• Foot & Ankle Conditions
• Orthopaedics Clinical Trials

• Foot & Ankle Conditions
• Orthopaedics Clinical Trials
• Orthopaedics

Treatment of plantar fasciitis with incobotulinum toxin A resulted in improved functional and pain outcomes and increased patient satisfaction as compared with placebo. Jamal Ahmad, MD, Rothman Institute, Philadelphia, Pennsylvania, USA, presented data from the Treatment of Plantar Fasciitis With Xeomin study [NCT01678001].

Up to 2 million patients per year require treatment for plantar fasciitis, with risk factors including prolonged weight-bearing activity, inappropriate shoe wear, greater body weight, and medical comorbidities. Botulinum toxin has been studied for the treatment of plantar fasciitis in several short-term prospective studies, demonstrating symptom improvement in up to 90% of patients at 3- and 6-month follow-up [Diaz-Llopis IV et al. Clin Rehabil. 2013; Placzek R et al. Clin J Pain. 2006]. The purpose of this study was to evaluate long-term outcomes of patients with plantar fasciitis treated with incobotulinum toxin A.

In this prospective double-blind study, 28 patients with plantar fasciitis who had unsuccessful nonsurgical treatment were randomly assigned to receive a 1-cc injection of 100 U of botulinum toxin or placebo. A board certified neurologist placed the injection at the flexor digitorum brevis muscle, which is continuous with the plantar fascia. Postinjection, patients completed physical therapy, including plantar fascial and Achilles stretching. Clinical end points included Foot and Ankle Ability Measure, visual analog scale, and patient satisfaction.

At 1-year follow-up, patients who received botulinum toxin had a significantly higher mean Foot and Ankle Ability Measure score of 73.8, compared with 40.9 in placebo-treated patients (P = .01). In addition, the mean visual analog scale score, a measure of pain, was significantly lower in the botulinum toxin arm, with a score of 3.6 out of 10, compared with 7.9 in the placebo arm (P = .01). Approximately 86% of patients in the botulinum toxin arm and 36% of patients in the placebo arm reported symptom improvement, with about 29% in the botulinum toxin arm indicating that they had achieved complete relief. In the botulinum toxin group, about 14% of patients experienced no change in symptoms, although none received surgery. In the placebo arm, about 64% of patients experienced no change in symptoms, with 2 patients undergoing surgery at 6 months.

Patient satisfaction was greater in the botulinum toxin arm, with about 29% and 50% reporting that they had excellent and good satisfaction, respectively, compared with 0% and 7% in the placebo arm (Table 1). There were no reports of injection-related complications in either study arm.

In conclusion, Dr Ahmad stated that, in his opinion, the data from this study indicate that treatment of plantar fasciitis with botulinum toxin resulted in greater functional scores and patient satisfaction, as well as lower pain scores, when compared with placebo. However, the study was limited by a small sample size, potential differences in physical therapy regimens, and potential use of patient-directed treatments.

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