BACKGROUND: Foot orthoses are widely used in conservative treatment of painful flexible flatfoot however research is limited to choose the best option in orthotic treatment. AIM: We aimed to compare the effects of computer-aided design/computer-aided manufacturing (CAD-CAM) and conventional insole types in comparison with sham insole, on pain and health related quality of life in patients with painful flexible flatfoot. DESIGN: Randomized controlled trial. SETTING: Outpatient rehabilitation clinic. POPULATION: Sixty-seven people with painful flexible flatfoot, aged between 18 and 45 years, were assigned to CAD-CAM (n = 22), conventional (n = 22) or sham (n = 23) groups. METHODS: In addition to insoles, a home-based exercise program was followed by all participants for eight weeks. Foot pain intensity and quality of life were assessed at the initial evaluation and at the end of two-month follow-up. RESULTS: Pain intensity (mean +/- SD, mm on VAS) was significantly lower in CAD-CAM (27.84 +/- 18.41) and conventional (27.05 +/- 16.82) insole groups than sham group (46.39 +/- 20.18) after two months (p < 0.05), but there was no difference between conventional and CAD-CAM (p > 0.05). All groups had significantly higher physical health scores at the second assessment (p < 0.05), but there was no intergroup difference (p > 0.05). CONCLUSIONS: CAD-CAM and conventionally designed insoles are both more effective than having sham insole in alleviating pain in painful flexible flatfoot.

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