Condition category
Injury, Occupational Diseases, Poisoning
Date applied
29/04/2015
Date assigned
30/04/2015
Last edited
19/05/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Ankle sprains are one of the most common soft tissue injuries, mostly involving the ligaments (strong bands of tissue connecting together bones) on the outside of the ankle. Many people go to A&E with a sprained ankle every year, with the extent of injury varying from minor stretching to complete tear of the ligaments. The injury itself is painful and, unless minor, makes walking difficult. Symptoms generally last for weeks but, for a significant minority of people, they can actually last for months or years. Treatment generally depends on how bad the injury is but includes advice, self care, physiotherapy, ankle support, immobilisation and surgical repair. It is often very difficult to determine how serious the injury is at initial presentation, due to the swelling and pain caused by the injury. Simple tests like standing on one leg can help to determine how bad the injury is. Summaries of the research literature conclude there is a lack of good-quality evidence to help clinical decision-making. Probably as a result of this, there is no standard guideline for UK emergency department (ED) clinicians to follow, so clinical practice varies. Our group have completed a large study looking at which types of ankle support are best for severe sprains. We are planning to use the data from this trial to develop a tool that will help clinicians assess the risk of patients having a good or poor recovery. We will then check how well it works in a new set of patients recruited from A&Es around the UK.

Who can participate?
Adult patients with ankle sprains.

What does the study involve?
The participants taking part in this study are followed up at set times by questionnaire over nine months. We believe poor recovery means serious problems with level of activity, pain, confidence/stability of the ankle and/or recurrent injury. It is a combination of these measures that we try and predict using a combination of clinical and patient reported measures taken at A&E visits. Examples include age, sex, ability to walk, stability of the ankle and swelling. To aid us in developing the prognostic model, we review the current research literature and consult clinical experts and patients on what are important factors and outcomes. Decisions are made from a choice of candidate tools, options on the presentation of tools and potential additional measurements. The decisions will be made at a face to face meeting called a Modified Nominal Group which aims to gain consensus on decisions. At the end of the two and a half years of research we aim to have developed a tool that will give a guide as to the chances of recovery for individual patients. A&E clinicians could then modify treatment or refer patients early for specialist treatment if they are at risk of poor recovery which could lead to more successful treatments and reduced costs to the NHS and society.

What are the possible benefits and risks of participating?
As this research is focused on using information, some of which is already routinely collected, the risk of harm is very low. The study will not interfere with ankle sprain treatment or any later rehabilitation participants might receive from their General Practitioner or Physiotherapist. We do not promise the study will help participants in particular, but the information we get from this study may help improve the NHS treatment for people with ankle sprains in the future

Where is the study run from?
A&E departments run by one of eight NHS trusts in the UK.

When is the study starting and how long is it expected to run for?
June 2015 to April 2017

Who is funding the study?
National Institute for Health Research (HTA programme).

Who is the main contact?
1. Mr Daryl Hagan (public)
sprained@ndorms.ox.ac.uk
2. Dr David Keene (scientific)

Trial website

http://www.nets.nihr.ac.uk/projects/hta/131906

Contact information

Type

Public

Primary contact

Mr Daryl Hagan

ORCID ID

Contact details

Clinical Trials Office
Kadoorie Centre - Level 3
John Radcliffe Hospital
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom
01865 228 368
sprained@ndorms.ox.ac.uk

Type

Scientific

Additional contact

Dr David Keene

ORCID ID

http://orcid.org/0000-0002-3488-847X

Contact details

Clinical Trials Office
Kadoorie Centre - Level 3
John Radcliffe Hospital
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Synthesising a clinical Prognostic Rule for Ankle Injuries in the Emergency Department

Acronym

SPRAINED

Study hypothesis

To validate a clinical prognostic tool that helps to detect risk of poor outcome following ankle sprain for patients presenting to Emergency Departments/Minor Injury Units.

Ethics approval

NRES Committee London-Chelsea, 10/04/2015, ref: 15/LO/0538

Study design

A multicentre cohort study for prognostic model validation

Primary study design

Observational

Secondary study design

Longitudinal study

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Ankle sprain

Intervention

In this validation study, we will recruit 675 adult patients with ankle sprains and follow these patients up by questionnaire at set time points over 9 months. We believe poor recovery means serious problems with level of activity, pain, confidence/stability of the ankle and/or recurrent injury. It is a combination of these measures that we will try and predict using a combination of clinical and patient reported measures taken at A&E visits examples are age, sex, ability to walk, stability of the ankle and swelling.

Intervention type

Phase

Drug names

Primary outcome measures

A composite measure indicating poor outcome for participants at 9 months, defined as either moderate/severe pain and/or moderate/severe functional difficulty and/or significant lack of confidence in the ankle and/or recurrent sprain.

Secondary outcome measures

1. Foot and Ankle Outcome Score (FAOS)
2. EuroQuol EQ-5D-3L
3. Health service resource use items

Overall trial start date

01/11/2014

Overall trial end date

30/04/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Participant is willing and able to give informed consent for participation in the study
2. Male or female, aged 16 years or above
3. Diagnosed with acute ankle sprain (<7 days old)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

675

Participant exclusion criteria

1. Ankle fracture (excluding flake fracture <2mm)
2. Other recent (<3 months) lower limb fracture

Recruitment start date

01/06/2015

Recruitment end date

29/02/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Oxford University Hospitals NHS Trust
Oxford
-
United Kingdom

Trial participating centre

Heart of England NHS Foundation Trust
Birmingham
-
United Kingdom

Trial participating centre

Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield
-
United Kingdom

Trial participating centre

Gloucestershire Hospitals NHS Foundation Trust
Gloucester
-
United Kingdom

Trial participating centre

University Hospitals Leicester NHS Trust
Leicester
-
United Kingdom

Trial participating centre

North Bristol NHS Trust
Bristol
-
United Kingdom

Trial participating centre

Royal Berkshire NHS Foundation Trust
Reading
-
United Kingdom

Trial participating centre

Milton Keynes University Hospital NHS Foundation Trust
Milton Keynes
-
United Kingdom

Sponsor information

Organisation

University of Oxford (UK)

Sponsor details

Nuffield Department of Orthopaedics
Rheumatology and Musculoskeletal Sciences
Nuffield Orthopaedic Centre
Windmill Road
Oxford
OX3 7HE
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Following analysis of the internal and external validation of the tool, we will publish the findings in a peer-reviewed journal and disseminate through international conferences. We will also publish an HTA monograph of the project. Should we develop a suitable tool, we will make the tool freely available on the web, with a simple registration to track areas and level of impact. We will investigate the possibility of using a mobile app for scoring the tool and utilising existing infrastructure used by clinicians to access decision tools e.g. MDCalc.com.

Intention to publish date

01/11/2017

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes