Eighty-eight patients with first metatarsophalangeal (MTP) joint osteoarthritis were randomized to receive contoured foot orthoses (n=47) or sham insoles (n=41). The primary outcomes of this trial were pain scores in the first MTP during the last week of follow-up using a numerical rating scale (NRS). Secondary outcomes such as pain and function were assessed using the Foot Health Status Questionnaire (FSHQ) and overall average pain using the Numeric Rating Scale (NRS), and quality of life using the Assessment of Quality of Life instrument. Physical activity was also assessed at 12 weeks using the Physical Activity Scale for the Elderly. No significant differences were reported between contoured foot orthoses versus sham with regard to all outcomes after 12 weeks.