Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000754943
Ethics application status
Approved
Date submitted
17/05/2011
Date registered
19/07/2011
Date last updated
19/07/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does the use of splints in adults with shoulder burns result in better range of shoulder movement?
Scientific title
Does the use of splints in adults with axillary burns result in better range of shoulder movement?
Secondary ID [1] 262184 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Use of splints in adults with shoulder burns 3601 0
Condition category
Condition code
Injuries and Accidents 3760 3760 0 0
Burns

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Standard ACRO shoulder splint worn continuosly for 6 weeks, then overnight for next 6 weeks. Removed for exercises, wound management and hygiene.
Daily one hour exercise program performed independently or with assistance as required. Exercises aimed at regaining full shoulder range of movement and strength. Exercises performed over the entire 12 weeks.
Intervention code [1] 3315 0
Treatment: Devices
Intervention code [2] 264592 0
Rehabilitation
Comparator / control treatment
No shoulder splint.
Daily exercise program.
Control group
Active

Outcomes
Primary outcome [1] 4656 0
Adverse events from splint use such as pressure areas. Questionnaires issued at weeks 1, 3, 6 and 12 to capture this information and participants also advised to notify primary researcher if any issues arise.
Timepoint [1] 4656 0
12 week duration of trial.
Primary outcome [2] 266767 0
Adherence with splint use. Questionnaires issued at weeks 1, 3, 6 and 12 asking participants how often they wore the splint or did their exercises and reasons for non adherence.
Timepoint [2] 266767 0
12 week duration of trial.
Secondary outcome [1] 7871 0
Shoulder range of flexion and abduction measured with a plurimeter by a blinded assessor.
Timepoint [1] 7871 0
By day 3 of admission to hospital.
Weeks 6 and 12 post injury.
Secondary outcome [2] 276350 0
Quality of life using the Burns Specific Health Scale Brief questionnaire, issued by a blinded assessor.
Timepoint [2] 276350 0
Weeks 6 and 12 post injury
Secondary outcome [3] 279178 0
Shoulder function using the Grocery Shelving Task measure conducted by a blinded assessor
Timepoint [3] 279178 0
Weeks 6 and 12

Eligibility
Key inclusion criteria
Acute burn injury to less than half the body involving the shoulder.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pre existing shoulder pathology.
Admission for chronic burn contracture release surgery.

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)
Study protocol explained to eligible patients and written information provided. Consent to participate obtained.
Individual unrelated to study opened a sealed, opaque envelope containing group allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random permutations.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Single centre.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
27/11/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
52
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3777 0
Hospital
Name [1] 3777 0
The Alfred Research Trust
Country [1] 3777 0
Australia
Funding source category [2] 267088 0
Charities/Societies/Foundations
Name [2] 267088 0
Physiotherapy Research Foundation
Country [2] 267088 0
Australia
Primary sponsor type
Hospital
Name
The Alfred
Address
Commercial Rd
Prahran 3181
Victoria
Country
Australia
Secondary sponsor category [1] 3388 0
University
Name [1] 3388 0
La Trobe University
Address [1] 3388 0
Faculty of Health Sciences
La Trobe University
Kingsbury Drive
Bundoora, 3086
Victoria
Country [1] 3388 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5840 0
The Alfred HREC
Ethics committee address [1] 5840 0
The Alfred
Commercial Rd
Prahran 3181
Victoria
Ethics committee country [1] 5840 0
Australia
Date submitted for ethics approval [1] 5840 0
25/08/2008
Approval date [1] 5840 0
02/10/2008
Ethics approval number [1] 5840 0
1/08/0253
Ethics committee name [2] 267065 0
La Trobe University Faculty Human Ethics Committee
Ethics committee address [2] 267065 0
La Trobe University
Kingsbury Drive
Bundoora
Victoria 3086
Ethics committee country [2] 267065 0
Australia
Date submitted for ethics approval [2] 267065 0
25/08/2008
Approval date [2] 267065 0
18/11/2008
Ethics approval number [2] 267065 0
FHEC08/157

Summary
Brief summary
Exercises are commonly prescibed to improve shoulder range following a burn injury but the additional benefits of splinting is unclear. The primary aim of this study was to determine if splinting is a safe and feasible treatment option in patients with shoulder burns. Secondary aims were to determine if wearing a splint resulted in better shoulder range and function.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28872 0
Address 28872 0
Country 28872 0
Phone 28872 0
Fax 28872 0
Email 28872 0
Contact person for public queries
Name 12029 0
Alison Kolmus
Address 12029 0
C/o Physiotherapy Department
The Alfred
Commercial Rd
Prahran 3181
Victoria
Country 12029 0
Australia
Phone 12029 0
+61 03 9076 3450
Fax 12029 0
+61 03 9076 5430
Email 12029 0
[email protected]
Contact person for scientific queries
Name 2957 0
Alison Kolmus
Address 2957 0
C/o Physiotherapy Department'
The Alfred
Commercial Rd
Prahran 3181
Victoria
Country 2957 0
Australia
Phone 2957 0
+61 03 9076 3450
Fax 2957 0
+61 03 9076 5430
Email 2957 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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.