| 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
|
|
|
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
|
|
|
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) |