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.

Rotator cuff disorders: An updated survey of current (2023) UK physiotherapy practice.

BACKGROUND: Clinical guidelines recommend treatment by a physiotherapist for people with shoulder pain due to rotator cuff disorder. Despite this recommendation, research evidence supporting the effectiveness of treatment by a physiotherapist is uncertain. While developing a randomised controlled trial to test the effectiveness of treatment by a physiotherapist for people with shoulder pain due to rotator cuff disorders, we first aimed to understand current practice as a basis for defining usual care. METHODS: An online survey was developed based on a clinical vignette used in a previous survey exploring physiotherapy practice for people with shoulder pain due to rotator cuff disorder. UK-based physiotherapists were invited to complete the survey via X and email across professional networks. RESULTS: One Hundred Seventy complete responses were received. 167 (98%) respondents would offer advice/education to patients with shoulder rotator cuff disorders; 146 (86%) would use isotonic exercise (including concentric/eccentric strengthening); 20 (12%) would offer a corticosteroid injection; 7 (4%) would use joint mobilisation. 168/169 (99%) would offer in-person assessment; 115 (68%) expect to deliver treatment over three to four sessions. Fifty percent agreed there is uncertainty about the effectiveness of physiotherapy treatment for patients with shoulder rotator cuff disorders. Seventy six percent agreed that patients with this condition can recover without physiotherapy intervention. CONCLUSIONS: Exercise and advice remain the most common treatments offered by physiotherapists for people with shoulder pain due to rotator cuff disorder. Corticosteroid injections are infrequently considered. Uncertainty about the effectiveness of treatment by a physiotherapist for shoulder pain due to rotator cuff disorder is evident.

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.

Current and future advances in practice: tendinopathies of the shoulder.

Tendinopathies of the shoulder are a burdensome problem. Current treatments include exercise, physical therapies, corticosteroid injections and surgery. However, the clinical outcomes from randomized controlled trials evaluating the effectiveness of these interventions are largely unremarkable. Given the apparent lack of progress in improving clinical outcomes for patients, it is appropriate to consider other avenues. Research has identified a link between lifestyle-related modifiable risk factors, including smoking, overweight and physical inactivity, and the onset and persistence of tendinopathies of the shoulder. Further research is required to understand whether addressing these factors results in better clinical outcomes for patients. Teachable moments and shared decision-making are concepts that could enable clinicians to integrate the assessment and management of these lifestyle factors. Given that these lifestyle factors also increase the risk of developing other common morbidities, including cardiovascular disease, an evolution of routine clinical care in this way could represent an important step forwards.

Physiotherapist-led exercise versus usual care (waiting-list) control for patients awaiting rotator cuff repair surgery: A pilot randomised controlled trial (POWER).

BACKGROUND: Once a decision to undergo rotator cuff repair surgery is made, patients are placed on the waiting list. It can take weeks or months to receive surgery. There has been a call to move from waiting lists to 'preparation' lists to better prepare patients for surgery and to ensure it remains an appropriate treatment option for them. OBJECTIVE: To evaluate the feasibility, as measured by recruitment rates, treatment fidelity and follow-up rates, of a future multi-centre randomised controlled trial to compare the clinical and cost-effectiveness of undertaking a physiotherapist-led exercise programme while waiting for surgery versus usual care (waiting-list control). DESIGN: Two-arm, multi-centre pilot randomised controlled trial with feasibility objectives in six NHS hospitals in England. METHOD: Adults (n = 76) awaiting rotator cuff repair surgery were recruited and randomly allocated to a programme of physiotherapist-led exercise (n = 38) or usual care control (n = 38). RESULTS: Of 302 eligible patients, 76 (25%) were randomised. Of 38 participants randomised to physiotherapist-led exercise, 28 (74%) received the exercise programme as intended. 51/76 (67%) Shoulder Pain and Disability Index questionnaires were returned at 6-months. Of 76 participants, 32 had not received surgery after 6-months (42%). Of those 32, 20 were allocated to physiotherapist-led exercise; 12 to usual care control. CONCLUSIONS: A future multi-centre randomised controlled trial is feasible but would require planning for variable recruitment rates between sites, measures to improve treatment fidelity and opportunity for surgical exit, and optimisation of follow-up. A fully powered, randomised controlled trial is now needed to robustly inform clinical decision-making.

Developing an application for the UK Pre-Doctoral Clinical and Practitioner Academic Fellowship (PCAF): the collective experience of a community of physiotherapists.

For physiotherapists and other healthcare professionals, developing capability and expertise in research can be challenging. However, involvement in research is beneficial at organisational and individual levels, both for clinicians and patients. One way to embark on research is to apply for a personal fellowship such as the National Institute for Health and Care Research (NIHR) Pre-Doctoral Clinical Academic Fellowship (PCAF). While the NIHR has guidance on how to complete the application form, it can be difficult to implement this guidance and understand what a competitive application looks like. As a group of physiotherapists and academic supervisors, who have applied for NIHR PCAFs, what follows is a supportive resource, to inform others who might be thinking of applying. CONTRIBUTION OF PAPER.

Are Corticosteroid Injections Associated With Secondary Adrenal Insufficiency in Adults With Musculoskeletal Pain? A Systematic Review and Meta-analysis of Prospective Studies.

BACKGROUND: Corticosteroid injection is a common treatment for individuals experiencing musculoskeletal pain, and it is part of the management of numerous orthopaedic conditions. However, there is concern about offering corticosteroid injections for musculoskeletal pain because of the possibility of secondary adrenal insufficiency. QUESTIONS/PURPOSES: In this systematic review and meta-analysis of prospective studies, we asked: (1) Are corticosteroid injections associated with secondary adrenal insufficiency as measured by 7-day morning serum cortisol? (2) Does this association differ depending on whether the shot was administered in the spine or the appendicular skeleton? METHODS: We searched the Allied and Complementary Medicine (AMED), Embase, EmCare, MEDLINE, CINAHL, and Web of Science from inception to January 22, 2021. We retrieved 4303 unique records, of which 17 were eventually included. Study appraisal was via the Downs and Black tool, with an average quality rating of fair. A Grading of Recommendations, Assessment, Development, and Evaluations assessment was conducted with the overall certainty of evidence being low to moderate. Reflecting heterogeneity in the study estimates, a pooled random-effects estimate of cortisol levels 7 days after corticosteroid injection was calculated. Fifteen studies or subgroups (254 participants) provided appropriate estimates for statistical pooling. A total of 106 participants received a spine injection, and 148 participants received an appendicular skeleton injection, including the glenohumeral joint, subacromial bursa, trochanteric bursa, and knee. RESULTS: Seven days after corticosteroid injection, the mean morning serum cortisol was 212 nmol/L (95% confidence interval 133 to 290), suggesting that secondary adrenal insufficiency was a possible outcome. There is a difference in the secondary adrenal insufficiency risk depending on whether the injection was in the spine or the appendicular skeleton. For spinal injection, the mean cortisol was 98 nmol/L (95% CI 48 to 149), suggesting secondary adrenal insufficiency was likely. For appendicular skeleton injection the mean cortisol was 311 nmol/L (95% CI 213 to 409) suggesting hypothalamic-pituitary-adrenal axis integrity was likely. CONCLUSION: Clinicians offering spinal injections should discuss the possibility of short-term secondary adrenal insufficiency with patients, and together, they can decide whether the treatment remains appropriate and whether mitigation strategies are needed. Clinicians offering appendicular skeleton injections should not limit care because of concerns about secondary adrenal insufficiency based on the best available evidence, and clinical guidelines could be reviewed accordingly. Further research is needed to understand whether age and/or sex determine risk of secondary adrenal insufficiency and what clinical impact secondary adrenal insufficiency has on patients undergoing spinal injection. LEVEL OF EVIDENCE: Level IV, therapeutic study.

Effectiveness of early versus delayed rehabilitation following total shoulder replacement: A systematic review.

OBJECTIVE: To investigate the effectiveness of early versus delayed rehabilitation following total shoulder replacement. DESIGN: Intervention systematic review with narrative synthesis. LITERATURE SEARCH: MEDLINE, EMBASE, CINAHL, Scopus and the Cochrane Library were searched from inception to the 29th of July 2021. STUDY SELECTION CRITERIA: Randomised controlled trials comparing early versus delayed rehabilitation following primary anatomic, primary reverse, or revision total shoulder replacement. DATA SYNTHESIS: A revised Cochrane risk of bias assessment tool for randomised controlled trials was used, as well as the Grading of Recommendations Assessment, Development and Evaluation approach to evaluate the quality of evidence. A narrative synthesis was undertaken. RESULTS: Three eligible randomised controlled trials (n = 230) were included. There was very low-quality evidence of no statistically significant difference (P > 0.05) in pain, shoulder function, health-related quality of life or lesser tuberosity osteotomy healing at 12 months between early or delayed rehabilitation. There was conflicting and very low-quality evidence of a difference between the effect of early and delayed rehabilitation on shoulder range of movement. There was limited, very low-quality evidence of statistically significantly improved pain and function (P < 0.05) in the early post-operative period with early rehabilitation following anatomic total shoulder replacement. CONCLUSIONS: No differences were seen in patient-reported or clinician-reported outcomes at 12 months post-surgery between early and delayed rehabilitation following total shoulder replacement. There is very low-quality evidence that early rehabilitation may improve shoulder pain and function in the early post-operative phase following anatomic total shoulder replacement.

Effectiveness of early versus delayed rehabilitation following rotator cuff repair: Systematic review and meta-analyses.

OBJECTIVE: To investigate the effectiveness of early rehabilitation compared with delayed/standard rehabilitation after rotator cuff repair for pain, function, range of movement, strength, and repair integrity. DESIGN: Systematic review and meta-analyses. METHODS: We searched databases and included randomised controlled trials (RCTs) comparing early with delayed/standard rehabilitation for patients undergoing rotator cuff repair surgery. We assessed risk of bias of the RCTs using the Cochrane RoB 2 tool. RESULTS: Twenty RCTs, with 1841 patients, were included. The majority of the RCTs were of high or unclear risk of overall bias. We found substantial variations in the rehabilitation programmes, time in the sling and timing of exercise progression. We found no statistically significant differences for pain and function at any follow-up except for the outcome measure Single Assessment Numeric Evaluation at six months (MD: 6.54; 95%CI: 2.24-10.84) in favour of early rehabilitation. We found statistically significant differences in favour of early rehabilitation for shoulder flexion at six weeks (MD: 7.36; 95%CI: 2.66-12.06), three (MD: 8.45; 95%CI: 3.43-13.47) and six months (MD: 3.57; 95%CI: 0.81-6.32) and one year (MD: 1.42; 95%CI: 0.21-2.64) and similar differences for other planes of movement. In terms of repair integrity, early mobilisation does not seem to increase the risk of re-tears (OR:1.05; 95%CI: 0.64-1.75). DISCUSSION: Current approaches to early mobilisation, based largely on early introduction of passive movement, did not demonstrate significant differences in most clinical outcomes, although we found statistically significant differences in favour of early rehabilitation for range of movement. Importantly, there were no differences in repair integrity between early and delayed/standard rehabilitation. Most rehabilitation programmes did not consider early active movement as soon as the patient feels able. With ongoing variation in rehabilitation protocols there remains a need for large high quality RCT to inform the optimal approach to rehabilitation after rotator cuff repair surgery.

Rehabilitation following rotator cuff repair: A survey of current practice (2020).

INTRODUCTION: Approaches to rehabilitation following rotator cuff repair are variable but typically include 4-6 weeks of immobilisation followed by a gradual introduction of movement and activity. However, research has questioned whether such an approach is optimal. The aim of this study was to undertake an updated survey to understand whether practice has evolved in line with contemporary research. METHODS: An electronic survey was developed describing three case scenarios (medium-sized rotator cuff repair [2 cm], large-sized rotator cuff repair [4 cm] and large-sized rotator cuff repair with biceps tenodesis). Clinicians involved with rehabilitation following rotator cuff repair were invited to participate. RESULTS: 129 responses were received (United Kingdom = 87, other regions [ORs] = 42). Respondents would most commonly recommend four to six weeks of immobilisation for all case scenarios. Passive movement would commence during this period, with active movement recommended from four to six weeks. Resisted exercise would commence between seven to 12 weeks along with return to driving. There were some minor differences in recommendations between respondents from the United Kingdom and ORs, including a greater proportion from the United Kingdom recommending sling immobilisation rather than abduction brace immobilisation. CONCLUSION: For many respondents to this survey, rehabilitation for the three case scenarios was similar and has not evolved in line with contemporary research evidence. The reasons behind this need to be explored and incorporated into the design of future research evaluating rehabilitation following rotator cuff repair.

Rehabilitation following rotator cuff repair: A multi-centre pilot & feasibility randomised controlled trial (RaCeR).

OBJECTIVE: To evaluate the feasibility of a multi-centre randomised controlled trial to compare the clinical and cost-effectiveness of early patient-directed rehabilitation versus standard rehabilitation following surgical repair of the rotator cuff of the shoulder. DESIGN: Two-arm, multi-centre pilot and feasibility randomised controlled trial. SETTING: Five National Health Service hospitals in England. PARTICIPANTS: Adults (n = 73) with non-traumatic rotator cuff tears scheduled for repair were recruited and randomly allocated remotely prior to surgery. INTERVENTIONS: Early patient-directed rehabilitation (n = 37); advised to remove their sling as soon as able and move as symptoms allow. Standard rehabilitation (n = 36); sling immobilisation for four weeks. MEASURES: (1) Randomisation of 20% or more eligible patients. (2) Difference in time out of sling of 40% or more between groups. (3) Follow-up greater than 70%. RESULTS: 73/185 (39%) potentially eligible patients were randomised. Twenty participants were withdrawn, 11 due to not receiving rotator cuff repair. The between-group difference in proportions of participants who exceeded the cut-off of 222.6 hours out of the sling was 50% (80% CI = 29%, 72%), with the early patient-directed rehabilitation group reporting greater time out of sling. 52/73 (71%) and 52/53 (98%) participants were followed-up at 12 weeks when withdrawals were included and excluded respectively. Eighteen full-thickness re-tears were reported (early patient-directed rehabilitation = 7, standard rehabilitation = 11). Five serious adverse events were reported. CONCLUSION: A main randomised controlled trial is feasible but would require allocation of participants following surgery to counter the issue of withdrawal due to not receiving surgery.

Rehabilitation following shoulder arthroplasty in the United Kingdom National Health Service: A survey of publicly facing information.

INTRODUCTION: The prevalence of shoulder arthroplasty (SA) is rising, but there is limited research evaluating rehabilitation following SA and whether there is an optimal approach remains unknown. The aim of this study was to understand current National Health Service (NHS) practice for rehabilitation following SA as a platform for conducting much needed further research. METHODS: Two reviewers independently undertook electronic searches for publicly available information sheets (PIS) from websites of NHS Trusts that included detail about rehabilitation following SA, for example, duration of immobilisation. One reviewer extracted data, and a second reviewer verified this. ETHICAL APPROVAL: Not required. RESULTS: Forty-three PIS from 40 Trusts were identified. Twenty-four referred to more than one type of arthroplasty (anatomic, reverse and hemiarthroplasty) but did not describe different approaches to rehabilitation based on prosthesis type. Twenty-five PIS provided some instruction regarding movement restrictions, which varied considerably. All PIS referred to postoperative immobilisation, typically with a sling, with median duration of 4 weeks (range 0 to 8). Thirty-four PIS reported commencing passive exercise immediately. Median time to commencing active exercise was 4 weeks (range 1 to 6) and 5 weeks (range 1 to 16) for resisted exercise. Median time expected to return to driving was 6 weeks (range 3 to 12) and general work 12 weeks (range 3 to 26). CONCLUSION: This study has highlighted significant heterogeneity between rehabilitation approaches following SA, not previously reported in the United Kingdom, with a lack of specific rehabilitation PIS for different prosthesis types. Our results will facilitate evaluation of rehabilitation strategies in future research.

Protocol for a multi-centre pilot and feasibility randomised controlled trial with a nested qualitative study: rehabilitation following rotator cuff repair (the RaCeR study).

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 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.