Plantar heel pain is a common complaint (estimated prevalence 10–15%) and has a negative impact on an individual's quality of life owing to reduced function compromising the activities of daily living (Alshami et al., 2008; Crawford and Thomson, 2008; Hunt et al., 2004; Irving et al., 2008; Landorff et al., 2004; Pribut, 2007). Localized pain in the heel has a number of causes; for example, plantar fasciitis, plantar calcaneal bursitis, nerve entrapment, calcaneal stress fracture and fat pad atrophy have all been described in the literature (Berkson et al., 2007). Plantar fasciitis is likely to be the most common complaint typified by pain of initial weight-bearing, whereas other complaints tend to get progressively worse with weight-bearing or activity. Additionally, inflammatory enthesopathy in systemic diseases such as inflammatory arthritis or sero-negative arthritis is also common in these patient groups, and the overall disease activity needs to be considered in this context, as local management alone may not suffice. Thus, the aetiology of heel pain is complex and multi-factorial; however, mechanical overload is thought to be a key element, with several contributing factors, with obesity and reduced heel pad thickness being reported, and altered foot mechanics being a key component (Irving et al., 2008; Rome, 1998a, 1998b; Stephens and Walker, 1997; Thomas et al., 2010).
Plantar heel reportedly accounts for 11–15% of new patient visits to foot specialists (Rompe et al., 2007), and numerous treatment interventions have been reported, including foot orthoses, corticosteroid injections, non-steroidal anti-inflammatory agents, therapeutic ultrasound, extracorporeal shock wave therapy, stretching exercises, night splints, strapping and surgical intervention (Hunt et al., 2004; Pfeffer et al., 1999; Theodore et al., 2004). Several reports identified custom-made foot orthoses as being the most efficacious intervention (Burns et al., 2006; Roos et al., 2006; Zifchock and Davis, 2008), but these studies tended to focus on a range of lower limb musculoskeletal complaints and not on heel pain per se. Sometimes, foot orthoses were part of a treatment strategy combining other modalities such as strapping and night splints (Turlik et al., 1999), making it difficult to extrapolate the impact made by the provision of orthoses. A Cochrane review (Hawke et al., 2008) identified custom-made foot orthoses as being more effective than placebo foot orthoses for improving function, but not for reducing heel pain. However, others have reported prefabricated foot orthoses to be equally effective in the management of lower limb musculoskeletal complaints, including plantar heel pain (Baldassin et al., 2009; Brocklesby and Wooles, 2009; Landsman et al., 2009; Rome et al., 2004; Stell and Buckley, 1998; Springett et al., 2007). Moreover, methodological quality across studies remains an issue (Hawke et al., 2008) and the need for detailed cost comparisons has been highlighted (Menz, 2009; Redmond et al., 2009; Rome, 1998a, 1998b). In 1994, it was estimated that, in the UK, some £12 million was spent on foot orthoses (Fox and Winston, 1994); yet, there remains little scientific evidence to draw conclusions about the efficacy of different devices. Although some considered bespoke orthoses to be a gold standard (Donatelli, 1996), the time and cost invested in such devices requires justification in the light of continued drives for more cost-effective solutions (Department of Health, 2010a,2010b). The present study aimed to investigate both the clinical efficacy and cost-effectiveness of prefabricated (over-the-counter) compared with custom-made (casted) foot orthoses for the management of plantar heel pain.