Determining the effect of high-power laser in improving facial nerve function in patients with Bell's palsy
Design
A clinical trial with a control group, with factorial groups, double-blind, randomized, 30 patients. SPSS statistical software was used for randomization.
Settings and conduct
In this study, patients are randomly divided into intervention and control groups, and the patients and the data analyst do not know which group each patient belongs to. Before the study, it is fully explained to the patients what the study is like and the satisfaction. This study is conducted in Amin Hospital.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1- Patients with Bell's palsy symptoms
2- At least one month has passed since receiving initial therapeutic interventions
Non-entry criteria:
1- Patients with malignancy, high blood pressure, uncontrolled diabetes mellitus, brain and nerve diseases, simultaneous multiple cranial nerve palsy, pregnancy and breastfeeding.
2- Patients with a history of recurrent facial paralysis or facial deformity
Intervention groups
The intervention group receives high-power laser and exercise, and the control group receives only exercise.
Main outcome variables
Improving the function of the facial nerve in the electrodiagnostic study and the HBS system related to the facial nerve.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190618043931N3
Registration date:2023-10-02, 1402/07/10
Registration timing:prospective
Last update:2023-10-02, 1402/07/10
Update count:0
Registration date
2023-10-02, 1402/07/10
Registrant information
Name
Shila Haghighat
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3627 5139
Email address
shila_haghighat@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-12, 1402/07/20
Expected recruitment end date
2024-04-02, 1403/01/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of high level laser in improving facial nerve function in patients with Bell's palsy
Public title
High level laser in Bell's palsy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with symptoms of Bell's palsy
At least one month has passed since receiving initial treatment interventions
Exclusion criteria:
Patients with malignancy, high blood pressure, uncontrolled diabetes mellitus, brain and nerve diseases, simultaneous multiple cranial nerve palsy, pregnancy and breastfeeding
Patients with a history of recurrent facial paralysis or facial deformity
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Referred patients are randomly divided into two intervention and control groups. In this way, each person is assigned a number and then they are entered into the study groups with the number randomization table. This randomization is without placement.
Blinding (investigator's opinion)
Single blinded
Blinding description
The data analyst is unaware of which group each patient was placed in.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Esfahan University of Medical Sciences
Street address
No.30,Taleghani Alley, East Hasht behesht Ave , Esfahan
City
Esfahan
Province
Isfehan
Postal code
8157955891
Approval date
2022-01-19, 1400/10/29
Ethics committee reference number
IR.MUI.MED.REC.1400.750
Health conditions studied
1
Description of health condition studied
Bell's palsy
ICD-10 code
G51.0
ICD-10 code description
Bell's palsy
Primary outcomes
1
Description
Severity of facial nerve palsy in HBS system and electrodiagnostic study
Timepoint
At the beginning of treatment, 3 and 6 weeks after treatment
Method of measurement
HBS system and electrodiagnostic study
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: high-power laser with Fisioline device in 12 sessions with a wavelength of 1064 and a frequency of 500 Hz is performed in the path of the facial nerve and exercises related to the facial nerve are taught. Regarding eye exercises, the patient is told to look down. Then gently place the index finger behind the upper eyelid and keep the eye closed. And with the fingers of the other hand, pull the eyebrow up. This exercise prevents the eyelids from tightening. After that, the patient tries to close the eyelids. press each other. Also, after this movement, the patient closes his eyes as if he were looking at the sunlight, in other words, he brings both eyelids closer to each other. To exercise in the mouth area, the patient should smile in such a way that the lips are closed and he can use his fingers to equalize the location of the corners of the mouth on both sides. After some time, the patient should perform this movement without the help of fingers and for a longer time. Gradually, the patient should raise only one side of the mouth and then repeat this movement for the other side. For the movements of the mouth and cheek area, the patient should also perform movements such as whistling and blowing. To exercise in the nasal area, the patient should try to take a deep breath by opening the nostrils and keep the mouth closed during this movement. It is recommended to do the exercises three times a day and each movement 5 times in Every turn should be done and exercises should be continued for 4 weeks.
Category
Rehabilitation
2
Description
Control group: exercises related to the facial nerve are taught. Regarding eye exercises, the patient is told to look down. Then gently place the index finger behind the upper eyelid and keep the eye closed. And with the fingers of the other hand, pull the eyebrow up. This exercise prevents the eyelids from tightening. After that, the patient tries to close the eyelids. press each other. Also, after this movement, the patient closes his eyes as if he were looking at the sunlight, in other words, he brings both eyelids closer to each other. To exercise in the mouth area, the patient should smile in such a way that the lips are closed and he can use his fingers to equalize the location of the corners of the mouth on both sides. After some time, the patient should perform this movement without the help of fingers and for a longer time. Gradually, the patient should raise only one side of the mouth and then repeat this movement for the other side. For the movements of the mouth and cheek area, the patient should also perform movements such as whistling and blowing. To exercise in the nasal area, the patient should try to take a deep breath by opening the nostrils and keep the mouth closed during this movement. It is recommended to do the exercises three times a day and each movement 5 times in Every turn should be done and exercises should be continued for 4 weeks.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Amin hospital
Full name of responsible person
Dr.Shila Haghighat
Street address
Sonbolestan Ave, Esfahan
City
Esfahan
Province
Isfehan
Postal code
8148653141
Phone
+98 31 3445 5051
Email
amin@mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Asgari
Street address
Medical university of Esfahan , Hezar jerib Ave
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8138
Email
askari@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Shila Haghighat
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Alzahra hospital,Sofe Ave
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3627 5139
Fax
Email
shila_haghighat@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shila Haghighat
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Alzahra hospital,Sofe Ave
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3627 5139
Fax
Email
shila_haghighat@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shila Haghighat
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Alzahra hospital,Sofe Ave
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3627 5139
Fax
Email
shila_haghighat@med.mui.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
Yes - There is a plan to make this available
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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data is potentially shareable after unidentifiable individuals
When the data will become available and for how long
2025
To whom data/document is available
Researchers working in universities and scientific centers
Under which criteria data/document could be used
no condition
From where data/document is obtainable
Shila_haghighat @mui.ac.ir
What processes are involved for a request to access data/document
Send a request email and explain the purpose of using the data.