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

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.