None listed
Conditions
Brief summary
Foot pain is highly prevalent in older people, and in many cases is associated with wearing inadequate footwear. In Australia, the Department of Veterans’ Affairs (DVA) covers the costs of medical grade footwear for veterans who have severe foot deformity. However, there is a high demand for footwear by veterans with foot pain who do not meet this eligibility criterion. Therefore, the purpose of this randomised controlled trial is to evaluate the effectiveness of low cost, off-the-shelf footwear in reducing foot pain in DVA recipients who are currently not eligible for medical grade footwear. One hundred and twenty DVA clients with foot pain residing in the northern suburbs of Melbourne, Australia, who are not eligible for medical grade footwear will be recruited from the DVA database, and will be randomly allocated to an intervention group or a “usual care” control group. The intervention group will continue to receive their usual DVA-subsidised podiatry care in addition to being provided with low-cost, supportive footwear (Dr Comfort [registered trademark]) fitted by a podiatrist. The control group will also continue to receive DVA-subsidised podiatry care, but will not be provided with the footwear until the completion of the study. The primary outcome measure will be pain subscale on the Foot Health Status Questionnaire (FHSQ), measured at baseline and 4, 8, 12 and 16 weeks. Secondary outcome measures measured at baseline and 16 weeks will include the function subscale of the FHSQ, the Manchester Foot Pain and Disability Index, the number of DVA podiatry treatments required during the study period, general health-related quality of life (using the Short Form 12), the number of falls experienced during the follow-up period, the Timed Up and Go Test, the presence of hyperkeratotic lesions (corns and calluses), the number of participants using co-interventions to relieve foot pain, and participants’ perception of overall treatment effect.
Interventions
Low cost, off-the-shelf footwear (Dr Comfort [registered trademark], Vasyli Medical, Labrador, Queensland, Australia).
Men will receive the “Brian” style and women will receive the “Annie” style. Both styles feature a stretchable Lycra upper with Velcro closure and are available in three width fittings (medium, wide, extra-wide). These shoes have been selected as they are relatively low-cost compared to medical grade footwear (approximately AUD$250) and meet all commonly-used criteria for appro
Low cost, off-the-shelf footwear (Dr Comfort [registered trademark], Vasyli Medical, Labrador, Queensland, Australia). Men will receive the “Brian” style and women will receive the “Annie” style. Both styles feature a stretchable Lycra upper with Velcro closure and are available in three width fittings (medium, wide, extra-wide). These shoes have been selected as they are relatively low-cost compared to medical grade footwear (approximately AUD$250) and meet all commonly-used criteria for appropriate footwear (such as a low heel, appropriate fixation and adequate depth to accommodate toe deformities). Participants will be asked to wear the shoes as often as possible/practical during the 16 week trial period.
Sponsors
La Trobe University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
To be included in the study, veterans will need to meet the following inclusion criteria: (i) be a current DVA client not eligible for medical grade footwear; (ii) have disabling foot pain, using the case definition of the Manchester Foot Pain and Disability Index; (iii) have persistent foot pain, defined as foot pain present for at least 12 weeks, and; (iv) be capable of understanding the English language in verbal and written form.
Exclusion criteria
Veterans will not be eligible for inclusion in the study if they: (i) have diabetes and a history of foot ulceration (or current foot ulceration) or diabetic peripheral neuropathy (diagnosed with the 5.07 Semmes-Weinstein monofilament, using the International Working Group on the Diabetic Foot protocol); (ii) have a neurodegenerative disorder (e.g: Parkinson’s disease); (iii) have had a lower limb amputation or partial foot amputation (although single toe amputations will be permitted); (iv) have been prescribed contoured foot orthoses within the last 3 months (although simple flat insoles will be permitted, as will contoured foot orthoses prescribed more than 3 months ago), or; (v) have cognitive impairment (defined as a score of <7 on the Short Portable Mental Status Questionnaire)
Outcome results
None listed