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CTRI Number  CTRI/2021/10/037360 [Registered on: 18/10/2021] Trial Registered Prospectively
Last Modified On: 15/10/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Maneuvers ]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A trial to compare efficacy of Epleys maneuver alone and Epleys maneuver with Brandt-Daroff exercises in treatment of posterior canal benign paroxysmal positional vertigo using videonystagmography  
Scientific Title of Study   Videonystagmographic analysis of efficacy of Epleys maneuver alone and Epleys maneuver with Brandt-Daroff exercises in treatment of posterior canal benign paroxysmal positional vertigo  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  SharanyaM 
Designation  Post graduate  
Affiliation  SRM Medical College Hospital and Research Centre  
Address  Department of ENT, SRM Medical College Hospital and Research Centre, SRM University, Kattankulathur, Kancheepuram district

Kancheepuram
TAMIL NADU
603203
India 
Phone  9976756694  
Fax    
Email  sharu.murali94@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  RaviK 
Designation  Professor  
Affiliation  SRM Medical College Hospital and Research Centre  
Address  Department of ENT, SRM Medical College Hospital and Research Centre, SRM University, Kattankulathur, Kancheepuram district

Kancheepuram
TAMIL NADU
603203
India 
Phone  9840209784  
Fax    
Email  ravientch2@gmail.com  
 
Details of Contact Person
Public Query
 
Name  RaviK 
Designation  Professor  
Affiliation  SRM Medical College Hospital and Research Centre  
Address  Department of ENT, SRM Medical College Hospital and Research Centre, SRM University, Kattankulathur, Kancheepuram district

Kancheepuram
TAMIL NADU
603203
India 
Phone  9840209784  
Fax    
Email  ravientch2@gmail.com  
 
Source of Monetary or Material Support  
SRM Medical College Hospital and Research Centre  
 
Primary Sponsor  
Name  SRM Medical College Hospital  
Address  Department of ENT, SRM Medical College Hospital and Research Centre, SRM University, Kattankulathur, Kancheepuram- 603203 
Type of Sponsor  Research institution and hospital 
 
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 
Sharanya M  SRM Medical College Hospital and Research Centre  Department of ENT Head and Neck Surgery
Kancheepuram
TAMIL NADU 
9976756694

sharu.murali94@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H829||Vertiginous syndromes in diseasesclassified elsewhere, unspecified ear,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Epleys maneuver   Patient is first moved from sitting into the Dix Hallpike position toward the side of the affected ear and remains in that position for 30 seconds or till the nystagmus stops. The patient’s head is then rotated slowly through moderate extension of the neck toward the unaffected side . The patient stays in this position for 30 seconds or till the nystagmus stops. The patient is then rolled to a side lying position with the head turned 45 degrees downwards towards the floor and the position is maintained for 30 seconds. Finally , keeping the head deviated toward the unaffected side and pitched down, the patient slowly sits up 
Comparator Agent  Epleys maneuver with Brandt-Daroff exercises  Epleys maneuver : Patient is first moved from sitting into the Dix Hallpike position toward the side of the affected ear and remains in that position for 30 seconds or till the nystagmus stops. The patient’s head is then rotated slowly through moderate extension of the neck toward the unaffected side . The patient stays in this position for 30 seconds or till the nystagmus stops. The patient is then rolled to a side lying position with the head turned 45 degrees downwards towards the floor and the position is maintained for 30 seconds. Finally , keeping the head deviated toward the unaffected side and pitched down, the patient slowly sits up. Brandt Daroff exercises: Followed by the patient at home, after the doctor performs the Epleys manruver. In this, The patient first sits over the edge of the table and turns his head 45 degrees towards the unaffected side and is then moved rapidly into the affected side lying and stays in the position for 30 seconds. The patient then returns to the sitting position, maintains the upright position for 30 seconds. The patient then repeats it on the opposite side. This entire maneuver has to be repeated 5 times, twice a day at home by the patient.  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1)Both sexes
2)Age group from 20 60 years
3)Posterior canal BPPV in Dix Hallpike maneuver 
 
ExclusionCriteria 
Details  1)Age below 18 and above 60 years
2)Patient refusal to participate
3)Anterior semicircular canal BPPV / Lateral semicircular canal BPPV/Multiple canal
involvement
4)Previous h/o BPPV/Past or present diagnosis of Meniere’s disease, labyrinthitis ,
vestibular neuronitis
5)Neurological or psychiatric disease
6)Patients with cervical spine disorders
7)Use of labyrinthine suppressants within 1 week at the time of evaluation 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Subjective resolution of symptomatic vertigo on postural changes and decrease in UCLA questionnaire score   1 week 
 
Secondary Outcome  
Outcome  TimePoints 
Absence of nystagmus on Dix Hallpike maneuver and videonystagmography   1 month  
 
Target Sample Size   Total Sample Size="94"
Sample Size from India="94" 
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   N/A 
Date of First Enrollment (India)   20/10/2021 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not yet published 
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 ) is the most common cause of peripheral vertigo. It is a peripheral vestibular disorder which involves any of the three semicircular canals , most commonly the posterior canal in 60 to 90 % cases and the most common cause being idiopathic. The presenting symptom of BPPV is classically a short duration vertigo, triggered by movements of the head in relation to gravity, often lying down or turning over in bed, tilting the head back or bending forward. 
This study aims at comparing the efficacy of Epley’s maneuver alone and Epley’s maneuver with Brandt-Daroff exercises in treating posterior canal benign paroxysmal positional vertigo. All patients with complaints of vertigo will undergo detailed history and clinical examination, and those diagnosed as posterior canal BPPV on Dix Hallpike maneuver will be included in the study, their symptoms scored using the UCLA dizziness questionnaire and the nystagmus assessed using videonystagmography, after obtaining their consent. The patients will be randomised into two groups. Group A will receive Epley’s maneuver while B will receive Epley’s maneuver followed by Brandt-Daroff exercises. 
The patients will be followed up weekly for 2 weeks and after a month. The treatment efficacy will be assessed by subjective resolution of symptomatic vertigo, a decrease in the UCLA score, and absence of nystagmus on Dix Hallpike maneuver and videonystagmography, thereby finding out which group has less recurrence. 
 
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