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
Scientific
University of Ulster
Jordanstown
Shore Road
Newtownabbey
BT37 OQB
United Kingdom
| s.mcdonough@ulster.ac.uk |
Study information
| Study design | A double blind, randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| 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 | 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 study start date | 01/09/2007 |
| Completion date | 01/07/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target number of participants | N = 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
BT37 OQB
United Kingdom
Sponsor information
University of Ulster, Jordanstown (UK)
University/education
University/education
c/o Nick Curry
Research Governance
University of Ulster, Jordanstown
Shore Road
Newtownabbey
BT37 OQB
Northern Ireland
United Kingdom
| n.curry@ulster.ac.uk | |
| Website | http://www.ulster.ac.uk/campus/jordanstown/ |
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
