NCT04027205

Brief Summary

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 16, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 19, 2019

Completed
8 months until next milestone

Study Start

First participant enrolled

March 3, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 3, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 3, 2021

Completed
Last Updated

February 18, 2021

Status Verified

February 1, 2021

Enrollment Period

11 months

First QC Date

July 16, 2019

Last Update Submit

February 16, 2021

Conditions

Traumatic Rotator Cuff Tear

Outcome Measures

Primary Outcomes (7)

  • 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

Secondary Outcomes (4)

  • 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

Other Outcomes (2)

  • 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

Study Arms (2)

Physiotherapist-led exercise

EXPERIMENTAL

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.

Other: Physiotherapist-led exercise

Surgical repair

ACTIVE COMPARATOR

Surgical repair of the rotator cuff plus usual post-operative rehabilitation.

Procedure: Surgical repair

Interventions

Physiotherapist-led exerciseOTHER

A programme of physiotherapist-led exercise over approximately 12 weeks.

Physiotherapist-led exercise
Surgical repairPROCEDURE

Surgical repair of the rotator cuff plus usual post-operative rehabilitation

Surgical repair

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients (≥18 years)
  • Diagnosed with a symptomatic tear of the rotator cuff following a traumatic incident thought to be of sufficient force to induce a tear.
  • Rotator cuff tear confirmed by diagnostic ultrasound or MRI scan undertaken as part of routine diagnostic work-up
  • Eligible for rotator cuff repair surgery or a programme of physiotherapist-led exercise as determined by the attending clinician (surgeon or physiotherapist, where appropriate)
  • Able to return to the participating NHS hospital or associated orthopaedic and physiotherapy services (where physiotherapists have been trained in trial interventions) for post-operative rehabilitation or the programme of physiotherapist-led exercise.
  • Able to understand English.

You may not qualify if:

  • Not eligible for rotator cuff repair surgery or a programme of physiotherapist-led exercise as determined by the attending clinician (surgeon or physiotherapist, where appropriate)
  • Patients who are unable to give full informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Derby & Burton NHS

Derby, United Kingdom

Location

Related Publications (2)

  • 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.

    PMID: 33413664DERIVED

  • 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.

    PMID: 33316867DERIVED

MeSH Terms

Interventions

Wound Healing

Intervention Hierarchy (Ancestors)

RegenerationBiological Phenomena

Study Officials

  • Chris Littlewood, PhD

    Manchester Metropolitan University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2019

First Posted

July 19, 2019

Study Start

March 3, 2020

Primary Completion

February 3, 2021

Study Completion

February 3, 2021

Last Updated

February 18, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, CSR

Locations

GB(1)