Effectiveness of low-intensity pulsed ultrasound for the treatment of viral pneumonia: study protocol for a prospective, randomized controlled trial

Background: Viral pneumonia has always been a problem faced by clinicians because of its insidious onset, strong infectivity and lack of effective drugs. Patients with advanced age or underlying diseases may experience more severe symptoms and are prone to severe ventilation dysfunction. Reducing pulmonary inflammation and improving clinical symptoms is the focus of current treatment. Low-intensity pulsed ultrasound (LIPUS) can mitigate inflammation and inhibit edema formation. We aimed to investigate the effectiveness of therapeutic LIPUS in improving lung inflammation in hospitalized patients with viral pneumonia. Methods: This study protocol entails a prospective, randomized controlled trial. 60 eligible participants with clinically confirmed viral pneumoniawill be assigned to either (1) test group (LIPUS stimulus), (2) external control group (null stimulus), or (3) self-control group (LIPUS stimulated areas versus non-stimulated areas). The primary outcome will be the difference in the extent of absorption and dissipation of lung inflammation on computed tomography andultrasonography images. Secondary outcomes include pulmonary function, blood gas analysis, fingertip arterial oxygen saturation, serum inflammatory factor levels, the sputum excretion volume, time to the disappearance of pulmonary rales, pneumonia status score, and course of pneumonia. Adverse events will be recorded. Intention-to-treat analyses will be used. Discussion: This study is the first clinical study of the effectiveness of therapeutic LIPUS in the treatment of viral pneumonia. Given that the current clinical recovery mainly depends on the body's self-limiting and conventional symptomatic treatment, LIPUS, as a new therapy method, might be a major advance in the treatment of viral pneumonia. Trial registration: ChiCTR2200059550 Chinese Clinical Trial Registry