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A Randomized Controlled Trial

Rachelle Buchbinder, MBBS, MSc; Ronnie Ptasznik, MBBS, FRANZCR; Jeanine Gordon, BAppSci; Joylene Buchanan, DipAppSci; Vasuki Prabaharan, BSc, MAppSci; Andrew Forbes, PhD

JAMA. 2002;288:1364-1372.

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, randomized, placebo-controlled trial conducted between April 1999 and June 2001.

Setting  Participants were recruited from the community-based referring physicians (primary care physicians, rheumatologists, orthopedic 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 1000 mJ/mm² (n = 81), or identical placebo to a total dose of 6.0 mJ/mm² (n = 85).

Main Outcome Measures  Overall, morning, and activity pain, measured on a visual analog scale; Maryland Foot Score; walking 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 = .74 for between-group difference], and 26.3 [34.8] and 25.7 [34.9] at 12 weeks [P = .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.

Author Affiliations: Department of Clinical Epidemiology, Cabrini Hospital, and Cabrini Medical Centre, Malvern, Victoria, Australia (Dr Buchbinder); Department of Epidemiology and Preventive Medicine, Monash University (Drs Buchbinder and Forbes and Ms Prabaharan); Radiology Department, Latrobe University Medical Centre (Dr Ptasznik); and Mayne Health Diagnostic Imaging, Epworth Hospital (Mss Gordon and Buchanan), Melbourne, Australia.

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