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Trial registered on ANZCTR


Registration number
ACTRN12614000933651
Ethics application status
Approved
Date submitted
21/08/2014
Date registered
1/09/2014
Date last updated
1/09/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Footwear for treatment of foot pain
Scientific title
In adults with current foot pain causing a limitation in activities of daily living, how effective is wearing flip-flop style footwear with a moulded foot bed, compared to usual routine, in reducing foot pain.
Secondary ID [1] 285201 0
nil
Universal Trial Number (UTN)
U1111-1160-6794
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
foot pain 292816 0
Condition category
Condition code
Musculoskeletal 293109 293109 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will receive a pair of flip flop footwear with a moulded foot bed to wear as often as they feel comfortable for 12 weeks. The foot bed is not individually moulded and consists of an arch support to redistribute plantar pressures.
A podiatrist will also deliver (during the baseline session) a single 20 minute session of general advice on footwear detailing the general features of a good shoe.
Participants will be required to record adherence to the intervention via a daily footwear diary recording the number of hours the flip flop is worn.
Intervention code [1] 290074 0
Treatment: Devices
Comparator / control treatment
Participants will continue with their usual routine for 12 weeks and a podiatrist will also deliver (during the baseline session) a single 20 minute session of general advice on footwear detailing the general features of a good shoe.
Control group
Active

Outcomes
Primary outcome [1] 292974 0
Foot health status from the Foot Health Status Questionnaire (FHSQ)
Timepoint [1] 292974 0
Baseline and 12 weeks
Primary outcome [2] 292975 0
Foot function via the Foot Function Index (FFI)
Timepoint [2] 292975 0
Baseline and 12 weeks
Primary outcome [3] 292976 0
Foot pain via the Visual Analog Scale (VAS)
Timepoint [3] 292976 0
Baseline and 12 weeks
Secondary outcome [1] 310061 0
Footwear comfort (modified footwear comfort survey)
Timepoint [1] 310061 0
Baseline and 12 weeks

Eligibility
Key inclusion criteria
Adults 18 years of age and over with current foot pain causing a limitation to activities of daily living
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Foot history of amputation of foot, current foot pain due to arterial insufficiency, venous insufficiency or peripheral neuropathy of any cause, any condition causing balance impairment or a history of falls.

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)
Adults with current foot pain affecting activities of daily living will be recruited by advertisement. Potential participants will be screened for inclusion and exclusion criteria. Subjects will be randomised into a treatment or control group. Allocation concealment by use of sealed opaque envelopes will be used to prevent selection bias.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The a priori sample size calculations were based on a minimal important difference of 14 points for the domain of foot pain from the FHSQ. Assuming a standard deviation of 20 points, a power of 95% and an alpha 0.05 and allowing for 20% attrition rate, 54 participants per group will be required making a total of 108 participants to be recruited.
Change in pain, function and foot health status will be
analysed adjusted for baseline scores will be calculated with analysis of covariance. Treatment effect sizes will be calculated (Cohen's d).Level of comfort of the footwear will be reported as a mean score.

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

Funding & Sponsors
Funding source category [1] 289816 0
Commercial sector/Industry
Name [1] 289816 0
Dan Archer Medical
Address [1] 289816 0
6/90 Carnarvon Street,
Silverwater, NSW 2128
Country [1] 289816 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
School of Health Sciences
PO Box 127
Ourimbah, NSW 2258
Country
Australia
Secondary sponsor category [1] 288508 0
None
Name [1] 288508 0
Address [1] 288508 0
Country [1] 288508 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291548 0
The University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 291548 0
The Chancellery
University of Newcastle Callaghan Campus
University Drive
Callaghan NSW 2308
Ethics committee country [1] 291548 0
Australia
Date submitted for ethics approval [1] 291548 0
Approval date [1] 291548 0
06/12/2013
Ethics approval number [1] 291548 0
H-2013-0426

Summary
Brief summary
The aim of this study is to investigate the ability for flip-flop style footwear with a moulded foot-bed to reduce foot pain. We will also assess the effect of the flip-flop style footwear on perception of general foot health and assess the comfort of the flip-flop style footwear.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 50830 0
Dr Vivienne Chuter
Address 50830 0
University of Newcastle
School of Health Sciences
Faculty of Health and Medicine
PO Box 127 Ourimbah, NSW 2258
Country 50830 0
Australia
Phone 50830 0
+ 61 2 43 494 424
Fax 50830 0
Email 50830 0
Vivienne.Chuter@newcastle.edu.au
Contact person for public queries
Name 50831 0
Dr Vivienne Chuter
Address 50831 0
University of Newcastle
School of Health Sciences
Faculty of Health and Medicine
PO Box 127 Ourimbah, NSW 2258
Country 50831 0
Australia
Phone 50831 0
+ 61 2 43 494 424
Fax 50831 0
Email 50831 0
Vivienne.Chuter@newcastle.edu.au
Contact person for scientific queries
Name 50832 0
Dr Vivienne Chuter
Address 50832 0
University of Newcastle
School of Health Sciences
Faculty of Health and Medicine
PO Box 127 Ourimbah, NSW 2258
Country 50832 0
Australia
Phone 50832 0
+ 61 2 43 494 424
Fax 50832 0
Email 50832 0
Vivienne.Chuter@newcastle.edu.au

No information has been provided regarding IPD availability
Summary results
No Results