ANZCTR - Registration

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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

Condition category

Condition code

Musculoskeletal

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]

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]

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]

At days 5 and 15 post injury.

Secondary outcome [1]

Likert 0-10 pain score on walking 4 steps

Timepoint [1]

Measured at days 5 and 15 post injury.

Secondary outcome [2]

Patient’s Global Assessment of Ankle Injury (see Petrella 2004)

Timepoint [2]

Measured at days 5 and 15 post injury.

Secondary outcome [3]

Patient’s reported outcome (see Patrick 1995)

Timepoint [3]

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?

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]

Hospital

Name [1]

Royal Melbourne Hospital Emergency department

Address [1]

Country [1]

Australia

Funding source category [2]

University

Name [2]

Royal Melbourne Insitute of Technology Department of Applied Chemistry

Address [2]

Country [2]

Australia

Primary sponsor type

Hospital

Name

Royal Melbourne Hospital Emergency department

Address

Country

Australia

Secondary sponsor category [1]

University

Name [1]

Royal Melbourne Insitute of Technology Department of Applied Chemistry

Address [1]

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Royal Melbourne Hospital ethics committee

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Dr Thomas Razga

Address

Emergency Department
Royal Melbourne Hospital
Grattan St
Parkville VIC 3050

Country

Australia

Phone

+61 407121571

Fax

+61 3 93428777

thomasrazga@optusnet.com.au

Contact person for scientific queries

Name

Dr Thomas Razga

Address

Emergency Department
Royal Melbourne Hospital
Grattan St
Parkville VIC 3050

Country

Australia

Phone

+61 407121571

Fax

+61 3 93428777

thomasrazga@optusnet.com.au

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

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

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Documents added manually

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