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Trial registered on ANZCTR

Registration number

ACTRN12614000125628

Ethics application status

Approved

Date submitted

23/01/2014

Date registered

3/02/2014

Date last updated

22/11/2019

Date data sharing statement initially provided

22/11/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

Efficient and effective management of stiffness following immobilisation of simple phalangeal and metacarpal fractures.

Scientific title

A randomised trial comparing the efficiency and effectiveness of educational exercise handouts and one on one hand physiotherapy in managing stiffness following immobilisation of simple phalangeal and metacarpal fractures in children aged 5 to 16 years.

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

simple, undisplaced phalanx fractures of the hand

simple, undisplaced metacarpal fractures of the hand

Condition category

Condition code

Physical Medicine / Rehabilitation

Physiotherapy

Public Health

Health service research

Injuries and Accidents

Fractures

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Following removal of their plaster cast, baseline assessments will be performed. Group 1 will then receive an educational handout from the plastics registrar that advises on how to self manage their hand now that their hand is no longer immobilised. Participants will be re-assessed at 2 weeks post.

Intervention code [1]

Rehabilitation

Comparator / control treatment

Following removal of their plaster cast, baseline assessments will be performed. Group 2 will receive the same handout that advises on how to self manage their hand now that their hand is no longer immobilised, but will also have one, one-on-one physiotherapy session (approximately 30 minutes) to supplement the handout. Participants will be re-assessed at 2 weeks post.

Control group

Active

Outcomes

Primary outcome [1]

Functional outcome measured using the Upper Limb Functional Index with three point response (ULFI-3 point) (Gabel et al. 2006).

Timepoint [1]

2 week follow up

Primary outcome [2]

Composite flexion (fist) and hook grip as compared to the other side measured using distance measured in mm from tip of index finger to palm and reported as a ratio of injured to uninjured side.

Timepoint [2]

2 week follow up

Primary outcome [3]

Active range of motion (AROM) i.e. flexion and extension; which would include metacarpal phalangeal joints (MCPJ), proximal interphalangeal joints (PIPJ) and distal interphalangeal joints (DIPJ) of the injured finger and the contralateral side. This will be measured using standard goniometry and will give us the total active motion (TAM) as a percent as described by the American Society for Surgery of the Hand, 1984.

Timepoint [3]

2 week follow up

Secondary outcome [1]

Wrist AROM of flexion and extension measured using a goniometer in standardised positions.

Timepoint [1]

2 weeks post

Secondary outcome [2]

Strength of power grip and lateral pinch, measured in Newtons using a calibrated Jamar dynamometer in standardized positions.

Timepoint [2]

2 weeks follow up

Secondary outcome [3]

A brief parent satisfaction survey to ascertain their child’s return to normal function and activities as well as their opinion with regards to the wait times. The survey used has been prepared specifically for this study.

Timepoint [3]

2 weeks post

Secondary outcome [4]

Pain scores with Active Range of Movement (AROM) and activities using 10 point Visual Analogue Scale

Timepoint [4]

2 weeks post

Secondary outcome [5]

Consumer review of the handout using an evaluation template specifically developed for the study.

Timepoint [5]

2 weeks post

Eligibility

Key inclusion criteria

Simple phalange or metacarpal fractures that are neither angulated nor displaced.
Stable fractures that are mildly displaced that did not require manipulation under anaesthetic (MUA).
Phalange shaft fracture with resultant axial angulations up to 10 degrees and no rotational deformity is accepted. Metacarpal neck fracture of 5 degrees to 30 degrees angulations (Bernstein and Chung 2006).
Stable fractures that are displaced and requiring MUA to achieve an acceptable anatomical alignment that is maintained without requiring internal fixation.

Minimum age

5 Years

Maximum age

16 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Displaced/angulated fracture that require MUA and requiring internal fixation
Any associated soft tissue injuries e.g. Mallet, Central slip or Ulnar collateral ligament strain (UCL)
Open wounds or lacerations i.e. open fractures e.g. Seymour’s fracture

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)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Who is / are masked / blinded?

Intervention assignment

Other design features

Phase

Not Applicable

Type of endpoint/s

Statistical methods / analysis

This is a non-inferiority study. We hypothesised that utilising a physiotherapy handout for education and self management post immobilisation (Group 1) for simple and undisplaced phalanx and metacarpal fractures is adequate to achieve full active range of motion and function compared with a one-on-one hand therapy by a physiotherapist (Group 2). The null hypothesis is that Group 1 is inferior to Group 2 and the alternative hypothesis is that Group 1 is not inferior to Group 2. The proportion of full active range of motion and function after two weeks with Group 2 is approximately >95%. With a margin of equivalence of 0.1 we need a sample size of 60 in each of the two groups to have a power of 83% for the non-inferiority study, at a significance of 0.05.

Non-inferiority design analysis method will be employed. The difference of the proportion of full active range of motion and function after two weeks, with the corresponding 90% confidence interval between the two groups will be calculated. We will also compare the difference for several continuous outcome variables such as pain scores and categorical variables between the two groups using independent sample T test and Chi-square test, respectively. For paired outcome variables general linear model with repeated measures will be utilised. Data will be analysed using SPSS.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

7/04/2014

Actual

1/12/2014

Date of last participant enrolment

Anticipated

31/08/2015

Actual

31/08/2015

Date of last data collection

Anticipated

Actual

6/10/2015

Sample size

Target

120

Accrual to date

Final

120

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Princess Margaret Hospital Foundation

Address [1]

Level 1, 68 Hay Street
Subiaco WA 6008

Country [1]

Australia

Primary sponsor type

Hospital

Name

Princess Margaret hospital

Address

Roberts Road
SUBIACO WA 6008

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Child and Adolescent Health Ethics Committee

Ethics committee address [1]

Roberts Road
SUBIACO WA 6008

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

13/01/2014

Approval date [1]

19/06/2014

Ethics approval number [1]

2014011EP

Summary

Brief summary

The PMH physiotherapy and plastics department would like to review the current practices of how we manage children with the simpler, uncomplicated finger fractures (broken bones). We want to see if we can provide treatment in a more time efficient and cost effective way, whilst ensuring the fractures continue to heal well.
	
These fractures tend to managed with a 3 week immobilisation in a plaster cast. Currently, after seeing the doctor and having the cast removed, families and patients may wait over two hours to see the physiotherapists for advice on exercise and a home program to help with the stiffness after the cast is taken off. This long wait to see the physiotherapy continues despite many changes made to the way we run the clinics in an attempt to decrease this wait time. Many families have complained about this long wait time.

We have investigated how other children’s hospitals in Australia manage simple fractures of the hand. We found that the treatment varies between the Australian states and there is little in the medical literature that gives us guidance as to whether children have any short or long term problems if they don’t have physiotherapy after the cast is taken off. 

We want to determine if children with simple hand fractures are able to achieve full active movement of all the fingers and wrist with just the provision of an education and physiotherapy exercise handout alone, instead of the one-on-one hand therapy currently provided by the physiotherapist.   This in turn will reduce the burden on the family to travel to PMH for unnecessary appointments and decrease the wait time for physiotherapy, as fewer children will need this service during clinic.  It will also ensure the physiotherapist can safely prioritise patients with other more complicated fractures where physiotherapy is essential to improve their recovery. The outcome of this study will identify the most efficient and effective way of managing the simple finger and hand fractures.  Other Australian states are interested in changing their practise based on our results.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Ms Cheng TAN

Address

Physiotherapy Department, Perth Children's Hospital, 15 Hospital Road, Nedlands. WA. 6909

Country

Australia

Phone

+61 8 6456 0412

Fax

[email protected]

Contact person for public queries

Name

Cheng TAN

Address

Physiotherapy Department, Perth Children's Hospital, 15 Hospital Road, Nedlands. WA. 6909

Country

Australia

Phone

+61 8 6456 0412

Fax

[email protected]

Contact person for scientific queries

Name

Noula Gibson

Address

Physiotherapy Department, Perth Children's Hospital, 15 Hospital Road, Nedlands. WA. 6909

Country

Australia

Phone

+61 8 6456 0412

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Email
5815	Study protocol	[email protected]
5816	Informed consent form	[email protected]
5817	Ethical approval	[email protected]

Results publications and other study-related documents

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No additional documents have been identified.

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