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

2020 ◽  
pp. 026921552097885
Author(s):  
Chris Littlewood ◽  
Marcus Bateman ◽  
Stephanie Butler-Walley ◽  
Sarah Bathers ◽  
Kieran Bromley ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Rotator Cuff ◽  
Rotator Cuff Repair ◽  
Controlled Trial ◽  
Rotator Cuff Tears ◽  
Serious Adverse Events ◽  
Feasibility Randomised Controlled Trial ◽  
Time Out ◽  
Randomised Controlled ◽  
Cuff Repair

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 Twenty participants were withdrawn, 11 due to not receiving rotator cuff repair.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.

scholarly journals Postoperative Mobilization After Superior Rotator Cuff Repair: Sling versus No-sling. A Randomized Controlled Trial: Sling versus no-sling after RCR

2019 ◽  
Vol 7 (5_suppl3) ◽  
pp. 2325967119S0021
Author(s):  
Jérome Tirefort ◽  
Adrien J. Schwitzguebel ◽  
Philippe Collin ◽  
Alexandra Nowak ◽  
Chantal Plomb-Holmes ◽  
...  
Keyword(s):  
Rotator Cuff ◽  
Rotator Cuff Repair ◽  
External Rotation ◽  
Controlled Trial ◽  
Patient Characteristics ◽  
Rotator Cuff Tears ◽  
Negative Effects ◽  
Radiographic Outcomes ◽  
Functional Scores ◽  
Cuff Repair

Objectives Patients are commonly advised to wear a sling for 4–6 weeks after rotator cuff repair (RCR) despite negative effects of early immobilization and benefits of motion rehabilitation. The study aimed to compare clinical and radiographic outcomes up to 6 months following RCR with sling immobilization and without sling immobilization. Methods We randomized 80 patients scheduled for arthroscopic repair of small or medium superior rotator cuff tears into 2 equal groups: ‘sling’ and ‘no-sling’ groups. Passive mobilization was performed in both groups during the first 4 postoperative weeks followed by a progressive active mobilization. Patients were evaluated clinically at 10 days, 1.5, 3 and 6 months, and using ultrasound at 6 months. Uni- and multi-variable analyses were performed to determine if postoperative scores are associated with gender, age at surgery, immobilization, arm dominance, biceps procedure, resection of the distal clavicle, as well as preoperative scores. Results The two groups had similar preoperative patient characteristics, function, or adjuvant procedures. At 10 days, there was no difference in pain among the two groups (5.2±2.3 vs 5.2±1.9, p=0.996). In comparison to the sling group, the no-sling group showed greater external rotation (23.5±15.6 vs 15.3±14.6, p=0.017) and active elevation (110.9±31.9 vs 97.0±25.0, p=0.038) at 1.5 months, as well as better active elevation (139.0±24.7 vs 125.8±24.4, p=0.015) and internal rotation (>T12 in 50% vs 27.5%, p=0.011) at 3 months. Ultrasound revealed no differences at 6 months in tendon thickness anteriorly (p=0.472) or posteriorly (p=639), bursitis (p=1.000), echogenicity (p=0.422), or repair integrity (p=0.902). Multi-variable analyses confirmed that ASES score increased with patient age (beta, 0.60; p=0.009), SANE decreased with sling immobilization (beta, -6.3; p=0.014), and that pain increased with sling immobilization (beta, 0.77; p=0.022). Conclusion No immobilization after RCR is associated with better early mobility and functional scores in comparison to sling immobilization. Postoperative immobilization with slings may therefore not be required for patients treated for small or medium tears.

scholarly journals Rehabilitation following rotator cuff repair: A survey exploring clinical equipoise among surgical members of the British Elbow and Shoulder Society

2021 ◽  
pp. 175857322110598
Author(s):  
Bruno Mazuquin ◽  
Marcus Bateman ◽  
Alba Realpe ◽  
Steve Drew ◽  
Jonathan Rees ◽  
...  
Keyword(s):  
Rotator Cuff ◽  
Rotator Cuff Repair ◽  
Online Survey ◽  
Controlled Trial ◽  
Clinical Equipoise ◽  
Early Mobilisation ◽  
Clinical Scenarios ◽  
Randomised Controlled ◽  
Cuff Repair ◽  
Tear Size

Background We investigated clinical equipoise across surgical members of the British Elbow and Shoulder Society (BESS) in relation to rehabilitation following rotator cuff repair. Method An online survey explored clinical equipoise regarding early patient-directed versus standard rehabilitation after rotator cuff repair to inform the design of a national randomised controlled trial (RCT). It described different clinical scenarios relating to patient age, tear size, location and whether other patient-related and intra-operative factors would influence equipoise. Results 76 surgeons completed the survey. 81% agreed/ strongly agreed that early mobilisation might benefit recovery; 57% were neutral/ disagreed that this approach risks re-tear. 87% agreed/ strongly agreed that there is clinical uncertainty about the effectiveness of different approaches to rehabilitation. As age of the patient and tear size increased, the proportion of respondents who would agree to recruit and accept the outcome of randomisation reduced, and this was compounded if subscapularis was torn. Other factors that influenced equipoise were diabetes and non-secure repair. Conclusion Surgical members of BESS recognise uncertainty about the effectiveness of different approaches to rehabilitation following rotator cuff repair. We identified a range of factors that influence clinical equipoise that will be considered in the design of a new RCT.

scholarly journals Articular-sided rotator cuff tears: which is the best repair? A three-year prospective randomised controlled trial

2013 ◽  
Vol 37 (8) ◽  
pp. 1487-1493 ◽  
Author(s):  
Francesco Franceschi ◽  
Rocco Papalia ◽  
Angelo Del Buono ◽  
Sebastiano Vasta ◽  
Vincenzo Costa ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Rotator Cuff ◽  
Controlled Trial ◽  
Rotator Cuff Tears ◽  
Randomised Controlled

scholarly journals Protocol for a multi-site pilot and feasibility randomised controlled trial: Surgery versus PhysiothErapist-leD exercise for traumatic tears of the rotator cuff (the SPeEDy study)

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Chris Littlewood ◽  
Julia Wade ◽  
Stephanie Butler-Walley ◽  
Martyn Lewis ◽  
David Beard ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Rotator Cuff ◽  
Surgical Repair ◽  
Controlled Trial ◽  
Cost Effective ◽  
Rotator Cuff Tears ◽  
Link Type ◽  
Effective Interventions ◽  
Randomised Controlled ◽  
Feasibility Rct

Abstract Background Clinically, a distinction is made between types of rotator cuff tear, traumatic and non-traumatic, and this sub-classification currently informs the treatment pathway. It is currently recommended that patients with traumatic rotator cuff tears are fast tracked for surgical opinion. However, there is uncertainty about the most clinically and cost-effective intervention for patients with traumatic rotator cuff tears and further research is required. SPeEDy will assess the feasibility of a fully powered, multi-centre randomised controlled trial (RCT) to test the hypothesis that, compared to surgical repair (and usual post-operative rehabilitation), a programme of physiotherapist-led exercise is not clinically inferior, but is more cost-effective for patients with traumatic rotator cuff tears. Methods SPeEDy is a two-arm, multi-centre pilot and feasibility RCT with integrated Quintet Recruitment Intervention (QRI) and further qualitative investigation of patient experience. A total of 76 patients with traumatic rotator cuff tears will be recruited from approximately eight UK NHS hospitals and randomly allocated to either surgical repair and usual post-operative rehabilitation or a programme of physiotherapist-led exercise. The QRI is a mixed-methods approach that includes data collection and analysis of screening logs, audio recordings of recruitment consultations, interviews with patients and clinicians involved in recruitment, and review of study documentation as a basis for developing action plans to address identified difficulties whilst recruitment to the RCT is underway. A further sample of patient participants will be purposively sampled from both intervention groups and interviewed to explore reasons for initial participation, treatment acceptability, reasons for non-completion of treatment, where relevant, and any reasons for treatment crossover. Discussion Research to date suggests that there is uncertainty regarding the most clinically and cost-effective interventions for patients with traumatic rotator cuff tears. There is a clear need for a high-quality, fully powered, RCT to better inform clinical practice. Prior to this, we first need to undertake a pilot and feasibility RCT to address current uncertainties about recruitment, retention and number of and reasons for treatment crossover. Trial registration ClinicalTrials.gov (NCT04027205) – Registered on 19 July 2019. Available via

scholarly journals Supporting wellbeing through peer-befriending (SUPERB) for people with aphasia: A feasibility randomised controlled trial

2021 ◽  
pp. 026921552199567 ◽  
Author(s):  
Katerina Hilari ◽  
Nicholas Behn ◽  
Kirsty James ◽  
Sarah Northcott ◽  
Jane Marshall ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Usual Care ◽  
Controlled Trial ◽  
Significant Others ◽  
Community Services ◽  
Serious Adverse Events ◽  
Post Stroke ◽  
Feasibility Randomised Controlled Trial ◽  
Low Levels ◽  
Randomised Controlled

Objective: To determine the feasibility and acceptability of peer-befriending, for people with aphasia. Design: Single-blind, parallel-group feasibility randomised controlled trial comparing usual care to usual care + peer-befriending. Participants and setting: People with aphasia post-stroke and low levels of distress, recruited from 5 NHS Hospitals and linked community services; their significant others; and 10 befrienders recruited from community. Intervention: Six 1-hour peer-befriending visits over three months. Main measures: Feasibility parameters included proportion eligible of those screened; proportion consented; missing data; consent and attrition rates. Acceptability was explored through qualitative interviews. Outcomes for participants and significant others were measured at baseline, 4- and 10-months; for peer-befrienders before training and after one/two cycles of befriending. Results: Of 738 patients identified, 75 were eligible of 89 fully screened (84%), 62 consented (83% of eligible) and 56 randomised. Attrition was 16%. Adherence was high (93% attended ⩾2 sessions, 81% all six). The difference at 10 months on the GHQ-12 was 1.23 points on average lower/better in the intervention arm (95% CI 0.17, −2.63). There was an 88% decrease in the odds of GHQ-12 caseness (95% CI 0.01, 1.01). Fourty-eight significant others and 10 peer-befrienders took part. Procedures and outcome measures were acceptable. Serious adverse events were few ( n = 10, none for significant others and peer-befrienders) and unrelated. Conclusions: SUPERB peer-befriending for people with aphasia post-stroke experiencing low levels of distress was feasible. There was preliminary evidence of benefit in terms of depression. Peer-befriending is a suitable intervention to explore further in a definitive trial. Clinical trial registration-URL: http://www.clinicaltrials.gov Unique identifier: NCT02947776 Subject terms: Translational research, mental health, rehabilitation, quality and outcomes, stroke

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