Consideration of pulsed and continuous ultrasound mechanism(s) in culture and real time PCR data of staphylococcus and streptococcus in chronic rhinosinusitis patients.
Inspection of chronic rhinosinusitis patient's sinuses secretion before and after ultrasound usage.
Design
The study is double blind randomized clinical trial. Sampling is done randomly among patients with chronic rhinosinusitis referring to treatment centers affiliated and non-affiliated to Iran University of Medical Sciences by an otolaryngologist.
Settings and conduct
Iran University of Medical Sciences
Participants/Inclusion and exclusion criteria
Patients enter the study based on CT scan image, the patients history and physical examination by the doctor. A patient is excluded if has sinus or nasal polyps or a deviated septum or has undertaken rhinoplasty. Other exclusion criteria include: diabetes, vasculitis, hepatics any type of malignancy in the skull and any immunodeficiency.
Intervention groups
Group 1: include chronic rhinosinusitis patients which 1 megahertz frequency pulsed ultrasound (1MHzPUS) will be used for them.
Group 2: include chronic rhinosinusitis patients which 1 megahertz frequency continuous ultrasound (1MHzCUS) will be used for them.
Group 3: include chronic rhinosinusitis patients which ultrasound therapy is not performed immediately for them but, based on the specialist idea, routine treatment or ultrasound therapy will be done 3 weeks after entering to the present study.
Group 4: include of healthy subjects who are not suffering from chronic rhinosinusitis and have not had any type of the respiratory system surgery.
Main outcome variables
CT scan score; colony count; SNOT-20 score.
General information
Reason for update
Acronym
ندارد
IRCT registration information
IRCT registration number:IRCT20140810018754N8
Registration date:2018-07-13, 1397/04/22
Registration timing:registered_while_recruiting
Last update:2018-07-13, 1397/04/22
Update count:0
Registration date
2018-07-13, 1397/04/22
Registrant information
Name
Javad Sarrafzadeh
Name of organization / entity
Iran University of Medical Sciences, School of Rehabilitation Sciences
Country
Iran (Islamic Republic of)
Phone
00982122228051-00982122227124
Email address
sarrafzadeh.j@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-07, 1397/04/16
Expected recruitment end date
2019-06-21, 1398/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Consideration of pulsed and continuous ultrasound mechanism(s) in culture and real time PCR data of staphylococcus and streptococcus in chronic rhinosinusitis patients.
Public title
Effect of ultrasound on sinusitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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.
Exclusion criteria:
Sinus or nasal polyps
A deviated nasal septum
Background of rhinoplasty
Diabetes
Vasculitis
Hepatitis
Any type of malignancy in the skull
Any immunodeficiency
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization
Blinding (investigator's opinion)
Double blinded
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.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
5th floor, Iran University of Medical Sciences, Hemmat highway, between Sheikh Fazlollah Nuri and Chamran highways.
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2016-12-13, 1395/09/23
Ethics committee reference number
ir.iums.rec1395.9211342214
Health conditions studied
1
Description of health condition studied
Chronic rhinosinusitis
ICD-10 code
J32.9
ICD-10 code description
Chronic sinusitis, unspecified
Primary outcomes
1
Description
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
2
Description
Type of microbe
Timepoint
Before and after intervention
Method of measurement
Microscopic and real-time polymerase chain reaction (PCR) assays
3
Description
Computed tomography (CT) scan score of Frontal and Maxillary sinuses
Timepoint
Before and after intervention
Method of measurement
Lund-Mackay method scoring
4
Description
SNOT-20 test score (Sino-nasal Outcome Test-20)
Timepoint
Before and after intervention
Method of measurement
From 0 up to 100 score
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Treatment - Other
2
Description
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.
Category
Treatment - Other
3
Description
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.
Category
Treatment - Other
4
Description
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.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Rehabilitation Sciences, Iran University of Medical Sciences
Full name of responsible person
Javad Sarrafzadeh
Street address
School of Rehabilitation Sciences, Iran University of Medical Sciences, Maddadkaran Ave., Madar Squr., Mirdamad Blvd.
City
Tehran
Province
Tehran
Postal code
۱۳۴۸۷ - ۱۵۴۵۹
Phone
+98 21 2222 8051
Email
sarrafzadeh.j@iums.ac.ir
Web page address
http://rehab.iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Seyed Kazem Malakouti, Vice chancellor for research
Street address
5th Floor, Iran University of Medical Sciences, Hemmat highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8670 2503
Email
research@iums.ac.ir
Web page address
http://vcr.iums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Javad Sarrafzadeh
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Physiotherapy department, School of Rehabilitation Sciences, Madadkaran street., Shahnazari street, Madar squ., Mirdamad street.
City
Tehran
Province
Tehran
Postal code
15459-13487
Phone
+98 21 2222 8051
Email
sarrafzadeh.j@iums.ac.ir
Web page address
http://rehab.iums.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Javad Sarrafzadeh
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Physiotherapy department, School of Rehabilitation Sciences, Madadkaran street., Shahnazari street, Madar squ., Mirdamad street.
City
Tehran
Province
Tehran
Postal code
15459-13487
Phone
+98 21 2222 8051
Email
sarrafzadeh.j@iums.ac.ir
Web page address
http://rehab.iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Javad Sarrafzadeh
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Physiotherapy department, School of Rehabilitation Sciences, Madadkaran street., Shahnazari street, Madar squ., Mirdamad street.
City
Tehran
Province
Tehran
Postal code
15459-13487
Phone
+98 21 2222 8051
Email
sarrafzadeh.j@iums.ac.ir
Web page address
http://rehab.iums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
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 the data will become available and for how long
After completing the present study and publishing the resulting article or articles.
To whom data/document is available
All researchers in the field of the present study.
Under which criteria data/document could be used
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.
From where data/document is obtainable
The corresponding author of the article or articles derived from this study.
What processes are involved for a request to access data/document
Written request from the author responsible for the present review after the publication of the resulting article or articles.