using a pain Numeric Rating Scale, at 3 months after randomisation. Secondary outcomes will be assessed up to 2 years after randomisation and include disability, health-related quality of life, psychological distress, time to pain recovery, satisfaction, adverse events, work outcomes and healthcare utilisation. The primary statistical analyses will be by intention to treat and will follow a prespecified analysis plan. The primary economic evaluation will take an NHS and social services perspective and estimate the discounted cost per quality-adjusted life-year and incremental net benefit of RFD over the 2-year follow-up period. ETHICS AND DISSEMINATION: Ethics approval was obtained from the London-Fulham Research Ethics Committee (21/LO/0471). Results will be disseminated in open-access publications and plain language summaries. TRIAL REGISTRATION NUMBER: ISRCTN16473239.

Lumbar spine fusion surgery versus best conservative care for patients with severe, persistent low back pain.

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. Results: There were 72 respondents, with a response rate of 9.0%. They comprised 39 orthopaedic spine surgeons, 17 neurosurgeons, one pain specialist, and 15 allied health professionals. Most respondents (n = 61,84.7%) chose conservative care as their first-choice management option for all five case vignettes. Over 50% of respondents reported willingness to randomize three of the five cases to either surgery or BCC, indicating a willingness to participate in the future randomized trial. From the respondents, transforaminal interbody fusion was the preferred approach for spinal fusion (n = 19, 36.4%), and the preferred method of BCC was a combined programme of physical and psychological therapy (n = 35, 48.5%). Conclusion: This survey demonstrates that there is uncertainty about the role of lumbar spine fusion surgery and BCC for a range of example patients with severe, persistent LBP in the UK.

Stratified health care for low back pain using the STarT Back approach: Holy Grail or doomed to fail?

ABSTRACT: There have been at least 7 separate randomised controlled trials published between 2011 and 2023 that have examined primary care for nonspecific low back pain informed by the STarT Back approach to stratified care based on risk prediction, compared with care not informed by this approach. The results, across 4 countries, have been contrasting-some demonstrating effectiveness and/or efficiency of this approach, others finding no benefits over comparison interventions. This review considers possible explanations for the differences, particularly whether this is related to poor predictive performance of the STarT Back risk-prediction tool or to variable degrees of success in implementing the whole STarT Back approach (subgrouping and matching treatments to predicted risk of poor outcomes) in different healthcare systems. The review concludes that although there is room for improving and expanding the predictive value of the STarT Back tool, its performance in allocating individuals to their appropriate risk categories cannot alone explain the variation in results of the trials to date. Rather, the learning thus far suggests that challenges in implementing stratified care in clinical practice and in changing professional practice largely explain the contrasting trial results. The review makes recommendations for future research, including greater focus on studying facilitators of implementation of stratified care and developing better treatments for patients with nonspecific low back pain at high risk of poor outcomes.

Musculoskeletal Health and Work: Development and Internal-External Cross-Validation of a Model to Predict Risk of Work Absence and Presenteeism in People Seeking Primary Healthcare.

PURPOSE: To develop and validate prediction models for the risk of future work absence and level of presenteeism, in adults seeking primary healthcare with musculoskeletal disorders (MSD). METHODS: Six studies from the West-Midlands/Northwest regions of England, recruiting adults consulting primary care with MSD were included for model development and internal-external cross-validation (IECV). The primary outcome was any work absence within 6 months of their consultation. Secondary outcomes included 6-month presenteeism and 12-month work absence. Ten candidate predictors were included: age; sex; multisite pain; baseline pain score; pain duration; job type; anxiety/depression; comorbidities; absence in the previous 6 months; and baseline presenteeism. RESULTS: For the 6-month absence model, 2179 participants (215 absences) were available across five studies. Calibration was promising, although varied across studies, with a pooled calibration slope of 0.93 (95% CI: 0.41-1.46) on IECV. On average, the model discriminated well between those with work absence within 6 months, and those without (IECV-pooled C-statistic 0.76, 95% CI: 0.66-0.86). The 6-month presenteeism model, while well calibrated on average, showed some individual-level variation in predictive accuracy, and the 12-month absence model was poorly calibrated due to the small available size for model development. CONCLUSIONS: The developed models predict 6-month work absence and presenteeism with reasonable accuracy, on average, in adults consulting with MSD. The model to predict 12-month absence was poorly calibrated and is not yet ready for use in practice. This information may support shared decision-making and targeting occupational health interventions at those with a higher risk of absence or presenteeism in the 6 months following consultation. Further external validation is needed before the models' use can be recommended or their impact on patients can be fully assessed.

Exploring experiences of people with knee osteoarthritis who received a physiotherapist-delivered dietary weight loss and exercise intervention: a mixed methods study.

OBJECTIVE: Explore the experiences of people with knee osteoarthritis who received a very low energy diet (VLED) and exercise program from a physiotherapist. METHODS: Mixed methods study involving questionnaires (n=42) and semi-structured interviews (n=22) with randomized control trial participants with knee osteoarthritis who had received a 6-month physiotherapist-delivered VLED weight loss and exercise intervention. Questionnaires measured participant satisfaction, and perceptions about physiotherapist's skills/knowledge in delivery of the dietary intervention (measured on 5-7 point Likert scales). Interviews explored participant's experiences and were analysed based on the principles of reflexive thematic analysis. RESULTS: Questionnaire response: 90%. Participants were satisfied with the program (95%), confident their physiotherapist had the required skills (84%) and knowledge (79%) to deliver the dietary intervention, felt comfortable talking to the physiotherapist about weight (74%), and would recommend others see a physiotherapist for the intervention they undertook (71%). Four themes were developed from the interviews: 1) one-stop-shop of exercise and diet; 2) physiotherapist-delivered weight loss works (unsure initially; successfully lost weight); 3) physiotherapists knowledge and skills (exercise is forte; most thought physiotherapists had the necessary weight loss skills/knowledge, but some disagreed); 4) physiotherapists have a role in weight loss (physiotherapists are intelligent, credible, and trustworthy; specific training in weight loss necessary). CONCLUSION: This study provides, to our knowledge, the first documented perspectives from people with osteoarthritis who have received a physiotherapist-delivered weight loss intervention. Findings suggest physiotherapists may have a role in delivering a protocolised dietary intervention for some people with knee osteoarthritis with overweight and obesity.

Supporting self-management of low back pain with an internet intervention with and without telephone support in primary care (SupportBack 2): a randomised controlled trial of clinical and cost-effectiveness.

BACKGROUND: Low back pain is prevalent and a leading cause of disability. We aimed to determine the clinical and cost-effectiveness of an accessible, scalable internet intervention for supporting behavioural self-management (SupportBack). METHODS: Participants in UK primary care with low back pain without serious spinal pathology were randomly assigned 1:1:1 using computer algorithms stratified by disability level and telephone-support centre to usual care, usual care and SupportBack, or usual care and SupportBack with physiotherapist telephone-support (three brief calls). The primary outcome was low back pain-related disability (Roland Morris Disability Questionnaire [RMDQ] score) at 6 weeks, 3 months, 6 months, and 12 months using a repeated measures model, analysed by intention to treat using 97·5% CIs. A parallel economic evaluation from a health services perspective was used to estimate cost-effectiveness. People with lived experience of low back pain were involved in this trial from the outset. This completed trial was registered with ISRCTN, ISRCTN14736486. FINDINGS: Between Nov 29, 2018, and Jan 12, 2021, 825 participants were randomly assigned (274 to usual care, 275 to SupportBack only, 276 to SupportBack with telephone-support). Participants had a mean age of 54 (SD 15), 479 (58%) of 821 were women and 342 (42%) were men, and 591 (92%) of 641 were White. Follow-up rates were 687 (83%) at 6 weeks, 598 (73%) at 3 months, 589 (72%) at 6 months, and 652 (79%) at 12 months. For the primary analysis, 736 participants were analysed (249 usual care, 245 SupportBack, and 242 SupportBack with telephone support). At a significance level of 0·025, there was no difference in RMDQ over 12 months with SupportBack versus usual care (adjusted mean difference -0·5 [97·5% CI -1·2 to 0·2]; p=0·085) or SupportBack with telephone-support versus usual care (-0·6 [-1·2 to 0·1]; p=0·048). There were no treatment-related serious adverse events. The economic evaluation showed that the SupportBack group dominated usual care, being both more effective and less costly. Both interventions were likely to be cost-effective at a threshold of £20 000 per quality adjusted life year compared with usual care. INTERPRETATION: The SupportBack internet interventions did not significantly reduce low back pain-related disability over 12 months compared with usual care. They were likely to be cost-effective and safe. Clinical effectiveness, cost-effectiveness, and safety should be considered together when determining whether to apply these interventions in clinical practice. FUNDING: National Institute for Health and Care Research Health Technology Assessment (16/111/78).

An online training resource for clinicians to optimise exercise prescription for persistent low back pain: Design, development and usability testing.

BACKGROUND: Low back pain (LBP) is the leading cause of disability worldwide. A recent realist review identified the behavioural mechanisms of trust, motivation, and confidence as key to optimising exercise prescription for persistent LBP. OBJECTIVES: Our objectives were to (1) design and develop an online training programme, and (2) gain end-user feedback on the useability, usefulness, informativeness and confidence in using the online training programme using a mixed-methods, pre-post study design. PARTICIPANTS AND INTERVENTION: The online training programme was designed and developed using the results from a realist review, and input from a multi-disciplinary stakeholder group. A five-module online training programme was piloted by the first 10 respondents who provided feedback on the course. Further modifications were made prior to additional piloting. The satisfaction, usefulness, ease of use, and confidence of clinicians in applying the learned principles were assessed on completion. RESULTS: The online programme was advertised to clinicians using social media. Forty-four respondents expressed initial interest, of which 22 enrolled and 18 completed the course. Of the participants, most were physiotherapists (n = 16/18, 88.9%), aged between 30 and 49 (n = 11/18, 61.1%). All participants were satisfied with the course content, rated the course platform as easy to use and useful, and reported that they were very confident to apply the learning. Most (n = 10/14, 71.4%) reported that their manner of prescribing exercise had changed after completion of the course. CONCLUSIONS: An online training programme to optimise exercise prescription for persistent LBP appears to be easy to use, informative and improves confidence to apply the learning.

Developing an international consensus Reporting guideline for intervention Fidelity in Non-Drug, non-surgical trials: The ReFiND protocol.

BACKGROUND: Inadequate reporting of fidelity to interventions in trials limits the transparency and interpretation of trial findings. Despite this, most trials of non-drug, non-surgical interventions lack comprehensive reporting of fidelity. If fidelity is poorly reported, it is unclear which intervention components were tested or implemented within the trial, which also hinders research reproducibility. This protocol describes the development process of a reporting guideline for fidelity of non-drug, non-surgical interventions (ReFiND) in the context of trials. METHODS: The ReFiND guideline will be developed in six stages. Stage one: a guideline development group has been formed to oversee the guideline methodology. Stage two: a scoping review will be conducted to identify and summarize existing guidance documents on the fidelity of non-drug, non-surgical interventions. Stage three: a Delphi study will be conducted to reach consensus on reporting items. Stage four: a consensus meeting will be held to consolidate the reporting items and discuss the wording and structure of the guideline. Stage five: a guidance statement, an elaboration and explanation document, and a reporting checklist will be developed. Stage six: different strategies will be used to disseminate and implement the ReFiND guideline. DISCUSSION: The ReFiND guideline will provide a set of items developed through international consensus to improve the reporting of intervention fidelity in trials of non-drug, non-surgical interventions. This reporting guideline will enhance transparency and reproducibility in future non-drug, non-surgical intervention research.

Prognostic Factors and Treatment Effect Modifiers for Physical Health, Opioid Prescription, and Health Care Utilization in Patients With Musculoskeletal Disorders in Primary Care: Exploratory Secondary Analysis of the STEMS Randomized Trial of Direct Access to Physical Therapist-Led Care.

OBJECTIVE: The aims of the study were to identify prognostic factors associated with health care outcomes in patients with musculoskeletal conditions in primary care and to determine whether characteristics associated with choice of care modify treatment effects of a direct-access physical therapist-led pathway in addition to general practitioner (GP)-led care compared to GP-led care alone. METHODS: A secondary analysis of a 2-parallel-arm, cluster randomized controlled trial involving general practices in the United Kingdom was conducted. Practices were randomized to continue offering GP-led care or to also offer a direct-access physical therapist-led pathway. Data from adults with musculoskeletal conditions who completed the 6-month follow-up questionnaire were analyzed. Outcomes included physical health, opioid prescription, and self-reported health care utilization over 6 months. Treatment effect modifiers were selected a priori from associations in observational studies. Multivariable regression models identified potential prognostic factors, and interaction analysis tested for potential treatment effect modifiers. RESULTS: Analysis of 767 participants indicated that baseline pain self-efficacy, pain severity, and having low back pain statistically predicted outcomes at 6 months. Higher pain self-efficacy scores at baseline were associated with improved physical health scores, reduced opioid prescription, and less health care utilization. Higher bodily pain at baseline and having low back pain were associated with worse physical health scores and increased opioid prescription. Main interaction analyses did not reveal that patients' age, level of education, duration of symptoms, or musculoskeletal presentation influenced response to treatment, but visual trends suggested those in the older age group proceeded to fewer opioid prescriptions and utilized less health care when offered direct access to physical therapy. CONCLUSIONS: Patients with musculoskeletal conditions with lower levels of pain self-efficacy, higher pain severity, and presenting with low back pain have less favorable clinical and health care outcomes in primary care. Prespecified characteristics did not modify the treatment effect of the offer of a direct-access physical therapist-led pathway compared to GP-led care. IMPACT: Patients with musculoskeletal conditions receiving primary care in the form of direct-access physical therapist-led or GP-led care who have lower levels of self-efficacy, higher pain severity, and low back pain are likely to have a less favorable prognosis. Age and duration of symptoms should be explored as potential patient characteristics that modify the treatment response to a direct-access physical therapist-led model of care.

Feasibility of blinding spinal manual therapy interventions among participants and outcome assessors: protocol for a blinding feasibility trial.

INTRODUCTION: Blinding is a methodologically important aspect in randomised controlled trials yet frequently overlooked in trials of spinal manual therapy interventions for back pain. To help inform the blinding methods of a future, double-placebo-controlled trial comparing spinal manual therapy and nerve root injection for lumbosacral radicular pain, we set four objectives: (1) to assess the feasibility of blinding participants, randomly allocated to an active or placebo-control spinal manual therapy intervention protocol, (2) to assess the feasibility of blinding outcome assessors within the trial, (3) to explore the influence of spinal manual therapy experience and low back pain on blinding, and (4) to explore factors contributing to perceptions about intervention assignment among participants and outcome assessors. METHODS AND ANALYSIS: Two-parallel-group, single-centre, placebo-controlled, methodological blinding feasibility randomised trial. We will recruit between 60 and 100 adults with or without back pain and with or without experience of spinal manual therapy from Zurich, Switzerland. Participants will be randomised to either an active spinal manual therapy or a placebo-control spinal manual therapy protocol-both interventions delivered over two study visits, up to two weeks apart. The primary outcome is participant blinding using the Bang blinding index within each intervention arm immediately after each of the two study visits. Secondary outcomes are participant blinding using the James blinding index, outcome assessor blinding (Bang and James blinding indices), self-reported factors influencing perceived intervention assignment among participants and outcome assessors, and participant-reported credibility and expectancy of study interventions. Other outcomes-included to blind the study objective from participants-are lumbar spine range of motion, self-rated general health, satisfaction with care, pain intensity, and function. Intervention provider outcomes include intervention component fidelity and quality of intervention delivery. ETHICS AND DISSEMINATION: The independent ethics commission of Canton Zurich granted ethical approval for this study (KEK 2023-00381). Written informed consent will be obtained from all participants. Findings will be disseminated in scientific conferences and a peer-reviewed publication and inform the blinding methods of a future double-placebo controlled trial comparing spinal manual therapy and nerve root injection for lumbosacral radicular pain-the SALuBRITY trial. TRIAL REGISTRATION: NCT05778396.

Alternative models to support weight loss in chronic musculoskeletal conditions: effectiveness of a physiotherapist-delivered intensive diet programme for knee osteoarthritis, the POWER randomised controlled trial.

OBJECTIVES: To determine if physiotherapists can deliver a clinically effective very low energy diet (VLED) supplementary to exercise in people with knee osteoarthritis (OA) and overweight or obesity. METHODS: 88 participants with knee OA and body mass index (BMI) >27 kg/m2 were randomised to either intervention (n=42: VLED including two daily meal replacement products supplementary to control) or control (n=46: exercise). Both interventions were delivered by unblinded physiotherapists via six videoconference sessions over 6 months. The primary outcome was the percentage change in body weight at 6 months, measured by a blinded assessor. Secondary outcomes included BMI, waist circumference, waist-to-hip ratio, self-reported measures of pain, function, satisfaction and perceived global change, and physical performance tests. RESULTS: The intervention group lost a mean (SD) of 8.1% (5.2) body weight compared with 1.0% (3.2) in the control group (mean (95% CI) between-group difference 7.2% (95% CI 5.1 to 9.3), p<0.001), with significantly lower BMI and waist circumference compared with control group at follow-up. 76% of participants in the intervention group achieved ≥5% body weight loss and 37% acheived ≥10%, compared with 12% and 0%, respectively, in the control group. More participants in the intervention group (27/38 (71.1%)) reported global knee improvement than in the control group (20/42 (47.6%)) (p=0.02). There were no between-group differences in any other secondary outcomes. No serious adverse events were reported. CONCLUSION: A VLED delivered by physiotherapists achieved clinically relevant weight loss and was safe for people with knee OA who were overweight or obese. The results have potential implications for future service models of care for OA and obesity. TRIAL REGISTRATION NUMBER: NIH, US National Library of Medicine, Clinicaltrials.gov NCT04733053 (1 February 2021).

Clinical and cost-effectiveness of individualised (early) patient-directed rehabilitation versus standard rehabilitation after surgical repair of the rotator cuff of the shoulder: protocol for a multicentre, randomised controlled trial with integrated Quintet Recruitment Intervention (RaCeR 2).

INTRODUCTION: Despite the high number of operations and surgical advancement, rehabilitation after rotator cuff repair has not progressed for over 20 years. The traditional cautious approach might be contributing to suboptimal outcomes. Our aim is to assess whether individualised (early) patient-directed rehabilitation results in less shoulder pain and disability at 12 weeks after surgical repair of full-thickness tears of the rotator cuff compared with current standard (delayed) rehabilitation. METHODS AND ANALYSIS: The rehabilitation after rotator cuff repair (RaCeR 2) study is a pragmatic multicentre, open-label, randomised controlled trial with internal pilot phase. It has a parallel group design with 1:1 allocation ratio, full health economic evaluation and quintet recruitment intervention. Adults awaiting arthroscopic surgical repair of a full-thickness tear are eligible to participate. On completion of surgery, 638 participants will be randomised. The intervention (individualised early patient-directed rehabilitation) includes advice to the patient to remove their sling as soon as they feel able, gradually begin using their arm as they feel able and a specific exercise programme. Sling removal and movement is progressed by the patient over time according to agreed goals and within their own pain and tolerance. The comparator (standard rehabilitation) includes advice to the patient to wear the sling for at least 4 weeks and only to remove while eating, washing, dressing or performing specific exercises. Progression is according to specific timeframes rather than as the patient feels able. The primary outcome measure is the Shoulder Pain and Disability Index total score at 12-week postrandomisation. The trial timeline is 56 months in total, from September 2022. TRIAL REGISTRATION NUMBER: ISRCTN11499185.

Health coaching intervention with or without the support of an exercise buddy to increase physical activity of people with chronic low back pain compared to usual care: a feasibility and pilot randomised controlled trial.

BACKGROUND: Exercise buddies (people to exercise together with) might support people with low back pain (LBP) to become active. However, involving buddies in randomised controlled trials (RCT) might challenge recruitment, data collection and follow-up. OBJECTIVES: To explore the feasibility of the intervention, recruitment and data collection approaches and potential effects of a health coaching intervention (focused on physical activity) with or without exercise buddies' support on physical activity of people with chronic LBP versus usual discharge care. DESIGN: Feasibility and pilot RCT. METHODS: Adults (n = 30) discharged from LBP treatment were randomised to the Buddy-Assisted (health coaching intervention with exercise buddy's support), Individual-Only (health coaching only), or usual care groups. Data were collected at baseline, three and six months. The feasibility of trial's procedures was assessed through recruitment rate (acceptable if >70%), data completion rate (acceptable if ≤ 20% missing data), and follow-up rate (successful if ≥ 85%). The intervention's acceptability was assessed via feedback questionnaires. Preliminary effects on physical activity and other outcomes were also explored. RESULTS: Recruitment and baseline data completion were acceptable. However, data collection and follow-up rates post-randomisation were not. 85% of the Buddy-Assisted Group believed the buddies helped them to increase physical activity and would recommend the intervention. 70% of the Individual-Only and Control groups believed exercise buddies would help them to become further active. CONCLUSION: The data collection and follow-up approaches were not successful and need amending before a large-scale RCT. Nonetheless, the buddy-assisted intervention was well-accepted. A future RCT will focus on differences in clinical outcomes. TRIAL REGISTRATION: The study was registered at the Australian New Zealand Clinical Trial Registry (ACTRN12620001118998).

Reinforcing informed medication prescription for low back pain in the emergency department (RIME): a controlled interrupted time series implementation study protocol.

INTRODUCTION: Management guidelines for low back pain (LBP) recommend exclusion of serious pathology, followed by simple analgesics, superficial heat therapy, early mobilisation and patient education. An audit in a large metropolitan hospital emergency department (ED) revealed high rates of non-recommended medication prescription for LBP (65% of patients prescribed opioids, 17% prescribed benzodiazepines), high inpatient admission rates (20% of ED LBP patients), delayed patient mobilisation (on average 6 hours) and inadequate patient education (48% of patients). This study aims to improve medication prescription for LBP in this ED by implementing an intervention shown previously to improve guideline-based management of LBP in other Australian EDs. METHODS AND ANALYSIS: A controlled interrupted time series study will evaluate the intervention in the ED before (24 weeks; 20 March 2023-3 September 2023) and after (24 weeks; 27 November 2024-12 May 2024) implementation (12 weeks; 4 September 2023-26 November 2023), additionally comparing findings with another ED in the same health service. The multicomponent implementation strategy uses a formalised clinical flow chart to support clinical decision-making and aims to change clinician behaviour, through clinician education, provision of alternative treatments, educational resources, audit and feedback, supported by implementation champions. The primary outcome is the percentage of LBP patients prescribed non-recommended medications (opioids, benzodiazepines and/or gabapentinoids), assessed via routinely collected ED data. Anticipated sample size is 2000 patients (n=1000 intervention, n=1000 control) based on average monthly admissions of LBP presentations in the EDs. Secondary outcomes include inpatient admission rate, time to mobilisation, provision of patient education, imaging requests, representation to the ED within 6 months and healthcare costs. In nested qualitative research, we will study ED clinicians' perceptions of the implementation and identify how benefits can be sustained over time. ETHICS AND DISSEMINATION: This study received ethical approval from the Metro North Human Research Ethics Committee (HREC/2022/MNHA/87995). Study findings will be published in peer-reviewed journals and presented at international conferences and educational workshops. TRIAL REGISTRATION NUMBER: ACTRN12622001536752.

Telerehabilitation consultations with a physiotherapist for chronic knee pain versus in-person consultations in Australia: the PEAK non-inferiority randomised controlled trial.

BACKGROUND: Telerehabilitation whether perceived as less effective than in-person care for musculoskeletal problems. We aimed to determine if physiotherapy video conferencing consultations were non-inferior to in-person consultations for chronic knee pain. METHODS: In this non-inferiority randomised controlled trial, we recruited primary care physiotherapists from 27 Australian clinics. Using computer-generated blocks, participants with chronic knee pain consistent with osteoarthritis were randomly assigned (1:1, stratified by physiotherapist and clinic) in-person or telerehabilitation (ie, video conferencing) physiotherapist consultations. Participants and physiotherapists were unmasked to group assignment. Both groups had five consultations over 3 months for strengthening, physical activity, and education. Primary outcomes were knee pain (on a numerical rating scale of 0-10) and physical function (using the Western Ontario and McMaster Universities osteoarthritis index of 0-68) at 3 months after randomisation. Primary analysis was by modified intention-to-treat using all available data. This trial is registered with the Australian and New Zealand Clinical Trials Registry, ACTRN12619001240134. FINDINGS: Between Dec 10, 2019, and June 17, 2022, 394 adults were enrolled, with 204 allocated to in-person care and 190 to telerehabilitation. 15 primary care physiotherapists were recruited. At 3 months, 383 (97%) participants provided information for primary outcomes and both groups reported improved pain (mean change 2·98, SD 2·23 for in-person care and 3·14, 1·87 for telerehabilitation) and function (10·20, 11·63 and 10·75, 9·62, respectively). Telerehabilitation was non-inferior for pain (mean difference 0·16, 95% CI -0·26 to 0·57) and function (1·65, -0·23 to 3·53). The number of participants reporting adverse events was similar between groups (40 [21%] for in-person care and 35 [19%] for telerehabilitation) and none were serious. INTERPRETATION: Telerehabilitation with a physiotherapist is non-inferior to in-person care for chronic knee pain. FUNDING: National Health and Medical Research Council.

Understanding how therapeutic exercise prescription changes outcomes important to patients with persistent non-specific low back pain: a realist review protocol.

INTRODUCTION: Persistent low back pain (LBP) is the leading cause of disability worldwide, and therapeutic exercise is recommended as a first-line treatment in international guidelines. The effects of exercise on clinical outcomes of pain and physical function are small to moderate, despite broader impacts on cardiovascular systems, biological health, mood, and emotional well-being. Therapeutic exercise prescription is defined as exercise that is prescribed by a clinician for a health-related treatment. It is unknown how therapeutic exercise prescription creates effects on outcomes of importance. Realist reviews explore how underlying mechanisms (M) may be active in the context (C) of certain situations, settings, or populations to create an intended or unintended outcome (O). Our objective is to explore and understand the mechanisms by which therapeutic exercise prescription changes outcomes for people with persistent LBP. METHODS: We will develop initial programme theories based on preliminary data from a previous systematic review and consensus workshop. These theories will be modified with input from a steering group (experts), a stakeholder group (people with lived experience of exercise for persistent LBP and clinicians), and a scoping search of the published literature. An information specialist will design and undertake an iterative search strategy. These will be used to create CMO configurations, which will be refined and tested using the literature. The realist review will be reported following RAMESES guidance. DISCUSSION: Realist reviews are uncommon in LBP research to date, yet those offer an opportunity to contrast with traditional methods of randomised controlled trials and systematic reviews and provide additional information regarding the contexts and mechanisms that may trigger certain outcomes. This can aid our understanding of the contextual features that may influence exercise prescription, such as for whom they are most effective, in what setting, how they are implemented and why. This realist synthesis will enhance our understanding of therapeutic exercise prescription to improve adherence and engagement and ultimately will provide clinically relevant recommendations regarding exercise prescription for those with persistent LBP. SYSTEMATIC REVIEW REGISTRATION: The review has been registered with PROSPERO (CRD42017072023).

Contexts, behavioural mechanisms and outcomes to optimise therapeutic exercise prescription for persistent low back pain: a realist review.

OBJECTIVE: Therapeutic exercises are a core treatment for low back pain (LBP), but it is uncertain how rehabilitative exercise facilitates change in outcomes. Realist reviews explore how the context (C) of certain settings or populations and underlying mechanisms (M) create intended or unintended outcomes (O). Our objective was to explore and understand the behavioural mechanisms by which therapeutic exercise creates change in outcomes of adherence, engagement and clinical outcomes for patients with LBP. METHODS: This was a realist review reported following the Realist and Meta-narrative Evidence Syntheses: Evolving Standards guidance. We developed initial programme theories, modified with input from a steering group (experts, n=5), stakeholder group (patients and clinicians, n=10) and a scoping search of the published literature (n=37). Subsequently, an information specialist designed and undertook an iterative search strategy, and we refined and tested CMO configurations. RESULTS: Of 522 initial papers identified, 75 papers were included to modify and test CMO configurations. We found that the patient-clinician therapeutic consultation builds a foundation of trust and was associated with improved adherence, engagement and clinical outcomes, and that individualised exercise prescription increases motivation to adhere to exercise and thus also impacts clinical outcomes. Provision of support such as timely follow-up and supervision can further facilitate motivation and confidence to improve adherence to therapeutic exercises for LBP. CONCLUSIONS: Engagement in and adherence to therapeutic exercises for LBP, as well as clinical outcomes, may be optimised using mechanisms of trust, motivation and confidence. These CMO configurations provide a deeper understanding of ways to optimise exercise prescription for patients with LBP.

Prognosis of Patients With Neuropathic Low Back-Related Leg Pain: An Exploratory Study Using Prospective Data From UK Primary Care.

This prospective cohort study investigates the prognosis of patients with neuropathic low back-related leg pain consulting in UK primary care. Data from 511 patients were collected using standardised baseline clinical examinations (including magnetic resonance imaging scan findings), self-report questionnaires at baseline, 4 months, 12 months, and 3 years. Cases of possible neuropathic pain (NP) and persistent-NP were identified using either of 2 definitions: 1) clinical diagnosis of sciatica, 2) self-report version of leeds assessment for neurological symptoms and signs (s-LANSS). Mixed-effects models compared pain intensity (highest of mean leg or mean back pain [0-10 Numerical Rating Scale]) over 3-years between persistent-NP versus non-persistent-NP based on 1) clinical diagnosis, 2) s-LANSS. Logistic regression examined associations between potential prognostic factors and persistent-NP at 4 months based on the 2 NP definitions. At 4-months, using both definitions: 1) approximately 4 out of 10 patients had persistent-NP, 2) mean pain intensity was higher for patients with persistent-NP at all follow-up points compared to those without, 3) only pain self-efficacy was significantly associated with persistent-NP (s-LANSS: OR .98, sciatica: .98), but it did not predict cases of persistent-NP in either multivariable model. Based on factors routinely collected from self-report and clinical examination, it was not possible to predict persistent-NP in this population. PERSPECTIVE: This study provides evidence that neuropathic back-related leg pain in patients consulting in primary care is not always persistent. Patients with persistent neuropathic pain had worse outcomes than those without. Neither leg pain intensity, pain self-efficacy nor MRI scan findings predicted cases of persistent neuropathic pain in this patient population.

A new measure of exercise adherence: the ATEMPT (Adherence To Exercise for Musculoskeletal Pain Tool).

OBJECTIVES: This study aimed to (1) develop a new measure of adherence to exercise for musculoskeletal (MSK) pain (Adherence To Exercise for Musculoskeletal Pain Tool: ATEMPT) based on previously conceptualised domains of exercise adherence, (2) report the content and structural validity, internal consistency, test-retest reliability, and measurement error for the ATEMPT outcome measure in patients managed with exercise for MSK pain. METHODS: ATEMPT was created using statements describing adherence generated by patients, physiotherapists and researchers, with content validity established. Baseline and retest questionnaires were distributed to patients recommended exercise for MSK pain in 11 National Health Service physiotherapy clinics. Items demonstrating low response variation were removed and the following measurement properties assessed: structural validity, internal consistency, test-retest reliability and measurement error. RESULTS: Baseline and retest data were collected from 382 and 112 patients with MSK pain, respectively. Confirmatory factor analysis established that a single factor solution was the best fit according to Bayesian Information Criterion. The 6-item version of the measure (scored 6-30) demonstrated optimal internal consistency (Cronbach's Alpha 0.86, 95% CI 0.83 to 0.88) with acceptable levels of test-retest reliability (intraclass correlation coefficient 0.84, 95% CI 0.78 to 0.88) and measurement error (smallest detectable change 3.77, 95% CI 3.27 to 4.42) (SE of measurement 2.67, 95% CI 2.31 to 3.16). CONCLUSION: The 6-item ATEMPT was developed from the six domains of exercise adherence. It has adequate content and structural validity, internal consistency, test-retest reliability and measurement error in patients with MSK pain, but should undergo additional testing to establish the construct validity and responsiveness.

Exploring the experiences and perceptions of patients awaiting rotator cuff repair surgery: An integrated qualitative study within the POWER pilot and feasibility trial.

BACKGROUND: As waiting times for orthopaedic surgery increase, there have been calls to move from 'waiting lists' to 'preparation lists', to better prepare patients for surgery. In this context, a pilot randomised controlled trial (POWER) was conducted, comparing physiotherapist-led exercise to waiting-list control (usual care), for patients awaiting rotator cuff repair surgery. This qualitative study was integrated within the pilot trial. OBJECTIVES: Explore the experiences of adults awaiting rotator cuff repair surgery in the NHS. Explore the acceptability of the physiotherapist-led exercise intervention. Explore the barriers and enablers to recruitment, retention, and adherence. DESIGN: Integrated qualitative study with semi-structured telephone interviews. METHODS: Adults awaiting rotator cuff repair, consenting to participate in the trial were eligible. Sampling was purposive regarding age, gender, randomised allocation, and hospital site. Interviews were audio-recorded and transcribed. Data were analysed using Reflexive Thematic Analysis. RESULTS: 20 participants were recruited (age range 49-81 years; 12 male, 10 randomised to physiotherapist-led exercise). Many participants were unable to recall their experiences of trial processes; nonetheless, three themes were identified from the data: experience of shoulder pain and pathway to treatment; communication and decision-making in the context of rotator cuff repair surgery; and experiences of the POWER physiotherapist-led exercise intervention and processes. CONCLUSIONS: Patients experience significant burden due to shoulder pain. Their journey to surgery can be long, confusing, and associated with perceived abandonment. In a future trial, the intervention should offer opportunity for shared decision-making, optional exit from the surgical pathway, and an individualised exercise programme.