Background: Foot orthoses are widely used in conservative treatment of painful flexible flatfoot (PFFF) 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 PFFF.
Design: Randomized controlled trial.
Setting: Outpatient rehabilitation clinic.
Population: Sixty-seven people with PFFF, 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 PFFF.
Clinical rehabilitation impact: CAD-CAM and conventionally designed semicustom insoles in conjunction with a home-based exercise program are both effective in controlling pain compared with sham insole and exercise in PFFF. Clinicians can prescribe both types of semicustom insoles as a part of conservative treatment instead of each other.