Study of Effectiveness and Safety of Extracorporeal Shock Wave Therapy (ESWT) for Treatment of Painful Heel Syndrome

Inclusion Criteria: * Age greater than 18 years * ability of subject or legal respondent to give written informed consent * signed informed consent * diagnosis of painful heel syndrome * 6 months of unsuccessful conservative treatment * washout from conservative treatment * scores of 5 or greater on three VAS scales * score of 3 or 4 on Roles and Maudsley Scale * willingness to refrain from specified concomitant therapies * willingness to keep subject diaries * negative urine pregnancy test (if applicable) required use of contraception (if applicable) Exclusion Criteria: * tendon rupture, neurological or vascular insufficiencies * inflammation of lower and upper ankle * history of rheumatic disease, collagen, or metabolic disorders * history of hyperthyroidism * active malignant disease with or without metastasis * Paget disease or calcaneal fat pad atrophy * osteomyelitis * fracture of calcaneus * immunosuppressive therapy * long term (6 months or greater) treatment with corticosteroid * insulin dependent diabetes, severe cardiac or respiratory disease * coagulation disorder or therapy with anticoagulants or antiplatelet drugs * bilateral painful heel * planned treatment within 8 weeks of enrollment that may confound pain results * less than required washout of other treatments * previous surgery for painful heel * previous unsuccessful treatment for painful heel with shock wave device * history of allergy or hypersensitivity to local anesthetics * significant abnormalities of hepatic function * poor physical condition * pregnant female * active infection or history of chronic infection in treatment area * history of peripheral neuropathy * history of systemic inflammatory disease * history of worker's compensation or litigation * participation in study of investigational device within 30 days of selection or current active study participation * in the opinion of the investigator, inappropriate for study inclusion * unwilling to comply with study requirements * implanted pacemaker, insulin pump, defibrillator, or neurostimulator * implanted prosthetic device in area of treatment * open wounds or skin rashes