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Trial registered on ANZCTR


Registration number
ACTRN12606000130561
Ethics application status
Approved
Date submitted
7/04/2006
Date registered
10/04/2006
Date last updated
10/04/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
Ice versus “synthetic ice” gel polymer for the treatment of ankle sprain: a randomized, controlled clinical trial
Scientific title
Ice versus “synthetic ice” gel polymer for the treatment of ankle sprain: a randomized, controlled clinical trial
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Grades 1, 2 and 3 lateral ligament sprains following an ankle inversion injury 1097 0
Condition category
Condition code
Musculoskeletal 1177 1177 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Randomised to 1 of 3 groups. The first group will apply ice to the affected ankle for 20 minutes every 2 hours while awake, for at least 48 hours, in keeping with standard discharge advice. The second group will wear a booty (containing cooling gel polymer) on the affected ankle for 20 minutes every 2 hours while awake, for at least 48 hours. The third group will wear the gel polymer booty on the affected ankle continuously throughout the day, for at least 48 hours. All participants will be telephoned on days 5 and 15 after the injury.
Intervention code [1] 974 0
Treatment: Other
Comparator / control treatment
The first group will apply ice to the affected ankle for 20 minutes every 2 hours while awake, for at least 48 hours, in keeping with standard discharge advice.
Control group
Active

Outcomes
Primary outcome [1] 1588 0
Ankle joint function will be assessed using the “Karlsson scoring system” (see Boyce 2005). This is a validated composite of eight “weighted” variables (eg. pain, swelling, stiffness etc). A score of 90 indicates no ankle problem and the lower the score, the worse the ankle. Does treatment of acute ankle sprains with the polymer gel compression boot improve the Karlsson ankle score by at least 15 points when compared with traditional treatment using ice?
Timepoint [1] 1588 0
At days 5 and 15 post injury.
Secondary outcome [1] 2879 0
Likert 0-10 pain score on walking 4 steps
Timepoint [1] 2879 0
Measured at days 5 and 15 post injury.
Secondary outcome [2] 2880 0
Patient’s Global Assessment of Ankle Injury (see Petrella 2004)
Timepoint [2] 2880 0
Measured at days 5 and 15 post injury.
Secondary outcome [3] 2881 0
Patient’s reported outcome (see Patrick 1995)
Timepoint [3] 2881 0
Measured at days 5 and 15 post injury.

Eligibility
Key inclusion criteria
Grades 1, 2 and 3 lateral ligament sprains after an ankle inversion injury, presenting within 24 hours of injury.
Minimum age
16 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Isolated deltoid ligament injury, >24 hours since injury occurrence, fractures, multiple injuries, residual symptoms from a previous injury, dementia, mental illness, intoxication (alcohol or drugs), long term disability problems, neurological problems, inability to contact for follow up, language or other communication difficulties.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Concealment by sealed envelope
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer program will be used to randomize patients to treatment arms. Block randomization will be undertaken (in each block patients will be assigned to each of the 3 treatment arms).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Enrolled patients will be randomized to one of three intervention arms. 1- Standard care with ice application, 2 - Standard care with gel polymer application and 3 - long-term application of the gel polymer booty.
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/05/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
135
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1287 0
Hospital
Name [1] 1287 0
Royal Melbourne Hospital Emergency department
Country [1] 1287 0
Australia
Funding source category [2] 1288 0
University
Name [2] 1288 0
Royal Melbourne Insitute of Technology Department of Applied Chemistry
Country [2] 1288 0
Australia
Primary sponsor type
Hospital
Name
Royal Melbourne Hospital Emergency department
Address
Country
Australia
Secondary sponsor category [1] 1138 0
University
Name [1] 1138 0
Royal Melbourne Insitute of Technology Department of Applied Chemistry
Address [1] 1138 0
Country [1] 1138 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2620 0
Royal Melbourne Hospital ethics committee
Ethics committee address [1] 2620 0
Ethics committee country [1] 2620 0
Australia
Date submitted for ethics approval [1] 2620 0
Approval date [1] 2620 0
Ethics approval number [1] 2620 0

Summary
Brief summary
The standard treatment regimen for uncomplicated ankle sprains comprises ‘RICE’ (Rest, Ice, Compression and Elevation). Assuming the patient is compliant then rest, compression and elevation can be applied with some consistency. Anecdotally, however, the application of ice to the affected area is more variable. This results from the availability of ice itself and the variability in which it is applied. Large ice blocks, chipped ice and ‘frozen peas’ could be expected to have differing levels of effectiveness. Furthermore, the areas of the affected part actually in contact with this ‘ice’ may vary considerably, depending upon the technique. Frozen gel packs have been used as an alternative to ice. However, these can be too cold and have been known to induce skin and subcutaneous tissue damage. They also lack ‘compliance’ when frozen and may be difficult to wrap around the injured area effectively.
Recently, a polymer gel has been developed that has the properties of gentle and sustained extraction of heat from the environment (convection) and contacting surfaces (conduction). This gel can be modified to continue heat extraction until its own temperature reaches a pre-determined level of 6oC. This polymer gel can be fashioned into small or large plates that can be inserted into a variety of cloth garments for application to a range of body parts. It has been successfully employed in cooling vests to avoid heat stress and improve the performance of elite athletes.
Does treatment with a gel polymer cooling regimen result in better function and reduced pain compared to traditional ice in the acute management of uncomplicated ankle sprains? This study will be a non-blinded randomised controlled trial comparing the use of standard ice with a cloth booty containing cooling gel polymer as an adjunct for treating sprained ankles. 135 patients will be randomised to one of three groups: episodic ankle cooling with ice, episodic cooling with gel polymer booty and continuous daytime cooling with the gel polymer booty. Each cooling regimen will last for at least 48 hours and all other treatments provided will be follow usual guidelines. Outcome measures of pain and ankle function will be sought at 5 and 15 days post-injury by telephone follow up. The findings of this study will inform best practice management of this common injury.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36128 0
Address 36128 0
Country 36128 0
Phone 36128 0
Fax 36128 0
Email 36128 0
Contact person for public queries
Name 10163 0
Dr Thomas Razga
Address 10163 0
Emergency Department
Royal Melbourne Hospital
Grattan St
Parkville VIC 3050
Country 10163 0
Australia
Phone 10163 0
+61 407121571
Fax 10163 0
+61 3 93428777
Email 10163 0
[email protected]
Contact person for scientific queries
Name 1091 0
Dr Thomas Razga
Address 1091 0
Emergency Department
Royal Melbourne Hospital
Grattan St
Parkville VIC 3050
Country 1091 0
Australia
Phone 1091 0
+61 407121571
Fax 1091 0
+61 3 93428777
Email 1091 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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