Intense Therapeutic Ultrasound for Treatment of Chronic Plantar Fasciitis: A Pivotal Study Exploring Efficacy, Safety, and Patient Tolerance.

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.

Intense Therapeutic Ultrasound for Pain Relief in the Treatment for Chronic Plantar Fasciopathy.

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.

Retrospective Analysis of Plantar Fascia by Ultrasound Imaging in Patients with Plantar Fasciitis.

BACKGROUND: We compared diagnostic ultrasound images of the plantar fascia with available patient histories for symptomatic patients previously diagnosed as having plantar fasciitis. Plantar fascia thickness and depth, the prevalence of perifascial hypoechoic lesions, and injury timelines in patients were reviewed. METHODS: Images and histories for 126 symptomatic patients were collected from a patient database. We documented plantar fascia depth and thickness and the visualization of hypoechoic perifascial lesions. After image analysis, the obtained plantar fascia thickness measurements were compared with various patient attributes for possible relationships, including age, weight, and body mass index. In addition, plantar fascia thickness measurements were separated based on injury timeline as well as symptomatic/asymptomatic foot for patients with unilateral conditions to check for significant differences between subgroups. These were, in turn, compared with a control group of 71 individuals with no heel pain or diagnosis of plantar fasciitis. RESULTS: Overall, mean ± SD symptomatic thickness (n = 148) was 6.53 ± 1.56 mm. Mean ± SD symptomatic depth (n = 136) was 13.36 ± 2.14 mm. For the control group, mean ± SD thickness was 3.20 ± 0.66 mm and depth was 10.30 ± 2.00 mm. Comparison of thickness based on injury timeline showed two significant differences: acute injuries (≤3 months) are significantly thicker than chronic injuries (>3 months), and only acute symptomatic thicknesses are significantly different from their asymptomatic thickness counterparts. Age, weight, and body mass index did not show significant correlations to thickness. Analysis of ultrasound images showed that 93% of symptomatic feet had hypoechoic lesions. CONCLUSIONS: Injury timeline and the presence of hypoechoic lesions may play important roles in patient discomfort, diagnosis, and treatment of plantar fasciitis.