Background: Intense therapeutic ultrasound (ITU) is an innovative ultrasound-based therapy where sound waves are concentrated into select musculoskeletal tissue. These focused waves generate thermal coagula at a controlled depth and space while preserving surrounding tissues. A multicenter study was conducted evaluating the efficiency, safety, and patient tolerance of ITU for the treatment of chronic plantar fasciitis (CPF) pain.
Methods: Seventy-four CPF patients, having failed conservative and/or minimally invasive treatment, participated in the study. Randomized participants either received 2 ITU treatments or 2 sham ITU treatments in addition to standard-of-care therapy. Plantar fascia pain was assessed pretreatment and at 4, 8, 12, and 26 weeks after treatment. Diagnostic ultrasonographic images were analyzed to examine hypoechoic, perifascial lesions whose volumes were calculated until week 12. Function and patient satisfaction were measured using self-reported outcome measures.
Results: The treated group reported significant average pain reduction (-26%, -33%, -43%) and hypoechoic lesion volume (-33%, -53%, -68%) at weeks 4, 8, and 12 compared to baseline. Although the control/sham group reported insignificant pain changes at the same time points (-5%, +8%, and +2%) and increased hypoechoic lesion volume (+15%, +28%, +58%). Treated patients reported a significant increase in daily living activities (+28%, +42%, +47%, +40%) compared to the sham/control group (+0.12%, +12%, +3%, +21%). Patient satisfaction remained more than 80% at weeks 8, 12, and 26 for all treatment groups.
Conclusion: ITU is an effective pain relief treatment for CPF, which is refractory to either conservative measures or minimally invasive treatments.
Level of evidence: Level II.
Keywords: FAAM; hypoechoic lesion; intense therapeutic ultrasound (ITU); musculoskeletal pain relief; plantar fascia therapy; plantar fasciitis; plantar fasciopathy.
© The Author(s) 2019.