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IRCT20140810018754N8 IRCT 2018-07-13 Iran University of Medical Sciences Effect of ultrasound on sinusitis ندارد Consideration of pulsed and continuous ultrasound mechanism(s) in culture and real time PCR data of staphylococcus and streptococcus in chronic rhinosinusitis patients. 2018-07-07 anticipated 40 Complete https://irct.ir/trial/16919 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization, Blinding description: Participants are classified in different groups after familiarization with execution of the present study and obtaining informed consent but they are not aware of which group they are in. The outcome evaluator is not aware of which patient is being studied in any of the present study groups. N/A Chronic rhinosinusitis. Intervention 1: First intervention group or group 1: include chronic rhinosinusitis patients which treat with a ultrasound device on Frontal and Maxilla sinuses and parameters of: 1 megahertz frequency pulsed ultrasound (1MHzPUS) with 10 percent duty cycle, 4 centimeter per second the probe velocity, 1 watt per centimeters square intensity for Maxillary sinus and 0.5 watt per centimeters square intensity for frontal sinuses for 10 sessions. Intervention 2: Second intervention group or group 2: include chronic rhinosinusitis patients which treat with a ultrasound device on Frontal and Maxilla sinuses and parameters of: 1 megahertz frequency continuous ultrasound (1MHzCUS) with 10 percent duty cycle, 4 centimeter per second the probe velocity, 1 watt per centimeters square intensity for Maxillary sinus and 0.5 watt per centimeters square intensity for frontal sinuses for 10 sessions. Intervention 3: Control group or group 3: include chronic rhinosinusitis patients which ultrasound therapy is not performed for them. Data from this group will compare with group 1 and group 2 data and will use for analyzing the effects of ultrasound therapy. Intervention 4: Healthy subjects group or group 4: include subjects without chronic rhinosinusitis. Data from this group will consider as normal values for comparing ​​with treatment groups of the present study. Yes - There is a plan to make this available What will be shared: All data or results of the present study will be presented in an article or some articles that will be published after completing the study. When: After completing the present study and publishing the resulting article or articles. To whom: All researchers in the field of the present study. Conditions: With the same goal as the present study and with mention of the present study as the reference. All intellectual property rights of the present study belongs to the Iran University of Medical Sciences. Where to obtain: The corresponding author of the article or articles derived from this study. How to obtain: Written request from the author responsible for the present review after the publication of the resulting article or articles. Comments:
public Javad Sarrafzadeh
Physiotherapy department, School of Rehabilitation Sciences, Madadkaran street., Shahnazari street, Madar squ., Mirdamad street.
Tehran Iran (Islamic Republic of) 15459-13487 +98 21 2222 8051 sarrafzadeh.j@iums.ac.ir Iran University of Medical Sciences scientific Javad Sarrafzadeh
Physiotherapy department, School of Rehabilitation Sciences, Madadkaran street., Shahnazari street, Madar squ., Mirdamad street.
Tehran Iran (Islamic Republic of) 15459-13487 +98 21 2222 8051 sarrafzadeh.j@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Presence of secretions in maxillary and frontal sinus cavities based on CT scan. Secretions in the back of the throat or rhinorrhea for at least three months. 18 years 65 years Both Sinus or nasal polyps A deviated nasal septum Background of rhinoplasty Diabetes Vasculitis Hepatitis Any type of malignancy in the skull Any immunodeficiency J32.9 Chronic sinusitis, unspecified Treatment - Other Treatment - Other Treatment - Other Treatment - Other First intervention group or group 1: include chronic rhinosinusitis patients which treat with a ultrasound device on Frontal and Maxilla sinuses and parameters of: 1 megahertz frequency pulsed ultrasound (1MHzPUS) with 10 percent duty cycle, 4 centimeter per second the probe velocity, 1 watt per centimeters square intensity for Maxillary sinus and 0.5 watt per centimeters square intensity for frontal sinuses for 10 sessions. Second intervention group or group 2: include chronic rhinosinusitis patients which treat with a ultrasound device on Frontal and Maxilla sinuses and parameters of: 1 megahertz frequency continuous ultrasound (1MHzCUS) with 10 percent duty cycle, 4 centimeter per second the probe velocity, 1 watt per centimeters square intensity for Maxillary sinus and 0.5 watt per centimeters square intensity for frontal sinuses for 10 sessions. Control group or group 3: include chronic rhinosinusitis patients which ultrasound therapy is not performed for them. Data from this group will compare with group 1 and group 2 data and will use for analyzing the effects of ultrasound therapy. Healthy subjects group or group 4: include subjects without chronic rhinosinusitis. Data from this group will consider as normal values for comparing ​​with treatment groups of the present study. Colony count (measurement of the growth of bacteria in a sample that has been cultured for 24 to 48 hours). Timepoint: Before and after intervention. Method of measurement: Microscopic and real-time polymerase chain reaction (PCR) assays. Type of microbe. Timepoint: Before and after intervention. Method of measurement: Microscopic and real-time polymerase chain reaction (PCR) assays. Computed tomography (CT) scan score of Frontal and Maxillary sinuses. Timepoint: Before and after intervention. Method of measurement: Lund-Mackay method scoring. SNOT-20 test score (Sino-nasal Outcome Test-20). Timepoint: Before and after intervention. Method of measurement: From 0 up to 100 score. Iran University of Medical Sciences Approved 2016-12-13 Ethics committee of Iran University of Medical Sciences 5th floor, Iran University of Medical Sciences, Hemmat highway, between Sheikh Fazlollah Nuri and Chamran highways. Tehran Tehran Iran (Islamic Republic of)