Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000209695
Ethics application status
Approved
Date submitted
19/02/2014
Date registered
27/02/2014
Date last updated
16/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of footwear in the reduction of foot pain and disability in people with gout
Scientific title
The clinical effectiveness of footwear in the reduction of foot pain and disability in people with gout
Secondary ID [1] 284091 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gout 291165 0
Condition category
Condition code
Metabolic and Endocrine 291497 291497 0 0
Other metabolic disorders
Physical Medicine / Rehabilitation 291498 291498 0 0
Other physical medicine / rehabilitation
Musculoskeletal 291499 291499 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The footwear intervention was selected based on extensive feasibility work. Four shoes from different brands, identified on the basis of availability and basic characteristics, were trialled. Across all footwear considered, the important characteristics associated with increase in comfort and reduction in pain were superior motion control, good shock attenuation, smooth heel-to-toe transition during the gait cycle and availability of wide-fitting option. The model selected by a majority of participants was the ASICS Cardio Zip, which satisfied all identified criteria. This model also demonstrates a medial side zip closure allowing for ease of fit and release. Each participant will wear the footwear once daily for a minimum of 2 hours per day over 6-months.

The pragmatic trial will be over 6 months. The time-point of 6 months has been selected as it will allow sufficient time for participants to become accustomed to the footwear and allows sufficient time for measuring changes in function.
Intervention code [1] 288785 0
Treatment: Devices
Comparator / control treatment
The standard podiatric rheumatology care will typically include toenail maintenance and scalpel debridement of hyperkeratotic lesions (corns and calluses). This approach has been successfully implemented at our podiatric rheumatology service based at Counties Manukau District Health Board. All participants in the study will receive this care
Control group
Active

Outcomes
Primary outcome [1] 291473 0
Foot pain using 100mm VAS
Timepoint [1] 291473 0
Baseline and 6-months
Secondary outcome [1] 306848 0
Health Assessment Questionnaire
Timepoint [1] 306848 0
Baseline and 6-months
Secondary outcome [2] 306849 0
General pain score and patient global assessment scale using 100mm VAS scale
Timepoint [2] 306849 0
Baseline and 6-months
Secondary outcome [3] 306850 0
Lower limb function will be evaluated using the Lower Limb Task Questionnaire
Timepoint [3] 306850 0
Baseline and 6-months
Secondary outcome [4] 306851 0
Foot disability and foot impairment will use the Leeds Foot Impairment Scale
Timepoint [4] 306851 0
Baseline and 6-months
Secondary outcome [5] 306852 0
Footwear comfort will be evaluated using a 100 mm visual analogue scales to ascertain their perceptions of: (i) the level of comfort of the footwear (using the anchors ‘extremely uncomfortable’ and ‘extremely comfortable’).
Timepoint [5] 306852 0
Baseline and 6-months
Secondary outcome [6] 306853 0
Footwear adherence will be measured using a self-reported diary. Participants will log data concerning hours of shoe use each day. The feasibility study demonstrated a high-completion rate of self-reported diaries.
Timepoint [6] 306853 0
6-months

Eligibility
Key inclusion criteria
Participants included in the study will (i) be over 18 years of age, (ii) have a history of gout according to ACR classification, 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 not be recruited into the study if they have (i) received any medication for foot pain in the previous 4 weeks, (ii) an acute gout flare at the time of assessment, (iii) previous surgery to the foot, or (iv) received treatment with foot orthoses or footwear within the previous 3 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)
Participants will be allocated to either study arm using unstratified block randomisation with random block sizes. Centralised assessment allows the use of a simple sealed opaque envelope system, successfully trialled in the feasibility study. Assessors and data analysts will be blinded to the intervention allocation; participants cannot be blinded.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


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
We have re-calculated the sample size for the study. We have found the withdrawal proportion is estimated in the worst case at 14% instead of 25%. At the assumed withdrawal rate of 15%, this figure yields a target recruitment of 46 participants per arm, or 92 in total instead of our original sample size of 140 participants

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2014
Actual
23/10/2014
Date of last participant enrolment
Anticipated
Actual
30/06/2016
Date of last data collection
Anticipated
Actual
18/01/2017
Sample size
Target
92
Accrual to date
Final
94
Recruitment outside Australia
Country [1] 5822 0
New Zealand
State/province [1] 5822 0
Auckland

Funding & Sponsors
Funding source category [1] 288720 0
Self funded/Unfunded
Name [1] 288720 0
Keith Rome
Country [1] 288720 0
New Zealand
Primary sponsor type
University
Name
AUT University
Address
90 Akoranga Drive, AA Building, Northcote 0627, Auckland
Country
New Zealand
Secondary sponsor category [1] 287454 0
None
Name [1] 287454 0
Address [1] 287454 0
Country [1] 287454 0
Other collaborator category [1] 277832 0
Individual
Name [1] 277832 0
Professor Peter McNair
Address [1] 277832 0
AUT University, Private Bag 92006,
Auckland 1020
Country [1] 277832 0
New Zealand
Other collaborator category [2] 277833 0
Individual
Name [2] 277833 0
Associate Professor Nicola Dalbeth
Address [2] 277833 0
Department of Medicine
University of Auckland
Private Bag 92-019
Auckland 1142
Country [2] 277833 0
New Zealand
Other collaborator category [3] 277834 0
Individual
Name [3] 277834 0
Associate Professor Alain Vandal
Address [3] 277834 0
AUT University
Akoranga Drive
Private Bag 92006
Auckland 1020
Country [3] 277834 0
New Zealand
Other collaborator category [4] 277835 0
Individual
Name [4] 277835 0
Dr Peter Gow
Address [4] 277835 0
Counties Manukau District Health Board
Private Bag 94052
South Auckland Mail Centre
Manukau 2240
Country [4] 277835 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290567 0
Health and Disability Ethics Committee
Ethics committee address [1] 290567 0
Ministry of Health
No 1 The Terrace
PO Box 5013
Wellington, 6011
Ethics committee country [1] 290567 0
New Zealand
Date submitted for ethics approval [1] 290567 0
30/03/2014
Approval date [1] 290567 0
06/08/2014
Ethics approval number [1] 290567 0
14/CEN/117

Summary
Brief summary
Gout is a major cause of musculoskeletal disability in Aotearoa New Zealand. Foot pain occurs in most people with gout. There is strong evidence that many people with gout wear inappropriate or poor quality footwear, and that ill-fitting footwear may contribute to further foot problems. We have shown in a recent feasibility study that footwear with good cushioning, motion control and adequate width reduces foot pain and disability in the short term. We propose a long-term randomised controlled trial examining the effects of a footwear intervention on foot pain and disability. The trial will compare standard podiatric care with a relevant footwear intervention. The study findings will be used to make evidence-based recommendations regarding footwear intervention for people with gout.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 46246 0
Prof Keith Rome
Address 46246 0
AUT University, 90 Akoranga Drive, AA Building, Northcote 0627, Auckland
Country 46246 0
New Zealand
Phone 46246 0
+6499219999
Fax 46246 0
+6499179780
Email 46246 0
[email protected]
Contact person for public queries
Name 46247 0
Prof Keith Rome
Address 46247 0
AUT University, 90 Akoranga Drive, AA Building, Northcote 0627, Auckland
Country 46247 0
New Zealand
Phone 46247 0
+6499219999
Fax 46247 0
+6499179780
Email 46247 0
[email protected]
Contact person for scientific queries
Name 46248 0
Prof Keith Rome
Address 46248 0
AUT University, 90 Akoranga Drive, AA Building, Northcote 0627, Auckland
Country 46248 0
New Zealand
Phone 46248 0
+6499219999
Fax 46248 0
+6499179780
Email 46248 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
Current Study Results
No documents have been uploaded by study researchers.

Update to Study Results
Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEffects of a footwear intervention on foot pain and disability in people with gout: A randomised controlled trial.2019https://dx.doi.org/10.1186/s13075-019-1886-y
N.B. These documents automatically identified may not have been verified by the study sponsor.