None listed
Conditions
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
Interventions
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 cont
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.
Sponsors
Keith Rome
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
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.
Outcome results
None listed