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Scientific Assessment of Over-the-Counter Foot Orthoses to Determine Their Effects on Pain, Balance, and Foot Deformities

Adam Landsman Podiatric Surgery, Harvard Medical School/Beth Israel Deaconess Medical Center, Boston, MA.

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Donna DeFronzo Weil Foot and Ankle Institute, Des Plaines, IL.

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Julie Anderson National Center for Limb Preservation at Lutheran General Hospital, Park Ridge, IL.

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Thomas Roukis Department of Vascular Surgery, Madigan Army Medical Center, Tacoma, WA.

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Background: A scientific study was conducted to evaluate the effects of non–custom-molded (over-the-counter) foot orthoses.

Methods: Several parameters were examined, including foot, knee, hip, and back pain; balance; and reduction in flexible deformities, such as hammer toes and hallux valgus. Wherever possible, objective measurements were used, including measurements of shifts in center of pressure to assess balance and changes in bone position examined on radiographs. Forty-one individuals were analyzed using one of two types of prefabricated, noncustom insoles. Insoles were fit by an assistant trained to follow the fitting recommendations of the manufacturer under the direct supervision of a podiatric physician.

Results: Use of these arch supports resulted in a significant reduction in some types of foot pain associated with hallux valgus (P = .04) and pain in the arch area (P = .004), knee (P = .002), and back (P = .007) by week 4. We also measured changes in foot position documented by radiography, although some changes may be attributed to parallax associated with measurement techniques. Improvement in balance was not observed to be significant when the orthoses were worn.

Conclusions: Using both subjective and objective measures, we found that these over-the-counter foot orthoses were effective in bringing about changes in foot shape and concomitant relief of certain specific painful conditions. This study indicates that there is a scientific basis for attempting to relieve pain with orthoses. (J Am Podiatr Med Assoc 99(3): 206–215, 2009)

Corresponding author: Adam Landsman, DPM, PhD, Podiatric Surgery, Harvard Medical School/Beth Israel Deaconess Medical Center, Baker 3, 1 Deaconess Rd, Boston, MA 02215. (E-mail: alandsma@bidmc.harvard.edu)