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 Twenty participants were withdrawn, 11 due to not receiving rotator cuff repair.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.
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.
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.
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. Electronic supplementary material The online version of this article (10.1186/s13063-019-3407-3) contains supplementary material, which is available to authorized users.
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.
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