The effect of different foot orthoses on pain and health related quality of life in painful flexible flat foot: a randomized controlled trial

Abstract

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 KIT, 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.