BACKGROUND: Up to 10% of people will experience heel pain. The purpose of this prospective, double-blind, randomized clinical trial was to compare custom foot orthoses (CFO), prefabricated foot orthoses (PFO), and sham insole treatment for plantar fasciitis. METHODS: Seventy-seven patients with plantar fasciitis for less than 1 year were included. Outcome measures included first step and end of day pain, Revised Foot Function Index short form (FFI-R), 36-Item Short Form Health Survey (SF-36), activity monitoring, balance, and gait analysis. RESULTS: The CFO group had significantly improved total FFI-R scores (77.4 versus 57.2; p = 0.03) without group differences for FFI-R pain, SF-36, and morning or evening pain. The PFO and CFO groups reported significantly lower morning and evening pain. For activity, the CFO group demonstrated significantly longer episodes of walking over the sham (p = 0.019) and PFO (p = 0.03) groups, with a 125% increase for CFOs, 22% PFOs, and 0.2% sham. Postural transition duration (p = 0.02) and balance (p = 0.05) improved for the CFO group. There were no gait differences. The CFO group reported significantly less stretching and ice use at 3 months. CONCLUSIONS: The CFO group demonstrated 5.6-fold greater improvements in spontaneous physical activity versus the PFO and sham groups. All three groups improved in morning pain after treatment that included standardized athletic shoes, stretching, and ice. The CFO changes may have been moderated by decreased stretching and ice use after 3 months. These findings suggest that more objective measures, such as spontaneous physical activity improvement, may be more sensitive and specific for detecting improved weightbearing function than traditional clinical outcome measures, such as pain and disease-specific quality of life.

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