ANNEXURE II
SYNOPSIS FOR REGISTRATION OF SUBJECT FOR DISSERTATION
1. / Name of candidate and Address / Dr. K Satish Kumar
Post Graduate
Department of ENT
A.J. Institute Medical Sciences, Mangalore
2. / Name of the Institution / A.J. Institute Medical Sciences, Mangalore
3. / Course of Study and Subject / MS in ENT
4. / Date of Admission / 27th MAY 2010
5. / Title of Topic / Contribution of sinus disease in patients with chronic headache : A prospective study.
6. / Brief Resume of the intended Work
6.1 Need For the Study / Headache is a common symptom. The life time prevalence of headache is 90% (1). Chronic headache presents considerable challenge to the ENT consultant with respect to correct diagnosis and appropriate management. The contribution of chronic sinusitis as a cause of chronic headache is controversial. Patients with chronic headache are often misdiagnosed or over-diagnosed as sinus headache and receive unnecessary sinusitis treatment and sinus graphy. Correct diagnosis of chronic sinusitis as a cause for chronic headache is the key to effective management andsymptom relief.
6.2. Review of
literature / A case control study was done at Dr. Sami Ulus Children’s Hospital, Ankara, Turkey between February 2001 and February 2004. The study included 214 patients with
complete data. 116 (54.2%) have been diagnosed as sinusitispreviously and 25% of them had at least one additional complaint, while 75% of them had none. Sinusitis treatment had no effect on headache in 60.3% of patients. Sinus graphy had been performed in 52.8% and 50.4% of them were normal. The prevalence of sinus headache concomitant with primary headache, and only sinus headache was detected in 7 and 1%, respectively. Approximately 40% of the patients with migraine and 60% of the patients with tension type headache had been misdiagnosed as sinus headache and treated accordingly (2).
A prevalence study was done by Curtis P. Schreiber, Susan Hutchison, Christopher J. Webster, Michael Ames, Mary S. Richardson in 2004. This study was conducted to determine the prevalence of migraine type headache in patients with a history of self described or physician diagnosed sinus headache. A total of 2991 patients were screened. 88% of the patients with a history of self described or physician-diagnosed “sinus” headache were determined to have migraine type headache. Patients experienced sinus pain, sinus pressure and nasal symptoms as features of migraine. Patients were significantly impacted by their “sinus” headache and they were dissatisfied with their prestudy headache medications, none of which was a migraine therapy. The results indicate that the presence of nasal or ocular symptoms often considered to be features of “sinus” headache should not automatically trigger a sinus diagnosis or exclude a diagnosis of migraine but should prompt assessment of the patient for migraine as well as sinus headache (3).
A clinical study of 200 patients complaining of headache reporting either in ENT- OPD or admitted in ENT wards of J N Medical college, AMU, Aligarh was undertaken from Jan1994 to Oct 1996. This study found that the prevalence of headache due to sinus disease was 23%, headache due to migraine and other non sinus causes was 69%, psychogenic headache was 8%. Headaches can be of sinugenic origin even if this cause may not be suspected from the case history. Recurrences are common in patient of headaches of multiple etiology, and more if not treated specifically (4).
A study was conducted at Akershus University hospital, Norway in 2008 in which 30000 persons were studied for association chronic headache and chronic rhinosinusitis. The criteria of American Academy of Otolaryngology-Head and Neck Surgery were applied to diagnose headache attributed to chronic rhinosinusitis(HARCS). Compared to general population, persons with chronic rhinosinusitis have an atleast nine fold increased risk of having chronic headache. A 3 year follow up showed that HARCS symptoms were significantly improved after treatment with nasal surgery nasal corticosteroids, discontinuation of overused headache medications and nasal decongestants (5).
6.3 Objective of the study / This study is designed to evaluate patients with chronic headache for presence of chronic sinusitis and to assess the contribution of chronic sinusitis to chronic headache.
7 / Materials and Methods
7.1 Source of Data / Patients presenting to Out Patient Department of AJ Institute of Medical Sciences, Mangalore.
Inclusion Criteria
1. Patients presenting with chronic headache to Out
Patient Department of AJ Institute of Medical
Sciences between January 2011 to December 2011
2. Patients with history of headache for atleast 12
weeks.
3. Study includes patients in the age group of 15 - 55
years.
Exclusion Criteria
1. Patients with severe headache suggestive
of intracranial disease.
7.2 Method of Collection of data and sample / Data Collection
Detailed history will be taken about duration, frequency and site of headache, diurnal variation, aggravating/relieving factors and associated symptoms viz. nausea/vomiting, photophobia, facial pain, facial congestion/fullness, nasal obstruction/blockage, nasal discharge, post nasal discharge, hyposmia/anosmia, halitosis, fatigue, dental pain, cough and ear pain/fullness and disturbances of vision.
Detailed ENT examination will be done.
Plain X ray PNS will be taken for radiological evidence of chronic sinusitis viz. sinus haziness, fluid level, mucosal thickening and polyps.
Diagnostic nasal endoscopy will be done and ostiomeatal complex evaluated for mucosal hypertrophy, inflammation, erythema, pathologic secretions and anatomic or mucosal abnormalities that can contribute to development of chronic rhinosinusitis.
Data will be analyzed and percentage will be calculated.
PROTOCOL – FLOW CHART
Patients with headache of atleast 12 weeks duration(Age group 15-55 years).
Detailed history taking
Detailed otorhinolaryngological examination
Plain X ray Paranasal sinuses
Diagnostic nasal endoscopy
Diagnosis No evidence of chronic rhinosinusitis
Chronic rhinosinusitis
American Academy of Otolaryngology- Head and Neck Surgery criteria will be used for diagnosis of chronic rhinosinusitis(6).
The baseline data will be represented by tables and diagrams where necessary.
Data will be analyzed and percentage will be calculated.
7.3 Does the study require any investigations or interventions to be conducted on patient or other human or animals? If so, please describe briefly. / Yes, detail given in 7.27.4 Has the ethical clearance obtained for your investigation. / Clearance obtained
8. / List of References / 1. Robert Kaniecki . Headcahe Assessment and Management. JAMA 2003; 289:11
2. Nesrin Senbil, Y. K. Yavuz Gurer, Cigdem Uner, Yasar Barut. Sinusitis in children and adolescents with chronic or recurrent headache: a case-control study. J Headache Pain 2008; 9:33-36
3. Curtis P. Schreiber, Susan Hutchison, Christopher J. Webster, Michael Ames, Mary S. Richardson. Prevalence of migraine in patients with a history of self-reported or physician diagnosed “sinus” headache. Arch Intern Med. 2004;164:1769-1772
4. Pramod Kumar, Praveen Chawla. A Correlative Study of Sinusitis Versus Headache Indian Journal of Otolaryngology and Head and Neck Surgery 2000;52:2
5. K Aaseth, RB Grande, K Kvaerner, C Lundqvist, MB Russell. Chronic rhinosinusitis gives a ninefold increased risk of chronic headache.The Akershus study of chronic headache 2010;30:152-160
6. Roger K Cady, David W Dodick, Howard L. Levine, Curtis P. Schreiber, Eric J. Eross, Michael Setzen et al. Sinus Headache: A Neurology, Otolaryngology, Allergy, and Primary Care Consensus on Diagnosis and Treatment. Mayo Clin Proc. 2005;80:908-916
7. Scott-Brown’s Otorhinolaryngology Head and Neck Surgery:7th Edition:Vol 2;1349
8. Scott-Brown’s Otorhinolaryngology Head and Neck Surgery:7th Edition:Vol 2;1440
9. / Signature of Candidate:
10 / Remarks of the Guide / A feasible work which can be completed in time.
11. / 11.1 Name and designation of
Guide / Dr. Devan P. P.
Professor & HOD of ENT
A.J. Institute of Medical Science Mangalore.
11.2 Signature
11.3 Co –Guide (if any) / No
11.4 Signature / -
11.5 Head of the department : / Dr. Devan P. P.
Professor & HOD of ENT
A.J. Institute of Medical Sciences Mangalore
11.6 Signature
12 / 12.1 Remarks of the Chairman and Principal
Signature
BUDGET ANALYSIS
TITLE : Contribution of sinus disease in patients with chronic headache : A prospective study.
PRINCIPAL INVESTIGATOR: - Dr. K Satish Kumar,Post Graduate ENT, A.J. Institute of Medical Sciences, Mangalore
DETAILED BUDGET FOR THE WHOLE PROJECT:-
SL NO. / PARTICULAR / TOTAL COST Rs.1. / Personal / 1000.00
2. / Investigation / 2000.00
3. / Printing & Copying supplies / 5000.00
4. / Miscellaneous / 1000.00
Total / 9000.00
TIMELINE
TITLE:Contribution of sinus disease in patients with chronic headache : A prospective study.
Phase / Time Period / Activity1. / June - 2010 to
December – 2010 / 1. Identification of the problem
2. Review of literature
3. Preparing of proforma
4. Pilot Study
5. Preparation and submission of synopsis
2. / January 2011
To
December 2011 / Collection of Data
3. / January 2012
To
November 2012 / Analysis and Discussion of collected data
Publication
From,
Dr. K Satish Kumar,
Post Graduate in Department of ENT
A.J. Institute of Medical Sciences
Mangalore
To,
The Registrar (Evaluation)
Rajiv Gandhi University of Health Sciences
Bangalore, Karnataka
(Through Proper Channel)
Sub:-Submission of Synopsis of Dissertation
Respected Sir,
Herewith, I am submitting synopsis of my dissertation work “Contribution of sinus disease in patients with chronic headache : A prospective study ” for registration in M.S. (ENT) of A.J. Institute of Medical Sciences, Mangalore.
Kindly accept the same and oblige.
Thanking you
Yours faithfully
Place : Mangalore
Date : 12/11/2010 (Dr. K Satish Kumar)
Head of the Department
Dr. Devan P.P.
Prof. and Head, Department of ENT
A.J. Institute of Medial Sciences
DEAN
A. J. Institute of Medical Sciences, Mangalore
A. J. INSTITUTE OF MEDICAL SCIENCES, MANGALORE
Title : “Contribution of sinus disease in patients with chronic headache : A
prospective study”
PROFORMA FOR DATA COLLECTION
A.Personal Details
1.Name :
2.Age:
3.Sex:
4. Occupation :
4. Father’s name :
5.I.P. No.:
9.Date of collection of data :
10.Address:
14.Family Income :
B. Questionnaire for history taking
1.Duration of headache :
2.Frequency of headache :
3.Site of headache:
4.Diurnal variation in headache:
5.Aggravating factors :
6.Relieving factors:
Associated symptoms
7. Nausea /vomiting:
8. Photophobia :
9. Facial pain:
10. Facial congestion/fullness:
11. Nasal obstruction/blockage:
12. Nasal discharge (purulent/mucoid):
13. Post nasal discharge:
14. Hyposmia/anosmia:
15 Halitosis :
16. Fatigue :
17. Dental pain:
18. Cough :
19. Ear pain/ fullness :
20. Disturbances of vision :
C. EXAMINATION OF EAR, NOSE AND THROAT :
Ear
Preauricular region
Pinna
Post auricular region
External Auditary Canal
Otoscopy
Nose
External nose
Vestibule
Anterior rhinoscopy
Nasal cavity
Posterior rhinoscopy
PNS tenderness
Throat
Anterior pillar
Posterior pillar
Tonsils
Posterior pharyngeal wall
E. Systemic Examinations: -
CVS
RS
PA
F. Investigations:
1. Plain X ray Paranasal sinuses:
Sinus haziness:
Fluid level:
Mucosal thickening:
Polyps:
2. Diagnostic nasal endoscopy:
Ostiomeatal complex Right Left
a. Mucosal hypertrophy
b. Inflammation
c. Erythema
d. Pathologic secretion
e. Anatomic or Mucosal
abnormalities
G.DIAGNOSIS
Chronic rhinosinusitis
No evidence of chronic rhinosinusitis
INFORMED CONSENT FORM
TITLE OF RESEARCH
Contribution of sinus disease in patients with chronic headache : A prospective study.
INVESTIGATORS: DR. DEVAN P.P, DR. K SATISH KUMAR
INTRODUCTION:-
You are being invited to participate in research project designed to identify sinus disease in patients with chronic headache. Correct diagnosis of chronic headache as sinus headache will lead to appropriate management. Detailed history taking, clinical examination, plain X ray PNS and diagnostic nasal endoscopy will be used to establish the presence of chronic rhinosinusitis. You have been selected for this study because you meet the inclusion criteria of the study.
EXPLANATION OF PROCEDURES:-
In this project, if you are selected, detailed history taking and clinical examination will be done. Plain X ray PNS and diagnostic nasal endoscopy will be performed.
POSSIBLE BENEFITS:
The investigators do not promise or guarantee that you will receive direct benefit from being in the study. There also may be benefits involved that are not known to the researchers at this time.
POSSIBLE RISKS:-
There are no known physical risks for the child or person associated with these methods.
ALTERNATIVES:-
If you don’t want to participate in the study you will receive the usual care given in the hospital.
CONFIDENTIALITY:-
The result of the study may be published for scientific purpose, however your identification will not be revealed.
WITHDRAWAL:-
Participation in the study is voluntary, if you do not wish to participate in the study you will not lose benefits to which you are entitled. You are free to withdraw your consent and discontinue your participation in this project at any time.
SIGNIFICANT NEW FINDINGS
Any significant new findings discovered during the course of the study, which may influence your decisions to continue participations, will be made known to you.
COSTS OF PARTICIPATIONS
The cost of the study will be covered by the investigators or by a research grant, there will be no additional cost to you for participating in this study.
PAYMENT FOR PARTICIPATION.
There will be no payment to you for participating in this study
Payment of Research Related Injuries:
If, as a result of your participation, you experience injuries from known or unknown risk of the research procedures as described, immediate care and treatment, including hospitalization if necessary, will be available. Neither investigator nor A.J. Institute of Medical Science has made provision for monetary compensation in the event of injury resulting from the research and in the event of such injury, treatment is provided, at free of charges.
QUESTIONS:
If you have any questions about this study, questions about a research related injury or experience, any problems during the study, you should contact Dr. K Satish Kumar at 9611978802 and Dr. Devan P.P. at 9243301213. if you have questions about your rights as a research participant, you may contact Research Ethics Committee, AJIMS, Mangalore.
LEGAL RIGHTS
By signing this consent form, you are not waiving any of your legal rights.
CONSENT STATEMENT
My signature below indicates that I have decided to participate in the study and that I have read (or been read) the information provided above and that I was given the opportunity to ask questions and that they have answered to my satisfaction and that I have received a copy of this signed consent form.
______
Signature or Thumb impression of patientDate
______
Signature of Person Obtaining consent Date
If other than the Principal Investigator
______
Signature of Principal Investigator Date
______
Signature of Witness Date