The Short-term Effectiveness of Full-Contact Custom-made Foot Orthoses and Prefa

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Journal of the American Podiatric Medical Association

Volume 98 Number 5 357-363 2008

The Short-term Effectiveness of Full-Contact Custom-made Foot

Orthoses and Prefabricated Shoe Inserts on Lower-Extremity

Musculoskeletal Pain

A Randomized Clinical Trial

http://www.japmaonline.org/cgi/content/abstract/98/5/357

C. Trotter, DC, MBA, MSc, CPed© * and

Pierrynowski, PhD

* Foot-Knee-Back Clinic, Ancaster, Ontario, Canada.

School of Rehabilitation Science, McMaster University, Hamilton,

Ontario, Canada.

Abstract

Background: Foot orthoses are commonly dispensed for musculoskeletal

complaints of the foot and lower limb. Few randomized clinical trials

evaluate the clinical effectiveness of foot orthoses.

Methods: In this randomized clinical trial with a crossover design,

42 participants wore custom orthoses and prefabricated inserts in

their regular footwear for 4 weeks each, consecutively. Twenty-seven

participants received prefabricated inserts first and 13 received

custom orthoses first. A numeric pain rating scale (possible score, 0–

10) was used to measure participant pain.

Results: Statistically and clinically important decreases in pain

were reported after 3 weeks by participants wearing custom orthoses

first (–1.39 pain units, t12 = 2.70, P = .02). Participants who wore

prefabricated inserts first reported no statistically significant

change in pain. When the alternative intervention was introduced,

participants now wearing prefabricated inserts had greater pain after

1 and 2 weeks (1.1 pain units, t12 = 3.09, P = .01 and 0.9 pain

units, t12 = 2.65, P = .02, respectively). Participants now wearing

custom orthoses did not demonstrate significantly lower pain at any

week compared with the second baseline but did have significantly

lower pain scores compared with their initial baseline scores (–0.81

pain units, t12 = 2.31, P = .03).

Conclusion: Full-contact custom-made foot orthoses provide

symptomatic relief after 3 weeks of use for patients with lower-

extremity musculoskeletal pain if they are prescribed as the initial

treatment. (J Am Podiatr Med Assoc 98(5): 357–363, 2008)