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Protocol for a Multi-Site Pilot and Feasibility Randomised Controlled Trial Littlewood et al. Pilot and Feasibility Studies (2021) 7:17 https://doi.org/10.1186/s40814-020-00714-x STUDY PROTOCOL Open Access 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) Chris Littlewood1,2* , Julia Wade3, Stephanie Butler-Walley1,4, Martyn Lewis1,4, David Beard5, Amar Rangan5,6, Gev Bhabra7, Socrates Kalogrianitis8, Cormac Kelly9, Saurabh Mehta10, Harvinder Pal Singh11, Matthew Smith12, Amol Tambe13, James Tyler14 and Nadine E. Foster1 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. (Continued on next page) * Correspondence: [email protected] 1School of Primary, Community and Social Care, Keele University, Staffordshire, UK 2Department of Health Professions, Faculty of Health, Psychology & Social Care, Manchester Metropolitan University, Manchester, UK Full list of author information is available at the end of the article © The Author(s). 2021 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data. Littlewood et al. Pilot and Feasibility Studies (2021) 7:17 Page 2 of 11 (Continued from previous page) 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 Keywords: Surgery, Physiotherapy, Exercise, Rotator cuff tear, Shoulder, Randomised controlled trial Introduction the programme of physiotherapist-led exercise [10]. Background and rationale Hence, there is uncertainty about optimal interventions Shoulder pain presents a significant personal, social and for traumatic rotator cuff tears based on evidence from a economic burden and impacts on work, ability to under- limited number of patients and from RCTs with rela- take leisure and household tasks and causes disturbed tively short-term follow-up. sleep [1]. Tears of the rotator cuff are regarded as a sig- Despite this uncertainty from RCTs, other reasons for nificant cause of shoulder pain and rates of surgery to current guidelines recommending fast track for surgical repair the torn rotator cuff have risen approximately opinion for people with traumatic rotator cuff tears in- 200% over recent years across Europe and the USA [2– clude a concern that a delayed surgical repair is more 5]. In the UK NHS, 8838 surgical repairs of the rotator technically challenging and that delay risks poorer clin- cuff were undertaken in 2018/2019 with approximately ical outcomes. Several non-randomised studies have one-third undertaken for traumatic tears [6]. Depending evaluated the impact of time to surgery on clinical out- on complexity, the cost of surgical repair ranges from comes. Findings vary considerably with some recom- £3676 to £6419 [7] meaning that direct NHS treatment mending surgery within 4 months of symptom onset costs alone range from £26.6 to £51.4 million annually, [11], some 6 months [12] and some 24 months [13], yet and £10.8 to £18.9 million specifically for traumatic rota- others conclude that time to surgery is not a critical fac- tor cuff tears. tor [14]. Thus, there is considerable uncertainty and Different treatment pathways are proposed in the given that asymptomatic rotator cuff tears are very com- current British Elbow & Shoulder Society and British mon, it is also difficult to attribute tears of the rotator Orthopaedic Association guidelines [8] for patients pre- cuff to recent trauma with confidence [15]. Imaging for senting with non-traumatic as opposed to traumatic ro- shoulder pain following trauma may in fact be identify- tator cuff tears. These guidelines recommend that ing an existing asymptomatic rotator cuff tear. Another patients with traumatic rotator cuff tears are fast tracked reason proposed in support of current guidelines recom- for surgical opinion. Three randomised controlled trials mending fast track for surgical opinion relates to pro- (RCTs) (n = 252) comparing surgery to non-surgical gression, i.e. the increasing size of a rotator cuff tear if treatment for rotator cuff tears have been undertaken not operated on [16]. It has been reported that 42 to and synthesised in a systematic review (SR) [9]. The re- 47% of symptomatic tears increase in size up to 100 view concluded that, although the evidence is limited in months follow-up [16, 17] with the greatest rate of in- terms of quality, current research suggests no difference crease in those with full-thickness tears observed in 82% in clinical outcomes at 1 year between surgery and non- versus 26% of those with partial-thickness tears [17]. surgical treatment. However, of the 252 patients in- Hence, most full thickness and some partial-thickness cluded in the SR, only 40 (16%) were diagnosed with rotator cuff tears do increase in size over time, but it is traumatic tears of the rotator cuff (24 randomised to apparent that some do not and, importantly, surgery is surgery; 16 to physiotherapist-led exercise). Since the not guaranteed to prevent progression and these in- publication of this SR, one further RCT (n = 58) focusing creases in the size of tear are not consistently associated specifically on traumatic rotator cuff tears has been pub- with poorer clinical outcome in terms of pain and func- lished [10]. This RCT compared surgical repair with a tion [17, 18]. To further highlight uncertainty in the programme of physiotherapist-led exercise for acute management of rotator cuff tears, the UKUFF trial [1] traumatic rotator cuff tears located mainly within reported a 40% re-tear or failed-healing rate following supraspinatus [10]. At 12 months, there was no signifi- surgical repair of non-traumatic rotator cuff tears but cant between-group difference in terms of shoulder pain the outcomes for these patients were not clinically sig- and function. Re-tear was reported in 6.5% of partici- nificantly different from those patients who did not re- pants undergoing repair and tear size progression tear their rotator cuff. Similar findings have also been re- greater than 5 mm in 29.2% of participants undergoing ported in a systematic review and meta-analysis of 14 Littlewood et al. Pilot and Feasibility Studies (2021) 7:17 Page 3 of 11 studies (n =861)[19]. This suggests that the tear might Eligibility criteria not be the only source of symptoms and surgical
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