Clinical Question: Is a prefabricated orthosis or a custom-manufactured orthosis effective in decreasing pain and improving function in patients with plantar fasciitis?

Setting: Outpatient (specialty)

Study Design: Randomized controlled trial (single-blinded)

Synopsis: Participants for this study were drawn from a podiatry clinic, and all were diagnosed as having had plantar fasciitis for at least four weeks. The 135 patients were randomly assigned (concealed allocation uncertain) to receive treatment with one of three foot orthoses: a prefabricated, off-the-shelf, firm orthosis; a rigid customized orthosis; or a soft sham (placebo) orthosis.

All but four patients participated for the full 12 months of the study, although by the end of the study, approximately 25 percent of patients had received additional treatment. Pain and function were measured using the Foot Health Status Questionnaire. Using intention-to-treat analysis, all three groups experienced an improvement in pain scores at three- and 12-month follow-up, and there was no difference between the sham orthotic and the other orthotics. At three months, function was slightly better with the prefabricated and customized orthoses compared with sham treatment, with an adjusted mean difference in function scores of 8.4 and 7.5 out of a possible 100 (P < .05). At 12 months, function scores in patients treated with the sham orthotic had improved and there was no difference among the three groups. The study had the power to find a 15-point difference in pain scores if one truly existed.

Bottom Line: Individually designed and retail orthotics are no more effective than a padded insert, on average, at decreasing pain in patients with plantar fasciitis. Patients report a small improvement in function, but this benefit is short-lived. (Level of evidence: 2b)