Abstract
BackgroundFoot problems in general and forefoot problems in particular can lead to a decrease in mobility and a higher risk of falling. Forefoot problems increase with age and are more common in women than in men. Around 20% of people over 65 suffer from non-traumatic foot problems and 60% of these problems are localised in the forefoot. Little is known about the best way to treat forefoot problems in older people. The aim of this study is to compare the effects of two common modes of treatment in the Netherlands: shoe advice and podiatric treatment. This paper describes the design of this study.MethodsThe study is designed as a pragmatic randomised clinical trial (RCT) with 2 parallel intervention groups. People aged 50 years and over who have visited their general practitioner (GP) with non traumatic pain in the forefoot in the preceding year and those who will visit their GP during the recruitment period with a similar complaint will be recruited for this study. Participants must be able to walk unaided for 7 metres and be able to fill in questionnaires. Exclusion criteria are: rheumatoid arthritis, neuropathy of the foot or pain caused by skin problems (e.g. warts, eczema). Inclusion and exclusion criteria will be assessed by a screening questionnaire and baseline assessment. Those consenting to participation will be randomly assigned to either a group receiving a standardised shoe advice leaflet (n = 100) or a group receiving podiatric treatment (n = 100). Primary outcomes will be the severity of forefoot pain (0-10 on a numerical rating scale) and foot function (Foot Function 5-pts Index and Manchester Foot Pain and Disability Index). Treatment adherence, social participation and quality of life will be the secondary outcomes. All outcomes will be obtained through self-administered questionnaires at the start of the study and after 3, 6, 9 and 12 months. Data will be analysed according to the "intention-to-treat" principle using multilevel level analysis.DiscussionStrength of this study is the comparison between two common primary care treatments for forefoot problems, ensuring a high external validity of this trial.Trial registrationNetherlands Trial Register (NTR): NTR2212
Highlights
Foot problems in general and forefoot problems in particular can lead to a decrease in mobility and a higher risk of falling
The communitybased survey among older people in The Netherlands [9] showed that only 56% of the respondents sought health care, by consulting their general practitioner (GP) (46%), a medical specialist (36%) or an allied health care professional (18%)
We expect that about one third of all consulters presenting with foot problems have forefoot problems that meet our criteria [2,5], and assuming about 50% of these patients are eligible and willing to participate, a practice with a population of average age distribution can generate a minimum of 5 participants per year
Summary
Foot problems in general and forefoot problems in particular can lead to a decrease in mobility and a higher risk of falling. Around 20% of people over 65 suffer from non-traumatic foot problems and 60% of these problems are localised in the forefoot. Pain and discomfort due to foot problems are common and increase with age. Population-based surveys have estimated the prevalence of foot problems between 14.9 and 41.9% for people aged 50 years and older [1,2,3,4]. Hallux valgus and hallux rigidus are the most common foot problems in older people [2,5,9]. A community-based study among 5689 older people in the Dutch area of Apeldoorn (a mixed urban-rural area) showed a prevalence rate of forefoot problems of 60% within the group of people reporting non-traumatic foot problems (n = 1130) [2]. The treatment by the GP usually consists of prescribing pain medication (simple analgesic or non-steroidal inflammatory drugs [NSAIDs]) or by giving lifestyle advice (e.g. try to lose weight, improve shoe wear) [13]
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