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)

Littlewood, Chris; Wade, Julia; Butler-Walley, Stephanie; Lewis, Martyn; Beard, David; Rangan, Amar; Bhabra, Gev; Kalogrianitis, Socrates; Kelly, Cormac; Mehta, Saurabh; Singh, Harvinder Pal; Smith, Matthew; Tambe, Amol; Tyler, James; Foster, Nadine E.

Abstract

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.

Citation

Littlewood, C., Wade, J., Butler-Walley, S., Lewis, M., Beard, D., Rangan, A., …Foster, N. E. (2021). 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 and Feasibility Studies, 7(1), https://doi.org/10.1186/s40814-020-00714-x

• Journal Article Type: Article
• Acceptance Date: Oct 27, 2020
• Online Publication Date: Jan 7, 2021
• Publication Date: 2021-12
• Deposit Date: May 30, 2023
• Journal: Pilot and Feasibility Studies
• Print ISSN: 2055-5784
• Publisher: BioMed Central
• Peer Reviewed: Peer Reviewed
• Volume: 7
• Issue: 1
• DOI: https://doi.org/10.1186/s40814-020-00714-x
• Keywords: Medicine (miscellaneous)
• Additional Information: Received: 3 September 2020; Accepted: 27 October 2020; First Online: 7 January 2021; : This study has been reviewed and a favourable opinion provided by the South East Scotland Research Ethics Committee (Reference: 19/SS/0098). All participants provide written consent to participate after receiving a full written and verbal explanation of the study’s aims, procedures and risks.; : Consent for publication is not applicable as there are no identifying images of other personal details of participants presented.; : AR receives educational and research grants from DePuy J&J Ltd. All other authors declare that they have no competing interests.