Evidence map›Paper›PMID 33413664›Full record

ArticlePilot and feasibility studies2021

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 Littlewood, Julia Wade, Stephanie Butler-Walley, Martyn Lewis, David Beard, Amar Rangan, Gev Bhabra, Socrates Kalogrianitis, Cormac Kelly, Saurabh Mehta and 5 more

Registry-linked trialOpen access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Pilot and feasibility studies, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04027205 (Surgery Versus PhysiothErapist-leD Exercise for Traumatic Tears of the Rotator Cuff), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact, top 100% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04027205 nawithdrawnnot on this map

Surgery Versus PhysiothErapist-leD Exercise for Traumatic Tears of the Rotator Cuff: a Multi-site Pilot and Feasibility Randomised Controlled Trial (the SPeEDy Study)

TypeinterventionalSponsorKeele UniversityRan2020 to 2021Enrolled0ConditionsTraumatic Rotator Cuff TearArmsPhysiotherapist-led exercise, Surgical repair
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 4 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors at 12 institutions in 1 country.

Chris LittlewoodSchool of Primary, Community and Social Care, Keele University, Staffordshire, UK. c.littlewood@mmu.ac.uk.ORCID http://orcid.org/0000-0002-7703-727X
Julia WadePopulation Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.
Stephanie Butler-WalleySchool of Primary, Community and Social Care, Keele University, Staffordshire, UK.
Martyn LewisSchool of Primary, Community and Social Care, Keele University, Staffordshire, UK.
David BeardNuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
Amar RanganNuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
Gev BhabraUniversity Hospitals Coventry & Warwickshire, Coventry, UK.
Socrates KalogrianitisQueen Elizabeth Hospital Birmingham, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.
Cormac KellyThe Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust, Oswestry, UK.
Saurabh MehtaRoyal Stoke University Hospital, University Hospitals of North Midlands NHS Trust, Stoke, UK.
Harvinder Pal SinghLeicester Shoulder Unit, University Hospitals of Leicester NHS Trust, Leicester, UK.
Matthew SmithThe Liverpool Upper Limb Unit, The Royal Liverpool and Broadgreen University Hospitals NHS Trust, Liverpool, UK.
Amol TambeDerby Shoulder Unit, University Hospitals Derby & Burton NHS Foundation Trust, Derby, UK.
James TylerAiredale General Hospital, Airedale NHS Foundation Trust, Keighley, UK.
Nadine E FosterSchool of Primary, Community and Social Care, Keele University, Staffordshire, UK.
Keele University · GBNuffield Orthopaedic Centre · GBAiredale General Hospital · GBManchester Metropolitan University · GBRobert Jones and Agnes Hunt Orthopaedic Hospital · GBRoyal Liverpool and Broadgreen University Hospital NHS Trust · GBUniversity Hospitals Birmingham NHS Foundation Trust · GBUniversity Hospitals Coventry and Warwickshire NHS Trust · GBUniversity Hospitals of Derby and Burton NHS Foundation Trust · GBUniversity Hospitals of Leicester NHS Trust · GBUniversity Hospitals of North Midlands NHS Trust · GBUniversity of Bristol · GB

Funding

Medical Research Council MR/K025643/1Research Trainees Coordinating Centre PDF-2018-11-ST2-005
6 · The paper itself

Abstract

backgroundClinically, 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.

methodsSPeEDy 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 registrationClinicalTrials.gov ( NCT04027205 ) - Registered on 19 July 2019. Available via.

Indexed as

ExercisePhysiotherapyRandomised controlled trialRotator cuff tearShoulderSurgery

Identifiers

PMID33413664
PMCPMC7788278
OpenAlexW3095855983

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.