None listed
Conditions
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.
Interventions
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 parti
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.
Sponsors
AUT University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
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.
Outcome results
None listed