The aim of this double blind clinical study is to compare the effect of pulsed ultrasound and erythromycin phonophoresis in patients with chronic maxillary and frontal sinusitis. In this study, 30 patients will randomly allocated to either pulsed ultrasound or phonophoresis groups. 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: 1:5). Patients in the phonophoresis group will recieve erythromycin phonophoresis with the same pulsed ultrasound parameters . Treatment sessions: 10 sessions, 3 days per week, every other day. The primary outcome measure is percentage improvement in symptoms.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201203273259N2
Registration date:2012-03-28, 1391/01/09
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-03-28, 1391/01/09
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
2010-07-23, 1389/05/01
Expected recruitment end date
2012-04-20, 1391/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study to investigate the effect of Pulsed Ultrasound and erythromycin phonophoresis in patients with Chronic Sinusitis
Public title
A comparative study to investigate the effect of Pulsed Ultrasound and erythromycin phonophoresis in patients with Chronic Sinusitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1) continuous symptoms for at least 3 months 2) unsuccessful medical or surgery treatments
Exclusion criteria: 1)the presence of tumor in the head and face 2) contarindications for ultrasoundtherapy
Age
From 18 years old to 65 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
Street address
Keshavarz BLV, Qods Ave
City
Tehran
Postal code
Approval date
2010-05-23, 1389/03/02
Ethics committee reference number
89-01-32-10200
Health conditions studied
1
Description of health condition studied
Chronic sinusitis
ICD-10 code
J32.0
ICD-10 code description
Chronic maxillary sinusitis
2
Description of health condition studied
Chronic sinusitis
ICD-10 code
J32.1
ICD-10 code description
Chronic frontal sinusitis
Primary outcomes
1
Description
Percent improvement
Timepoint
pretest-posttest
Method of measurement
Change in symptom score devided by pre score multiplied by 100
Secondary outcomes
empty
Intervention groups
1
Description
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: 1:5).
Category
Rehabilitation
2
Description
Treatment protocol for phonophoresis group: Phonophoreis of erythromycin; Duration: 5 minutes for each maxillary sinuses and 4 minutes for each frontal sinuses; Frequency 1MHz; Intensity: 1 Watt/cm2 for maxllary sinus and 0.5 Watt/cm2 for frontal sinus; Ultrasound type: pulsed (1:5).
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Rehabilitation , Tehran University of Medical Sciences
Full name of responsible person
Dr. Noureddin Nakhostin Ansari
Street address
Enghelab Ave, Pitch-e-shemiran
City
Tehran
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
Tehran
Grant name
Grant code / Reference number
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
School of Rehabilitation, 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 7772 7009
Email
nakhostin@sina.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Rehabilitation, 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 7772 7009
Email
nakhostin@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of Rehabilitation, 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 7772 7009
Email
nakhostin@sina.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)