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