Benign positional paroxysmal vertigo (BPPV) is one of the most common cause of peripheral vertigo and one of the presented rehabilitation treatments for patient with BPPV is maneuver therapy. All patients with vertigo that will refer to the neurology clinic in Poursina hospital and ENT clinic in Amir Al-Momenin hospital in Rasht city in the period from November in 2015 to March in 2016 and BPPV diagnose for them by a specialist using the Dix-Hallpike test will enroll in this randomized clinical trial. Samples will divide in randomized quadripartite blocks into two groups: Epley and Gans Maneuvers. Exclusion criteria: a severe systemic disease and vestibular disease and being forced to use the sedative, tranquilizer and anti-vertigo medicines and not referring again. All patients will refer after 24 h and one week to evaluate their symptoms
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201511091138N22
Registration date:2015-11-17, 1394/08/26
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-11-17, 1394/08/26
Registrant information
Name
Fataneh Bakhshi
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1223 8307
Email address
entrc@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Guilan University of Medical Science, Vice Chancellor for Resarch
Expected recruitment start date
2015-11-22, 1394/09/01
Expected recruitment end date
2016-03-20, 1395/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison The Efficacy of Gans and Epley maneuvers in treatment of patient with BPPV
Public title
The Efficacy of Gans and Epley maneuvers in treatment of patiant with BPPV
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients 18-75 years and BPPV diagnose for them by a specialist using the Dix-Hallpike test.
Exclusion criteria: a severe systemic disease and vestibular disease and being forced to use the sedative, tranquilizer and anti-vertigo medicines and not referring again
Age
From 18 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
73
Randomization (investigator's opinion)
Randomized
Randomization description
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
Guilan University of Medical Sciences
Street address
Tehran avenue
City
Rasht
Postal code
4139637459
Approval date
2015-11-09, 1394/08/18
Ethics committee reference number
IR.GUMS.REC.1394.309
Health conditions studied
1
Description of health condition studied
Benign paroxysmal vertigo
ICD-10 code
H81.1
ICD-10 code description
benign paroxysmal positional vertigo
Primary outcomes
1
Description
Improvment of dizziness
Timepoint
First 24h and 1 week after starting maneuver
Method of measurement
Physical examination
2
Description
beeing Negative Dix-Hallpike maneuver
Timepoint
First 24h and 1 week after starting maneuver
Method of measurement
Physical examination
Secondary outcomes
1
Description
Nausea
Timepoint
First 24h and 1 week after starting maneuver
Method of measurement
Observation and questions
2
Description
Vomiting
Timepoint
First 24h and 1 week after starting maneuver
Method of measurement
Observation and questions
3
Description
pain in the neck
Timepoint
First 24h and 1 week after starting maneuver
Method of measurement
questions
4
Description
back ache
Timepoint
First 24h and 1 week after starting maneuver
Method of measurement
questions
Intervention groups
1
Description
Intervention group : Gans maneuver
Category
Treatment - Other
2
Description
Control Group : Epley maneuver
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Neurology Clinic in Poursina Hospital and ENT Clinic in Amir Al-Momenin Hospital in Rasht City
Full name of responsible person
Dr Alia Saberi
Street address
Amiralmomenin Hospital, 17 Shahrivar St.
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Guilan University of Medical Science, Vice Chancellor for Resarch
Full name of responsible person
Susan Komaee
Street address
Vice-Chancellor for Research Building, Opposite of Sepah Bank,Shahid Beheshti Blvd, Rasht
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Guilan University of Medical Science, Vice Chancellor for Resarch
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
Guilan University of Medical Sciences
Full name of responsible person
Dr Alia Saberi
Position
Professor
Other areas of specialty/work
Street address
Amiralmomenin Hospital, 17 Shahrivar St
City
Rasht
Postal code
Phone
+98 13 3322 5242
Fax
Email
a_saberi@gums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Dr Alia Saberi
Position
Professor
Other areas of specialty/work
Street address
Amiralmomenin Hospital, 17 Shahrivar St
City
Rasht
Postal code
Phone
+98 13 3322 5242
Fax
Email
a_saberi@gums.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)