Welcome
Support Centre
03 September 2014 
ISRCTN Register - International Standard Randomized Controlled Trial Number
Trial registration
Unique identification scheme
International databases
home  |   my details  |   ISRCTN Register  |   mRCT  |   links  |   information  |   news
Find trials
ISRCTN Register
tips on searching

Registration
New application
Updating record

Information
introduction
governing board
ISRCTN FAQs
data set
letter of agreement
request information
guidance notes
statistics

[ Print-friendly version ]
The use of PRICE (Protection, Rest, Ice, Compression and Elevation) in the management of acute soft tissue injury
ISRCTN ISRCTN13903946
DOI 10.1186/ISRCTN13903946
ClinicalTrials.gov identifier
EudraCT number
Public title The use of PRICE (Protection, Rest, Ice, Compression and Elevation) in the management of acute soft tissue injury
Scientific title
Acronym PRICE
Serial number at source Sponsor: PRF/05/2
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.
Lay summary
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
Countries of recruitment United Kingdom
Disease/condition/study domain Subjects with acute ankle sprains will be recruited
Participants - 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.
Participants - 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
Anticipated start date 01/09/2007
Anticipated end date 01/07/2008
Status of trial Completed
Patient information material
Target number of participants N = 106
Interventions 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
Primary outcome measure(s) The primary outcome measure will be subjective ankle function, assessed using Binkley’s 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 measure(s) 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
Sources of funding Physiotherapy Research Foundation (UK)
Trial website
Publications 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
Contact name Prof  Suzanne  McDonough
  Address University of Ulster
Jordanstown
Shore Road
  City/town Newtownabbey
  Zip/Postcode BT37 OQB
  Country United Kingdom
  Email s.mcdonough@ulster.ac.uk
Sponsor University of Ulster, Jordanstown (UK)
  Address c/o Nick Curry
Research Governance
University of Ulster, Jordanstown
Shore Road
  City/town Newtownabbey
  Zip/Postcode BT37 OQB
  Country United Kingdom
  Email n.curry@ulster.ac.uk
  Sponsor website: http://www.ulster.ac.uk/campus/jordanstown/
Date applied 24/10/2006
Last edited 12/05/2010
Date ISRCTN assigned 14/02/2007
Submit your trial protocol
Submit to Trials journal
Follow us on Twitter
© 2014 ISRCTN unless otherwise stated.