Contact information
Type
Scientific
Primary contact
Prof Suzanne McDonough
ORCID ID
Contact details
University of Ulster
Jordanstown
Shore Road
Newtownabbey
BT37 OQB
United Kingdom
s.mcdonough@ulster.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Sponsor: PRF/05/2
Study information
Scientific title
Acronym
PRICE
Study hypothesis
The aim of the project is to further enhance the evidence for the management of acute soft tissue injuries.
The specific objective is to compare the effectiveness of an intermittent icing protocol when applied with and without early mobilisation in treating subjects with acute ankle sprains.
Please note that as of 10/12/2007 the anticipated duration of this trial was updated to 01/09/2007 to 01/07/2008. The previous anticipated start and end dates of this trial were as follows:
Anticipated start date: 01/01/2007
Anticipated end date: 01/06/2008
The secondary outcome measures have also been updated, and changes are entered under the date 10/12/2007.
Ethics approval
Full ethics approval received on the 18th August 2007 from the Office for Research Ethics Committees in Northern Ireland (ORECNI).
Study design
A double blind, randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Condition
Subjects with acute ankle sprains will be recruited
Intervention
Group one: Intermittent ice only (10 minutes ice/10 minutes rest /10 minutes ice).
Group two: Intermittent ice (10 minutes ice/10 minutes rest /10 minutes ice) plus early mobilisation (patients will be encouraged to perform a range of mobility and flexibility exercises during icing, and for 10 minutes after icing).
The mode of cryotherapy will be standardised across groups, consisting of melting iced water (0°C) in a standard sized pack. All groups will receive standardised physiotherapy management, and advice regarding general mobility and proprioceptive exercises.
This trial has joint sponsorship with University of Ulster, Jordanstown and Royal Victoria Hospitals Trust. For details of University of Ulster, see Sponsor section.
Details of Royal Victoria Hospitals Trust (UK):
Frances Burns
Royal Research Office
Royal Victoria Hospital
Grosvenor Road
Belfast
BT12 6BA
Email: Frances.Burns@royalhospitals.n-i.nhs.uk
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
The primary outcome measure will be subjective ankle function, assessed using Binkleys lower extremity functional scale. This scale has excellent test retest reliability, and good construct validity. This will be recorded at baseline, one, two, three, four and six weeks post injury.
Secondary outcome measures
Current secondary outcome measures as of 10/12/2007:
1. Ultrasound imaging of the injured ankle. Subjective and objective measurement of swelling, ligament damage. This will be recorded at baseline, one, two, three, four and six weeks post injury
2. Pain at rest and on activity will be assessed using a 10 cm visual analogue scale
3. Swelling will be measured using a figure of eight method. All measurements will be undertaken using one-quarter inch wide plastic tape following a standard written protocol and valid tool for measuring the girth, of both healthy and oedematous ankles. This will be recorded at baseline, one, two, three, four and six weeks post injury
4. Muscle strength measured on the KinCom 500H Isokinetic Dynamometer, according to a standard written protocol. This will be measured at twelve weeks post injury
Previous secondary outcome measures:
1. Ultrasound imaging of the injured ankle. Subjective and objective measurement of swelling, ligament damage. This will be recorded at baseline, one, two, three, four and six weeks post injury
2. Pain at rest and on activity will be assessed using a 10 cm visual analogue scale
3. Swelling will be measured using a figure of eight method. All measurements will be undertaken using one-quarter inch wide plastic tape following a standard written protocol and valid tool for measuring the girth, of both healthy and oedematous ankles. This will be recorded at baseline, one, two, three, four and six weeks post injury
4. Eversion strength will be measured on the Biodex 3 dynamometer, according to a standard written protocol. This will be measured at six weeks post injury
Overall trial start date
01/09/2007
Overall trial end date
01/07/2008
Reason abandoned
Eligibility
Participant inclusion criteria
Subjects with an acute (less than 72 hours) grade one or two acute ankle injury, between 16 and 65 years of age will be considered for inclusion in the study.
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
N = 106
Participant exclusion criteria
They will not be admitted to the study if any of the following criteria are present:
1. Non English speaking
2. Learning disabilities or mental illness
3. Under the influence of drugs or alcohol
4. A bony ankle injury (diagnosed by Ottawa ankle rules or X-Ray) or ankle ligament rupture
5. Multiple injuries
6. Injuries more than 72 hours old
7. Insufficient address for follow up
8. Unwillingness to return for follow up
9. Contraindication for cryotherapy
Recruitment start date
01/09/2007
Recruitment end date
01/07/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Ulster
Newtownabbey
BT37 OQB
United Kingdom
Sponsor information
Organisation
University of Ulster, Jordanstown (UK)
Sponsor details
c/o Nick Curry
Research Governance
University of Ulster
Jordanstown
Shore Road
Newtownabbey
BT37 OQB
United Kingdom
n.curry@ulster.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
Physiotherapy Research Foundation (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2006 pilot study results in http://www.ncbi.nlm.nih.gov/pubmed/16611722
2. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20457737
Publication citations
-
Pilot study results
Bleakley CM, McDonough SM, MacAuley DC, Bjordal J, Cryotherapy for acute ankle sprains: a randomised controlled study of two different icing protocols., Br J Sports Med, 2006, 40, 8, 700-5; discussion 705, doi: 10.1136/bjsm.2006.025932.
-
Results
Bleakley CM, O'Connor SR, Tully MA, Rocke LG, Macauley DC, Bradbury I, Keegan S, McDonough SM, Effect of accelerated rehabilitation on function after ankle sprain: randomised controlled trial., BMJ, 2010, 340, c1964.