| 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
|
|
|
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
|
|
|
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. |