One hundred fifty patients were enrolled in a multicenter, randomized, placebo-controlled, prospective, double-blind study to assess the clinical safety and effectiveness of extracorporeal shock wave therapy (ESWT) using the Dornier Epos Ultra for the treatment of plantar fasciitis. The Active Group was treated with electromagnetically generated shocks using ultrasound guidance during a single therapy session. The Control Group received a sham treatment under similar clinical conditions. The groups were demographically similar with respect to age, height, and weight. The average duration of symptoms was nearly 2 years in both groups. All patients were evaluated by the visual analog scale for pain, American Orthopaedic Foot and Ankle Society scores, Roles and Maudsley Score, SF-12 health status questionnaire, and physical examination. The Active Group reported 56% success at 3 months and 94% success at 12 months posttreatment. The Control Group reported 47% success at 3 months posttreatment. Twelve-month data were not collected for the Control Group as they were unblinded at 3 months and offered treatment. ESWT represents a safe treatment option for chronic proximal plantar fasciitis.

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