The curative effects of shortwave diathermy on treating Novel coronavirus (COVID-19) pneumonia: A structured summary of a study protocol for a randomised controlled trial

• Published in: Current controlled trials in cardiovascular medicine 2020-07, Vol.21 (1), p.609-609, Article 609
• Main Authors: Nasb, Mohammad, Sayed Shah, Zulfiqar Ali, Huang, Liangjiang, Li, Qian, Chen, Hong
• Format: Article
• Language: English
• Subjects: Acids; Adolescent; Adult; Aged; Analysis; Betacoronavirus - pathogenicity; China; Clinical trials; Coronavirus; Coronavirus Infections - diagnosis; Coronavirus Infections - therapy; Coronavirus Infections - virology; Coronaviruses; COVID-19; Equivalence Trials as Topic; Female; Health aspects; Host-Pathogen Interactions; Humans; Letter; Lungs; Male; Middle Aged; Pandemics; Pneumonia; Pneumonia, Viral - diagnosis; Pneumonia, Viral - therapy; Pneumonia, Viral - virology; Protocol; Randomised controlled trial; SARS-CoV-2; Short-Wave Therapy - adverse effects; Time Factors; Treatment Outcome; Ultra short-wave diathermy; Young Adult
• ISSN: 1745-6215; 1745-6215
• DOI: 10.1186/s13063-020-04534-5

To evaluate the therapeutic effects of ultra-short-wave diathermy (SWD) on COVID-19 pneumonia. The hypothesis is that SWD may minimise pneumonic inflammation and shorten the duration of the time to positive-to-negative conversion of COVID-19 nucleic acid test. This is a single centre, 2-arm (1:1 ratio), evaluator blinded, parallel group design superiority randomised, controlled clinical trial. The inclusion criteria were: (1) Age 18-65 years, (2) COVID-19 nucleic acid test is positive, (3) Lung CT showed multiple patchy ground glass shadows or other typical manifestations of both lungs. The exclusion criteria were: (1) Patients who need ICU management, (2) Positive tests for other pathogens such as Tuberculosis, Mycoplasma, (3) Patients with respiratory failure or requiring mechanical ventilation, (4) Patients with metal implants or pacemakers, (5) Those with shock (6) Those that have bleeding tendency or active bleeding in the lungs, (7) Patients with multiple organ failure who need ICU monitoring and treatment, (8) Cancer patients and those with severe underlying diseases, (9) Pregnant or lactating women, (10) Patients with severe cognitive impairment who cannot follow the instructions to complete the treatment, (11) Those without signed informed consent and (12) Those with other contraindications to short wave. This study will be conducted in Tongji Hospital, Caidian, Wuhan, People's Republic of China. The experimental group will be given the nationally recommended standard medical treatment + ultra-short-wave diathermy treatment. Ultra-short-wave therapy treatment will be performed through application of ultra-short-wave therapy machine electrodes on the anterior and posterior parts of the trunk for 10 minutes, twice a day for 12 consecutive days. The comparator will be the control, not receiving ultra-short-wave therapy, and will be given only the nationally recommended standard medical treatment. The primary outcome measures will be time to positive-to-negative conversion of COVID-19 nucleic acid test by pharyngeal swab, in days assessed at 7 , 14 ,21 and 28 days. The secondary outcome measures include nucleic acid test rate and recovery from symptoms, Vital signs assessment, Computed Tomography, Complete blood count, serum analysis and SIRS scale scores. Blinded evaluation will be at baseline (the day of starting ultra-short-wave diathermy) and after 28 days following the interventions. A Randomization plan will be generated online on www.randomizat