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CTRI Number  CTRI/2023/08/056503 [Registered on: 16/08/2023] Trial Registered Prospectively
Last Modified On: 11/08/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [MANUEVER]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   In patients with rotatory type of giddiness patients are treated with and without head shake along with its treatment 
Scientific Title of Study   Effect of head shaking maneuver on subjective and objective treatment outcomes in patients treated with epley maneuver for Benign Paroxysmal Positional Vertigo -Randomized control trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  GOKUL 
Designation  JUNIOR RESIDENT 
Affiliation  PIMS 
Address  512, ENT department, Opd building, PIMS road, Ganapathichettikulam, pudhucherry
512, ENT department, Opd building, PIMS road, Ganapathichettikulam, pudhucherry
Pondicherry
PONDICHERRY
604303
India 
Phone  9444438017  
Fax    
Email  gokul2210s@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr sithananda kumar 
Designation  PROFFESOR 
Affiliation  PIMS 
Address  ENT department, Opd building, PIMS road, Ganapathichettikulam, pudhucherry
ENT department, Opd building, PIMS road, Ganapathichettikulam, pudhucherry
Pondicherry
PONDICHERRY
604303
India 
Phone  8903307394  
Fax    
Email  drkumar123@gmail.com  
 
Details of Contact Person
Public Query
 
Name  GOKUL 
Designation  JUNIOR RESIDENT 
Affiliation  PIMS 
Address  512, ENT department, Opd building, PIMS road, Ganapathichettikulam, pudhucherry
512, ENT department, Opd building, PIMS road, Ganapathichettikulam, pudhucherry
Pondicherry
PONDICHERRY
604303
India 
Phone  9444438017  
Fax    
Email  gokul2210s@gmail.com  
 
Source of Monetary or Material Support  
244,ENT opd Department of ENT PIMS, PIMS road, Ganapathichettikulam, pudhucherry 
 
Primary Sponsor  
Name  PIMS 
Address  PIMS, PIMS road, Ganapathichettikulam, pudhucherry 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Gokul  PIMS  244, Department of ENT, OPD building, Kalathumettupathai, Ganapathichettikulam Village No.20, Kalapet, Puducherry 605014
Pondicherry
PONDICHERRY 
9444438017

gokul2210s@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H60-H95||Diseases of the ear and mastoid process,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  epley manuever  Start by sitting on a bed. Turn your head 45 degrees to the right. Quickly lie back, keeping your head turned. ... Turn your head 90 degrees to the left, without raising it. Turn your head and body another 90 degrees to the left, into the bed Sit up on the left side. duration:1 min 
Intervention  head shake manuever  The patients head was brought to a 30° flexion position and eyes were left open. Then the maneuver was applied by the examiner by turning the patients head horizontally at approximately 45° with a frequency of approximately 2–3 Hz duration:10sec 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1)Patients with BPPV
2)Age above 18yrs and below 60 years
 
 
ExclusionCriteria 
Details  1)Patients on vestibular sedatives in last 72 hours
2)Patients with central causes and other peripheral causes of giddiness
3)Pregnant women and mentally challenged persons
4)Orthostatic Hypotension
5)Alcoholic withdrawal Syndrome
6)Middle ear pathology
7)Uncontrolled Diabetic mellitus
8)Uncontrolled Hypertension
9)Severe Cervical spondylosis

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To measure the effect of head shaking maneuver on subjective treatment outcomes (measured by dizziness handicap inventory, Berg balance scale) among the patients with Benign Paroxysmal Positional Vertigo undergoing treatment with epley maneuver.  7-10 days 
 
Secondary Outcome  
Outcome  TimePoints 
To measure the effect of head shaking maneuver on objective treatment outcome (measured by Vestibular evoked myogenic potential) among the patients with Benign Paroxysmal Positional Vertigo undergoing treatment with epley maneuver  3 to 5 days 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   22/08/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Benign paroxysmal positional vertigo (BPPV), which was first identified by Barany, is the most common peripheral vestibular pathologic condition. BPPV is defined as an abnormal sensation of movement, usually evoked by sudden head movements.The specific cause of BPPV is still unknown, however it may be associated with various disorders of the inner ear or head trauma(1)

Otoliths called autoconial debris that pass from the utricular macula to the semicircular canal are responsible for the pathogenesis of BPPV. This can happen in two different ways: canalolithiasis and cupulolithiasis. Canalolithiasis occurs when otoliths enter the canal from the non-bulbous end and move freely in the canal. Cupulolithiasis occurs by the adhesion of otoliths in the cupule of the crista ampullaris. The most commonly involved canal is the posterior semicircular canal and the form of posterior canal canalolithiasis is mostly observed. Epley maneuver is done in posterior canal Benign paroxysmal positional vertigo to reposition these otolith into original position

The diagnosis of BPPV is performed by using the Dix---Hallpike Maneuver The success rate of Epley Manuever is ranged between 75%---89%Epley maneuver In patients with posterior canal canalolithiasis may increase the success of Epley Maneuver. In this study, the results of Berg Balance Scale (BBS) and Dizziness Handicap Index (DHI) and VEMP are evaluated in patients who underwent head-shaking maneuver before Epley Maneuver and who underwent Epley Maneuver without head-shaking maneuver before treatment and at the 1st week after treatment.(1)

 
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