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Trial registered on ANZCTR


Registration number
ACTRN12612000735853
Ethics application status
Approved
Date submitted
6/07/2012
Date registered
10/07/2012
Date last updated
18/02/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Footwear for patients with gout
Scientific title
The effects of commercially available footwear on foot pain and disability in people with gout: a pilot study
Secondary ID [1] 280598 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gout 286603 0
Condition category
Condition code
Musculoskeletal 286819 286819 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 286879 286879 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The characteristics of all shoes include: an enclosed walking shoe, adequate cushioning, good motion control, midsole stability and sufficient width at the forefoot.
Shoe A: A walking shoe with cushioning and motion control. Cost at retail: $40.
Shoe B: A casual walking shoe with minimal cushioning but additional tread for motion control. Cost at retail: $40.
Shoe C: A walking shoe that promotes cushioning and stability. Cost at retail: $40.
Shoe D: A shoe that provides cushioning, motion control, midsole stability and additional width at the forefoot. Cost at retail: $150.

Feasibility Part 1: Randomised crossover study for intervention evaluation
Each participant will complete the baseline measurements and be randomised to one of the 24 possible crossover sequences of the four footwear types. Participants will be asked to complete a walking circuit that includes walking on carpet, on a hard level surface and ascending and descending stairs for each type of the footwear and their own footwear. Measurements will be carried out after each circuit. To reduce fatigue, each participant will be allowed to rest for 5 min between footwear changes. All footwear will be covered with surgical booties held in place with tape, so the footwear brand being worn will be unknown to the participant. Following completion of the measurements, the identity of the four footwear types will be revealed to the participants. Each participant will be asked by the researcher to identify the most important features on a check-list and choose the most comfortable shoe. Primary and secondary outcome measures will be evaluated. We anticipate 60mins to complete all measurements.

Feasibility Part 2: Prospective observational study for sustainability evaluation

Immediately after the data collection is completed in part 1, participants will commence part 2. During part 2, participants will wear the most comfortable footwear they chose in part 1 over a period of 8 weeks. Each participant will be given a study diary to complete over the 8 weeks and will note the amount of time the footwear was worn each day, any flares, pain or discomfort. At the eight-week follow-up both primary and secondary outcomes will be recorded.
Intervention code [1] 284935 0
Prevention
Intervention code [2] 285009 0
Treatment: Devices
Comparator / control treatment
In Part 1 the control intervention is the patients own footwear. The comparator intervention is the four types of new footwear based upon cost and footwear characterstics.

In Part 2 the patients will wear the footwear of choice based upon the findings of part 1 over 8 weeks.
Control group
Active

Outcomes
Primary outcome [1] 287261 0
Mean Foot pain using a 100mm VAS pain scale
Timepoint [1] 287261 0
Part 1: baseline
Part 2: 8 weeks after randomisation
Secondary outcome [1] 297777 0
Plantar pressure using an in-shoe pressure system: mean peak pressure and mean pressure time intergral
Timepoint [1] 297777 0
Part 1: baseline
Part 2: 8 weeks after randomisation
Secondary outcome [2] 297792 0
Mean walking velocity, cadence, step length, stride length and toe-angle using a gait mat system
Timepoint [2] 297792 0
Part 1: baseline
Part 2: 8 weeks after randomisation
Secondary outcome [3] 298195 0
The level of lower limb function will be evaluated using the Lower Limb Task Questionnaire
Timepoint [3] 298195 0
Part 1: baseline
Part 2: 8 weeks after randomisation
Secondary outcome [4] 298220 0
Shoe Comfort using a 100mm VAS
Timepoint [4] 298220 0
Part 1: baseline
Part 2: 8 weeks after randomisation
Secondary outcome [5] 298221 0
Leeds Foot Impact Scale to measure foot disability and impairment
Timepoint [5] 298221 0
Part 1: baseline
Part 2: 8 weeks after randomisation
Secondary outcome [6] 298222 0
Acceptability of footwear will be determined by a standard set of questions using a Likert Scale. A list of factors include: comfort, style, fit, support, sole, weight, colour, uppers, fastenings, non-slippage, heel-height, costs, cushioning and stability.
Timepoint [6] 298222 0
Part 1: baseline
Part 2: 8 weeks after randomisation

Eligibility
Key inclusion criteria
To be included in the study, participants must (i) be over 18 years of age, (ii) history of clinical diagnosis of acute gout according to ACR diagnostic criteria, and (iii) be able to walk a minimum of 10m without the use of a walking aid
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
People will be ineligible for the study if they (i) have received any treatment for foot pain in the previous 4 weeks, (ii) have an acute gout flare at the time of assessment, (iii) have a history of surgery to the foot, or (iv) have received treatment with foot orthoses or footwear within the previous 3 months. We have used similar inclusion and exclusion criteria in a previous study evaluating footwear characteristics in gout.

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)
Thirty-six (n =36) patients will be recruited from the rheumatology and podiatric rheumatology clinics based in Auckand District Health Board and Counties Manukau District Health Boards, Auckland New Zealand.

Randomisation will be conducted through a series of sealed envelopes generated by the study statistician and indicating the order in which the footwear will be tested. Twelve randomly chosen sequences will appear once and the other 12 twice in the randomisation schedule
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
The study design involves two parts. Part 1 is a randomised crossover design and Part 2 a prospective observational study over 8-weeks. In both parts the participants and outcome measures are the same. However, in Part 1, all data will be collected in a single session at the time of measurement, whereas in Part 2 data will be collected after eight weeks. Eight weeks was chosen so that meaningful clinical data can be collected. A health care professional researcher will collate the data.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2012
Actual
1/10/2012
Date of last participant enrolment
Anticipated
Actual
9/12/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
36
Accrual to date
Final
Recruitment outside Australia
Country [1] 4332 0
New Zealand
State/province [1] 4332 0
Auckland

Funding & Sponsors
Funding source category [1] 285564 0
Government body
Name [1] 285564 0
Health Research Council, New Zealand
Country [1] 285564 0
New Zealand
Primary sponsor type
Individual
Name
Keith Rome
Address
AUT University
Private Bag 92006
Auckland 1142
New Zealand
Country
New Zealand
Secondary sponsor category [1] 284425 0
None
Name [1] 284425 0
Address [1] 284425 0
Country [1] 284425 0
Other collaborator category [1] 276903 0
Individual
Name [1] 276903 0
Peter McNair
Address [1] 276903 0
AUT University
Private Bag 92006
Auckland 1142
New Zealand
Country [1] 276903 0
New Zealand
Other collaborator category [2] 276917 0
Individual
Name [2] 276917 0
Peter Gow
Address [2] 276917 0
Counties Manukau District Health Board
Private Bag 94052
South Auckland Mail Centre
Manukau 2240
Country [2] 276917 0
New Zealand
Other collaborator category [3] 276918 0
Individual
Name [3] 276918 0
Alain Vandal
Address [3] 276918 0
AUT University
Private Bag 92006
Auckland 1142
Country [3] 276918 0
New Zealand
Other collaborator category [4] 276920 0
Individual
Name [4] 276920 0
Nicola Dalbeth
Address [4] 276920 0
Department of Medicine
University of Auckland
Private Bag 92-019
Auckland 1142
Country [4] 276920 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287580 0
Northern X Regional Ethics Committee
Ethics committee address [1] 287580 0
Private Bag 92522
Wellesley Street
Auckland 1141
Ethics committee country [1] 287580 0
New Zealand
Date submitted for ethics approval [1] 287580 0
Approval date [1] 287580 0
11/06/2012
Ethics approval number [1] 287580 0
NTX/12/EXP/119

Summary
Brief summary
Gout is major problem in Aotearoa New Zealand. Previous research has shown that patients reported comfort, fit, support and cost as important factors in choosing their own footwear. The proposed research design is aiming to undertake a feasibility study looking at key issues such as identifying an inexpensive walking shoe, recruitment, footwear acceptability and calculating the numbers required for a future clinical trial. At the first visit the objectives are to evaluate four different types of walking shoe and measure pain, comfort, footwear characteristics, acceptability and foot function. Each participant will be randomised to one type of shoe and measured again after 8 weeks. After 8 weeks the same measures taken on the first visit will be obtained. In the long term we will see further funding from HRC to undertake a clinical trial based upon the results from the feasibility study
Trial website
Trial related presentations / publications
Results published:

Rome K, Stewart S, Vandal AV, Gow P, McNair PJ, Dalbeth N. The effects of commercially available footwear on foot pain and disability in people with gout: a pilot study. BMC Musculoskel Disorders 2013; 14: 278.
Public notes

Contacts
Principal investigator
Name 34222 0
Prof Professor Keith Rome
Address 34222 0
AUT University Health & Rehabilitation Research Institute Faculty of Rehabilitation & Occupation Studies School of Podiatry Akoranga Drive Auckland, 0627
Country 34222 0
New Zealand
Phone 34222 0
+6499219999
Fax 34222 0
+6499179780
Email 34222 0
[email protected]
Contact person for public queries
Name 17469 0
Professor Keith Rome
Address 17469 0
AUT University
Health & Rehabilitation Research Institute
Faculty of Rehabilitation & Occupation Studies
School of Podiatry
Akoranga Drive
Auckland, 0627
Country 17469 0
New Zealand
Phone 17469 0
+64 9 921 9999
Fax 17469 0
+64 9 921 9589
Email 17469 0
[email protected]
Contact person for scientific queries
Name 8397 0
Professor Keith Rome
Address 8397 0
AUT University
Health & Rehabilitation Research Institute
Faculty of Rehabilitation & Occupation Studies
School of Podiatry
Akoranga Drive
Auckland, 0627
Country 8397 0
New Zealand
Phone 8397 0
+64 9 921 9999
Fax 8397 0
+64 9 921 9589
Email 8397 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
SourceTitleYear of PublicationDOI
Dimensions AIThe effects of commercially available footwear on foot pain and disability in people with gout: a pilot study2013https://doi.org/10.1186/1471-2474-14-278
N.B. These documents automatically identified may not have been verified by the study sponsor.