| CTRI Number |
CTRI/2021/09/036817 [Registered on: 24/09/2021] Trial Registered Prospectively |
| Last Modified On: |
23/09/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To Study Whether Pain at a point behind and below The Ear Indicates Eustachian Tube Blockade |
|
Scientific Title of Study
|
A Clinical Study To Evaluate The Diagnostic Value Of Infratemporal Fossa Pain In Obstructive Eustachian Tube Dysfunction |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vikram Bhat |
| Designation |
Professor and Unit Chief |
| Affiliation |
Karnataka Institute of Medical Sciences, Hubli |
| Address |
Department of ENT
KIMS Hubli
Dharwad
Karnataka
Dharwad
KARNATAKA
580031
India |
| Phone |
7899610213 |
| Fax |
|
| Email |
vikram.ent@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vikram Bhat |
| Designation |
Professor and Unit Chief |
| Affiliation |
Karnataka Institute of Medical Sciences, Hubli |
| Address |
Department of ENT
KIMS Hubli
Dharwad
Karnataka
Dharwad
KARNATAKA
580031
India |
| Phone |
7899610213 |
| Fax |
|
| Email |
vikram.ent@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ankitha M |
| Designation |
ENT postgraduate student |
| Affiliation |
Karnataka Institute of Medical Sciences, Hubli |
| Address |
Department of ENT
KIMS Hubli
Dharwad
Karnataka
Dharwad
KARNATAKA
580031
India |
| Phone |
9632345083 |
| Fax |
|
| Email |
ankithamk@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Karnataka Institute of Medical Sciences Hubli |
|
|
Primary Sponsor
|
| Name |
Karnataka Institute of Medical Sciences |
| Address |
P B Road, Vidyanagar,Hubli 580021
Dharwad
Karnataka |
| Type of Sponsor |
Government 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 Vikram Bhat |
KIMS Hubli |
Department of ENT, OPD No-60,Karnataka Institute of Medical Sciences, Vidyanagar, Hubli-580031
Dharwad
KARNATAKA |
7899610213
vikram.ent@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KIMS Hubli |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H681||Obstruction of Eustachian tube, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients complaining of pain in deep ear canal, temporomandibular joint or infratemporal region.
2)Controls- Patients of same age group complaining of nose or throat symptoms without Eustachian Tube Dysfunction confirmed by barotubometry. |
|
| ExclusionCriteria |
| Details |
1)Diabetic or hypertensive patients.
2)Immunocompromised or HIV patients.
3)Tubercular lymphadenitis.
4)Malignancy of head and neck.
5)Otitis externa.
6)Mastoiditis and other complications of chronic otitis media.
7)Parotitis.
8)Any other cause of referred ear pain.
9)Cleft palate cases.
10)Elongated styloid cases. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)Diagnostic value of Infratemporal fossa pain in obstructive Eustachian tube dysfunction.
2)Correlation of ear pain(Visual analog scale) and obstructive Eustachian tube dysfunction score. |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Association of diagnostic endoscopy findings of nasopharynx and pain around the ear. |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
25/09/2021 |
| 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 applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Many patients who complain of pain below and behind the ear have been found to have Eustachian Tube Dysfunction which goes undiagnosed and untreated.Apart from causing pain, Eustachian Tube Dysfunction can lead to middle ear retraction pockets and cholesteatoma in the long run.This study tries to find out an easier method to diagnose Eustachian Tube Dysfunction. |