This qualitative study has provided new insight into how the process of providing foot orthoses contributes to the success in achieving improvements in the participant’s experience of low back pain. The interviews revealed that for these participants, the foot orthoses did improve back pain. This result is supported with the results of the Roland-Morris Disability Questionnaire  which was completed as a standard ‘clinical’ outcome measure.
The most revealing aspect of this work is that the physical effects of the foot orthoses is clearly augmented by the defined process of providing them which considers the psychological, emotional and social factors. As it has previously been identified that psychological reactions contribute to low back pain and its persistence [18, 19], it would seem that to address these factors in the assessment process is essential if the positive physical effect of the foot orthoses is to be maximised.
When considering how the process of providing the foot orthoses has impacted on the participants experiences, it became clear that there were differences between the ‘research’ assessment process and the usual ‘clinical’ assessment. The podiatrist as the researcher in this study had twice the amount of time with each of the participants than in the usual clinical context. Further, the process of informed consent included a patient information sheet, verbal explanation and opportunity for the participants to ask questions. Their suitability for inclusion into the study involved the researcher asking the potential participants about their understanding of how their back pain could be related to lower limb function, information as to how they would be assessed and then how foot orthoses effect changes in lower limb mechanics. In addition to the usual assessment of the structure and function of the lower limb, part of the assessment process involved producing a 3D image of the participant’s feet showing the results of abnormal lower limb function. This was shown to the participants with verbal explanation as to the meaning of the image. The interplay of all these factors may have contributed to the reported feelings of being valued and hence their anxieties reduced.
Anxiety and other psychological effects have not been measured in studies that have investigated foot orthoses as an intervention [9–13] with the focus being the physical effects. Main and George  suggested the notion of 'psychologically informed practice', which they describe as the integration of physical and psychological approaches to treatment of low back pain. It has been highlighted by Main et al.  that in addition to the physical effects of interventions, attention needs to be given to the beliefs/expectations, emotional responses and behavioural responses associated with low back pain, as these are associated with outcome of treatment. Overmeer et al.  provide an important model for future studies in this area and clearly recommend evaluation of the psychological effects of living with pain as an influence on the patient’s experience and on the outcome of interventions.
From the results of this study, it is clear that a consultation style in which the clinician spends time listening to these patients’ expectations, beliefs and fears, with explanation about the potential reasons for their back pain, can have the effect of reducing their anxiety and hence their experience of pain. It is known that anxiety can influence the level of pain experienced by individuals  and it might also become a barrier to symptom improvement through its negative effect on compliance. Good communication skills that are underpinned by a psychosocial approach are the basis for an effective consultation and also to patient compliance with interventions . Such is the potential impact of communication on outcomes, that allowing sufficient time for the consultation and effective communication could be seen as part of the intervention, rather than simply the process through which the intervention is dispensed. Indeed, communication skills have been identified as worthy of investigation in relation to physiotherapy consultations with patients with low back pain  and we suggest that this should also be investigated in relation to the provision of foot orthoses.
The use of technology to visually explain the patients underlying problem with foot function and how foot orthoses work can improve engagement and might alter expectations too. This reinforces the vital link between the problem and the potential cure. The visual component of gait analysis has been shown to be beneficial in demonstrating the effects of footwear in a cohort of elderly people . Vilallonga  identified that imagery improves communication between patients and clinicians and hence improves understanding, compliance and symptom improvement. The participants in this study valued the time that was spent with them in relation to listening, and visual and verbal explanation and this clearly had an effect on reducing their anxiety.
One of the challenges in this study was that the foot orthoses had to be worn in footwear that can accommodate them. It is known that this can be an obstacle  and it is clear that careful explanation about footwear choices in relation to levels of activity is crucial in maintaining the choices that people expect in their everyday lives. That the foot orthoses were not worn for social but low impact activities may not be a problem in relation to outcomes, since these occasions are typically of short duration. Indeed it can be said that maintaining choice is important in relation to patient compliance over the period of time required to achieve and maintain improvements.
A further influence on their engagement with foot orthoses could be that the participants were reassessed after 16 weeks. This provided the opportunity for reinforcement of information and an evaluation of the short term outcomes such as improved posture. This could have encouraged the participants to continue with their use and may also have elevated their tolerance of any issues, such as the inconvenience of swapping orthoses between footwear, or having to change their footwear styles. It is therefore of concern that there is anecdotal evidence that in some health care settings reassessment and review of foot orthoses is not routine practice due to increasing demands for shorter waiting lists and limited appointments.
Potential limitations to this study could be that a heterogeneous population was utilised in relation to age range and duration of low back pain. However, the aim of the research was to explore experiences of these participants and in this respect the purposive sampling has provided results which illuminate influences on an area of practice which has previously been ignored. Furthermore, the research setting was a pain clinic focusing on chronic low back pain cases that had failed to respond to other treatments and thus the sample represents the reality of practice for this particular setting.
In respect of future research, both Sahar et al.  and van Middelkoop et al.  recommended large scale clinical trials of foot orthoses. However, as this study has demonstrated, there are complex patient focussed factors which have the potential to influence the outcome. These factors are the patients understanding about the cause of their low back pain, their level of anxiety, expectations about the foot orthoses as an intervention, their initial experience of wearing them and the process by which they are provided. These factors may be independent or complementary to the physical effect of the foot orthoses. Either way, we consider that it is crucial that these factors are considered during the planning of future clinical trials. The most recent clinical trial  demonstrated that the physical effect of foot orthoses achieved short term benefits. However, they did not detail any of the factors that may have contributed to the short term successful outcome or may influence sustained success.
If these multiple influences on outcome are ignored, there is the risk incomplete appraisal of the value and role of foot orthoses for whatever condition that they are provided for. This seems especially critical in the context of health policy that continually elevates the importance of the voice of patients in relation to their own care . Arguably, all of the factors identified in this study could all be reasonably considered as part of the intervention. This would move foot orthoses from being a mechanical to a “complex intervention”  and in turn could influence both the future research approach and the approach to their provision in clinical practice.