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 to 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, t[12] = 2.70, p = 0.02). 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, t[12] = 3.09, p = 0.01 and 0.9 pain units, t[12] = 2.65, p = 0.02, 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, t[12] = 2.31, p = 0.03). 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.

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