Condition category
Musculoskeletal Diseases
Date applied
24/10/2006
Date assigned
14/02/2007
Last edited
12/05/2010
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 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 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

http://www.ulster.ac.uk/campus/jordanstown/

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

  1. 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.

  2. 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.

Additional files

Editorial Notes