title: Effectiveness of off-the-shelf footwear in reducing foot pain in Australian Department of Veterans' Affairs recipients not eligible for medical grade footwear: study protocol for a randomized controlled trial.
abstract: BACKGROUND
  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, this article describes the design of a randomized controlled trial 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.
  
  
  METHODS
  One hundred and twenty DVA clients with disabling foot pain residing in 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-subsidized podiatry care in addition to being provided with low-cost, supportive footwear (Dr Comfort®, Vasyli Medical, Labrador, Queensland, Australia). The control group will also continue to receive DVA-subsidized 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® Version 2.0), 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. Data will be analyzed using the intention-to-treat principle.
  
  
  CONCLUSIONS
  This study is the first randomized controlled trial to evaluate the effectiveness of off-the-shelf footwear in reducing foot pain in DVA recipients. The intervention has been pragmatically designed to ensure that the study findings can be implemented into policy and clinical practice if found to be effective.
  
  
  BACKGROUND
  Australian New Zealand Clinical Trials Registry: ACTRN12612000322831.
authors.affiliation: Lower Extremity and Gait Studies Program, Faculty of Health Sciences, La Trobe University, Bundoora, Victoria 3086, Australia. h.menz@latrobe.edu.au
authors.forename: Hylton B
authors.initials: HB
authors.lastname: Menz
authors.forename: Nicoletta
authors.initials: N
authors.lastname: Frescos
authors.forename: Shannon E
authors.initials: SE
authors.lastname: Munteanu
mesh_terms: D000058:Accidental Falls / Q000517:prevention & control; D002985:Clinical Protocols; D004185:Disability Evaluation; D004608:Eligibility Determination; D004867:Equipment Design; D005534:Foot Diseases / Q000175:diagnosis / Q000209:etiology / Q000517:prevention & control* / Q000523:psychology; D006077:Government Agencies; D017048:Health Care Costs; D006801:Humans; D009989:Orthotic Devices; D010146:Pain / Q000175:diagnosis / Q000209:etiology / Q000517:prevention & control* / Q000523:psychology; D010147:Pain Measurement; D011032:Podiatry / Q000191:economics / Q000295:instrumentation*; D011237:Predictive Value of Tests; D011446:Prospective Studies; D011788:Quality of Life; D012107:Research Design; D012775:Shoes / Q000009:adverse effects / Q000191:economics; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D014728:Veterans; D014739:Victoria