Intense therapeutic ultrasound for chronic plantar fasciitis musculoskeletal tissue pain reduction was evaluated in a pivotal clinical trial examining effectiveness, safety, and patient tolerance. In this single-blinded study, 33 patients received 2 treatments that were 4 weeks apart on plantar fascia tissue along with conservative standard of care. Patients were followed for up to 6 months after the first treatment, receiving a physical examination and diagnostic ultrasound at each follow-up visit and completing patient-/subject-reported outcome measure and Foot Function Index surveys. The goal was to reduce overall pain by ≥25% on average and >25% individually. Hypoechoic area changes on diagnostic ultrasound and adverse events were measured. The percentage meeting pain reduction criteria at weeks 4, 8, 12, and 26 were 72%, 81%, 86%, and 79%, respectively. Mean pain scores at each visit were significantly different from baseline (p < .001) at -39%, -49%, -51%, and -44%. Hypoechoic lesions were found in all patients and decreased in size significantly (p < .05) at weeks 8 and 12 (-56% and -67%). Foot Function Index scores declined favorably from baseline (p < .001) at all time points (-32%, -46%, -49%, and -32%). The percentages of patients meeting satisfaction criteria were 72%, 85%, 90%, and 83%. The mean pain score during treatment 1 was 3.4, and during treatment 2, 2.9. Attrition of only 1 patient owing to pain occurred, after treatment 1. No adverse events occurred. Intense therapeutic ultrasound for chronic plantar fasciitis is shown to be effective, safe, and well tolerated in this pivotal clinical trial.
Keywords: heel pain; hypoechoic lesions; intense therapeutic ultrasound; plantar fasciitis; plantar fasciosis; therapeutic ultrasound; ultrasound.
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