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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.

Abstract Purpose To evaluate the agreement in tear size obtained through preoperative imaging and intraoperative measurement, and to determine the accuracy of preoper-ative imaging in the classification of tear size and identification of tears in each rotator cuff tendon. Methods Data from 44 patients recruited to a randomized controlled trial were reviewed retrospectively. Size and location of the rotator cuff tears were confirmed by either ultrasound or magnetic resonance imaging scans preoperatively and evaluated during surgery. A t-test and Bland and Altman plot were used to determine the agreement between the preoperative and intraoperative measurements. Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) were calculated for tear size and involvement of the rotator cuff tendon. Results There was good agreement in terms of the measurements (91%) and classification (89%) of the tear size preoperatively and during surgery. When classifying tear size, the sensitivity and PPV were high for medium-sized tears (100%) and lower for large tears (75%), reflecting that all medium-sized tears but not all large tears were identified preoperatively. For the preoperative identification of the tears, the sensitivity and PPV were highest for the supraspinatus (84%), with progressively lower sensitivities and PPV for the infraspinatus (57%), subscapularis (17%) and teres minor (0%). Conclusions Through preoperative imaging, the measurement or classification of the tear size can be accurately performed. Where there is disagreement, it is unclear whether the tear size is either underestimated on the scan or overestimated during surgery. The high sensitivity demonstrates that a supraspinatus tear is usually detected by scan. The lower sensitivities for the infraspinatus and subscapularis indicate that the identification of tears in these tendons is less accurate.

Objectives To explore the acceptability of an optimised physiotherapy (OPTimisE) intervention for people with lateral elbow tendinopathy (LET) and feasibility of comparing it to usual care in a randomised controlled trial.Design Semistructured interviews, analysed using thematic analysis and mapped onto the COM-B model of behaviour change.Setting Conducted as part of the OPTimisE Pilot & Feasibility randomised controlled trial within physiotherapy departments in the United Kingdom National Health Service.Participants 17 patients with LET (purposively sampled to provide representativeness based on age, sex, ethnicity, deprivation index and treatment allocation) and all 8 physiotherapists involved as treating clinicians or site principal investigators.Results Four themes were identified. First, participants reported the OPTimisE intervention as acceptable. Second, differences between the OPTimisE intervention and usual care were identified, including the use of an orthosis, holistic advice/education including modifiable risk factors, forearm stretches, general upper body strengthening and a more prescriptive exercise-dosing regimen. Third, participants provided feedback related to the trial resources, which were viewed positively, but identified language translation as a need. Fourth, feedback related to trial processes identified the need for changes to outcome collection and reduction of administrative burden. From the perspective of adopting the OPTimisE intervention, we found evidence that participants were able to change their behaviour. Considering the findings through the lens of the COM-B model, the intervention is likely to be deliverable in practice and the trial can be delivered at scale with some additional support for physiotherapists.Conclusions Overall, the OPTimisE intervention was found to be different to usual care and acceptable to patients and physiotherapists. The study highlighted the need to refine trial processes and resources prior to a full-scale trial, to reduce administrative burden, increase support for physiotherapists, improve return rate of outcome questionnaires and provide language translation.Trial registration number ISRCTN database 19 July 2021. https://www.isrctn.com/ISRCTN64444585.

Background Shoulder arthroplasty incidence is projected to continue its exponential growth and the resultant burden of monitoring patients with shoulder arthroplasty implants creates significant pressure on orthopaedic services. Surveillance offers the opportunity to study implant longevity, detect failing implants and potentially perform revision at lower morbidity and cost. There is a paucity of evidence to support recommendations on long-term follow-up in shoulder arthroplasty. Prospective studies comparing long-term follow-up and structure are impractical from time, resource and cost perspectives. A real-time Delphi technique represents a mechanism by which experts involved in long-term follow-up of primary shoulder arthroplasty can formulate recommendations via a transparent, reproducible and efficient process. We outline the protocol for a real-time Delphi study seeking consensus on long-term follow-up and surveillance of primary shoulder arthroplasty .Methods A real-time Delphi technique will be used. A planning committee will design the Delphi statements. A steering committee will supervise and monitor the real-time Delphi process. Participants will be asked to rate their agreement with statements using a 5-point Likert scale. The Delphi statements will be derived from review of published literature, and the strength of evidence available for each statement will be provided. We will offer participation to all surgeons and extended-scope practitioners who are current members of the British Elbow & Shoulder Society (BESS) and have clinical practice involving shoulder arthroplasty follow-up. The questionnaire will be active for 4 weeks and requires a minimum of 20 participants. Consensus agreement is defined as 70% of participants selecting at least a 4-point on a 5-point Likert scale.Discussion We anticipate the outlined study will achieve consensus on long-term follow-up and surveillance of primary shoulder arthroplasty. We intend to use the expert consensus recommendations achieved, in addition to the limited applicable published evidence available, to produce BESS-affiliated guidelines on long-term follow-up and surveillance of primary shoulder arthroplasty.EthicsEthical approval is not required for the real-time Delphi study.We expect the results of this initiative will be published in a peer-reviewed, high-impact journal.

Objectives To explore the lived experience of people with lateral elbow tendinopathy (LET) and its impact on everyday life.Design Qualitative semi-structured interviews, analysed using thematic analysis.Setting Conducted as part of the mixed-methods OPTimisE pilot and feasibility randomised controlled trial of outpatient physiotherapy patients in the UK.Participants 17 participants with LET, purposively sampled from the trial to provide representativeness based on age, sex, ethnicity, deprivation index and treatment allocation.Results Four themes were identified from the participants’ responses: (1) cause of onset—typically symptoms were attributed to: sudden changes in activity, repetitive work or compensating for other musculoskeletal conditions; (2) impact on everyday life—which included substantial impacts on quality-of-life, particularly due to pain disturbing sleep and difficulties performing daily tasks (related to work and hobbies) due to pain, although most reported being able to persevere with work; (3) self-help and understanding of the condition—with uncertainty about the appropriateness and potential harm of online advice and confusion from the diagnostic term ‘Tennis Elbow’ that non-sporting individuals struggled to relate to; (4) healthcare experiences—the treatments received were highly variable and often perceived as ineffectual.Conclusions For the first time, the lived experience of people from a range of backgrounds suffering from LET has been explored. Findings suggest that people frequently related the cause to a specific activity. They reported substantial impacts on daily tasks, sleep, work and hobbies. People also reported hesitancy to trust online information without formal healthcare advice, were confused by the common label of ‘Tennis Elbow’, and perceived the wide array of healthcare treatment options they had received to offer false hope and be largely ineffective. This study provides stimulus for clinicians to consider the advice and treatment provided, and whether the messages conveyed reflect the favourable natural history of the condition.Trial registration number ISRCTN64444585

Objective To undertake a UK-based James Lind Alliance (JLA) Priority Setting Partnership for elbow conditions and be representative of the views of patients, carers and healthcare professionals (HCPs).Setting This was a national collaborative study organised through the British Elbow and Shoulder Society.Participants Adult patients, carers and HCPs who have managed or experienced elbow conditions, their carers and HCPs in the UK involved in managing of elbow conditions.Methods The rigorous JLA priority setting methodology was followed. Electronic and paper scoping surveys were distributed to identify potential research priority questions (RPQs). Initial responses were reviewed and a literature search was performed to cross-check categorised questions. Those questions already sufficiently answered were excluded and the remaining questions were ranked in a second survey according to priority for future elbow conditions research. Using the JLA methodology, responses from HCP and patients were combined to create a list of the top 18 questions. These were further reviewed in a dedicated multistakeholder workshop where the top 10 RPQs were agreed by consensus.Results The process was completed over 24 months. The initial survey resulted in 467 questions from 165 respondents (73% HCPs and 27% patients/carers). These questions were reviewed and combined into 46 summary topics comprising: tendinopathy, distal biceps pathology, arthritis, stiffness, trauma, arthroplasty and cubital tunnel syndrome. The second (interim prioritisation) survey had 250 respondents (72% HCP and 28% patients/carers). The top 18 ranked questions from this survey were taken to the final workshop where a consensus was reached on the top 10 RPQs.Conclusions The top 10 RPQs highlight areas of importance that currently lack sufficient evidence to guide diagnosis, treatment and rehabilitation of elbow conditions. This collaborative process will guide researchers and funders regarding the topics that should receive most future attention and benefit patients and HCPs.

Abstract Background Lateral elbow tendinopathy (LET) is a common condition that can cause significant disability and associated socioeconomic cost. Although it has been widely researched, outcome measures are highly variable which restricts evidence synthesis across studies. In 2019, a working group of international experts, health care professionals and patients, in the field of tendinopathy (International Scientific Tendinopathy Symposium Consensus (ICON) Group), published the results of a consensus exercise defining the nine core domains that should be measured in tendinopathy research. The aim of this study is to develop a core outcome set (COS) for LET mapping to these core domains. The primary output will provide a template for future outcome evaluation of LET. In this protocol, we detail the methodological approach to the COS-LET development. Methods This study will employ a three-phase approach. (1) A systematic review of studies investigating LET will produce a comprehensive list of all instruments currently employed to quantify the treatment effect or outcome. (2) Instruments will be matched to the list of nine core tendinopathy outcome domains by a Steering Committee of clinicians and researchers with a specialist interest in LET resulting in a set of candidate instruments. (3) An international three-stage Delphi study will be conducted involving experienced clinicians, researchers and patients. Within this Delphi study, candidate instruments will be selected based upon screening using the Outcome Measures in Rheumatology (OMERACT) truth, feasibility and discrimination filters with a threshold of 70% agreement set for consensus. Conclusions There is currently no COS for the measurement or monitoring of LET in trials or clinical practice. The output from this project will be a minimum COS recommended for use in all future English language studies related to LET. The findings will be published in a high-quality journal and disseminated widely using professional networks, social media and via presentation at international conferences. Trial registration Registered with the Core Outcome Measures in Effectiveness Trials (COMET) database, November 2019. https://www.comet-initiative.org/Studies/Details/1497 .

Objectives There are a wide range of physiotherapy treatment options for people with lateral elbow tendinopathy (LET); however, previous studies have reported inconsistent approaches to treatment and a lack of evidence demonstrating clinical effectiveness. This study aimed to combine the best available research evidence with stakeholder perspectives to develop key components of an optimised physiotherapist-led treatment protocol for testing in a future randomised controlled trial (RCT).Design Online consensus groups using nominal group technique (NGT), a systematic approach to building consensus using structured multistage meetings.Setting UK National Health Service (NHS).Participants 10 physiotherapists with special interest in LET, 2 physiotherapy service managers and 3 patients who had experienced LET.Interventions Two consensus groups were conducted; the first meeting focused on agreeing the types of interventions to be included in the optimised treatment protocol; the second meeting focused on specific details of intervention delivery. Participants were sent an evidence summary of available treatments for LET prior to the first meeting. All treatment options were discussed before anonymous voting and ranking of priority. Consensus for inclusion of each treatment option was set at ≥70% based on OMERACT guidelines. Options with 30%–69% agreement were discussed again, and a second vote was held, allowing for a change of opinion.Results The optimised physiotherapist-led treatment package included: advice and education, exercise therapy and orthotics. Specific components for each of these interventions were also agreed such as: condition-specific advice, health-promotion advice, exercise types, exercise into ‘acceptable’ levels of pain, exercise dosage and type of orthoses. Other treatment options including electrotherapy, acupuncture and manual therapy were excluded.Conclusion An optimised physiotherapist-led treatment protocol for people with LET was successfully developed using an online NGT consensus approach. This intervention is now ready for testing in a future pilot/feasibility RCT to contribute much needed evidence about the treatment of LET.Trial registration number This is the pre-cursor to the OPTimisE Pilot and Feasibility Randomised Controlled Trial. Registration: https://www.isrctn.com/ISRCTN64444585

Background Enhanced recovery (ER) programmes are well established in hip and knee arthroplasty, but are not yet commonplace for total shoulder arthroplasty (TSA). This study analyses the effect of implementing an ER programme with TSA, on length of stay (LOS), functional outcome and patient satisfaction.Local problem No established programme applying ER to the specifics of upper-limb arthroplasty existed at our unit.Methods A three-cycle plan–do–study–act quality improvement methodology was applied, involving development of our multifactorial programme, a pilot phase and wider roll-out. A consecutive series of patients who underwent TSA and were enrolled in an ER programme were compared with a matched control group of consecutive patients who underwent TSA in the year before the programme started. For all patients, LOS as well as mean Oxford Shoulder Score (OSS) and Constant Score (CS) were quantified and patient satisfaction assessed.Interventions A dedicated multidisciplinary team led preoperative class involving patient education, advice and occupational therapy assessment. A standardised perioperative anaesthetic regime based on regional anaesthetic techniques with preoperative analgesic and nutritional loading was introduced. Postoperative rehabilitation was also standardised with slings for comfort only and early safe-zone mobilisation. New patient information was developed.Results 71 patients were included in matched cohorts. Mean LOS was reduced from 2.4 nights to 1.9 nights. The single night stay rate improved from 40% to 49%. Across the ER cohort, 15 less nights were required to complete same volume of surgeries as in the non-ER cohort.Parity in OSS and CS measured at 3 and 12 months after surgery were observed in both cohorts.Satisfaction was already high before ER but scores stayed the same or improved across all areas surveyed.Absolute complication rates of 9.9% in the non-ER group and 7% in the ER group were recorded.Conclusion Our ER programme benefited patients and the Trust by reducing time in hospital and improving patient satisfaction without an adverse effect on complication rate.

Abstract Background Shoulder pain is a highly prevalent complaint and disorders of the rotator cuff, including tears, are thought to be the most common cause. The number of operations to repair the torn rotator cuff has risen significantly in recent years. While surgical techniques have progressed, becoming less invasive and more secure, rehabilitation programmes have remained largely like those initially developed when surgical techniques were less advanced and more invasive. Uncertainty remains in relation to the length of post-surgical immobilisation and the amount of early load permitted at the repair site. In the context of this uncertainty, current practice is to follow a generally cautious approach, including long periods of immobilisation in a sling and avoidance of early active rehabilitation. Systematic review evidence suggests early mobilisation might be beneficial but further high-quality studies are required to evaluate this. Methods/design RaCeR is a two-arm, multi-centre pilot and feasibility randomised controlled trial with nested qualitative interviews. A total of 76 patients with non-traumatic rotator cuff tears who are scheduled to have a surgical repair will be recruited from up to five UK NHS hospitals and randomly allocated to either early patient-directed rehabilitation or standard rehabilitation that incorporates sling immobilisation. RaCeR will assess the feasibility of a future, substantive, multi-centre randomised controlled trial to test the hypothesis that, compared to standard rehabilitation incorporating sling immobilisation, early patient-directed rehabilitation is both more clinically effective and more cost-effective. In addition, a sample of patients and clinicians will be interviewed to understand the acceptability of the interventions and the barriers and enablers to adherence to the interventions. Discussion Research to date suggests that there is the possibility of reducing the patient burden associated with post-operative immobilisation following surgery to repair the torn rotator cuff and improve clinical outcomes. There is a clear need for a high-quality, adequately powered, randomised trial to better inform clinical practice. Prior to a large-scale trial, we first need to undertake a pilot and feasibility trial to address current uncertainties about recruitment, retention and barriers to adherence to the interventions, particularly in relation to whether patients will be willing to begin moving their arm early after their operation. Trial registration ISRCTN Registry, 18357968. Registered on 10 August 2018.

Abstract Background A novel loaded self-managed exercise programme that includes pain education and self-management strategies may result in better outcomes for people with patellofemoral pain (PFP). However, establishing program feasibility is an essential first step before testing efficacy. The purpose of this study was to evaluate the feasibility and acceptability of conducting a definitive RCT which will evaluate the clinical and cost-effectiveness of a loaded self-managed exercise programme for people with PFP compared with usual physiotherapy. Methods In a mixed methods, pragmatic, randomised controlled feasibility study, 60 participants with PFP (57% female; mean age 29 years) were recruited from a physiotherapy clinic within a large UK teaching hospital. They were randomly allocated to receive either a loaded self-managed exercise programme (n = 30) or usual physiotherapy (n = 30). Feasibility indicators of process, resources, and management were collected through follow-up of standardised questionnaires six months after recruitment and semi-structured interviews with 20 participants and physiotherapists. Results Recruitment rate was 5 participants per month; consent rate was 99%; adherence to intervention appointments was 87%; completeness of questionnaire data was 100%; and adherence to intervention delivery was 95%. Three exercise diaries were returned at six months (5%). At six months, 25 questionnaire booklets were returned (9 in the loaded self-managed group, 16 in the usual physiotherapy group), with a total retention rate of 42%. At six months, 56% (5/9) of respondents in the loaded self-managed group and 56% (9/16) in the usual physiotherapy group were classified as ‘recovered’. Both groups demonstrated improvements in average pain (VAS), kinesiophobia, pain catastrophizing, general self-efficacy and EQ-5D-5 L from baseline to six months. Conclusion The results of this feasibility study confirm that it is feasible and acceptable to deliver a loaded self-managed exercise programme to adults with PFP in an NHS physiotherapy outpatient setting. However, between group differences in lost to follow up and poor exercise diary completion mean we are uncertain on some feasibility aspects. These methodological issues need addressing prior to conducting a definitive RCT. Trial registration ISRCTN 35272486. Registered 19th December 2016.

Abstract Background Patellofemoral pain (PFP) is one of the most common forms of knee pain in adults under the age of 40, with a prevalence of 23% in the general population. The long-term prognosis is poor, with only one third of people pain-free 1 year after diagnosis. The biomedical model of pain in relation to persistent PFP has recently been called into question. It has been suggested that interventions for chronic musculoskeletal conditions should consider alternative mechanisms of action, beyond muscles and joints. Modern treatment therapies should consider desensitising strategies, with exercises that target movements and activities patients find fearful and painful. High-quality research on exercise prescription in relation to pain mechanisms, not directed at specific tissue pathology, and dose response clearly warrants further investigation. Our primary aim is to establish the feasibility and acceptability of conducting a definitive RCT which will evaluate the clinical and cost-effectiveness of a loaded self-managed exercise programme for people with patellofemoral pain. Method This is a single-centred, multiphase, sequential, mixed-methods trial that will evaluate the feasibility of running a definitive large-scale randomised controlled trial of a loaded self-managed exercise programme versus usual physiotherapy. Initially, 8–10 participants with a minimum 3-month history of PFP will be recruited from an NHS physiotherapy waiting list and interviewed. Participants will be invited to discuss perceived barriers and facilitators to exercise engagement, and the meaning and impact of PFP. Then, 60 participants will be recruited in the same manner for the main phase of the feasibility trial. A web-based service will randomise patients to a loaded self-managed exercise programme or usual physiotherapy. The loaded self-managed exercise programme is aimed at addressing lower limb knee and hip weakness and is positioned within a framework of reducing fear/avoidance with an emphasis on self-management. Baseline assessment will include demographic data, average pain within the last week (VAS), fear avoidance behaviours, catastrophising, self-efficacy, sport and leisure activity participation, and general quality of life. Follow-up will be 3 and 6 months. The analysis will focus on descriptive statistics and confidence intervals. The qualitative components will follow a thematic analysis approach. Discussion This study will evaluate the feasibility of running a definitive large-scale trial on patients with patellofemoral pain, within the NHS in the UK. We will identify strengths and weaknesses of the proposed protocol and the utility and characteristics of the outcome measures. The results from this study will inform the design of a multicentre trial. Trial registration ISRCTN35272486 .

Abstract Background Patellofemoral pain (PFP) is considered one of the commonest forms of knee pain. This study aimed to identify how physiotherapists in the United Kingdom (UK) currently manage patellofemoral pain (PFP), particularly in relation to exercise prescription, and response to pain. Methods An anonymous survey was designed with reference to previous surveys and recent systematic reviews. Practising UK physiotherapists who treat patients with PFP were invited to take part via an invitation email sent through professional networks, the ‘interactive Chartered Society of Physiotherapy (iCSP)’ message board, and social media (Twitter). Descriptive statistics were used to analyse the data. Results A total of 99 surveys were completed. Responders reported a wide range of management strategies, including a broad selection of type and dose of exercise prescription. The five most common management strategies chosen were: closed chain strengthening exercises (98%); education and advice (96%); open chain strengthening exercises (76%); taping (70%) and stretches (65%). Physiotherapists with a special interest in treating PFP were statistically more likely to manage patients with orthotics (P = 0.02) and bracing (P = 0.01) compared to physiotherapists without a special interest. Approximately 55% would not prescribe an exercise if it was painful. Thirty-one percent of physiotherapists would advise patients not to continue with leisure and/or sporting activity if they experienced any pain. Conclusion Current UK practice in the management strategies of PFP is variable. Further high quality research on which to inform physiotherapy practice is warranted for this troublesome musculoskeletal condition.

Patellofemoral pain is considered one of the most common forms of knee pain, affecting adults, adolescents, and physically active populations. Inconsistencies in reported incidence and prevalence exist and in relation to the allocation of healthcare and research funding, there is a clear need to accurately understand the epidemiology of patellofemoral pain.An electronic database search was conducted, as well as grey literature databases, from inception to June 2017. Two authors independently selected studies, extracted data and appraised methodological quality. If heterogeneous, data were analysed descriptively. Where studies were homogeneous, data were pooled through a meta-analysis.23 studies were included. Annual prevalence for patellofemoral pain in the general population was reported as 22.7%, and adolescents as 28.9%. Incidence rates in military recruits ranged from 9.7-571.4/1,000 person-years, amateur runners in the general population at 1080.5/1,000 person-years and adolescents amateur athletes 5.1%-14.9% over 1 season. One study reported point prevalence within military populations as 13.5%. The pooled estimate for point prevalence in adolescents was 7.2% (95% Confidence Interval: 6.3%-8.3%), and in female only adolescent athletes was 22.7% (95% Confidence Interval 17.4%-28.0%).This review demonstrates high incidence and prevalence levels for patellofemoral pain. Within the context of this, and poor long term prognosis and high disability levels, PFP should be an urgent research priority.CRD42016038870.

Objectives: To conduct a feasibility study to compare concentric and eccentric rotator cuff strengthening exercises for rotator cuff tendinopathy. Methods: A total of 11 patients with rotator cuff tendinopathy who were on the waiting list for arthroscopic subacromial decompression surgery were randomised to perform eccentric rotator cuff strengthening exercises, concentric strengthening exercises or no exercises. Patients were evaluated in terms of levels of pain and function using the Oxford Shoulder Score and a Visual Analogue Scale initially, at 4 weeks and at 8 weeks. Results: The study design was found to be acceptable to patients and achieved a high level of 86% compliance. The drop-out rate was 0%. Two patients performing eccentric strengthening exercises improved sufficiently to cancel their planned surgery. Conclusion: Further research in this area is recommended. The study design was feasible and power calculations have been conducted to aid future research planning.