Clinical Question

Are custom-made foot orthoses effective for the treatment of foot pain?

Evidence-Based Answer

Compared with placebo or sham, custom-made foot orthoses modestly reduce foot pain from pes cavus (high arch), arthritis, plantar fasciitis, and painful hallux valgus. However, there is no evidence that custom orthoses are more effective than prefabricated ones.

Practice Pointers

There are limited treatment options for many common causes of foot pain.^1–3 Foot orthoses are commonly prescribed by podiatrists. Custom orthoses are custom-contoured, removable in-shoe devices that are molded or milled from an impression of the foot. Custom orthoses are significantly more expensive than prefabricated shoe inserts. Most insurance companies do not cover the cost of foot orthoses for foot pain that is unrelated to trauma or surgery.

In this Cochrane review, the authors searched for randomized controlled trials of custom-made orthoses for the treatment of any kind of foot pain. They found 11 trials with a total of 1,332 participants. Duration of follow-up ranged from two months to three years. Custom orthoses were compared with a variety of controls, including sham orthoses, no intervention, manipulation, mobilization and stretching, night splints, surgery for hallux valgus, and prefabricated foot orthoses. The quality of the studies was limited because it was not possible for participants to be blinded to the intervention. Therefore, it is possible that patient or physician expectations could have biased results. There was evidence of benefit for painful pes cavus (number needed to treat [NNT] = 5), foot pain in juvenile idiopathic arthritis (NNT = 4), rheumatoid arthritis (NNT = 4), and painful hallux valgus (NNT = 6).

In family medicine settings, plantar fasciitis is one of the most common causes of foot pain. In this review, custom orthoses were found to be more effective than sham orthoses for improving function, but not for reducing pain. They were not more effective than night splints or stretching, but did improve the effectiveness of night splints. At two to three months and at 12 months, prefabricated orthoses were as effective as custom orthoses. Adverse effects were uncommon and occurred at similar rates in intervention and control groups.