Shockwave Therapy for Plantar Fasciitis of the Eposcorporus Dornier

Authors: Christopher Zingas, David Collon, Kyle Anderson

Institution: Henry Ford Health System William Clay Ford Center for Athletic Medicine

The study is designed to assess the safety and efficacy of musculoskeletal shock wave therapy in the treatment of chronic plantar fasciitis. The authors hypothesize that shock wave therapy will be useful in the treatment of chronic plantar fasciitis which has failed conventional conservative methods.

Preliminary twelve month results indicate that shock wave therapy may provide an effective alternative treatment for chronic plantar fasciitis with minor transient adverse effects.

One hundred and fifty patients with chronic plantar fasciitis were enrolled in a randomized, 1:1 allocated, placebo-controlled, prospective, double blind clinical study with two groups: one receiving Extracorporeal Shock Wave Therapy (**eswt**) with Dornier Epos Ultra and the other receiving sham treatment. All 150 patients had failed at least six months of physician supervised conventional conservative methods and would have been considered surgical candidates by guidelines set forth by the AOFAS. All patients were greater than 18 years of age with unilateral single site plantar medial heel pain, and had a visual analog score of >5 (scale 1-10) for the first few minutes of morning walking. There were 119 women and 31 men enrolled. The mean age was 50 years (26-69) for the active group and 53 years (31-72) for the sham group. Each active treatment patient was subjected to a single 20 minute **eswt** session which delivered approximately 1300mJ/mm2 to the treatment area. The control group patients went through the identical treatment procedure without shock wave penetration. All patients were evaluated 3-5 days, 6 weeks, 3 months, 6 months, and 1 year post-treatment. Patients were assessed using the Visual Analog Score (VAS) during the first few minutes of walking and the Roles and Maudsley score. The participants were unblinded at 3 months post-treatment. Patients in the sham treatment group who did not improve at 3 months were offered active **eswt** and were considered the 'Crossover Group'.

The VAS for the first few minutes of walking at 3 months post-treatment showed a 45% success rate in the sham treatment group and 56% success in the active group. The Roles and Maudsley scoring showed a 40% success rate in the sham group and 62% success rate in the active group at 3 months. The VAS for the first few minutes of walking at 12 months post-treatment showed a 94% success rate in the active group. The Roles and Maudsley scoring showed also 94% success rate in the active group at 12 months. The crossover group at 12 months had a VAS score 63% success and Roles and Maudsley scoring of 93% success.

There were 17 active, 19 sham, 11 crossover mild transient complications seen. These included ecchymosis, edema, hypesthesia, paresthesia, petechiae, rash, neuralgia, injections site hemorrhage, nonpalpable pulse (sham treatment), and infection. These all resolved within a few days post-treatment. There was 1 permanent minor complication of paresthesia. No major transient or permanent complications were noted.