Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000185460
Ethics application status
Approved
Date submitted
23/03/2007
Date registered
29/03/2007
Date last updated
20/08/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised trial of two types of orthoses for exertional medial shin pain
Scientific title
Comparison of effects of prefabricated and customised orthoses on pain and function in people with medial exertional shin pain
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Medial exertional shin pain 1703 0
Condition category
Condition code
Musculoskeletal 1795 1795 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The trial compares two active interventions. The prefabricated orthoses will be a three-quarter length Vasyli device made from a firm high density EVA (ethyl vinyl acetate) which will be heat moulded to the participant's neutral foot position. Both will be worn for gradually increasing periods for day, eventually all day, for the three month trial period.
Intervention code [1] 1659 0
Rehabilitation
Comparator / control treatment
The customised orthoses will be a Modified Root Device fabricated from a neutral suspension cast using 4mm polypropylene (thermoplastic) with a vinyl cover. It will be worn for gradually increasing periods for day, eventually all day, for the three month trial period.
Control group
Active

Outcomes
Primary outcome [1] 2515 0
1. pain intensity (visual analogue scale)
Timepoint [1] 2515 0
At one month
Primary outcome [2] 2516 0
2. patient-specific measure of function (average of three ratings on a visual analogue scales)
Timepoint [2] 2516 0
At one month
Secondary outcome [1] 4333 0
1. pain
Timepoint [1] 4333 0
At three months
Secondary outcome [2] 4334 0
2. patient-specific function
Timepoint [2] 4334 0
At three months
Secondary outcome [3] 4335 0
3. comfort of the orthosis (Comfort Questionnaire)
Timepoint [3] 4335 0
At one and three months

Eligibility
Key inclusion criteria
Participants will be military personnel presenting to military medical clinics. Seeking treatment for the first time for pain or tenderness along the medial border of the leg that i) is induced by exercise, ii) persists after exercise, and iii) limits participation in routine daily physical activities; symptoms have persisted for at least one month.
Minimum age
18 Years
Maximum age
Not stated
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Symptoms have persisted for more than six months.

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)
Each participant will be randomly assigned to one of two groups by drawing the next of a series of opaque, consecutively numbered envelopes. The randomisation schedule and envelopes will be prepared by another of the investigators who will not be involved in the recruitment process, so allocation will be concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The allocation schedule will be blocked but will be otherwise unrestricted. The sequence will be generated by computer.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
26/03/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
110
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1947 0
University
Name [1] 1947 0
University of Western Sydney
Country [1] 1947 0
Australia
Primary sponsor type
Individual
Name
Verona du Toit
Address
School of Biomedical and Health Sciences
University of Western Sydney
Campbelltown Campus
Locked Bag 1797
Penrith South DC 1797
Country
Australia
Secondary sponsor category [1] 1760 0
None
Name [1] 1760 0
delete
Address [1] 1760 0
Country [1] 1760 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3624 0
Holsworthy Army Barracks- Australian Defence Human Research Ethics Committee
Ethics committee address [1] 3624 0
Ethics committee country [1] 3624 0
Australia
Date submitted for ethics approval [1] 3624 0
Approval date [1] 3624 0
10/07/2006
Ethics approval number [1] 3624 0
441/06
Ethics committee name [2] 3625 0
Holsworthy Army Barracks-Human Research Ethics Committee of the University of Sydney
Ethics committee address [2] 3625 0
Ethics committee country [2] 3625 0
Australia
Date submitted for ethics approval [2] 3625 0
Approval date [2] 3625 0
13/11/2006
Ethics approval number [2] 3625 0
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Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27762 0
Address 27762 0
Country 27762 0
Phone 27762 0
Fax 27762 0
Email 27762 0
Contact person for public queries
Name 10848 0
Verona du Toit
Address 10848 0
School of Biomedical and Health Sciences
University of Western Sydney
Building 24 Campbelltown Campus
Locked Bag 1797
Penrith South DC NSW 1797
Country 10848 0
Australia
Phone 10848 0
+61 2 46203758 or 0414257185
Fax 10848 0
+61 2 46203792
Email 10848 0
[email protected]
Contact person for scientific queries
Name 1776 0
Verona du Toit
Address 1776 0
School of Biomedical and Health Sciences
University of Western Sydney
Campbelltown Campus
Locked Bag 1797
Penrith South DC 1797
Country 1776 0
Australia
Phone 1776 0
+61 2 4620 3758
Fax 1776 0
Email 1776 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.