Investigating the effect of Epley therapy in patients with benign paroxysmal positional vertigo
Design
Non-blind phase 2 clinical trial. Available sampling method is used. In this way, people will be selected based on the entry criteria from among the people who refer to Matini Hospital in Kashan. Then, the samples will be assigned to two intervention and control groups by block randomization using Excel software in the form of 7 quadruple blocks, and 35 people will be placed in each group.
Settings and conduct
Non-blind phase 2 clinical trial. Available sampling method is used. In this way, people will be selected based on the entry criteria from among the people who refer to Matini Hospital in Kashan. Then, the samples will be assigned to two intervention and control groups by block randomization using Excel software in the form of 7 quadruple blocks, and 35 people will be placed in each group.
Participants/Inclusion and exclusion criteria
Inclusion criteria
1-Having informed consent to enter the study
2- Absence of other diseases involving the vestibule
3- Absence of pregnancy
Exclusion criteria
1- Lack of cooperation with the researcher
2- having systemic diseases such as diabetes, blood pressure, acute cardiovascular disease, active connective tissue disorder, chronic kidney disease and chronic liver disease
3-Patients suffering from central dizziness
4- BBPV sufferers whose type of involvement is not of the posterior canal type.
5- People suffering from psychological diseases
Intervention groups
Intervention: People who receive Epley's maneuver in addition to betahistine
No intervention: subjects receiving only betahistine
Main outcome variables
Severity of BPPV symptoms based on DHI questionnaire at the beginning of the study, on the 3rd day, 7th day and at the end of the 4th week
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240514061802N1
Registration date:2024-07-17, 1403/04/27
Registration timing:prospective
Last update:2024-07-17, 1403/04/27
Update count:0
Registration date
2024-07-17, 1403/04/27
Registrant information
Name
Nargess Mohammadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8805 5345
Email address
narsis.mo1378@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-22, 1403/06/01
Expected recruitment end date
2025-03-19, 1403/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of Epley therapy in patients with benign paroxysmal positional vertigo
Public title
the effect of Epley therapy in patients with benign paroxysmal positional vertigo
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having informed consent to enter the study
Not suffering from other diseases involving the vestibule
Absence of pregnancy
Exclusion criteria:
Patients with central vertigo
Patients with BBPV whose type of involvement is not of the posterior canal type.
People with psychological diseases
Having systemic diseases such as diabetes, hypertension, acute cardiovascular disease, active connective tissue disorder, chronic kidney disease, and chronic liver disease.
Lack of cooperation with the researcher
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
The samples will be assigned to two intervention and control groups by block randomization using Excel software in the form of 7 quadruple blocks, and 35 people will be placed in each group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kashan University of Medical Sciences
Street address
Kashan - Qutb Rawandi Boulevard - Kashan University of Medical Sciences
City
Kashan
Province
Isfehan
Postal code
8715981151
Approval date
2024-06-01, 1403/03/12
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1403.032
Health conditions studied
1
Description of health condition studied
سرگیجه ی حمله ای خوش خیم وضعیتی
ICD-10 code
HB1.1
ICD-10 code description
Beinign paroxysmal vertigo
Primary outcomes
1
Description
Severity of BPPV symptoms
Timepoint
at the beginning of the study, on the 3rd day, 7th day and the end of the 4th week
Method of measurement
DHI questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: patients receiving epley maneuvre in addition to betahistine
Category
Treatment - Drugs
2
Description
Control group: patients receiving betahistine alone
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Matini hospital
Full name of responsible person
Nargess Mohammadi
Street address
Amir kabir street,Matini hospital,kashan
City
Kashan
Province
Isfehan
Postal code
8719674591
Phone
+98 31 5534 2020
Fax
+98 31 5534 2025
Email
matinihospital@kaums.ac.ir
Web page address
https://matini.kaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Amir hosein Ahsani
Street address
Kashan, Qutb Rawandi Boulevard, Kashan University of Medical Sciences
City
Kashan
Province
Isfehan
Postal code
8719674591
Phone
+98 913 264 0295
Fax
+98 31 5534 2025
Email
amirhosein.ahsani1397@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Kashan universiry 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
Kashan University of Medical Sciences
Full name of responsible person
Nargess Mohammadi
Position
intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Kashan, Qutb Rawandi Boulevard, Kashan University of Medical Sciences
City
Kashan
Province
Isfehan
Postal code
8719674591
Phone
031-55342020-24
Fax
+98 31 5534 2025
Email
narsis.mo1378@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Amir hosein Ahsani
Position
دانشیار
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Kashan, Qutb Rawandi Boulevard, Kashan University of Medical Sciences
City
Kashan
Province
Isfehan
Postal code
8719674591
Phone
0098 31 55342020-24
Fax
+98 31 5534 2025
Email
amirhosein.ahsani1397@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Nargess Mohammadi
Position
intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Kashan, Qutb Rawandi Boulevard, Kashan University of Medical Sciences
City
kashan
Province
Isfehan
Postal code
8719674591
Phone
031-55342020-24
Fax
+98 31 5534 2025
Email
narsis.mo1378@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available