Objective: The effect of Therapeutic pulsed ultrasound in adult with a rhinosinusitis؛ Design: Non randomised، Single blind، Without control group، Without placebo، For one stage clinical trial؛ Setting and conduct: The patient was treat in 10 sessions؛ Inclusion criteria: 1- Age 20 -50 years، 2- Without face surgery and face malignancy tumor، 3- Understanding literacy and verbal power؛ Exclusion criteria: 1- Cold-infection in the course of treatment؛ Intervention: Pulsed ultrasound؛ Main outcome measures (variables): The sinusitis symptom severity questionnaire and smell test.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017050533821N1
Registration date:2017-09-04, 1396/06/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-09-04, 1396/06/13
Registrant information
Name
Atieh Nazem
Name of organization / entity
Faculty of Rehabilitation in Tehran University of Medical science
Country
Iran (Islamic Republic of)
Phone
+98 21 7753 3939
Email address
a-nazem@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2017-06-16, 1396/03/26
Expected recruitment end date
2017-07-16, 1396/04/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of therapeutic pulsed ultrasound on smell disorder in adults with chronic rhinoisinusitis
Public title
The effect of therapeutic ultrasound on smell disorder with chronic rhinoisinusitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age 20 to 50 years؛ with a Chronic rhinosinusitis (diagnosis of a especial physician؛ clinical finding CT-scan and having symptoms such as posterior throat، cough، headache when bending forward، feeling full pressure of face and smell disorder)؛ No history of surgery in the nose and sinuses؛ Not having a malignant tumor on the face and head and mental disorders (Hallucination)؛ Understanding literacy and verbal power؛ Ability to recognize and understand at normal level؛ Exclusion criteria: Cold-infection in the course of treatment؛ Acute recurrence of rhinosinusitis.
Age
From 75 years old to 45 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
15
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences، Qods ST، Keshavarz BLV
City
Tehran
Postal code
Approval date
2017-04-15, 1396/01/26
Ethics committee reference number
IR.TUMS.FNM.REC.1396.2079
Health conditions studied
1
Description of health condition studied
CHRONIC RHINOSINUSITIS
ICD-10 code
J32.9
ICD-10 code description
•Inflammation of the paranasal sinuses that typically lasts beyond eight weeks. It is caused by infections, allergies, and the presence of sinus polyps or deviated septum. Signs and symptoms include headache, nasal discharge, swelling in the face, dizzine
Primary outcomes
1
Description
Smell disorder
Timepoint
Ten days and one month after treatment
Method of measurement
Smell identification test
2
Description
Severity of chronic rhinosinusitis symptoms
Timepoint
Ten session and one month later
Method of measurement
SNOT-20 valid qustionare
Secondary outcomes
1
Description
Gender
Timepoint
First session
Method of measurement
Based on apparent phenotype
2
Description
History of disease
Timepoint
First session
Method of measurement
Ask the patient
3
Description
Affected sinuses
Timepoint
First session
Method of measurement
CT-scan
4
Description
Age
Timepoint
First session
Method of measurement
Birth cetificate information
Intervention groups
1
Description
In treatment group، intervention was used by ultrasonic machine، ITO 750 model
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Rehabilitation of Tehran university of Medical Sciences
Full name of responsible person
Doctor Sofia Naghdi (Associate Professor)
Street address
Faculty of Rehabilitation of Tehran University of Medical Sciences، Pich-e-shemiran ST، Enghelab AV، Tehran، Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Vice chancellor for research of Tehran University of Medical Sciences
Street address
Tehran university of medical science, Qods ST, 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
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
Faculty of Rehabilitation of Tehran University of Medical Science