Abstract
Introduction. Rib fractures are an important health issue worldwide, with significant, pain, morbidity, and disability for which only symptomatic treatment exists. Objectives Based on our previous experimental model, the objective of the current study was to assess for the first time whether pulsed ultrasound (PUS) application could have beneficial effects on humans. Methods. Prospective, double-blinded, randomized, controlled trial of 51 patients. Four were excluded, and 47 were randomized into the control group (N=23) or PUS group (N=24). The control group received a PUS procedure without emission, and the PUS group received 1 Mhz, 0.5 W/cm(2) for 1 min/cm(2). Pain level, bone callus healing rate, physical and work activity, pain medication intake, and adverse events were blindly evaluated at baseline and one, three, and six months. Results. There were no significant differences at baseline between groups. PUS treatment significantly decreased pain by month 1 (P=0.004), month 3 (P=0.005), and month 6 (P=0.025), significantly accelerated callus healing by month 1 (P=0.013) and month 3 (P<0.001), accelerated return to physical activity by month 3 (P=0.036) and work activity (P=0.001) by month 1, and considerably reduced pain medication intake by month 1 (P=0.057) and month 3 (P=0.017). No related adverse events were found in the PUS group. Conclusions. This study is the first evidence that PUS treatment is capable of improving rib fracture outcome, significantly accelerating bone callus healing, and decreasing pain, time off due to both physical activity and convalescence period, and pain medication intake. It is a safe, efficient, and low-cost therapy that may become a new treatment for patients with stable rib fractures.