Footwear for patients with gout

Not Applicable

• Conditions: Gout; Musculoskeletal - Other muscular and skeletal disorders; Physical Medicine / Rehabilitation - Other physical medicine / rehabilitation

• Registration Number: ACTRN12612000735853
• Lead Sponsor: Keith Rome

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-07-10
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 36

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean Foot pain using a 100mm VAS pain scale[Part 1: baseline<br>Part 2: 8 weeks after randomisation]

Secondary Outcome Measures

Name	Time	Method
Plantar pressure using an in-shoe pressure system: mean peak pressure and mean pressure time intergral[Part 1: baseline<br>Part 2: 8 weeks after randomisation];Mean walking velocity, cadence, step length, stride length and toe-angle using a gait mat system[Part 1: baseline<br>Part 2: 8 weeks after randomisation];The level of lower limb function will be evaluated using the Lower Limb Task Questionnaire[Part 1: baseline<br>Part 2: 8 weeks after randomisation];Shoe Comfort using a 100mm VAS[Part 1: baseline<br>Part 2: 8 weeks after randomisation];Leeds Foot Impact Scale to measure foot disability and impairment[Part 1: baseline<br>Part 2: 8 weeks after randomisation];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.[Part 1: baseline<br>Part 2: 8 weeks after randomisation]