The aim of this double blind study was to compare the effect of continuous ultrasound and pulsed ultrasound in patients with chronic maxillary and frontal sinusitis. In this study, 30 patients were randomly allocated to either continuous or pulsed groups. Treatment protocol for continuous ultrasound group: Treatment duration: 5 min for each maxillary sinuses, and 4 min for each frontal sinuses; Frequency: 1 MHz; Intensity: 1 W/Cm2 for maxillary sinuses and 0.5 W/Cm2 for frontal sinuses; Ultrasound type: continuous. Treatment protocol for pulsed ultrasound group: Treatment duration: 5 min for each maxillary sinus, and 4 min for each frontal sinuses; Frequency: 1 MHz; Intensity: 1 W/Cm2 for maxillary sinuses and 0.5 W/Cm2 for frontal sinuses; Ultrasound type: Pulsed (ratio: 1:9). The primary outcome measure was improvement in symptoms. After the end of the treatment, the patients were followed-up for 2 months after completion of the treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138811133259N1
Registration date:2010-05-29, 1389/03/08
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-05-29, 1389/03/08
Registrant information
Name
Noureddin Nakhostin Ansari
Name of organization / entity
Tehran University of Medical Sciences, Faculty of Rehabilitation
Country
Iran (Islamic Republic of)
Phone
+98 21 7753 3939
Email address
nakhostin@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research deputy, Tehran University of Medical Sciences
Expected recruitment start date
2008-03-03, 1386/12/13
Expected recruitment end date
2010-03-04, 1388/12/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A study to compare the effect of pulsed and continuous ultrasound in patients with chronic maxillary and frontal sinusitis
Public title
The effect of ultrasound on chronic sinusitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Chronic sinusitis criteria (persistent symptoms for 3 months, 4 episodes per year with each episode lasting at least 10 days and positive CT scan findings), no response to medical treatment
Exclusion criteria: Taking drugs (antibiotics, antihistamins, and pain relievers), tumor in the area of the head and face
Age
From 16 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research dputy, Tehran University of Medical Sciences
Treatment protocol for continuous ultrasound group:Treatment duration: 5 minutes for each maxillary sinus and 4 minutes for each frontal sinus, Frequency: 1 MHz, Intensity: 1 W/cm2 for maxillary sinuses and 0.5 W/cm2 for frontal sinuses, Ultrasound type: continuous. Patients will recieve no drugs during the study.
Category
Rehabilitation
2
Description
Treatment protocol for pulsed ultrasound group: Treatment duraion: 5 minutes for each maxillary sinus and 4 minutes for each frontal sinus, Frequency: 1 MHz, Intensity: 1 W/cm2 for maxillary sinuses and 0.5 W/cm2 for frontal sinuses, Ultrasound type: pulsed (pulse ratio 1:9). Patients will recieve no drugs during the study.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Rehabilitation Faculty, Tehran University of Medical Sciences
Full name of responsible person
Dr. Noureddin Nakhostin Ansari
Street address
Enghelab Ave, Pitch-e-shemiran
City
Teharn
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research deputy, Tehran University of Medical Sciences
Full name of responsible person
Dr. Fotouhi
Street address
Qods Ave, Keshavarz BLV
City
Teharn
Grant name
Grant code / Reference number
132/8768
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research deputy, Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Rehabilitation Faculty, Tehran University of Medical Sciences
Full name of responsible person
Dr. Noureddin Nakhostin Ansari
Position
PhD, PT/ Associate Professor
Other areas of specialty/work
Street address
Enghelab Ave, Pitch-e-shemiran
City
Tehran
Postal code
11489
Phone
+98 21 7753 3939
Fax
+98 21 7788 2009
Email
nakhostin@sina.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rehabilitation faculty, Tehran University of Medical Sciences
Full name of responsible person
Dr. Noureddin Nakhostin Ansari
Position
PhD, PT/ Associate professor
Other areas of specialty/work
Street address
Enghelab Ave. Pitch-e-shemiran
City
Tehran
Postal code
11489
Phone
+98 21 7753 3939
Fax
+98 21 7788 2009
Email
nakhostin@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Rehabilitation faculty, Tehran University of Medical Sciences
Full name of responsible person
Dr. Noureddin Nakhostin Ansari
Position
PhD, PT/Associate professor
Other areas of specialty/work
Street address
Enghelab Ave, Pitch-e-shemiran
City
Tehran
Postal code
11489
Phone
+98 21 7753 5132
Fax
+98 21 7788 2009
Email
nakhostin@sina.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)