CONTEXT: Extracorporeal shock wave therapy (ESWT) is increasingly used for plantar fasciitis, but limited evidence supports its use. OBJECTIVE: To determine whether ultrasound-guided ESWT reduces pain and improves function in patients with plantar fasciitis. DESIGN: Double-blind, randomised, placebo-controlled trial conducted between April 1999 and June 2001. SETTING: Participants were recruited from the community-based referring physicians (primary care physicians, rheumatologists, orthopaedic surgeons, and sports physicians) of a radiology group in Melbourne, Australia. PARTICIPANTS: We screened 178 patients and enrolled 166; 160 completed the 15-week protocol. Entry criteria included age at least 18 years with plantar fasciitis, defined as heel pain maximal over the plantar aspect of the foot of at least 6 weeks' duration, and an ultrasound-confirmed lesion, defined as thickening of the origin of the plantar fascia of at least 4 mm, hypoechogenicity, and alterations in the normal fibrillary pattern. INTERVENTIONS: Patients were randomly assigned to receive either ultrasound-guided ESWT given weekly for 3 weeks to a total dose of at least 1,000mj/mm2 (n = 81), or identical placebo to a total dose of 6.0mj/mm2 (n = 85). MAIN OUTCOME MEASURES: Overall, morning, and activity pain, measured on a visual analog scale; Maryland Foot Score; waling ability; Short-Form-36 Health Survey (SF-36) score; and Problem Elicitation Technique score, measured at 6 and 12 weeks after treatment completion. RESULTS: At 6 and 12 weeks, there were significant improvements in overall pain in both the active group and placebo group (mean (SD) improvement, 18.1 (30.6) and 19.8 (33.7) at 6 weeks (p = 0.74 for between-group difference), and 26.3 (34.8) and 25.7 (34.9) at 12 weeks (p = 0.99), respectively). Similar improvements in both groups were also observed for morning and activity pain, walking ability, Maryland Foot Score, Problem Elicitation Technique, and SF-36. There were no statistically significant differences in the degree of improvement between treatment groups for any measured outcomes. CONCLUSION: We found no evidence to support a beneficial effect on pain, function, and quality of life of ultrasound-guided ESWT over placebo in patients with ultrasound-proven plantar fasciitis 6 and 12 weeks following treatment.

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