NCT04027205|Withdrawn
Study Stopped
Due to Covid-19 disruption
Surgery Versus PhysiothErapist-leD Exercise for Traumatic Tears of the Rotator Cuff
SPeEDy
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Due to Covid-19 disruption
SPeEDy
Sponsor study identifier
interventional
0
1 country
1
Study Start
March 3, 2020
Actual (reported)Primary Completion
February 3, 2021
Actual (reported)Study Completion
February 3, 2021
Actual (reported)The SPeEDy study is a parallel group, pilot and feasibility randomised controlled trial (RCT) with integrated Quintet Recruitment Intervention (QRI) and further qualitative interviews. The study hypothesis is: In adult patients diagnosed with traumatic tears of the rotator cuff, is it feasible to conduct a future, substantive, multi-site RCT to test the hypothesis that physiotherapist-led exercise is not inferior to surgical repair of the rotator cuff in terms of clinical outcomes but is more cost-effective.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 3, 2021
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 16, 2019
Actual (reported)July 19, 2019
Actual (reported)March 3, 2020
Actual (reported)February 3, 2021
Actual (reported)February 3, 2021
Actual (reported)Numbers of patients screened, number eligible, number approached, number consenting, number randomised, and number accepting allocation
Numbers of patients screened, number eligible, number approached, number consenting, number randomised, and number accepting allocation will be recorded descriptively
Over recruitment period, 15 months
Numbers of participants continuing in allocated treatment
Numbers of participants continuing in allocated treatment will be recorded descriptively
Six months
Follow-up response rates to questionnaires (including Oxford Shoulder Score and EQ-5D-5L)
Follow-up response rates to questionnaires will be recorded descriptively
Three months post-randomisation
Follow-up response rates to questionnaires (including Oxford Shoulder Score and EQ-5D-5L)
Follow-up response rates to questionnaires will be recorded descriptively
Six months post-randomisation
Determination of zone of clinical equipoise
Data from screening logs, including reasons for not approaching potentially eligible patients will be recorded descriptively to inform determination of zone of clinical equipoise
Over recruitment period, 15 months
Treatment cross-over
Numbers of participants receiving treatment (surgery or PT-led exercise) other than that which was allocated to determine proportion of participants who cross-over will be recorded descriptively
Six months
Participant satisfaction with the interventions: five-point ordinal scale
Participant satisfaction with the interventions on a five-point ordinal scale; Very Satisfied/Satisfied/Neutral/Dissatisfied/Very Dissatisfied
Six months
Pain and disability assessed using the Oxford Shoulder Score (OSS)
Three and six months post-randomisation
Health related quality of life assessed using the EQ-5D-5L
Three and six months post-randomisation
Days lost from work due to the shoulder problem
Three and six months post-randomisation
Time taken to return to driving
Three and six months post-randomisation
Number of recruiting participating sites and numbers of additional sites who are interested in participating in the main trial
Whole study period, 36 months
Number and type of adverse events
Up to six months post-randomisation
Structured and progressive physiotherapist-led exercise programme. Reflective of current guidance for exercise programmes for people with rotator cuff disorders, an individualised programme developed in relation to the participant's specific goals will be prescribed by the physiotherapist and supported over approximately six contact sessions across a 12-week period.
Surgical repair of the rotator cuff plus usual post-operative rehabilitation.
A programme of physiotherapist-led exercise over approximately 12 weeks.
Surgical repair of the rotator cuff plus usual post-operative rehabilitation
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
University Hospital of Derby & Burton NHS
Derby, United Kingdom
Littlewood C, Wade J, Butler-Walley S, Lewis M, Beard D, Rangan A, Bhabra G, Kalogrianitis S, Kelly C, Mehta S, Singh HP, Smith M, Tambe A, Tyler J, Foster NE. 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). Pilot Feasibility Stud. 2021 Jan 7;7(1):17. doi: 10.1186/s40814-020-00714-x.
Littlewood C, Astbury C, Bush H, Gibson J, Lalande S, Miller C, Pitt L, Tunnicliffe H, Winstanley R. Development of a physiotherapist-led exercise programme for traumatic tears of the rotator cuff for the SPeEDy study. Physiotherapy. 2021 Jun;111:66-73. doi: 10.1016/j.physio.2020.07.008. Epub 2020 Aug 3.
Chris Littlewood, PhD
Manchester Metropolitan University
0 participants (actual enrollment reported by the registry).
First Submitted
July 16, 2019
First Posted
July 19, 2019
Study Start
March 3, 2020
Actual (reported)Prospective/Retrospective Registry of the E-vita OPEN PLUS Stent Graft System in France
Contact the study team to confirm eligibility.
Primary Completion
February 3, 2021
Actual (reported)Study Completion
February 3, 2021
Actual (reported)Last Updated
February 18, 2021
Record last verified: 2021-02
The anonymised datasets generated during and/or analysed during the current study are/will be available upon request from primarycare.datasharing@keele.ac.uk. Core data will be available immediately after publication of the trial results. A data request form is required to be completed and must outline the type of data to be obtained, the reason for obtaining this data (research question / objective), the timing for when the data is required to be available (start date/end date). Checks will be performed by a Data Custodian and Academic Proposals (DCAP) committee at Keele to ensure that the data set requested is appropriately suited to answer the research question/objective and that the request fits with the original ethical approval and participant consent and adheres to funder and legal restrictions. Only de-identified data are available for request in aggregated format or at the level of the individual participant.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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