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
Secondary identifying numbers Sponsor: PRF/05/2
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

Study designA double blind, randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Scientific title
Study acronymPRICE
Study objectivesThe 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) studiedSubjects with acute ankle sprains will be recruited
InterventionGroup 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 typeOther
Primary outcome measureThe 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 measuresCurrent 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 study start date01/09/2007
Completion date01/07/2008

Eligibility

Participant type(s)Patient
Age groupAdult
SexNot Specified
Target number of participantsN = 106
Key inclusion criteriaSubjects 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 criteriaThey 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 enrolment01/09/2007
Date of final enrolment01/07/2008

Locations

Countries of recruitment

  • United Kingdom

Study participating centre

University of Ulster
Newtownabbey
BT37 OQB
United Kingdom

Sponsor information

University of Ulster, Jordanstown (UK)
University/education

c/o Nick Curry
Research Governance
University of Ulster, Jordanstown
Shore Road
Newtownabbey
BT37 OQB
Northern Ireland
United Kingdom

Email n.curry@ulster.ac.uk
Website http://www.ulster.ac.uk/campus/jordanstown/
ROR logo "ROR" https://ror.org/01yp9g959

Funders

Funder type

Research organisation

Physiotherapy Research Foundation (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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