Comparison of Newly Designed Three Spike Insole and Total Contact Insole in Refractory Plantar Fasciitis: A Randomized, Double-Blinded, Non-Inferiority Study

Abstract

Category:Ankle; HindfootIntroduction/Purpose:Plantar fasciitis is one of the common foot complaints that is chronic and can induce dysfunction. Total contact insole (TCI) is simple but effective in treating plantar fasciitis. Nevertheless of the effect, the cost and the long duration for production have been the major flaws. Therefore, we developed newly designed three-spike insole (TSI) that can be commercially productive and compared the clinical outcomes with TCI.Methods:Patients with plantar fasciitis refractory to conservative treatment for more than 6 weeks were candidates. We produced insoles with hardness of 58 +- 5 Shore-A. Twenty-eight patients were randomly allocated to use either TSI or TCI evenly (Figure 1). The following assessment tools were used: visual analog scale (VAS), American Orthopaedic Foot & Ankle Society score, Foot and Ankle Outcome Score, Karlsson-Peterson (KP) score, Short Form-36 for quality of life, and Foot Function Index. Non-inferiority was declared if VAS was within the statistical variability of minimal important difference. A blinded assessor evaluated the groups at baseline and after 6, 12, and 24 weeks.Results:The groups were homogenous for majority of variables at baseline. Overall patient-reported satisfaction showed improvement from mean 5.2 (range, 1 - 12) weeks of wearing and all clinical outcome scores showed significant improvements in both groups over time on the basis of Friedman test (p <.05). TSI showed non-inferiority to TCI at each time point. Post hoc analysis revealed that many scales showed significant superiority of TSI at 3 month (p <.0125) and KP score at 6 month (p <.001).Conclusion:We reaffirmed that semi-rigid insole is effective in refractory plantar fasciitis and showed TSI restores pedal function more rapidly than TCI. TSI can be not only effective in deriving better clinical outcomes but also be manufactured for popularization to lower the price and producing time of orthosis.