The short-term and long-term effects of laser therapy on pulmonary function and inflammatory factors in patients with COVID-19 during acute stage

The effect of laser therapy on pulmonary function and inflammatory factors in patients with Covid 19 in the acute phase of the disease

َA randomized controlled double-blind clinical trial with parallel groups. Phase 3 on 30 patients. A random table of numbers will be used for randomization.

This research will be conducted in Kosar Hospital of Semnan University of Medical Sciences. After enrollment in the study, patients will be randomly assigned into active and sham-laser groups and then in the intervention group, patients will be intervened with 5 sessions of high power laser. In both groups, standard treatments include non-invasive ventilation, antibiotics (oral and injectable if needed), supportive vasopressor, artificial kidney, and extracellular membrane oxygenation. In the control group, standard treatment with sham-laser will be performed on the same points.

Inclusion criteria included individuals with COVID-19 with a positive PCR test who will be hospitalized due to severe pulmonary involvement. Patients who inevitably undergone to use invasive ventilation or if there is a contraindication for laser treatment will also excluded from the study.

The first group includes active laser in which the laser will be applied for 5 daily sessions. In the control group, exactly the same method, but when the device set is off , the probe will move. The laser protocol including C.P.S waves, will be used for 30 minutes (15 minutes on each side) at 650 and 905 nm to reduce pneumonia.

Pneumonia severity indices, and laboratory tests including O2 saturation (SaO2), inflamatory factors including Lymph percentage, Neutrophil / Lymphocyte ratio, Interleukin-6, Ferritin, Erythrocyte sedimentation ratio، low density lipoprotein, C-Reactive protein.

A simple randomization method using a random number table, individuals will be randomly divided into two groups including intervention and control. Random units are each of patients infected with covid-19 that admitted to the emergency department. Also, The randomization tool is a random number table. The researcher select one of the numbers in the random numbers table and moves to the right and down. Record the numbers and assign them to different study groups whose numbers are already specified.

Patients will be blinded whether they are in the active or sham LASER group (the laser device will be used at the same points and for the same duration, which will be set on in the intervention group and off in the control group). In addition, the evaluator will not aware which patient assigned in two groups.