The use of PRICE (Protection, Rest, Ice, Compression and Elevation) in the management of acute soft tissue injury

ISRCTN	ISRCTN13903946
DOI	https://doi.org/10.1186/ISRCTN13903946
Protocol serial number	Sponsor: PRF/05/2
Sponsor	University of Ulster, Jordanstown (UK)
Funder	Physiotherapy Research Foundation (UK)

Submission date: 24/10/2006
Registration date: 14/02/2007
Last edited: 12/05/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Suzanne McDonough
Scientific

University of Ulster
Jordanstown
Shore Road
Newtownabbey
BT37 OQB
United Kingdom

Email	s.mcdonough@ulster.ac.uk

Study information

Primary study design	Interventional
Study design	A double blind, randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	PRICE
Study objectives	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(s)	Full ethics approval received on the 18th August 2007 from the Office for Research Ethics Committees in Northern Ireland (ORECNI).
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key 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
Completion date	01/07/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target sample size at registration	106
Key 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.
Key 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
Date of first enrolment	01/09/2007
Date of final enrolment	01/07/2008

Locations

Countries of recruitment

United Kingdom

Study participating centre

University of Ulster

Newtownabbey
BT37 OQB
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	pilot study results	01/08/2006		Yes	No
Results article	results	10/05/2010		Yes	No