Comparison between customised foot orthoses and insole combined with the use of extracorporeal shock wave therapy in plantar fasciitis, medium-term follow-up results: A randomised controlled trial.

Objective: To determine the clinical results of custom-made foot orthoses versus placebo flat cushioning insoles combined with an extracorporeal shock wave therapy on pain and foot functionality in patients with plantar fasciitis.
Design and Setting: A randomised controlled clinical trial with follow-up at six months. Faculty of Podiatry and Centre Clinical private of Physiotherapy, Seville, Spain.
Subjects and Interventions: Patients with plantar fasciitis were randomly assigned to either group A ( n  = 42), which received custom-made foot orthoses, or group B ( n  = 41), which received placebo insoles. All the participants received active extracorporeal shock wave therapy including stretching exercises. Recruitment period was from Mach 2019 to July 2020.
Main Measurements: The main outcome was foot pain, measured by visual analogue scale and the secondary outcome measures were recorded by Roles and Maudsley scores respectively, at the beginning and at one week, one month and six months.
Results: Eighty-eight patients were assessed for eligibility. Eighty-three patients were recruited and randomised. This study showed significant differences between both groups according to the visual analogue scale. In control group, the difference was at baseline ( P 0.01) and, in the experimental group was at the one- and six-month follow-up ( P 0.001). The mean (SD) visual analogue scale at baseline were Control group 6.31 (1.69) and Experimental group 5.27 (1.64); and at six months were 7.52 (3.40) and 3.29 (4.26), respectively. The custom-made foot orthosis was perceived as 'good' (85%) and 'excellent' (97.5%) at medium-long term.
Conclusion: Wearing a custom-made foot orthosis leads to a improvement in patients with plantar fasciitis; it reduced foot pain and improved foot functionality.